Final Full Thesis - Removed

FORMULATION AND IN-VITRO EVALUATION OF HERBAL
LOZENGES USING ZINGIBER OFFICINALE AND

TERMINALIA CHEBULA
Submitted
In partial fulfilment of regulations for the award of the degree of
Bachelor of Pharmacy
MAJJI PURNIMA 20T51R0060
MAKKA KEERTHANA 20T51R0061
MASA SAMUEL RAJ 20T51R0062
METTA GAYATHRI 20T51R0063
MODALAVALASA SRAVANI 20T51R0064
Under the guidance of
Mr. A NANAJI, M Pharm
Associate Professor
AVANTHI INSTITUTE OF PHARMACEUTICAL SCIENCES

CHERUKUPALLY, CHITTIVALASA, BHOGAPURAM
VIZIANAGARAM- 531162
2023-2024
(Approved by AICTE, PCI, Recognized by the Govt. of A.P. & Affiliated to JNTU-GV, Vizianagaram)
Cherukupally (Village), Chittivalasa (SO), Bhogapuram (Mandal), Vizianagaram (Dist) -531162.
www.avanthipharma.ac.in, [email protected]
CERTIFICATE BY THE PRINCIPAL
This is to certify that the thesis entitled “FORMULATION AND IN-VITRO EVALUATION
OF HERBAL LOZENGES USING ZINGIBER OFFICINALE AND TERMINALIA
CHEBULA” done for the partial fulfilment for the award of degree of Bachelor of pharmacy,
was carried out by MAJJI PURNIMA (20T51R0060), MAKKA KEERTHANA
(20T51R0061), MASA SAMUEL RAJ (20T51R0062), METTA GAYATHRI
(20T51R0063), MODALAVALASA SRAVANI (20T51R0064) under the supervision of
Mr. A Nanaji, Associate Professor and guidance at Avanthi Institute of Pharmaceutical
sciences, during the year 2023-24. It is further certified that the work is original and has not
been submitted in part or full for any diploma or degree of this or any other university and
institute.
Principal
Place: Cherukupally
Date:
CERTIFICATE BY GUIDE
I Mr. A Nanaji, Associate Professor of Avanthi Institute of Pharmaceutical sciences,
Cherukupally-531162 certify that the project work on “FORMULATION AND IN-VITRO
EVALUATION OF HERBAL LOZENGES USING ZINGIBER OFFICINALE AND
TERMINALIA CHEBULA ” by MAJJI PURNIMA (20T51R0060), MAKKA KEERTHANA
(20T51R0061), MASA SAMUEL RAJ (20T51R0062), METTA GAYATHRI (20T51R0063),
MODALAVALASA SRAVANI (20T51R0064) of Ⅳ B. Pharmacy students of 2020-2024 is a
bonafide work done under the guidance of mine and it is submitted to Jawaharlal Nehru
Technological University-GV, Vizianagaram, 531162 to meet academic regulations of 2020-2024
batch for the award of Bachelor of degree in Pharmacy.
Guided by
Mr. A Nanaji,
Associate Professor,
Place: Cherukupally
Date:
CERTIFICATE BY THE EXAMINER
This is to certify that the thesis entitled “FORMULATION AND IN-VITRO

EVALUATION OF HERBAL LOZENGES USING ZINGIBER
OFFICINALE AND TERMINALIA CHEBULA” done for the partial
fulfillment for the award of degree of Bachelor of Pharmacy has been carried
out by Majji Purnima, Makka Keerthana, Masa Samuel Raj, Metta Gayathri,
Modalavalasa Sravani, under the supervision and guidance of Mr. A Nanaji
M.pharm and Dr. M. B.V. Raju garu M. pharm, (Ph.D) at Avanthi
Institute of Pharmaceutical sciences during the year 2023-2024. It is further
certified that this work or any part of this has not been previously formed the
basis for the award on degree, diploma, fellowship of this or any other
university or institute.
External Examiner
Place: Cherukupally
Date:
DECLARATION
The work embodied in this project entitled “FORMULATION AND IN-
VITRO EVALUATION OF HERBAL LOZENGES USING ZINGIBER OFFICINALE
AND TERMINALIA CHEBULA” was carried out by MAJJI PURNIMA (20T51R0060),
MAKKA KEERTHANA (20T51R0061), MASA SAMUEL RAJ (20T51R0062), METTA
GAYATHRI (20T51R0063), MODALAVALASA SRAVANI (20T51R0064) at Avanthi
Institute of Pharmaceutical sciences, Cherukupally, Vizianagaram district, Andhra Pradesh,
under the supervision of Mr. A Nanaji, M Pharm, Associate Professor of Avanthi Institute
of Pharmaceutical sciences. The extent and source of information derived from the existing
literature have been indicated throughout the thesis at Avanthi Institute of Pharmaceutical
Sciences. The work is original and has not been submitted in part or full for any diploma or
degree of this or any other university and institute.
Majji Purnima
Makka Keerthana
Masa Samuel Raj
Metta Gayathri
Modalavalasa Sravani
ACKNOWLEDGEMENT
We take opportunity to acknowledge all the people who helped me to successfully
complete my project work.
We extend our profound sense of gratitude to Sri M. SRINIVASA RAO, Chairman,
Avanthi Institute of Pharmaceutical Sciences for providing us the basement to develop our
skills by providing all the facilities which helped us to overcome all the hurdles during the
course of completion of the project work.
We sincerely thank Prof. M B VENKATAPATHI RAJU (M Pharm, Ph.D) Principal,
Avanthi Institute of Pharmaceutical Sciences for his timely being and support.
We express our sincere acknowledgement and thank to our project guide Assoc. Prof.
Mr, A Nanaji (M Pharm), Department of pharmaceutics, Avanthi Instititue of pharmaceutical
sciences for his constant support and encouragement and we sincerely thank his for being with
us during the hard times and helping us to bring the project work into a good shape. We thank
sir for his patience and ignoring our ignorance and giving us the light of knowledge to develop
ourself in the field of pharmacy.
We express our sincere thanks to Mrs. Sravani Boyapati madam for giving us thought
provoking suggestions and helping us to explore different fields which helped us for successful
completion of the project.
We are grateful to all the faculty members for giving us thought provoking suggestions
and helping us to explore different fields which helped us for successful completion of the
project. We also thank all the non teaching staff for their timely assistance.
Last but the least we want thank our beloved parents, relatives and all our friends for
giving us courage and strength to complete the project within the time and helped us to fly out
in different colors.
M. PURNIMA (20T51R0060)
M. KEERTHANA (20T51R0061)
M. SAMUEL RAJ (20T51R0062)
M. GAYATHRI (20T51R0063)
M. SRAVANI (20T51R0064)
DEDICATED TO OUR
BELOVED PARENTS
AND GOD
LIST OF ABBREVIATIONS
API Active Pharmaceutical Ingredients

PEG Polyethylene glycol
FT-IR Fourier Transform Infra- Red
Non-steroidal anti-inflammatory
NSAID
drugs
High performance liquid
HPLC chromatography
IP Indian Pharmacopoeia
Eur European Pharmacopoeia
NF National formulary
BP British Pharmacopoeia
USP United states Pharmacopoeia
PEG Poly ethylene glycol
PG Propylene glycol
o
C Degree of Celsius
NC No Change
ICH International council for Harmonization
GMP Good manufacturing practices
FTIR Fourier transform infrared spectroscopy
HPM
Hydroxypropyl methylcellulose
C
HEC Hydroxyethyl cellulose
IR Infrared radiation
UV Ultraviolet
5-
Serotonin receptor
HT3
Ph-
European pharmacopoeia
Eur
% Percentage
CONTENTS
Chapter Title Page No
1 INTRODUCTION 1-17
2 LITERATURE REVIEW 18-29
3 AIM AND OBJECTIVES 30
4 PLANT AND EXCIPIENT PROFILE 31-39
5 MATERIALS AND METHODOLOGY 40-50
6 RESULTS AND DISCUSSION 51-6
7 SUMMARY AND CONCLUSION 64-66
8 BIBLIOGRAPHY 67-71
LIST OF TABLES
Table No Name of the table Page No
1.1 Additives Used in Lozenges Formulation 6
1.2 Marketed lozenges and their ingredient 17
5.1 Material used in the formulation 40
5.2 List of the equipments used in experient 41
5.3 Formulation of Terminalia Chebula and Zingiber 43

Officinale Lozenges
6.1 API Preliminary studies of Terminalia Chebula 50
6.2 API Preliminary studies of Zingiber Officinale 50
Physical Compatibility of Drug and Excipients 51

6.3
FTIR spectral interpretation of herbal powders and 54

6.4
excipients
Standard calibration curve of Terminalia Chebula 54

6.5
Standard calibration curve of Zingiber Officinale 55

6.6
Evaluation of Terminalia Chebula and Zingiber 56

6.7
Officinale
In-vitro drug release profile of herbal lozenges 58

6.8
The summarized data of the In vitro release kinetics 61

6.9
Evaluation parameters after the stability studies 61

6.10
LIST OF FIGURES
Table No Name of figures Page No

1.1 Chewable lozenges 4
1.2 Hard lozenges 4

1.3 Soft lozenges 5
1.4 Compressed lozenge 5
1.5 Different shapes of silicon Mould 8
1.6 Dome shaped mould 9
1.7 Square mould 9
1.8 Hexagonal mould 9
5.1 Materials used for formulation of herbal lozenges 45
5.2 Process of formulation of herbal lozenges 45
5.3 Vernier calipers 46
5.4 Monsanto hardness tester 47
5.5 USP dissolution apparatus type 2 48
6.1 Uv spectrum of terminalia chebula in phosphate 50
buffer 6.8
6.2 UV spectrum of zinger officinale in phosphate 51

buffer 6.8
6.3 UV spectrum of Terminalia Chebula 52
6.4 UV spectrum of Terminalia Chebula and selected 52
excipients in formulation
6.5 UV spectrum of Zingiber officinale 53
6.6 UV spectrum of Zingiber officinale and selected 54
excipients in formulation
6.7 Standard calibration curve of Terminalia Chebula 55
6.8 Standard calibration curve of Zingiber Officinale 56
6.9 Percentage drug content uniformity of formulated 57
medicated lozenges
6.10 In-vitro drug release profile of herbal lozenges 58
containing Terminalia Chebula
6.11 In-vitro drug release profile of herbal lozenges 59
containing Zingiber Officinalis
6.12 Zero order Kinetics for optimized formulation 60
(F4)
6.13 First order kinetics for optimized formulation(F4) 60
6.14 Comparative cumulative % drug release curve 62
for the optimized formulation (F4)
INTRODUCTION
INTRODUCTON
Then term “Lozenges” are Procure by designation “Lozenge” that indicates the
pearl like structure with four sides. Lozenges are solid dosage form, Sweetened or
flavoured medicament form which is proposed to be drew and detain in oral cavity to
cure the infection mouth or pharynx. Lozenges are alone famous and best creative not
only dosage form but also oral confectionary product. Reasons for the widely accepted
by the geriatric and pediatric patient are easy of administration, improved the drug
efficacy, By pass first pass metabolism, Not required water intake and enhanced
bioavailability by reducing the dose recurrence with less side effects. In the formulation
of lozenges the diluents and binders plays vital role. [1][2]
The word “Troches” and “Lozenges” are used inter changeable, the term troches
may be used for compressed lozenges. Lozenges are very helpful for those patients who
has problem of swallowing (Dysphagia) of solid dosage form in addition to gradual and
constant release of the drug. Lozenges are allocated due to their ability to retain or hold
on to the nasopharyngeal mucosa moist and improve the swallowing reflex and keep the
drug in contact with mucosal layer for prolong period of time. Lozenges are apply for
local effect as well as integral effect when the API go through the systemic circulation
and shows its pharmacological effect. Overall, lozenges offer a convenient and effective
means of medication administration, especially for patients with swallowing difficulties,
while also providing localized and systemic therapeutic benefits. The combination of
their unique shape, pleasant taste, and medicinal properties makes lozenges a widely
accepted and valuable pharmaceutical and confectionary product. In addition to their
pearl-like shape, lozenges are available in various other shapes, catering to different
preferences and needs. These shapes can range from round and oval to square and
rectangular, depending on the manufacturer and specific product. The composition of
lozenges typically includes a medicinal agent, which is the active ingredient responsible
for the therapeutic effect. This can be a wide range of substances, such as analgesics,
antiseptics, cough suppressants, or throat soothing agents, among others. To enhance
palatability and make them more enjoyable to consume, lozenges are formulated with
sweeteners and flavouring agents. These ingredients not only mask the taste of the
medicinal agent but also add a pleasant flavour to the lozenge. Common sweeteners used
in lozenges include sugar, artificial sweeteners, or natural sweeteners like honey or stevia.
The choice of flavourings can vary widely, encompassing fruity, minty, herbal, or other
Avanthi Institute of Pharmaceutical Sciences 1

INTRODUCTON
appealing tastes. The primary mode of administration for lozenges is through slow
dissolution in the buccal cavity (mouth). This allows for both localized effects, such as
soothing a sore throat or reducing oral discomfort, as well as systemic effects when the
active ingredients are absorbed through the oral mucosa and enter the bloodstream.
Overall, the availability of different shapes, the inclusion of medicinal agents,
sweeteners, and flavourings and the potential for both localized and systemic effects
make lozenges a versatile and widely used product for oral medication delivery and
confectionary enjoyment.[3]
Definition: Lozenges are a type of solid medication that dissolves or disintegrates

gradually in the mouth or oral cavity. They contain flavoring agents and sweetening
agents." They are most commonly used to treat localized issues in the buccal cavity, but
if they are well absorbed in the pharynx and buccal lining, they may potentially have
systemic effects.[4]
Advantages: [5,6,7]
 Facilitates the prolongation of medication exposure within the buccal cavity, thereby
enhancing a targeted therapeutic impact.
 It is convenient for administration to patients encountering dysphagia.
 Its adaptability to both geriatric and pediatric demographics renders it convenient for a
wide range of patients.
 Enables systemic drug absorption via the buccal cavity, enhancing bioavailability.
 The incorporation of sugars and flavors in the formulation allows for effective masking
of the medication's taste.
 Diminishes the necessity for frequent dosing, optimizing patient adherence.
 Enhances drug absorption, potentially leading to improved therapeutic outcomes.
 Exhibits structural integrity, avoiding dissolution in the oral cavity.
 Eliminates the need for water intake during administration.
 Streamlines production processes, resulting in reduced manufacturing time and cost.
 Offers flexibility in dosing, allowing for the withdrawal of lozenges if the prescribed dose
is no longer required.
 Avoids first pass metabolism
 Easy to prepare, with minimum amount of equipment and time.

INTRODUCTON
Disadvantages:
 Accidental swallowing of entire dosage may occur
 Mistakenly taken by children as candy.
 Certain drugs may not be compatible with aldehyde-based candy formulations, such as
Benzocaine.
 The uneven dispersion of drugs within saliva may limit the efficacy of local therapy.
 Potential drainage of medication from the buccal cavity into the gastrointestinal tract
through saliva may reduce therapeutic efficacy.
Preparation of hard candy lozenges requires exposure to high temperatures,
complicating the manufacturing process
Types of Lozenges:
They are mainly two types:
a. Lozenges with medication
b. Lozenges without medication
Lozenges Classification:
I. In accordance with the site of action:
a. Local Impact-
e.g: Decongestants, Antiseptics
b. Systemic Impact-
e.g: Nicotine, vitamins
II. In accordance to its texture and composition:
a. Chewable-
e.g: Vitamins
b. Hard-
e.g: Lollipops
c. Soft-
e.g: Bentasil
d. Compressed
e.g: Troches
A. CHEWABLE LOZENGES[8]

INTRODUCTON
Chewable lozenges are chewed rather than dissolved in the mouth because the
medications are mixed into the caramel base. Water, gelatin, and glycerin are also used
in the formulation of these lozenges. They have a strong fruit flavour and a somewhat
acidic taste that is added on purpose to cover up the harsh glycerin flavor. These particular
lozenges are intended specifically for pediatric use, enabling the acquisition of
medication intended for GIT absorption and systemic action. Chewable lozenges'
glycerin foundation is exactly the same as that of glycerin suppositories or glycerin
gelatinized suppositories. This is made up of 10% pure water, 20% gelatin,
and 70% glycerin.
Fig No. 1.1 Chewable lozenges
B. HARD LOZENGES [9, 10]

Hard lozenges contain a blend of carbhohydrates and sugar. They are often
amorphous or glassy in non-crystalline forms. Another name for them is "syrups of
sugar." Hard candy lozenges range in weight from 1.5 to 4.5 grams. Those have a
moisture content of 0.5–1.5%. Instead of disintegrating, these lozenges must dissolve
immediately; nevertheless, because their manufacturing calls for a high temperature,
heat-sensitive materials or ingredients cannot be used. By administering a medication
with topical anesthetic or antibiotic activity, hard lozenges are commonly used to relieve
discomfort and cure a variety of throat infections and sore throats.
Fig No. 1.2 Hard lozenges

INTRODUCTON
C. SOFT LOZENGES [11, 12, 13]

Soft lozenges are mainly consists of components like PEG (polyethylene glycol),
chocolate, or acacia base and are intended to deliver drugs gradually into the mouth. The
major element in these soft lozenges that gives them their smoothness and texture is
acacia, which is also present in some of the soft lozenges' base formulation. Because
PEG-based lozenges are hygroscopic and soften at high temperatures, it is best to store
them somewhere dry and cool.
Fig No. 1.3 Soft lozenges

D. COMPRESSED LOZENGES [9, 10]
It is not possible to synthesize heat-sensitive compounds, also known as heat-liable
ingredients, using the same technique as soft or hard lozenges. To put it simply, the
compression method works with these kinds of components, just like it does with
compressed tablets. Their non-disintegrating and delayed disintegration profiles are the
only dissimilarities between them. Compressed lozenges employ the granulation process.
Fig No. 1.4 Compressed lozenges

INTRODUCTON
Table No. 1.1 Additives Used in Lozenges Formulation

Additives Name Examples
Candy Base: Dextrose, Sucrose, Maltose, Lactose
Sugar Sorbitol, Mannitol, Polyethylene Glycol
Unsweetened
Vehicle
Diluent Monohydrate, Xylitol, Lactaid, Calcite,
Gypsum, Avicel
Binder Maize Syrup, Glucose syrup, Collagen ,
wattles, Astragal, Avicel.
Lubricants Octadecanoic acid, Calcium Salt, Miralax,
Triglycerides, Fats.
Whipping Agents Para Casein, Albumen, Collagen, Xanthan
gum, Amylum, Pectic polysaccharides,
Alginate
Humectant Honey, Glycerol, Hydroxyacetic Acid,
Propylene Glycol, Sorbitol and lactic acid
Seasoning Agent Lemon, Orange, Menthol, Basil, Spearmint,
Mint
colorants Water Soluble dyes, Food and drug cosmetic
colours, Titanium oxide, Orange Colour
DIFFERENT TYPES OF DRUGS FORMULATED AS LOZENGES[14, 15 ]

I. Nicotine lozenges: Nicotine lozenges are used to assist smokers in giving up the habit.
It functions as a smoking deterrent by supplying modest doses of nicotine, which may
facilitate quitting by reducing the physical signs of withdrawal.
 If a person is allergic to any of the ingredients in nicotine lozenges, they should not take
nicotine.
 A person who recently suffered a heart attack.
 A person with intense or exacerbating dysrhythmia in their heartbeat. Nicotine lozenges
may interact with certain medical conditions, such as acetaminophen, beta-blockers (like
labetalol, propranolol), adrenergic antagonists (like prazosin), insulin,
caffeine,oxazepam, pentazocine, theophylline, or tricyclic antidepressants (like

INTRODUCTON
imipramine), as stopping smoking may increase the risk of these

medications' side effects.
II. Linctagon lozenges: Eucalyptus oil and Pelargonium sidoides, the active ingredient,
are both present in linctagon lozenges. It offers comforting support for coughing as well
as relief from sore, irritated throats. Diabetes patients can use it.
III. Fungilin lozenges: Candida-like fungus are the source of infections in and around
the mouth, throat, and tongue. Fungilin lozenges are used to treat these diseases. This
illness is called thrush, or candidiasis. Thrush is most frequently caused by
Candida albicans.
IV. Flurbiprofen lozenges: Flurbiprofen is a member of the NSAID medication class.
These drugs are intended to reduce inflammation and pain. The purpose of the lozenges
is to relieve sore throat symptoms.
Flurbiprofen is a member of the NSAID medication class. These drugs are intended to
reduce inflammation and pain. The purpose of the lozenges is to relieve sore
throat symptoms.
V. Low-dose natural human interferon-alpha lozenges: Lozenges containing low-
dose natural human interferon-alpha are used to treat Behcet's syndrome. Evidence
suggested that managing recurrent mouth ulcers could benefit from low-dose local IFN.
VI. Actiq lozenges: Fentanyl, an opioid analgesic (painkiller) medication, is the active
ingredient in these lozenges. The opioids are a class of highly potent analgesics linked to
morphine. Opioid medications are prescribed as relievers to people who have severe,
chronic pain, such as cancer-related discomfort.
Even with these potent medications, there are times when the pain can get worse. We
refer to this anguish as "breakthrough" pain. Actiq lozenges are used to treat patients who
are already on opioid medicines for this "breakthrough" discomfort. The lozenges are
made out of a lozenge that is glued to the handle with edible glue. The lozenge is pushed
around the mouth with the handle after being inserted close to the cheek. It is used to
treat breakthrough pain in patients receiving regular opioid medication for chronic,
severe pain that is brought on by cancer.
VII. Zinc gluconate lozenges and Zinc acetate lozenges: Zinc is a known necessary
mineral and antioxidant that is present in every cell in the body. More than 200 enzymes
depend on it as a cofactor, making it crucial for a broader range of physiological processes

INTRODUCTON
than any other mineral. Zinc has been researched as a potential treatment for or mitigation
of cold virus symptoms.
According to the study, consuming zinc during the first few days of a cold—either as
syrup or lozenges—may reduce how long the illness lasts. For a period of approximately
five months, those who used it also seemed to be immune against colds. Thus far, the
research findings regarding the use of zinc as a cold treatment.
The usage of zinc for the common cold depends on a few key elements. One is that some
flavoring compounds and the formulation (gluconate, sulfate, and acetate) might matter;
our researchers are still figuring this out. According to a study, if zinc is taken during the
earliest stages of the cold and in doses larger than 75 mg daily, it may help shorten the
length of the symptoms. There is evidence to support a number of potential processes
through which zinc may work as a therapy. However, it is still uncertain how this
chemical works to treat the common cold. It is well known that zinc ions prevent the
common cold virus from replicating.
Also, zinc has been shown to reduce recurring skin infections caused by the herpes
simplex virus.Zinc gluconate lozenges have been demonstrated to be efficacious in
shortening the duration of common colds.
Different shapes of moulds:
Fig No 1.5 Different shapes of silicon Mould

INTRODUCTON
Fig No 1.6 Dome Shaped Mould
Fig No. 1.7 Square Mould
Fig No. 1.8 Hexagonal Mould

INTRODUCTON
Manufacturing of Lozenges
 Manufacturing of Chewy or Caramel Based Medicated Lozenges: [16]
Medicated lozenges with a chewy or caramel base :
Medications are combined with a caramel basis that is chewed rather than dissolved in
the mouth to create chewy or caramel-based medicated lozenges. The majority of
formulations follow the recipe for glycerinated gelatin suppository, which calls for
glycerin, water, and gelatin. These lozenges may taste slightly acidic to counteract the
glycerin's harsh taste, and they are frequently quite fruit-flavored. The candy foundation,
whipping agent, humectants, lubricants, flavor, and, of course, the medications mixed
into the lozenges are its constituent elements. A combination of sugar and corn syrup,
ranging from 50:50 to 75:25, makes up the candy basis. To get the right level of soft
chew, air is added to toffee-based confections using whipping agents. Milk protein, egg
albumin, gelatin, xanthan gum, starch, pectin, algin, and carageenen are examples of
these. The humectants, which include sorbitol, propylene glycol, and glycerin, enhance
chewing and mouthfeel. In order to prevent candy from sticking to teeth when being
chewed, lubricants are added. Vegetable fats and oils are part of it. Up to 35–40% of
medications may be included. In order to seed crystals and accelerate crystallization,
warm candy mass is mixed with 3–10% finely powdered sugar. This allows the base to be
formed into tablets in a much shorter time. Seeding crystals involves addition of fine
powdered sugar at 3-10% to warm candy mass to speed up the crystallization and allow
the base to be formed into tablets in a much shorter time.
Process:
Step 1: The candy base is cooked at 95-125℃ and transferred to planetary or sigma blade
mixer. Mass is allowed to cool to 120℃.
Step2: This is followed by the addition of whipping agent below 105℃. The
medicaments are then added between 95-105℃.
Step3: Color is dispersed in humectant and added to the above mass at a temperature
above 90℃
Step4: Seeding crystals and flavour are then added below 85℃ followed by lubricant
addition above
Step5: Candies are then formed by rope forming.

INTRODUCTON
 Manufacturing of Compressed Tablet Lozenges: [17]

Compressed Tablet Lozenges:
If the active ingredient is heat labile, it may be made into lozenge by compression. The
granulation is prepared in a manner similar to that used for any compressed tablet. The
lozenge tablets differ from conventional tablets in terms of organolepticity, non-
disintegrating characteristics and slower dissolution profiles [2] [6].
The lozenge is made using heavy compression equipment to give a tablet that is harder
than usual, as it is desirable for the troche to dissolve slowly in mouth. They are usually
flat faced with sizes, weight, hardness, and erosion time ranging between, 5/8-3/4 inch,
1.5-4 g, 30-50 kg inch2 and 5-10 min, respectively. The ingredients for compressed tablet
lozenges are tablet based or vehicles which are sugar such as dextrose, sucrose. Other
vehicles are sugar free vehicles such as mannitol, sorbitol, polyethylene glycol (PEG)
6000 and 8000. Some commercially available sugar based vehicles include- Emdex, Nu-
tab, Sweetrex, Mola-tab, Hony-tab, Sugartab. Other fillers include dicalcium phosphate,
calcium sulphate, calcium carbonate, lactose and microcrystalline cellulose. Binders are
also included to hold the particles of mass as discrete granules and include acacia, corn
syrup, sugar syrup, gelatin, polyvinyl-pyrrolidone, tragacanth and methylcellulose.
Lubricants are used to improve flow of final troche mixture and include magnesium
stearate, calcium stearate, stearic acid and PEG. The colours used include water soluble
and lakolene dyes.
Process:
Step1: Wet granulation or direct compression can be used in the production of
compressed tablet lozenges.
Step2: Ingredients are completely blended and then compressed in a direct compression
process.
Step3: Wet granulation involves mechanically pulverizing the sugar content into a fine
powder(40–80 mesh size). The medication is added and well mixed.
Step4: The combined material is sieved through a 2–8 mesh screen after being granulated
with sugar or corn syrup.
Step5: Drying and milling to a mesh size of 10–30 come next. After that, flavor and
lubrication are added before compression.

INTRODUCTON
 Manufacturing of Soft Lozenges:[18]

Soft lozenges:
They are either meant for chewing or for slow drug release in mouth. They can be made
from PEG 1000 or 1450, chocolate or sugar-acacia base while some soft candy
formulations can also contain acacia and silica gel. Acacia is used to provide texture and
smoothness and silica gel is used as a suspending agent to avoid settling of materials to
the bottom of the mold cavity during the cooling. The formulation requires heating
process at about 50℃, hence is only suitable to heat resistant ingredients. These are
mixtures of sugar and other carbohydrates in an amorphous (non crystalline) or glassy
state. They can also be regarded as solid syrups of sugars.
The moisture content and weight of hard candy lozenge should be in between, 0.5 – 1.5%
and 1.5-4.5 g respectively. These should undergo a slow and uniform dissolution or
erosion over 5- 10 min., and they should not disintegrate. The disadvantage of this
method is that the temperature required for their preparation is high hence heat labile
materials cannot be prepared.
Process:
These lozenges are so soft that they may be rolled by hand and then cut into pieces, or
the heated mixture can be poured into a plastic mold. If PEG is utilized, the mold cavity
should be overfilled because PEG shrinks when it cools. Since chocolate does not shrink,
this is not necessary .Clotrimazole soft lozenges were created by Phaechamud and
Tuntarawongsa using a molding technique, and they assessed the variables influencing
the lozenge's physical characteristics. They discovered that the hardness of the lozenge
increased with increasing concentrations of PEG 1500, xanthan gum, or xylitol.
Additionally, it was discovered that disintegration time increased with increasing
actives and hardness of the lozenge. And also disintegration time was found to be
increased on increasing amount of actives and hardness.
 Manufacturing of Hard Candy Lozenges: [19]

Hard Candy Lozenges:
Hard candy lozenges are mixtures of sugar and other carbohydrates in an amorphous
(noncrystalline) or glassy state. They can also be regarded as solid syrups of sugars. The

INTRODUCTON
moisture content and weight of hard candy lozenge should be between, 0.5 to 1.5% and
1.5-4.5g respectively. These should undergo a slow and uniform dissolution or erosion
over 5-10min., and should not disintegrate. The temperature requirements for their
preparation is usually high hence heat labile materials cannot be incorporated in them .
The ingredients for hard candy lozenges include body agent or base which is corn syrup
that is available on Baume basis. A 43° Baume corn syrup is preferred in hard candy
lozenges. Sweetening agents such as sucrose, dextrose, maltose and lactose are added.
Acidulents are added to candy base to strengthening the flavor characteristics of the
finished product. Commonly used acids are citric, tartaric, fumaric and malic acid.
Colours include FD & C colours, orange colour paste, red colour cubes etc while flavours
used include menthol, eucalyptus oil, spearmint, cherry flavor etc. Medicaments up to 2-
4% can be incorporated in the hard candy lozenges. Salvage solution can be liquid or
solid .
Process:
Step1: The candy base is cooked by dissolving desired quantity of sugar in one third
amount of water in a candy base cooker.
Step2: This is continued till the temperature rises to 110℃. Corn syrup is added and
cooked till the temperature reaches 145-156℃.
Step3: The candy mass is removed from the cooker and transferred to a lubricated
transfer container mounted onto a weight check scale where the weight of the mass is
checked.
Step4: This is followed by color addition in form of solutions, pastes or color cube
Step5: The mass is then transferred to a water-jacketed stainless steel cooling table for
mixing and the flavor, drug and ground salvage is added.
Step6: The mass is either poured in mold or pulled into a ribbon while cooling and then
cut to desired length.
Step7: The obtained lozenges are packaged.

INTRODUCTON
Advance Technologies:[20]
Advanced equipment plays a important role in the formulation and production of
lozenges. These features of advanced equipment contribute to the efficient and precise
formulation of lozenges, ensuring consistency in quality, efficacy, and patient
compliance.
1. High Shear Mixer: This equipment is used for the uniform mixing of ingredients,
ensuring homogeneity in the formulation of lozenges. It helps in dispersing active
ingredients evenly throughout the mixture.
2. Spray Dryer: Spray drying technology is employed to convert liquid formulations

into powdered form. It is often used for flavoring agents and active ingredients to enhance
their stability and shelf life.
3. Tablet Press: Advanced tablet presses are utilized for the compression of lozenge
formulations into solid dosage forms. These presses can accurately control the
compression force, ensuring uniformity in size, weight, and hardness of the lozenges.
4. Vacuum Emulsifier: Vacuum emulsifiers are employed for the homogenization of

emulsions used in lozenge formulations. They help in achieving a fine and stable
emulsion, improving the texture and consistency of the lozenges.
5. Coating Machine: Coating machines are used for the application of protective
coatings on lozenges to mask the taste of active ingredients or enhance their stability.
Advanced coating technologies ensure precise and uniform coating thickness.
6. Hot-Melt Extruder: Hot-melt extruders are utilized for the continuous manufacturing
of lozenges. They enable the extrusion of molten mass through a die, which is then cooled
to form solid dosage forms with controlled release properties.
7. Analytical Instruments: Advanced analytical instruments such as HPLC (High-

Performance Liquid Chromatography) and FTIR (Fourier Transform Infrared

INTRODUCTON
Spectroscopy) are employed for the characterization and quality control of raw materials
and finished lozenge products.
Advanced equipment features of Fully Automatic candy forming machine DCF-

3:[21]
Fully automatic candy/lozenges forming machines are sophisticated pieces of equipment
designed to streamline the production process of lozenges. Here's a step-by-step
explanation of how these machines typically work:
 Ingredient Mixing: Before the production process begins, the ingredients for the
lozenges are mixed according to the desired formulation. This may involve blending
sugars, binding agents, flavoring agents, and any active ingredients or additives.
 Feeding System: The mixed ingredients are then fed into the forming machine through
a hopper or feeding system. This ensures a continuous supply of ingredients to the
machine throughout the production cycle.
 Heating and Melting: In some cases, the ingredients may need to be heated or melted to
achieve the desired consistency. This can be done using built-in heating elements or
external heating sources, depending on the machine design.
 Forming and Shaping: Once the ingredients are properly prepared, they are fed into the
forming section of the machine. Here, the mixture is shaped into individual lozenges
using molds or dies that are custom-designed to the desired shape and size.
 Cooling and Solidification: After shaping, the lozenges pass through a cooling chamber
where they are allowed to cool and solidify. This ensures that they maintain their shape
and structural integrity once they are removed from the machine.
 Cutting and Packaging: Once the lozenges have cooled and solidified, they are ready
to be cut and packaged. This may involve using automated cutting mechanisms to
separate individual lozenges from the continuous sheet of candy, followed by packaging
them into wrappers or containers.
 Quality Control: Throughout the entire process, quality control measures are
implemented to ensure that the lozenges meet the desired specifications in terms of size,
shape, consistency, and flavor. This may involve visual inspections, weight checks, and
taste testing, among other techniques.

INTRODUCTON
 Cleaning and Maintenance: After the production run is complete, the machine is
cleaned and sanitized to prepare it for the next batch. Regular maintenance is also
performed to keep the machine in optimal working condition and prevent breakdowns or
malfunctions.
In conclusion, fully automatic candy/lozenges forming machines offer a highly efficient
and streamlined solution for mass production of lozenges, allowing manufacturers to
produce large quantities of high-quality products with minimal manual intervention.
Applications:[16, 17, 18, 19 ]
 Antifungal lozenges:Fungal infections are treated using oral lozenges such as nystatin
and clotrimazole.
 Nicotine lozenges: Nicotine lozenges are a smoking cessation aid. The Mayo Clinic
states that as you suck on the lozenges, nicotine is released into your bloodstream. The
goal of using nicotine cigarettes is to use them as often as needed until the urge to smoke
goes away.
 Zinc lozenges:
Your body can fight infections by using zinc as an antioxidant. Zinc is thought to help
shorten the duration of colds and their symptoms when it is present in lozenges. However,
the Mayo Clinic points out that there are contradicting research on the veracity of those
zinc claims.
 Throat/cough lozenges:
To relieve your painful throat, sore throat lozenges contain an anesthetic, like benzocaine.
To provide momentary relief, the anesthetic acts by numbing the affected area. In order
to treat throat conditions like strep throat, some throat lozenges may also include an
antibiotic. Cough suppressants such as menthol or eucalyptus can be found
in cough lozenges.
 Lozenges for erectile dysfunction:
The New Zealand Men's Clinic states that lozenges can be used to treat erectile
dysfunction. The lozenges are taken up to thirty minutes prior to sexual activity.
Compared to tablets, erectile dysfunction lozenges have less adverse effects.
 Prenatal lozenges:
which contain pyridoxine, or vitamin B6, assist to alleviate symptoms of nausea and
vomiting associated with morning sickness. Prenatal lozenges should be used as

INTRODUCTON
prescribed by your doctor because high prenatal B6 dosages can have negative effects on
your unborn child.
Table No 1.2 Marketed Lozenges and their ingredients

Sl.No Product Main Ingredients Indication
1. VICKS® Menthol sore throat

2. THERA ZINC® Zinc (Gluconate) common cold and flu
3. NICORETTE® Nicotine smoking cessation
4. STREPSILS® Amylmetacresol, Sore throat and blocked nose
dichlorobenzyl alcohol
5. CLOTRIMAZOLE Clotrimazole Oral thrush
LOZENGE®
6. SUCRETS® Dextromethorphan Sore throat
Hydrobromide
7. CEPACOL® Menthol, Sore throat
8. VIGROIDS® Liquorices Expectorant
9. CHLORASEPTIC® Benzocaine Relief of minor sore throat and
mouth pain
10. LOCKETS® Eucalyptus and menthol Nasal congestion and sore
throat
11. KOFLET-H® Madhu Alleviate cough and quickly
relieves throat irritation
12. SUALIN® Glycyrrhiza glabra Influenza, bronchitis, sore
throat, cold and cough,
congestion of head and lungs

REVIEW OF
LITERATURE
REVIEW OF LITERATURE
Popli Anmol et al., [2024] formulated hard lozenges by using garlic tinctures with
minimum excipients. According to ICH recommendations, stability experiments were
conducted. According to the stability investigations, there were no major changes noticed
during the period after the one-month stability test. The antimicrobial activity was studied
under different time intervals after 8-72 hours. The inhibition zone value for the test
sample was found to be 0.1-0.5 mm and for the standard sample was noticed from 0.5-
0.8 mm, respectively. The statistical test outcome revealed, no remarkable difference
shown between the prepared and the marketed formulation (p>0.05). From the present
work, it was concluded that the prepared lozenges have similar result with minimum
ingredients as compared to the marketed formulation (Tulsi-ginger lozenges). Hence, the
formulation, testing, and antimicrobial activity for oral use in garlic lozenges were
effective.[22]
Dhokale manasvi avinash et al., [2023] assessed a polyherbal hard and soft lozenges
cure for cold, sore throat, and cough suppression containing prickly pear fruit, Guduchi,
mint tulsi, ginger, and cinnamon as well as other herbs. The current research project was
successfully completed by gathering feedback and responses from 100 volunteers,
including both children and adults of either sex. It was discovered from the survey that
both soft and hard polyherbal lozenges were effective in treating cough and sore throat
conditions and had a tolerable taste. physicochemical parameters—such as weight
variation, thickness, hardness, moisture content, hardness friability, and disintegration
diameter—were assessed, and the results showed that they all fell within the monograph
standard that is outlined in GMP Guidelines.[23]
Sai Datri et al., [2023] formulated Embelin hard candy lozenges for slow release of the
medicament for the treatment of bronchitis. It helps to make breathing easier by means
of relaxing and opening air passage in the lungs. The formulation of hard candy lozenges
was subjected to physico-chemical as well as in vitro drug release. Among all the
formulations of hard candy lozenges F10 had shown in vitro drug release of 100.6% at
the end of 30 minutes.[24]
Shibanjan Paul Roy et al., [2023] formulated herbal based lozenges for cough by using
combination of calamansi, ginger, miracle berry fruit (Synsepalum dulcificum)

belonging from the family Sapotaceae and manuka honey. The herbal based lozenges
were formulated properly to provide proper relief from the cough symptoms by using
natural herbal ingredients with potential and therapeutic properties. Our research
involved with the proper and appropriate preparation of the lozenges we followed by
evaluation, identification and analysis of their physical characteristics, organoleptic
properties and in vivo dissolution behavior. [25]
Prashant Chitale et al., [2023] formulated and evaluated polyherbal lozenge remedy for
suppressing cough for sore throat and cold the polyherbal extract based lozenge includes
Tulsi (Osmium sanctum) Dashmola Powder, Honey, Jaggary Gokhru Powder. The herb
in polyherbal lozenges is osmium sanctum is utilized in cough treatment in unani and
ayurvedic medicine. The Tulsi is benificial in relieving cough and cold symptoms due to
its antimicrobial, anti-inflammatory, antitussive and anti-inflammatory properties Tulsi
along with honey helps relives cough and flu and improve inmmunohealth. Both the
polyherbal lozenges were evaluated for their physicochemical parameters such as weight
variation, thickness, hardness, moisture content, hardness friability, disintegration
diameter was identified and their results were revealed as all the physicochemical
parameter for both soft and hard lozenges were within the monograph standard which are
mentioned in GMP Guidelines.[26]
Pramodini et al., [2022] formulated and evaluated polyherbal lozenge remedy for
suppressing cough for sore throat and cold the polyherbal extract based lozenge includes
vasaka [Adhatoda vasica], ajwain [Trachyspermum ammi], mint tulsi [Ocimum
tenuiflorum], ginger which are traditionally used for cough suppressant and in cold and
flu and the other ingredients are honey and jaggery which are nutritive effect and soothing
effect on the mucus membrane of the respiratory tract. The fresh leaf juices of all the
ingredients were used for the preparation of polyherbal lozenges of both soft herbal
lozenge and hard lozenge were prepared. Both the polyherbal lozenges were evaluated
for their physicochemical parameters such as weight variation, thickness, hardness,
moisture content, hardness friability, disintegration diameter were identified and there
results were revealed as all the physicochemical parameter for both soft and hard
lozenges were within the monograph standard which are mentioned in GMP Guidelines.
The present research work was successfully concluded by taking feedback and responses

from a hundred volunteers which includes both children and adults of either sex from the
survey it was found that the polyherbal lozenges of both the types of soft and hard were
effective in cough and sore throat conditions and with a acceptable taste. From the above
investigations it was expertise to develop a polyherbal lozenge of both soft and hard
herbal lozenges and it was just an attempt to make a polyherbal lozenges in which the
leaves of mint tulsi and ajwain were incorporated for the first time and these polyherbal
lozenges can be an effective, economical and easily available remedy for minor throat
infections.[27]
Vijayasri Kadirvel et al., [2022] formulated lozenges by employing traditional

ingredients such as Adhatoda vasica, Althaea officinalis, Glycyrrhiza glabra,
and Trachyspermum ammi possess functional bio-active compounds to treat sore throat.
The lozenge composition was optimized based on taste, flavor, and the ability to form
structure. The formulated lozenge was subjected to FTIR, nutritional, physical, sensory,
and shelf-life analysis. The FTIR analysis indicated the presence of functional groups
of the targeted bio-active compounds, vasicine, and vasicinone chiefly present
in Adhatoda vasica. The nutritional analysis revealed the presence of phenolic content
(115.5 ± 1.22 mg/GAE 100 g) in the fortified lozenge. The product's shelf life was
60 days when packed in blister packaging. The developed product is proposed to
suppress sore throat effectively.[28]
Rupali Chanda et al., [2020] formulated and evaluated lozenges for a sore throat using
Loratadine. Solid dispersions of Loratadine was prepared using β-cyclodextrin in the
ratios of 1:1, 1:2, and 1:3 to enhance the solubility of Loratadine. The prepared solid
dispersion of Loratadine was analyzed for solubility enhancement. Loratadine lozenges
were then formulated with mannitol, sucrose, acacia, xanthan gum, liquid glucose by
heat, and congealing technique. The prepared lozenges were evaluated for drug-excipient
incompatibility study, diameter, thickness, weight variation, hardness, friability, in vitro
release study, and drug content. The results of the Fourier transform infrared study
showed that there was no interaction between the selected drug and excipients. In-vitro
drug release study of Loratadine lozenges were performed in pH 6.8 phosphate buffer,
wherein >90% of the drug was released within 30 min for all the formulations. The
lozenges were optimized based on in vitro release data. Formulation F7 of Loratadine

lozenges exhibited 99.1% release in 30 min. Stability studies revealed that the
formulation was stable. From the present work, it was concluded that the Loratadine
lozenges can be considered as a suitable delivery system for the treatment of sore
throat.[29]
Shivani Kotamkar et al., [2020] developed Fluoxetine Hydrochloride candy lozenges

by using different polymers like HPMC K4M and sodium alginate with different ratios,
which serves the purpose of increasing the bioavailability. The average weight of the
prepared lozenges was found to be in the range of 2.16±0.006 to 3.08±0.004 gram, the
percent friability was found to be in the range of 1.86±0.008 to 2.14±0.003, the hardness
was found to be in the range of 10.15±0.004 to 12.27±0.003 kg/cm2, the disintegration
time was found to be in the range of 23.35±0.007 to 24.25±0.0012 min, the percent drug
content was found to be 96.5±0.006 to 99.4±0.005, and the percent moisture content was
found to be in the range of 0.5±0.015 to 0.8±0.026. From all the evaluation parameters
FL2 was considered as the optimized formulation. The in-vitro drug release was carried
out in phosphate buffer of pH 6.8 and was found that the drug release depends on the
concentration of the polymer. The drug release kinetics of optimized formulation FL2
fitted best to the zero order kinetics with the mechanism of Korsmeyer-peppas drug
release. The stability study of the optimized formulation shows no significant changes in
the product. In the view of above findings, effect of polymers like, HPMC K4M shows
better result in heat congealing technique for preparation of lozenges [30].
Binu Anand et al., [2018] studied the effect of extracts of Eucalyptus oil and Coleus
aromaticus oil, and to formulated the lozenge tablets in order to investigate a profitable
dosage form. Lozenge tablets were prepared using Roller compression method. The
tablets also were evaluated for the physicochemical properties such as hardness,
friability, weigh uniformity, thickness and disintegration time. The formulated product
yshowed inhibitory activity against non-resistant C.albicans infections thus providing a
very good release matrix for the eucalyptus and coleus aromaticus combined extract.
The results clearly indicate that the prepared lozenge tablets can be a good alternative
for traditional forms.[31]
Rao TV et al., [2018] prepared and evaluated the sugar based medicated Tramadol
hydrochloride hard lozenges for pediatrics to overcome the administration of dosage

forms like tablets, capsules, etc. The lozenges were prepared by heating and congealing
method on laboratory scale with corn syrup as base. All the formulations prepared were
subjected to various physico-chemical parameters such as hardness, friability, content
uniformity, weight variation, thickness, drug content and in vitro dissolution studies.
Drug-excipients compatibility studies were conducted by FT-IR spectroscopy and
results revealed that no interactions were found between drug and excipients. The results
of in- vitro drug release studies showed that formulation F9 releases the drug 95.66
percentage using methylcellulose as a polymer at the end of30 minutes. The result
concludes hard lozenge can provide an attractive alternative formulation in the treatment
of pain in pediatric patients[32].
YAMASANI SK et al., [2018]formulated Doxofylline lozenges to provide slow release

medicament for the management of asthma for cough and itchy throat. The benefits of
these prepared lozenges showed increase in bioavailability, reduction in gastric
irritation by passing of first pass metabolism and increase in onset of action. The
lozenges were prepared using sucrose as base; liquid glucose in the formulation made
the lozenges transparent and smooth; hydroxypropyl methylcellulose (HPMC) and
hydroxyethyl cellulose (HEC) are used as polymers. Aspartame and saccharin areused
as artificial sweeteners. Sweeteners along with flavours are used to mask the bitter taste
of drug. All the formulations prepared were subjected to various physicochemical
parameters like hardness, content uniformity, friability, weight variation, moisture
content etc. The prepared formulations have a hardness of 8-11 Kg/cm², non gritty and
pleasant mouth feel. Some selected formulations were tested for drug excipients
interactions subjecting to infrared (IR) Spectral analysis. In vitro drug dissolution
studies showed least of 82.7% for FL7 and maximum of 98.8% for FL6.[33
Fathima SR et al., [2018] formulated combinations of Paracetamol, Diclofenac and

Domperidone in the lozenge form to make available the immediate release of the drugs
in fever, pain and nausea conditions. Lozenges were prepared by heat congealing
method with varying concentrations of sugar base and polymer. Formulated lozenges
were evaluated for various physicochemical parameters like hardness, weight variation,
moisture content, friability and in-vitro dissolution. The results obtained were compared
with pharmacopoeia limits. FTIR studies revealed no signs of incompatibility between

the drugs and its excipients. Hardness, friability, moisture content of the prepared
lozenges was found within the limits. In-vitro dissolution studies showed the drug
release of 90% at the end of 30 minutes. Thus, it can be concluded that medicated
lozenges are suitable for large doses and immediate drug release requirements with
improved bioavailability.[34]
Manasa A et al., [2016] formulated and evaluated Cetirizine sweetened tablet lozenges
were designed for the effective treatment of cough and cold to reduce throat pain. The
main interest was for the development of new dosage forms and the effect of different
concentration on the in-vitro release. At the outset, estimation of drug by UV
spectrophotometer was carried out. The possible interaction between the drug and
excipient was studied by FTIR spectroscopy which showed that there was no interaction
between the selected drug and polymer under study. Lozenges could be successfully
prepared by fusion method using sucrose, liquid glucose, aspartame, sucrose, dextrose,
mistri, flavor and colour. In-vitro release rate studies showed that the drug release for
lozenges was maximum in formulation FL2 (98.89±0.5%) which was at 25 minutes.[35]
Lakshmi MB et al., [2017] formulated and evaluated Domperidone lozenges is a

selective serotonin receptor (5-HT3) antagonist and its lozenges are mainly used for the
treatment of chemotherapy induced nausea and vomiting. In the study lozenges dosage
form is chosen due to their benefits of good patient compliance due to its taste, increased
bioavailability, reduced gastric irritation, reduced first pass metabolism and increased
onset of action when compared to its tablet dosage form which is in practice
conventionally. The preparation process involves mixing of Domperidone with all
excipients, used in the formulation in different ratios by using heat congealing technique
in which sucrose and dextrose heated separately up to 60ºC fusioned together and
reheated upto 160ºC after which polymer HPMC K 100M, HPMC E5 and all other
excipients are added and moulded. The lozenges were subjected to evaluation viz.,
weight variation test, hardness, friability, drug content and in vitro release studies.[36]
Jagadeesh P et al., [2017] prepared and evaluated the sugar based Tramadol
hydrochloride medicated lollipops for pediatrics to overcome the administration. They

were prepared by heating on congealing method on laboratory scale with sugar syrup as
base. All the formations were subjected to various physico chemical parameters such as
hardness, friability, content uniformity, Wight variation, thickness, drug content and in
vitro dissolution studies. Drug excipients compatibility studies were conducted by FT-
IR spectroscopy and result release studies showed that formulations F15 release the
drug 89.41% at the end of 30 min. The medicated lollipops can provide an attractive
alternative formulation in the treatment of pain in paediatric patient.[37]
Choursiya S et al., [2016] formulated and evaluated Roxithromycin lozenges for oral
bacterial infection. In that study, taste is one of the most important parameters of oral
formulations so β-Cyclodextrin is used as a good taste masking agent for bitter drug and
also enhances the solubility of the drug. Roxithromycin Compressed tablet lozenges
were formulated by wet granulation technique with excipients like sucrose, lactose,
citric acid, flavour and colour and evaluated for organoleptic properties the test like
diameter, thickness, weight variation, hardness, friability, mouth dissolving time, and
% drug content. The Optimized formulation of Roxithromycin Compressed tablet
lozenges (C6) were sweet in taste, smooth in texture and having a diameter 13.708 ±
0.00 mm, thickness 6.704 ± 0.00 mm, hardness is 12 ± 1kg/cm2 and drug content
uniformity is 96 ± 0.02%. The weight variation and friability of lozenges (C6) was
passed as per IP and mouth dissolving time is found at 25 ± 2 min. In vitro dissolution
study for Roxithromycin compressed tablet lozenge was performed in pH 6.8
phosphate buffer wherein 95 % of the drug was released within 30 min.
Lekshmi L et al., [ 2016]Candy based lozenges of antifungal agent prepared using

hydrophilic natural polymers (gelatin, acacia and tragacanth) by heating and congealing
method in order to enhance bioavailability, reduce gastric irritation, bypass first
metabolism and increase onset of action. These lozenges were evaluated for various
parameters like hardness, friability, thickness, drug content, mouth dissolving time,
moisture content and in vitro dissolution etc... The optimized formulation was having
good transparency and pourability with mouth dissolving time, in vitro drug release
98.23% and follows first order release kinetics and the mechanism of drug release was
found to be Non fickian. The DSC and FTIR studies indicated that there was no drug-
excipients interaction. Accelerated stability study conducted as per ICH guidelines at

45ºC and 75% relative humidity over a period of one month found that there wasn’t any
substantial interaction between the drugs, flavour and colour and the prepared
formulation were stable. The antifungal studies showed that they retained similar
antifungal activity of pure drug. It was concluded that development of Ketoconazole
loaded gelatin lozenges tablets were successfully formulated cost effectively and has
high efficiency in treatment of oral candidiasis.[39]
Aparna C et al., [2015] medicated hard candy and soft lozenges of Albendazole were
formulated to bypass first pass metabolism and increase bioavailability by absorption
through oral mucosa. Medicated hard lozenges were prepared by heating and
congealing technique using different polymers. Soft lozenges (PEG-base) lozenges
were prepared by melting and moulding technique using PEG 1500. Stability studies
were carried out according to ICH guidelines. All the formulations were subjected to
various physicochemical evaluations like weight variation, hardness, drug content,
thickness, disintegration time and moisture content etc. Based on results obtained from
hard and soft lozenges, formulation containing methyl cellulose 25mg i.e., hard candy
lozenge showed better drug release when compared to soft lozenge. The in- vitro
dissolution of Albendazole from the selected formula was found to be 99.37% at 30
min. In case of soft lozenges, a formula containing acacia 300mg formulation was
further optimized and in-vitro dissolution study from the resultant product was found to
be 88.92% in 50min. FTIR studies revealed that there were no drug-excipient
interactions.[40]
Pothu R et al., [2015] formulated Chlorhexidine and Flurbiprofen as lozenges to

provide local antiseptic and anti-inflammatory action. The candy based lozenges were
prepared by heat and congealing method by sugar as lozenge base, HPC, HPMC as
polymers, citric acid artificial flavours and colours and other essential excipients. Some
selected formulations were tested for drug excipient interactions subjecting to IR
Spectral analysis. Formulated lozenges were evaluated for weight variation, crushing
strength, friability, thickness, taste, dissolution time, and %assay. Crushing strength of
optimized troches was found between 8-9.50 kg/cm2. The study concludes candies can
provide an attractive alternative formulation in the alleviation of pain and

Inflammation.[41]
Bharkad VB et al., [2015] formulated fluconazole lozenges using sucrose as base and
gelatin solution as a binder. Lozenges were prepared by wet granulation method using
different concentration of maize starch, acacia, HPMC E50.The benefits of these
prepared lozenges are increased bioavailability, reduction in gastric irritation by passing
first pass metabolism. All the formulations prepared were subjected to various
physicochemical parameters like hardness, content uniformity, friability, weight
variation etc. The prepared formulations have a hardness of 3.5-10.2 Kg/cm², with good
taste.[42]
Yamsani MR et al., [2015] prepared Lidocaine hard candy lozenges by heat fusion
method using sugar as a base. The usage of corn syrup in the formulation made the
lozenges transparent and smooth, which helped in improving the elegancy of
formulation. The controlled release of medicament from Lozenges was achieved by
using polymers like methyl cellulose, locust bean gum, HPMC K4M and xanthan gum.
The prepared lozenges were subjected to physico-chemical as well as in vitro drug
release study. Among all the formulations of hard candy lozenges FL8 showed the in
vitro release of 98.7% at the end of 25 minutes.[43]
Patel DM et al., [2014] developed the Diphenhydramine hydrochloride as lozenges to

provide effective release for the management of cough. Formulated and evaluate
lozenges to meet the need of improved bioavailability by avoiding hepatic first pass
metabolism of the drug. The lozenges were formulated using various sugars like
mannitol, dextrose, sucrose and Isomalt. Polyethylene glycol 200, propylene glycol and
glycerine were tested as plasticizer in formulation. The prepared formulations were
subjected to various evaluation parameters. After completion of stability study for a
period of 1 month, the optimized formulation was subjected to evaluation parameters.
Lozenges formulated using isomalt and 0.1 ml glycerine remained as hard candy, while
lozenges were not formed with any other sugar. The optimized formulation showed a
hardness of around 15 kg/cm²; drug content and content uniformity of 97 % and in vitro
drug release of more than 99 % within 20 min. After stability study, it was found that
the lozenges were not altered in terms of above parameters and were stable. The study

concluded that the Isomalt can be successfully used as tooth friendly sugar substitute in
the formulation of medicated lozenges.[44]
Kumar D et al.,[2014] formulated and characterized chewable tablets of Paracetamol
and Metoclopramide hydrochloride. The investigation was carried out to study the
effect of different proportion of Avicel 101, Avicel 102 and moringa gum, which are
super disintegrating agents. The chewable tablets of Paracetamol and Metoclopramide
hydrochloride were prepared by wet granulation method. Several physicochemical
parameters like thickness, diameter, hardness, %weight variation, %loss in weight, drug
content, disintegration time, in vitro dissolution studies, kinetics of drug release and
stability studies for all the formulations were studied and were found within the
acceptance limits. Formulation F7 (containing moringa gum 1%) showed the best
cumulative drug release and disintegration time of 56 secs.[45]
Aparna C et al., [2014] formulated Itraconazole Compressed tablet lozenges were

prepared by wet granulation technique using three different binders, at different
concentrations. Soft lozenges (hand-rolled and PEG-base) lozenges were formulated
using different excipients. They were evaluated for post-compression parameters by
pharmaceutical standard methods. Stability studies were carried out according to ICH
guidelines. The optimized formulations were subjected to microbial studies to see their
antimycotic activity. The formulated lozenges were evaluated for physical parameters
and the results complied with the pharmacopeia limits. In vitro dissolution studies
showed 90% drug release by the end of 60 min[46]
Renuka P et al., [2014] prepared and evaluated hard candy lozenges of nicotine 2mg
for low dependent smokers and 4mg for high dependent smokers. The benefits of these
prepared lozenges are increased bioavailability, reduction in gastric irritation and
avoiding first pass metabolism. The lozenges were prepared by heat and congealing
method in a candy base using sucrose as base. In-vitro drug dissolution studies showed
100% release in 30 minutes for optimized formulations NC11 and NC25.The Hard
candy lozenges can provide an attractive alternative formulation in the Nicotine
replacement therapy.[47]

Pundir S et al., [2014] prepared and evaluate the medicated lozenges of Ondansetron
hydrochloride for the treatment of chemotherapy induced nausea and vomiting. Taste
masking was done by complexing Ondansetron HCl with Eudragit E100 in ratio 1:1.
The lozenges were prepared by heating and congealing method using sucrose as base;
sodium carboxy methyl cellulose (NaCMC), hydroxy propyl methyl cellulose (HPMC
K4M) and methyl cellulose (MC) are used as polymers and comparing with lozenges
of without hydrocolloids. It was found that the formulation without hydrocolloids (F0)
was more stable compare to other formulations. Accelerated stability study conducted
as per ICH guidelines (zone IV) at 45°C and 75% relative humidity over a period of
seven weeks found that there wasn’t any substantial interaction between the drugs,
flavour and colour and the prepared formulations were stable.[48]
Maheshwari R et al., [2013] reviewed lozenges a unit dosage form of medicament

meant to be dissolved in mouth or pharynx. Lozenges currently available in market are
of four types: Caramel based soft lozenges, hard candy lozenges and compressed tablet
lozenges. The present review covers more or less all aspects associated with lozenge.
It includes various researches performed till date, formulation and evaluation
parameters adopted for the dosage form. Furthermore, it throws light on the applications
of lozenge.[49]
Charles O Esimone et al., [2010] The present work is an antimicrobial evaluation of

lozenge dosage forms containing garlic and ginger lozenges containing pulverized garlic
and ginger were produced by the moulding method and was evaluated against
oropharyngeal microbial isolates after time-release in a normal saline-saliva sink
solution. The solution was withdrawn at different intervals and screened for antimicrobial
activities using the agar diffusion method against Escherichia coli, Staphylococcus
aureus, and Candida albicans. Nystatin tablets were used as standard. Lozenges
containing pulverized garlic and ginger were produced by the moulding method and was
evaluated against oropharyngeal microbial isolates after time-release in a normal saline-
saliva sink solution. The solution was withdrawn at different intervals and screened for
antimicrobial activities using the agar diffusion method against Escherichia coli,
Staphylococcus aureus, and Candida albicans. Nystatin tablets were used as standard.
There was inhibition of growth by Nystatin tablet but garlic-ginger combination only

inhibited growth of laboratory strains of C. albicans. The result of this study showed that
the garlic and ginger can be formulated into lozenges and used in nonresistant oral
thrush.[50]

AIM
AND
OBJECTIVES
AIM AND OBJECTIVES
Aim of the Work

The main objective of the present study is to formulate herbal lozenges
using Terminalia Chebula and Zingiber Officinale powder, assessing their efficacy
in providing relief from sore throat and cough symptoms, and evaluating their
safety and stability for potential medicinal use.
Objectives
 Preformulation studies for Terminalia Chebula and Zingiber Officinale powders.
 Formulation of medicated lozenges of Terminalia Chebula and Zingiber Officinale.
 Testing of chemical compatibility between drug and excipients by Fourier
Transform Infrared Spectrophotometer.
 Evaluation of prepared medicated lozenges for physical appearance, hardness,
weight variation, thickness, drug content uniformity, moisture content, in-vitro drug
release, mouth dissolving time.
 Stability studies of the optimized formulation.
PLAN OF THE WORK

 Begin by researching various herbal ingredients known for their soothing or
medicinal properties, such as ginger, T. chebula and eucalyptus.
 Experiment with different combinations and concentrations of herbs to formulate a
lozenges that balances effectiveness, taste, and safety.
 Identify reputable suppliers for high-quality herbal ingredients that meet your
standards for purity and sustainability
 Develop a detailed manufacturing process, including mixing, molding, and
packaging, ensuring consistency and quality control at each step.
 Research and comply with regulations governing the production and labeling of
herbal products, including any requirements for safety testing, including any
requirements for safety testing, ingredient disclosures or health claims.

PLANT
PROFILE
PLANT PROFILE
TERMINALIA CHEBULA[51]
Botanical Name: Terminalia chebula
Family: Combretaceae
Genus: Terminalia
Species: T.chebula
Common Names: Haritaki, Chebulic myrobalan, Black myrobalan
Description: Terminalia chebula is a medicinal plant widely used in traditional Ayurvedic
medicine. Its powder is derived from the dried fruit of the tree and is known for its various
health benefits. Terminalia chebula powder is typically dark brown in color and has a slightly
bitter taste.
Habitat: It is commonly found in subtropical regions of Southeast Asia, including India, Sri
Lanka, Nepal, Bangladesh, and Myanmar. Terminalia chebula can grow at altitudes ranging
from sea level to about 1,500 meters. t prefers warm and humid climates but can tolerate a wide
range of temperatures. It grows well in a variety of soil types, including sandy, loamy, and clay
soils, as long as they are well-drained.
Fruit Characteristics: The fruit is drupe-like, roughly spherical, with a diameter of 2-4 cm. It
has a hard, wrinkled shell that turns from green to blackish-brown when ripe. Each fruit
contains a single seed.
Storage: Terminalia Chebula can be kept in an airtight container in a cool, dark place for
longer-term storage.
Applications:
 It is used in some herbal remedies for respiratory issues like coughs and asthma.
 Some use it in oral hygiene products due to its potential to promote gum health and
alleviate dental problems.
 It contains antioxidants that may help protect cells from damage caused by free radicals.
 T. Chebula has ability to support digestion, relieve constipation, and promote regular
bowel movements.

PLANT PROFILE
ZINGIBER OFFICINALE[52]
Botanical Name: Zingiber officinale
Common Names: Ginger
Family: Zingiberaceae
Genus: Zingiber
Species: z. officinale
Description: Ginger is a flowering perennial herb with thick, underground rhizomes (modified
stems) that are harvested for culinary and medicinal purposes. It has long, green leaves that
arise from the rhizome and can reach heights of up to 1 meter.
Habitat: Native to tropical regions of Southeast Asia, ginger thrives in warm, humid climates
with well-draining soil. Ginger is cultivated as a commercial crop in many tropical and
subtropical regions worldwide. It is propagated from rhizome cuttings and grown in well-
draining, fertile soil.
Storage: Fresh ginger can be stored in the refrigerator for several weeks, while dried ginger
can be kept in an airtight container in a cool, dark place for longer-term storage.
Applications:
 Culinary: Ginger is widely used as a spice and flavoring agent in various cuisines. It
adds a distinctive spicy, slightly sweet flavor to dishes and beverages.
 Medicinal: Ginger has been used for centuries in traditional medicine for its anti-
inflammatory, digestive, and anti-nausea properties. It is consumed fresh, dried, or in
the form of extracts, teas, and supplements.

EXCIPIENT
PROFILE
EXCIPIENTS PROFILE
SUCROSE 76
Non proprietary names: BP: Sucrose
JP: Sucrose
Ph Eur: Sucrose
USP-NF: Sucrose
Synonyms: Beet sugar: cane sugar: refined sugar: saccharose: saccharum, sugar.
Chemical name: β-D-fractofuranosyl-α-D- glucopyranoside
Molecular weight: 342.30
Melting point :160–186ºC
Functional category: Confectionary base; coating agent; granulation aid; suspending agent;
sweetening agent; tablet binder; tablet and capsule diluent; tablet filler; therapeutic agent;
viscosity-increasing agent.
Description: Sucrose occurs as colourless crystals, as crystalline masses or blocks, or as a white
crystalline powder; it is odourless and has a sweet taste.
Solubility:
Soluble in ethanol 1in 400 at 20°C
Soluble in water 1 in 0.5 at 20°C at and 1 in 0.2 at 100°C.
Incompatibility: Powdered sucrose may be contaminated with traces of heavy metals, which
can lead to incompatibility with active ingredients, e.g., ascorbic acid. In the presence of dilute
or concentrated acids, sucrose is hydrolysed or inverted to dextrose and fructose (invert sugar).
Applications: It is used for oral liquid formulations in the concentration of 67%w/w as syrup
and sweetening agent.

EXCIPIENTS PROFILE
POLY ETHYLENE GLYGOL 200

Non proprietary names: BP: Macrogols
JP: Poly Ethylene Glygol
PhEur: Macrogols
USP-NF: Polyethylene Glycol
Synonyms: Carbowax; Carbowax Sentry; Lipoxol; Lutrol E; macrogola; PEG;Pluriol E;
polyoxyethylene glycol.
Chemical name: A-Hydro-o-hydroxy poly(oxy-1,2-ethanediyl)
CAS Registry Number: [2532268-3]
Empirical Formula:HO CH2 (CH2OCH2) mCH2OH where m represents the average
number ofoxyethylene group
Molecular Weight: 190-210
Functional category: Ointment base; plasticizer; solvent; suppository base; tablet andcapsule
lubricant.
Description: Liquid grades (PEG 200–600) occur as clear, colourless or slightly yellow- colour,
viscous liquids. They have a slight but characteristic odour and a bitter, slightly burning taste.
Solubility: All grades of polyethylene glycol are soluble in water and miscible in all
proportions with other polyethylene glycols. Liquid polyethylene glycols are soluble in acetone,
alcohols, benzene, glycerin, and glycols.
Applications:
i. Liquid polyethylene glycols are used as water-miscible solvents for the contents of
soft gelatin capsules. However, they may cause hardening of the capsule shell by
preferential absorption of moisture from gelatin in the shell.
ii. Polyethylene glycols have been used in the preparation of urethane hydrogels, which
are used as controlled-release agent.

EXCIPIENTS PROFILE
MANNITOL
Non-proprietary Names: BP: Mannitol
JP: D-Mannitol
PhEur: Mannitol
USP NF: Mannitol
Synonyms: Cordycepic acid; C PharmMannidex; E421; Emprove; manna sugar; D-mannite;
mannite; mannitolum; Mannogem; Pearlitol.
Chemical Name: D-Mannitol
CAS Registry Number: [69-65-8]
Molecular weight: 182.17
Functional Category: Diluents, plasticizer, sweetening agent, tablet capsule diluents,
therapeutic agent, and tonicity agent.
Melting point: 166-168ºC
Description: Mannitol is D-mannitol. It is a hexahydric alcohol related to mannose and is isomeric
with sorbitol. Mannitol occurs as a white, odourless, crystalline powder, or free flowing granules.
It has a sweet taste, approximately as sweet as glucose and half as sweet as sucrose, and imparts a
cooling sensation in the mouth. Microscopically, it appears as orthorhombic needles when
crystallized from alcohol. Mannitol shows polymorphism.
Solubility:
Soluble in ethanol 1in 83 at 20°C
Soluble in water 1 in 5.5 at 20°C
Practically insoluble in ether
Incompatibilities
 Mannitol is incompatible with xylitol infusion and may form complexeswith some
metals such as aluminium, copper, and iron.
 Mannitol was found to reduce the oral bioavailability of cimetidinecompared to
sucrose.
Applications:
 Mannitol is widely used in pharmaceutical formulations and food products.
 Mannitol is commonly used as an excipient in the manufacture of chewable tablet
formulations because of its negative heat of solution, sweetness, and ‘mouth feel’.

EXCIPIENTS PROFILE
ISOMALT
Non proprietary Names: BP: Isomalt
PhEur: Isomalt
USP: Isomalt
Synonyms: C PharmIsomaltidex; E953; galen IQ; hydrogenated isomaltulose;
hydrogenated palatinose; Isomaltidex 16500; isomaltum; Palatinit.
Chemical Name: D-(þ)-Glucose monohydrate
Empirical Formula and Molecular weight:
C12 H24 O11 - 344.32 (for anhydrous)
C12H24O112H2O -380.32 (for dihydrate)
Melting point: 168–171ºC
Solubility: Soluble in water.
Description: Isomalt is a sugar alcohol (polyol) that occurs as a white or almost white
powder or granular or crystalline substance. It has a pleasant sugar like taste with a mild
sweetness approximately 50–60% of that of sucrose.
Functional Category: Coating agent, granulation aid, sweetening agent, tablet and capsule
diluent, medicated base.
Applications:
 In buccal applications such as chewable tablets it is commonly used because of its
negligible negative heat of solution, mild sweetness, and ‘mouth feel’.
 It is also used widely in lozenges, sugar-free chewing gum, and hard- boiled candies, and
as a sweetening agent in confectionery for diabetics.

EXCIPIENTS PROFILE
HYDROXYPROPYL METHYLCELLULOSE E15

Non proprietary Names: BP: Hypromellose
JP: Hydroxypropyl Methylcellulose
PhEur: Hypromellosum
USP-NF: Hypromellose
Synonyms: Beneccel MHPC; hydroxypropyl cellulose methyl ether; methocel
Chemical Name: Cellulose hydroxypropyl methyl ether
Empirical Formula and Molecular Weight: C56H108O30 - 1,261.45 g/mol
Melting point: 225 to 254ºC
Solubility: Soluble in water.
Description: HPMC is an odorless and tasteless, white or creamy-white fibrous or granular
powder.
Functional Category: Coating agent, film-former, rate controlling Polymer for sustained release.
Applications:
 It is extensively used in the food industry as a stabilizer, as an emulsifier, as a protective
colloid, and as a thickener.
 HPMC is used as a raw material for coatings with moderate strength, moderate moisture
and oxygen barrier properties, elasticity, transparency, and resistance to oil and fat.

EXCIPIENTS PROFILE
CITRIC ACID
Non proprietary Names: BP: Citric Acid Monohydrate
JP: Citric Acid Hydrate
PhEur: Citric Acid Monohydrate
USP: Citric Acid Monohydrate
Synonyms: Acidum citricum monohydricum; E330; 2-hydroxypropane-1,2,3- tricarboxylicacid
monohydrate.
Chemical Name: 2-Hydroxy-1, 2, 3-propanetricarboxylic acid monohydrate
Empirical Formula: C6H8O7H2O
Molecular Weight: 210.14
Melting point: 100ºC
Functional Category: Acidifying agent, antioxidant, buffering agent, chelating agent, flavour
enhancer, preservative.
Description:Citric acid monohydrate occurs as colourless or translucent crystals, or as a white
crystalline, efflorescent powder. It is odourless and has a strong acidic taste. The crystal structure
is orthorhombic.
Solubility:Soluble 1 in 1.5 parts of ethanol and 1 in less than 1 part of water.
Applications:
 Citric acid (as either the monohydrate or anhydrous material) is widely used in
pharmaceutical formulations and food products, primarily to adjust the pH of solutions.
 In food products, citric acid is used as a flavour enhancer for its tart, acidic taste.

EXCIPIENTS PROFILE
MENTHOL
Non proprietary Names: BP: Racementhol
JP: dl-Menthol
PhEur: Menthol, Racemic
USP: Menthol
Synonyms: Hexahydrothymol,2-isopropyl-5-methylcyclohexanol,4-isopropyl-1-
methylcyclohexan-3-ol, 3-p-menthanol, p-menthan-3-ol, d,l menthol, mentholumracemicum,
menthomenthol, mentoli, mentolis, peppermint camphor, racemic menthol.
Chemical Name: (1RS, 2 RS, 5RS)-(±)-5-Methyl-2-(1-methylethyl)cyclohexanol
Empirical Formula: C10H20O
Molecular Weight: 156.27
Functional Category: Flavouring agent, therapeutic agent.
Incompatibilities: Incompatible with: butylchloral hydrate; camphor; chloral hydrate; chromium
trioxide; b-naphthol; phenol; potassium permanganate; pyrogallol; resorcinol; and thymol.
Applications:
Menthol is widely used in pharmaceuticals, confectionery, and toiletry products as a flavouring
agent or odour enhancer. In addition to its characteristic peppermint flavour, l-menthol, which
occurs naturally, also exerts a cooling or refreshing sensation that is exploited in many topical
preparations.

MATERIALS
AND
METHODS
MATERIALS AND METHODS
MATERIALS USED
Table 5.1: Materials used in the formulations
S.No Chemicals Purpose Suppliers
From local Ayurvedic shop,

1. Terminalia Chebula API
Vishakapatnam
From local Ayurvedic shop,
2. Zingiber officinale API
Vishakapatnam
3. HPMC Binder TTK Pharma Ltd, Chennai.
4. Sucrose Sweetener Finar Limited, Ahemadabad
Qualikems Fine Chem Pvt.Ltd.

5. Mannitol Sweetener
Vadodara
6. Isomalt Sweetener Loba Chemie Pvt.Ltd. Mumbai
Salivary stimulating
7. Citric acid Pharma fabrikon, Madurai.
agent
Poly ethylene glycol
8. Humectant Saimirra Innopharm, Chennai
200
Cooling and
9. Menthol TTK Pharma Ltd, Chennai
flavouring agent

INSTRUMENTS USED
Table 5.2: List of the Equipment’s used in experiment
Sl. No INSTRUMENTS SUPPLIERS
1 UV spectrophotometer BVK Technology Services, India
2 Weighing balance Bharat electronics Ltd. India
3 Magnetic Stirrer Shimadzu Corporation, Japan
4 pH meter MC Dalal, India
Sri Siddhi Instruments and

5 Dissolution Apparatus
Chemicals, India
6 FT-IR Shimadzu, Japan
7 Vernier caliper Mitutoyo, Japan
8 Monsanto hardness tester Campbell Electronics

METHODOLOGY
Pre-formulation Studies[54]
Pre-formulation studies were the first step in the rational development of any formulation.
It can be defined as “investigation of physical and chemical properties of the drug substance
alone and combined with the excipients”. These studies focus on those physiochemical
properties of the new compound that could affect drug performance and development of an
efficacious formulation. The overall objective of pre-formulation testing is to generate
information useful to the formulator in developing stable and bio available dosage forms that
can be
 To establish physical characteristics.
 To establish its compatibility with the excipient
Drug-Excipient Compatibility Studies

The proper design and formulation of a dosage form requires consideration for the physical
and chemical characteristics of all drug substances and excipients used in fabricating the final
product. The successful formulation of a stable and effective dosage forms depends on the
careful selection of the excipients that are added in the formulation. The drug and excipients
must be compatible with one another to produce a product that is stable, efficacious and easy
to administer and safe.
Compatibility study was carried out by recording the sample using Fourier Transform
Infra-Red Spectrophotometer (FTIR) in the range of 4000 cm-1 to 400 cm-1 by Potassium
Bromide pellet technique. The spectra was examined and analysed for the study.
Determination of λmax of Terminalia Chebula Powder and Dry Zingiber Officinale

Powder
Terminalia Chebula Powder and Dry Zingiber Officinale Powder solution in phosphate buffer
6.8 was prepared, then the solution was scanned by UV -Visible spectrophotometer from 200-
400 nm. Then λmax of API powders were analyzed from the spectrum.
PREPARATION OF PHOSPHATE BUFFER pH 6.8 [55]

13.609 g of potassium hydrogen orthophosphate dissolved in 500ml of distilled water
to give 0.2M of solution. 4g of sodium hydroxide is dissolved in 500ml of water to give 0.2M
of solution. 500 ml of 0.2M of solution potassium hydrogen orthophosphate and 224ml of 0.2M

sodium hydroxide solution are mixed together and made up to 2 litres concentration with
distilled water.
Preparation of standard graph of Terminalia Chebula
100 mg of Terminalia Chebula was weighed accurately and dissolved in 100mL of phosphate
buffer solution, pH 6.8 in 100 mL volumetric flask. The resulting solution had a concentration
of 1mg/mL (1000µg/mL). From the stock solution, different aliquots of 0.1, 0.2, 0.3 0.4 and
0.5 mL were taken and diluted up to 100 mL with buffer to give concentrations in the range of
1 µg/mL, 2 µg/mL, 3 µg/mL, 4 µg/mL, 5 µg/mL concentration of Terminalia Chebula
respectively. The absorbance of each solution was measured by UV-Visible spectrophotometer
at 285 nm using the phosphate buffer solution, pH 6.8 as blank. The graph of concentration
versus absorbance was plotted.
Preparation of standard graph of Zingiber officinale
100 mg of Zingiber officinale was weighed accurately and dissolved in 100mL of phosphate
buffer solution, pH 6.8 in 100 mL volumetric flask. The resulting solution had a concentration
of 1mg/mL (1000µg/mL). From the stock solution, different aliquots of 0.1, 0.2, 0.3 0.4 and
0.5 mL were taken and diluted up to 100 mL with buffer to give concentrations in the range of
1 µg/mL, 2 µg/mL, 3 µg/mL, 4 µg/mL, 5 µg/mL concentration of Zingiber officinale
respectively. The absorbance of each solution was measured by UV-Visible spectrophotometer
at 281 nm using the phosphate buffer solution, pH 6.8 as blank. The graph of concentration
versus absorbance was plotted.

Formulation of Terminalia Chebula and Zingiber Officinale Lozenges

Table 5.3: Formulation of Terminalia Chebula and Zingiber Officinale Lozenges
Ingredients (mg) F1 F2 F3 F4 F5 F6
Teminalia Chebula
830 830 830 --- --- ---
Zingiber Officinale ---

--- --- 830 830 830
Sucrose 3130 --- --- --- 3130 ---
Isomalt --- 3130 --- 3130 --- ---
Mannitol --- --- 3130 --- --- 3130
HPMC E15 83 83 83 83 83 83
Citric acid 7 7 7 7 7 7
0.1 0.1
PEG 200 0.1 ml 0.1 ml 0.1 ml 0.1 ml
ml ml
Menthol 0.3 0.3 0.3 0.3 0.3 0.3
Purified water q.s. q.s. q.s. q.s. q.s. q.s.
Total (g) 4.00 4.00 4.00 4.00 4.00 4.00
Preparation of Lozenges using Terminalia Chebula powder

The lozenges were formulated by heating and congealing technique. Syrupy base
was prepared in a beaker by dissolving the required amounts of sugar in water and kept for
heating on a hotplate. Temperature was maintained at 105°C-110°C till it became thick. The d
Terminalia Chebula Powder and other excipients (except plasticizer) were added manually and
mixed thoroughly after 30 minutes with continue process of heating. The prepared mass was
further heated for 45 minutes and then plasticizer was added into it. Then above syrupy base
was poured into pre-cooled and pre lubricated mould and the mould was kept aside for 10-15

minutes. Prepared lozenges were separated from mould and were kept for air drying. The
prepared Lozenges were wrapped in aluminium foil and stored in desiccators for the better
storage conditions for the evaluation study and also to prevent the moisture uptake.
Preparation of Lozenges Dry Zingiber Officinale Powder

The lozenges were formulated by heating and congealing technique. Syrupy base
was prepared in a beaker by dissolving the required amounts of sugar in water and kept for
heating on a hotplate. Temperature was maintained at 105°C-110°C till it became thick. The
Dry Zingiber Officinale Powder and other excipients (except plasticizer) were added manually
and mixed thoroughly after 30 minutes with continue process of heating. The prepared mass
was further heated for 45 minutes and then plasticizer was added into it. Then above syrupy
base was poured into pre-cooled and pre lubricated mould and the mould was kept aside for
10-15 minutes. Prepared lozenges were separated from mould and were kept for air drying.
The prepared Lozenges were wrapped in aluminium foil and stored in desiccators for the better
storage conditions for the evaluation study and also to prevent the moisture uptake.
Fig. 5.1:Materials Used for Formulation Of Herbal Lozenges

Fig. 5.2: Process of Formulation of Herbal Lozenges
Evaluation Parameters of Lozenges

Physical Appearance [56]
The characteristics like shape, texture, colour were analysed by visual inspection of each
formulation.
Weight Variation Test: [56]
Five lozenges of each batch were selected and weighed on an electronic balance. From
the collective weight, the average weight and standard deviations are calculated. Individual
weight of each lozenge is also calculated using the same and compared with average weight.
If any weight variation is there, that should fall within the prescribed limits (generally
10% for lozenge weighing 120 mg or less, 7.5% for lozenge weighing 120 mg to 300 mg and
5% for lozenge weighing more than 300 mg):
% Deviation= (Individual weight - Average weight) x100
Average weight
Thickness Test:[56]
The thickness in millimetres (mm) was measured individually for 5 pre weighed
lozenges by using a vernier Calipers. The average thickness and standard deviation are reported.
The thickness of a lozenge can vary without any change in its weight.

Fig No 5.3: Vernier Calipers

Friability test:
The friability of the 5 Lozenges from each batch was tested by a fribilator (Total 30
Lozenges were used). At a speed of 25 rpm for 4 min. The lozenges were then dedusted,
reweighed and percentage weight loss was calculated by the equation,
% Friability = (Initial Wt.- Wt. after friability) × 100
Initial Weight
[56]
Hardness Test:
The hardness of lozenges was measured using a Monsanto Hardness Tester. The
crushing strength of the 5 lozenges with known weight and thickness of each batch was
recorded in kg/cm2 and the average hardness and the standard deviation is reported
Fig No 5.4: Monsanto Hardness Tester

Drug Content Uniformity: [56]
The drug content uniformity was tested by powdering one lozenge in a mortar pestle
and dissolving the powder content in 60ml of methanol in a 200ml volumetric flask and shaken
until completely dissolved and then make up the volume by using phosphate buffer of pH 6.8.
From this 10ml was taken in another volumetric flask diluted with phosphate buffer of pH 6.8
up to 100mland sonicated for 30 min and then the solution was filtered and the absorbance was
recorded at 285 nm and 281 nm respectively.

Moisture Content: [57]

By Gravimetric method, one gram sample is weighed and placed in a desiccator at for
24 hrs. Final weight is subtracted from initial and the difference in moisture content is
calculated:
% Moisture content = Initial weight – Final weight /Initial weight × 100
Mouth dissolving Time: [58]

The mouth dissolving time was determined by in-house method. The time taken by the
lozenge to dissolve completely was determined by placing each lozenge in separate beaker
containing 100 ml phosphate buffer pH 6.8 at 50 rpm using mechanical stirrer and time was
noted at 37°C.
In-vitro Drug Release [56]

The modified dissolution test apparatus USP type II (paddle) is used and 250 ml of the
dissolution medium phosphate buffer pH 6.8 is placed in the beaker containing the lozenge
and stirred at 100 rpm. Five ml aliquot samples are withdrawn at 5 min interval and replaced
immediately with an equal volume of fresh medium i.e., phosphate buffer pH 6.8. Each aliquot
is diluted and analyzed using blank, by UV-Visible spectrophotometer. The amount of drug
release is determined from the standard calibration curve of pure drug.
Following parameters were used for the dissolution study
1. Apparatus : USP dissolution apparatus type II (paddle)
2. Speed of the paddle : 100 RPM.
3. Temperature : 37.5ºC ± 0.5ºC
4. Dissolution medium : Phosphate buffer pH 6.8.
5. Volume of dissolution fluid : 250ml
The samples were analysed at 285 nm and 281 nm respectively using UV-Visible
spectrophotometer.

Fig No 5.5: USP dissolution apparatus type II

Kinetics of drug release 80
Kinetics of drug release was studied by plotting the data obtained from in-vitro release
in various kinetic models.
1. Zero order equation
The graph was plotted as % drug released vs time in hours.
C=K0t
Where,
K0 – Zero order constant in concentration/time
t – Time in hours
The graph would yield a straight line with a slope equal to K0 and intercept the origin of the
axis. Zero order represents an ideal release profile in order to achieve the pharmacological
prolonged action. This is applicable to dosage forms like transdermal and transmucosal
systems, coated forms, osmotic systems, as well as matrix tablets with low soluble drugs.
2. First order equation
The graph was plotted as log % cumulative drug remaining vs time in hrs.
Log C = log C0- Kt /2.303
Where,
C -Initial concentration of drug
K- First order constant.
t- Time in hrs
First order is applicable to study of hydrolysis Kinetics and to study the release profiles
of pharmaceutical dosage forms such as those containing water‐soluble drugs in porous
matrices.

Stability Studies
The optimized formulations were subjected to stability studies at temperature i.e.
40ºC /75% RH for a period of one month. All the evaluations were performed and tabulated.

RESULTS
AND
DISCUSSION
RESULTS AND DISCUSSION
Pre- formulation studies of Terminalia Chebula:
Preliminary studies of Terminalia Chebula were performed and the results were
tabulated.
Table 6.1: API Preliminary studies of Terminalia Chebula
S No Characteristics Results
1. Description Dark brown powder
2. Taste Bitter
3. Odor Strong Unpleasant
Pre- formulation studies of Zingiber Officinale:
Preliminary studies of Zingiber Officinale were performed and the results were tabulated.
Table 6.2: API Preliminary studies of Zingiber Officinale
S No Characteristics Results
1. Description Off- White powder
2. Taste Spicy
3. Odor Pungent
Determination of λmax of Terminalia Chebula
Fig. 6.1: UV spectrum of Terminalia Chebula in phosphate buffer 6.8

Discussion
The maximum absorbance of the Terminalia Chebula was studied and found to be 285 nm.
Hence the wavelength of 285 nm was selected for the analysis of the drug in dissolution media.
Determination of λ max of Zingiber Officinale
Fig. 6.2: UV spectrum of Zingiber Officinale in phosphate buffer 6.8

Discussion
The maximum absorbance of the Zingiber Officinale was studied and found to be 281 nm.
Hence the wavelength of 281 nm was selected for the analysis of the drug in dissolution media.
Drug-Excipient Compatibility Study

The drug excipient study was conducted to reveal the excipient compatibility with the drug.
Table No 6.3: Physical Compatibility of Drug and Excipients
Room Temperatureand
40ºC/75% RH in days
S No Drug+Excipients Description and Condition
10th 20th 30th
Terminalia
1. Light brown powder NC NC NC
Chebula
2. Zingiber Officinale Light yellow powder NC NC NC
3. Mannitol White crystalline powder NC NC NC
4. Isomalt White powder NC NC NC
5. HPMC E15 White powder NC NC NC
6. Citric Acid White crystalline powder NC NC NC
NC-No Change

Discussion
From the physical compatibility was observed visually. The study reveals that the drug andthe
excipients were physically compatible with each other as there was no change of colour. The
excipients are compatible with the drug selected for the formulation.
FTIR spectral analysis of herbal powders and excipients
Fig. 6.3: UV spectrum of Terminalia Chebula
Fig. 6.4: UV spectrum of Terminalia Chebula and selected excipients in formulation

Fig. 6.5: UV spectrum of Zingiber officinale
Fig. 6.6: UV spectrum of Zingiber officinale and selected excipients in formulation

Table: 6.4: FTIR spectral interpretation of herbal powders and excipients
Terminalia Zingiber
Functional Terminalia Chebula and Zingiber officinale
Stretching
group chebula selected officinale and selected
excipients excipients
Ar-NH2 3500-3350 3500-3350 3394.4 -
CO-NH 1700-1500 1700-1500 1635.5 -
Ar-C=C 1600-1400 1600-1400 1596.9 -
C-O-C 1250-1050 1250-1050 1265.2 -
5 C-Cl3 800-600 - 678.8 -
Discussion
There was no disappearance of characteristic peaks of drug in FT-IR Spectra. Hence there was no
interaction between herbal powder and the selected excipients in the formulation
Standard Curve of Terminalia Chebula in pH 6.8 phosphate buffer

Table 6.5: Standard calibration curve of Terminalia Chebula
Concentration (µg/ml) Absorbance at 285 nm
0 0
2 0.106±0.005
4 0.215±0.005
6 0.295±0.003
8 0.402±0.005
10 0.512±0.004

0.6
0.5
0.4
y = 0.0511x
Absorbance
R² = 0.999
0.3
0.2
0.1
0
0 2 4 6 8 10 12
Concentration (µg/ml)
Fig. 6.7: Standard calibration curve of Terminalia Chebula
Discussion
The λ max was obtained at 285 nm in pH 6.8 phosphate Buffer. The standard calibration curve
for sofosbuvir with regression value of 0.9997. The relation between drug concentration and
absorbance was linear and the curve obeyed Beer–Lamberts law within the concentration range
of 2 to 10 µg/mL.
Standard Curve of Zingiber Officinale in pH 6.8 phosphate buffer

Table 6.6: Standard calibration curve of Zingiber Officinale
Concentration (µg/ml) Absorbance at 281 nm
0 0
2 0.115±0.005
4 0.213±0.005
6 0.315±0.003
8 0.413±0.005
10 0.522±0.004

0.6
0.5
0.4
y = 0.0527x
%CDR R² = 0.9989
0.3
0.2
0.1
0
0 2 4 6 8 10 12
Concentration (µg/ml)
Fig. 6.8: Standard calibration curve of Zingiber Officinale

Discussion
The λ max was obtained at 281 nm in pH 6.8 phosphate Buffer. The standard calibration curve
for sofosbuvir with regression value of 0.9997. The relation between drug concentration and
absorbance was linear and the curve obeyed Beer–Lamberts law within the concentration range
of 2 to 10 µg/mL.
Evaluation Of Terminalia Chebula And Zingiber Officinale

Table 6.7: Evaluation of Terminalia Chebula and Zingiber Officinale
Weight Mouth Moisture
Formulati Thickness Hardness Drug content
variation dissolving Content
on code (mm) kg/cm2 (%)
(g) time (mins) %
F1 4.10±0.52 10.24 ±0.051 10.5 ±0.57 10.16±0.51 1.19 93.13±2.32
F2 4.02±0.57 10.01 ±0.044 10.75 ±0.92 11.00±0.3 1.44 91.43±3.31
F3 4.04±0.64 10.02 ±0.043 7.3 ±0.42 7.06±0.43 0.69 94.84±3.85
F4 4.01±0.68 10.24±0.054 13.6±0.64 12:50±0.19 1.02 98.24±3.52
F5 4.09±0.73 10.25±0.057 10.65±0.57 15:61±0.45 1.15 90.22±2.50
F6 4.03±0.81 10.24±0.041 8.6+0.49 10.47±1.25 0.84 95.15±2.65

Discussion:
The Lozenges of different formulations of Terminalia chebula and Zingiber officinale were
subjected to evaluation tests such as weight variation, thickness, pH and uniformity of content.
A) Weight Variation:
The average weight of 6 lozenges was taken to determine weight variation from each
formulated lozenge. There was no specified deviation in the weight of lozenges, comparing
each formulation. This indicates the uniform weight of the prepared lozenges.
B) Thickness:
Thickness of the lozenges was found to be in the uniform range of 10.01-10.25mm. The mean
values are tabulated. The values are almost uniform in all formulations.
C) Hardness:
The hardness of all formulated lozenges was found within the range up to 7.3 kg/cm2 to 13.6
kg/cm2.Among the six formulations of lozenges, the lowest value for hardness was noted for
F3 (i.e., 7.3 kg/cm2) and highest i.e., 10.75kg/cm2 for F2.
D) Moisture Content:
Moisture content determination is a critical parameter of lozenges quality. It influences
lozenges manufacturing and packaging. The standard limits of moisture content should be in
the range of 0.5 to 1.5 %. As per the result obtained that moisture content in the prepared
lozenges was found in the range 0.5 to 1.5 % which is within the standard limits.
E) Drug content:
The drug content of all lozenges (F1 to F6) is within 90% to 115% as per specification when
compared with the Terminalia Chebula and Zingiber Officinale (IP2018), Volume II).
Formulation Drug Content Uniformity

120
PERCENTAGE DRUG
100
CONTENT(%)
80
60
40
20
F1 F2 F3 F4 F5 F6
FORMULATIONS
Fig 6.9: Percentage drug content uniformity of formulated medicated lozenges

In-Vitro Dissolution Study Of Formulated Terminalia Chebula And Zingiber Officinale

Lozenges
Table.6.8: In-vitro drug release profile of herbal lozenges
Time Percentage Drug Release (%)
(min.) F1 F2 F3 F4 F5 F6
0 0 0 0 0 0 0
5 53.64±0.15 73.24±0.21 84.54±0.12 71.54±0.42 51.50±0.22 63.08±0.28
10 74.28±0.26 92.46±0.64 96.38±0.34 96.86±0.27 88.06±0.14 82.02±0.34
15 99.42±0.42 -- -- 101.12±0.28 96.58±0.16 97.74±0.46
20 -- -- -- -- 100.22±0.32 ---
Dissolution Profile of Lozenges containing Terminalia

120 Chebula F1-F3
100
80
%CDR
60
F1 F2 F3
40
20
0
0 5 10 15 20 25
Time (min)
Fig.6.10: In-vitro drug release profile of herbal lozenges containing Terminalia Chebula

Dissolution Profile of Lozenges containing

Zingiber Officinalis F4-F6
120
100
80
%CDR
60
F4 F5 F6
40
20
0
0 5 10 15 20 25
Fig.6.11: In-vitro drug release profile of herbal lozenges containing

Zingiber Officinalis
The cumulative percentage of drug release for the F1 which contains the sucrose as sugar
showed 99.4 % at 15 minutes. F2, F3 formulations containing Isomalt and mannitol as a base
showed the drug release 92.4 %, 96.8 % respectively within 10 minutes.
In F4 formulation isomalt as a sugar base it showed the drug release 101 % at 15 minutes. F5
formulation showed the release rate at 100.22% within 20 minutes. For F6 cumulative drug
release 97.7% at 15 minutes.
Hence the formulation F4 containing isomalt as a base which showed 101.12% drug release
at the end of 15 minutes was considered as the optimized formulation.

In-vitro RELEASE KINETICS
Zero order kinetics

120
y = 3.42x + 7.3429
100 R² = 0.9569
Cum. % Drug release
80
60
Linear (Cum. % Drug
40 release)
20
10 20 30 40
Time (mins)
Fig.6.12: Zero order Kinetics for optimized formulation (F4)
First order Kinetics

2.5
Log Cum. % drug remaining
y = -0.0436x + 2.0903
R² = 0.9635
1.5
Linear (Log Cum. % Drug

release)
0.5
10 15 20 25 30
Time (mins)
Fig.6.13: First order kinetics for optimized formulation(F4)

Table.6.9: The summarized data of the In vitro release kinetics
Interc
S.No Data fitted in X-axis Y-axis Slope R2 Linear equation
ept
Cumulative
Zero -order Time in
1 % drug y = 3.42x + 7.342
equation hours
Release 3.42 9.757 0.956
Log
cumulative
First -order y=-0.043x+ 2.090
2 Time in drug
equation 0.043 2.090 0.963
hours remaining
The order of release of the drug was found to be first -order, in which R2 valuewas
close to 1 than the value compared to R2 of the zero-order equation. Thus the release
kinetics of the optimized formulation showed first order release with Non-fickian
diffusion.
STABILITY STUDIES
Table.6.10 Evaluation parameters after the stability studies
EVALUATION OPTIMIZED AFTER STABILITY
PARAMETER FORMULATION(F4) STUDY OF 1 MONTH

Weight variation 4.01± 0.0290 3.99 ± 0.030
Hardness 13.60±0.64 13.13 ±0.08
Thickness 10.24± 0.054 11.08 ± 0.16
Moisture Content 1.02% 0.95 %
Mouth dissolving Time 12:50±0.19 13:20±0.98
Content uniformity 98.24%±3.52 96.48±1.20
Drug release 101.12% 99.7%

Stability studies for F4

120
100
Percentage CDR
80
60
40 F4 F4 after 1 month
20
0
0 2 4 6 8 10 12 14 16
Time In mins
Fig .6.14: Comparative cumulative % drug release curve for the optimized formulation
(F4)
The optimized formulations were subjected to stability studies at temperature i.e. 45ºC
/75% RH for a period of one month. There is no change in physicochemicalproperties after
performing stability studies. There is no relative change in the release kinetics of the formulation
F4 after stability studies.

Summary
And
Conclusion
SUMMARY AND CONCLUSION
SUMMARY
The present study was aimed to formulate and evaluate Terminalia chebula and Zingiber
Officinale lozenges to provide the antitussive action through the buccal absorption by the
addition of polymer.
 The lozenges were formulated by heating and congealing technique using different
types of sugar bases.
 Physical compatibility study showed that the drug and excipients are physically
compatible with each other.
 The average weight of 6 lozenges was taken to determine weight variation from each
formulated lozenge. There was no specified deviation in the weight of lozenges,
comparing each formulation. This indicates the uniform weight of the prepared
lozenges.
 Chemical compatibility study was performed using FT-IR spectroscopy and FT-IR
studies revealed that there was no change in major peaks, thus confirming no
interactionbetween the drug and excipients.
 After performing formulation of batches for sugar selection (F1 to F4), the
observations were reported. Mannitol was easily dissolved in water, but the mass
formulated with mannitol was stuck on the wall of beaker while heating and thick
viscous mass was not obtained. The batches formulated with dextrose and sucrose
showed re-crystallization of sugars. Batch formulated with isomalt showed hard
candy type lozenges, but the appearance was not good. Due to lack of physical
appearance, it was decided to add plasticizer in further formulations.
 All formulations were prepared and evaluated for in-vitro drug release, physical
appearance, weight variation, thickness, hardness, moisture content, mouth
dissolving time and drug content.
 The formulation F4 containing isomalt as a base which showed 101.12% drug
release at the end of 15 minutes was considered as the optimized formulation.
 The formulated lozenges showed the uniformity in weight and thickness.
 The hardness of all formulated lozenges was found within the standard range up to
7.3 kg/cm2 to 10.75 kg/cm2.
 Mouth dissolving time of medicated lozenges was found to be within the range upto

7:06 to 15:58 minutes. F5 formulation showed the maximum time to dissolve in a

medium.
 The standard limits of moisture content should be in the range of 0.5 to 1.5 %.
 As per the result obtained that moisture content in the prepared lozenges was
found in the range 0.5 to 1.5 % which is within the standard limits.
 The drug content of all formulated lozenges (F1 to F6) was within the
acceptable limits (90% -100%).
 The order of release of the drug was found to be first -order, in which R2
value was close to 1 than the value compared to R2 of the zero-order
equation. Thus the release kinetics of the optimized formulation showed
first order release with Non-fickian diffusion.
 The optimized formulations were subjected to stability studies at temperature i.e.
45ºC /75% RH for a period of one month. There is no change in physicochemical
properties after performing stability studies. There is no relative change in the
release kinetics of the formulation F4 after stability studies.

CONCLUSION
 From the present work, it can be concluded that Zingiber officinale with Isomalt can
be successfully used as the tooth friendly sugar substitute in the formulation of
medicated lozenges and owing to its low caloric value and its ability to withstand
formation of plaques, it could be used safely for diabetic and pediatric patient
concerns.
 It is found that candy based medicated lozenges will be an alternative dosage form.
These will have additional advantages of patient compliance, convenience and
comfortness for efficient treatment including low dose, immediate onset of action,
reduced dosage regimen and economy.

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FORMULATION AND IN-VITRO EVALUATION OF HERBAL

LOZENGES USING ZINGIBER OFFICINALE AND

AVANTHI INSTITUTE OF PHARMACEUTICAL SCIENCES

CERTIFICATE BY THE PRINCIPAL

OF HERBAL LOZENGES USING ZINGIBER OFFICINALE AND TERMINALIA

was carried out by MAJJI PURNIMA (20T51R0060), MAKKA KEERTHANA

(20T51R0061), MASA SAMUEL RAJ (20T51R0062), METTA GAYATHRI

(20T51R0063), MODALAVALASA SRAVANI (20T51R0064) under the supervision of

Mr. A Nanaji, Associate Professor and guidance at Avanthi Institute of Pharmaceutical

I Mr. A Nanaji, Associate Professor of Avanthi Institute of Pharmaceutical sciences,

Cherukupally-531162 certify that the project work on “FORMULATION AND IN-VITRO

EVALUATION OF HERBAL LOZENGES USING ZINGIBER OFFICINALE AND

TERMINALIA CHEBULA ” by MAJJI PURNIMA (20T51R0060), MAKKA KEERTHANA

(20T51R0061), MASA SAMUEL RAJ (20T51R0062), METTA GAYATHRI (20T51R0063),

MODALAVALASA SRAVANI (20T51R0064) of Ⅳ B. Pharmacy students of 2020-2024 is a

Technological University-GV, Vizianagaram, 531162 to meet academic regulations of 2020-2024

batch for the award of Bachelor of degree in Pharmacy.

CERTIFICATE BY THE EXAMINER

This is to certify that the thesis entitled “FORMULATION AND IN-VITRO

The work embodied in this project entitled “FORMULATION AND IN-

VITRO EVALUATION OF HERBAL LOZENGES USING ZINGIBER OFFICINALE

AND TERMINALIA CHEBULA” was carried out by MAJJI PURNIMA (20T51R0060),

MAKKA KEERTHANA (20T51R0061), MASA SAMUEL RAJ (20T51R0062), METTA

GAYATHRI (20T51R0063), MODALAVALASA SRAVANI (20T51R0064) at Avanthi

Institute of Pharmaceutical sciences, Cherukupally, Vizianagaram district, Andhra Pradesh,

degree of this or any other university and institute.

Masa Samuel Raj

API Active Pharmaceutical Ingredients

Chapter Title Page No

2 LITERATURE REVIEW 18-29

3 AIM AND OBJECTIVES 30

4 PLANT AND EXCIPIENT PROFILE 31-39

5 MATERIALS AND METHODOLOGY 40-50

6 RESULTS AND DISCUSSION 51-6

7 SUMMARY AND CONCLUSION 64-66

Table No Name of the table Page No

1.1 Additives Used in Lozenges Formulation 6

1.2 Marketed lozenges and their ingredient 17

5.1 Material used in the formulation 40

5.2 List of the equipments used in experient 41

5.3 Formulation of Terminalia Chebula and Zingiber 43

6.2 API Preliminary studies of Zingiber Officinale 50

Physical Compatibility of Drug and Excipients 51

FTIR spectral interpretation of herbal powders and 54

Standard calibration curve of Terminalia Chebula 54

Standard calibration curve of Zingiber Officinale 55

Evaluation of Terminalia Chebula and Zingiber 56

In-vitro drug release profile of herbal lozenges 58

The summarized data of the In vitro release kinetics 61

Evaluation parameters after the stability studies 61

Table No Name of figures Page No

1.2 Hard lozenges 4

6.2 UV spectrum of zinger officinale in phosphate 51

Avanthi Institute of Pharmaceutical Sciences 1

Definition: Lozenges are a type of solid medication that dissolves or disintegrates

Avanthi Institute of Pharmaceutical Sciences 2

Avanthi Institute of Pharmaceutical Sciences 3

Fig No. 1.1 Chewable lozenges

B. HARD LOZENGES [9, 10]