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SYRUPS

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SYRUPS

Syrups consist of sugar in water. These are highly concentrated, viscous


preparations. They may or may not contain therapeutic agent. These are
advantageous as they contain very less or no alcohol, it can be administered to
small children. But patients who have to take food having less calories should be
aware of amount of sugar present in liquid orals.
Syrups are classified into three types:

Simple syrup: When water alone is used for the preparation of solution of
sucrose, the preparation is called simple syrup.

Eg: Simple syrup IP consists of 66.7%w/w of sucrose in water.

Medicated syrups : When syrups contain certain medicated substances , which


are used for therapeutic purpose are called medicated syrups.

Eg: Codeine phosphate syrup, Ephedrine sulphate syrup

Flavoured syrups: When syrups containing only aromatic or flavouring agents,


they are called flavoured syrups. These are used as flavouring agents, for masking
the disagreeable, bitter or saline taste of drugs.

Eg: Orange syrup, lemon syrup, Raspberry syrup

Formulation of syrups :

Vehicles purified water,


Glycerin.

Chemical stabilizers a) poly-hydric alcohols like glycerin,


sorbitol and propylene glycol.

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b) Surfactants (eg : tweens) used to
dissolve certain ingredients in syrup.

Coloring agents Amaranth solution, Compound


tartarazine solution.

Flavoring agents Tinctures : Tincture of lemon,


Tincture of ginger

Fruit juices : Raspberry juice, Wild


cherry juice

Essences : Vanilla flavor, Orange


flavor

Preservatives Benzoic acid, Sodium benzoate

Effect of concentration on various factors is as follows:


 If the solution is saturated and if the temperature decreases, it results in the
crystallization.
 The sugar solution should be near to saturation point, but should not be
saturated.
 The solution at low concentration favors the growth of moulds but at higher
concentration stops the growth of organism.
Preparation of the syrup:
There are four methods. Based on the physical and chemical properties of the
ingredients, the method is selected.

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1. Solution with heat: The temperature of purified water is increased to 80 to 85
C and then taken off from the heat source. Then add sucrose and shake it
thoroughly. The ingredients which are resistant to high temperatures are added.
Those substances that are heat sensitive and volatile agents are added after the
solution attains the room temperature. But during heating, the sucrose gets
hydrolysed, results in the formation of dextrose and fructose, these two sugars are
together called as invert sugar and the process is known as inversion. This
reaction takes place more rapidly in presence of acids. The inversion leads to
darkening of the solution.
2. Agitation without heat: This is a simple technique in which a vessel is taken
generally made up of stainless steel or glass. The vessel should be larger than the
desired volume of syrup required. Then the ingredients according to the
formulation are added to water and mixed. It is better to dissolve solid ingredients
in the water first and then add them to syrup. This results in easy mixing as sugar
solution generally retards mixing.
3. Addition of sucrose to liquid medicament: This method is generally used for
fluid extracts. But those substances which are soluble in alcohol will precipitate
out as soon as the addition of water. An alternate is to first dissolve all the
ingredients in water. Now after sometime all the precipitates formed are filtered
out. Now add sucrose. But this method is of no use if the precipitates formed have
active ingredients.
4. Percolation method: As the name suggests, the principle of percolation is
used. A sucrose bed is prepared and then water or vehicle containing therapeutic
agent is passed. Here the sucrose bed should be coarse and the shape of percolator
must be cylindrical or cone shaped.
Sucrose syrups are replaced by agents like sorbitol solution or mixture of sorbitol
and glycerin. Sorbitol is osmotic laxative and so it must be administered within
the limits. Sorbitol solution contains about 64% of sorbitol.

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Advantages of syrups :

1) Syrups retard oxidation reaction, because it is partially hydrolysed into


reducing sugars, dextrose and levulose, which acts as anti oxidants and prevent
the oxidation of the medicament.

2) Syrup prevents the growth of micro organisms , which are the chief cause of
decomposition, because strong solution of sugar has great osmotic pressure due to
which it withdraws water from the micro organisms.

3) Syrups are used as sweetening agent for masking the taste of bitter drugs.

Disadvantages :

1) Syrups is highly concentrated leads to crystallization of sucrose.

2) Syrups are not suitable for diabetic patients.

Dispensing of syrups :

Simple syrups are dispensed in bulk volumes but medicated syrups are dispensed
in small volumes. Syrups should be dispensed in well dried, completely filled and
well stopped bottles because, moisture present in the wet bottles and atmospheric
moisture causes fermentation of the sucrose. Therefore they should be dispersed
in narrow mouthed amber coloured bottles, fitted with white, poly propylene
moulded or black thermosetting plastic screw cap.

Storage : Syrups are very sensitive to light, moisture and temperature. Cold place
induces the crystallization of sucrose and warm place favors fermentation and
also caramelization. Therefore syrups should be stored at fairly cool temperature
not exceeding 25oc, in dark place.

Label : The label must bear all the necessary requirements of liquid dosage forms.
In addition it should contain auxiliary label like ‘ store at fairly cool temperature,
not exceeding 250c in dark place.
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Date : Experiment No. :

SIMPLE SYRUP IP

Aim : Prepare and submit 20gms of simple syrup IP.

Requirements:
Apparatus: weighing balance, beaker, stirrer, measuring cylinder.
Chemicals : Sugar and Purified water

Formula

Ingredients Standard Working


Sucrose 667gms 13.34gms

Water 1000gms 20gms

Principle : Simple syrup (IP) is a concentrated, nearly saturated viscous solution


of sucrose in purified water. It contains 66.7% w/w of sucrose in purified water.
Sucrose at 66.7% w/w exerts high osmotic pressure which withdraws water from
micro organisms and causes their dehydration followed by death. Simple syrup
(IP) is prepared by solution heat method.

Procedure : Clean all the glassware and dry them according to sop (standard
operating procedure). Take accurate quantity of sucrose and dissolve it in 3/4 th of
volume of total volume of purified water in a beaker. Heat the solution on a water
bath with occasional stirring and add remaining amount of purified water to
dissolve sucrose completely. Allow to cool the solution to room temperature and
filter it through muslin cloth. Transfer the preparation into narrow mouth like
resistant container. Label and submit.

Category: pharmaceutical aid

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Uses : It is used as sweetening agent and vehicle

Storage: stored in a tightly stored container, away from sunlight.

Report :

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Date : Experiment
No. :

PARACETAMOL PEDIATRIC SYRUP IP

Aim : To prepare and submit 20ml of paracetamol pediatric syrup IP

Requirements:

Apparatus: weighing balance, beaker, stirrer, measuring cylinder.

Chemicals : Paracetmol, sucrose, glycerin, distilled water, methyl paraben, citric


acid, colouring agent.

Formula : Part 1 :

Ingredients Standard Formula Working Formula


Paracetmol
Polyethylene glycol
Glycerin
Distilled water
Part 2 :

Ingredients Standard Formula Working Formula


Sucrose
Methyl Paraben
Propyl Paraben
Citric acid monohydrate
Sodium Saccharin
Sunset yellow
Sodium benzoate
Orange flavour
Distilled water

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Principle :

Paracetamol is insoluble in 1gm in 70ml of water 8ml of ethanol , 9ml of


propylene glcol, 50ml of chloroform and 50 ml of glycerin . Due to poor
solubility aqueous preparation, only water is not sufficient as a solvent. The non
aqueous solvents due to toxicity cannot be used in higher proportion. Therefore
monophasic liquid forms of paracetamol are prepared by co-solvency technique.
Paracetamol is chemically more stable between pH 5 and pH 6 . Propyl paraben,
methyl paraben, Sodium benzoate are used as preservatives.

Procedure :

Step -1 :

Polyethylene glycol is heated at 50 C paracetamol is added to it. stir the solution


for 30 min. Glycerin is heated separately and added to above solution with
continous stirring. Stirring is continued till transparent solution is obtained.

Step- 2:

Water was taken in a beaker and heated. To it sucrose was added and stirred until
it dissolves completely. If necessary it has to be filtered. citric acid monohydreate
methyl paraben, propyl paraben, sodium saccharin, sodium benzoate were added
to the solution and stirred continuously.

Step 3:

Under continuous stirring Step-1 solution was added to step-2 solution until a
clear solution was obtained. pH range was checked it should be between 3.8 to
6.1(if not add citic acid) colouring and flavoring agents were added to above
preparation.

Storage : Store in light resistant container in a cool and dry place.

Caution : Overdose may be injurious to lives.

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Category : Anti pyretic

Directions to use: Teaspoonful 3-4 times a day.

For 1-3yrs of age : ½ Teaspoonful 3-4 times a day.

For 3-7 yrs of age : 1 Teaspoonful 3-4 times a day.

For 7-12 yrs of age : 2 Teaspoonful 3-4 times a day.

Report :

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ELIXIRS

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ELIXIRS

Elixirs are clear, pleasant flavored,sweetened hydro alcoholic liquid preparation


meant for oral administration. In elixirs the percentage of alcohol varies from 4-
40%. Glycerin and syrup are used in elixirs either from enhancing the solubility of
medicament or for sweetening agent. Elixirs have low viscosity than syrups and
they can flow more freely as there will be very less use of agents that increase
viscosity like sucrose. There is no clear cut difference between elixirs and syrups.
To call a formulation as elixir, it must be hydro alcoholic and the amount of
alcohol may vary greatly.

Elixirs are classified into two types


Non-medicated elixirs:
These are the elixirs which do not contain any medicament but consists of some
aromatic pleasantly flavored substances. these elixirs are used as vehicle for the
preparation of other pharmaceutical liquid formulations.
ex: Simple elixir IP, Aromatic elixirs.

Medicated elixirs:
These elixirs contain some medicinal substance along with other
excipient .
Example : Paracetamol elixirs, Piperazine elixirs.

FORMULATION OF ELIXIRS
INGREDIENTS EXAMPLES
Vehicles Water, alcohol
Preservative propylene glycol, methyl paraffin
Sweetening agent sucrose,sorbitol syrup, invert syrup
Flavouring agent Aromatic water,tincture of lemon,
orange oil
Colouring agent amaranth solution,tartarazine solution

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Stabilizers EDTA,citric acid

DISPENSING
Elixirs consists of alcohol and flavouring agents, which are volatile in nature.
Therefore to prevent their volatilization elixils should be dispersed in tightly
closed, narrow mouthed, screw capped, light resistant bottle.

Medicated elixirs are dispensed in small volume, and non medicated


elixirs are dispensed in large volume bottles.

STROAGE
Elixirs should be stored in a cool place, to prevent the volatilization at
higher temperature.

Label: Label must bear all necessary requirements of liquid dosage forms meant
for internal use. In addition, the amount of alcohol content used should be
mentioned on the label.

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Date : Experiment No. :

PARACETAMOL PAEDIATRIC ELIXIR.

Aim : To prepare and submit 20ml of paracetamol pediatric elixir.


Requirements
Apparatus : spatula, measuring cylinder, beakers, weighing balance
Chemicals : Paracetamol, ethanol, propyleneglycol, concentrated raspberry juice,
chloroform spirit, amaranth solution, glycerin, invert syrup.

Formula

Ingredient Standard value Working value


Paracetamol
ethanol
propylene glycol
Concentrated raspberry
juice
chloroform spirit
amaranth solution
Glycerin
invert syrup

Principle : Paracetamol is sparingly soluble in water and is freely soluble in


alcohol. Therefore, alcohol is used to dissolve paracetamol. Propylene glycol is
used as co-solvent. Paracetamol has unpleasant taste to mask this taste, invert
syrup (contains fructose and glucose) is used instead of simple syrup, as sucrose
is present in simple syrup which is insoluble in alcohol. Along with invert syrup,
concentrated rasberry juice is used as flavoring agent where as amaranth solution

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is used as colouring agent. Glycerin is used to increase the viscosity of
preparation.
Procedure : Accurately weigh the paracetamol, dissolve in alcohol and propylene
glycol. To the above mixture. Add chloroform spirit. Add conc. Raspberry juice
along with invert syrup with stirring. Add amaranth solution and make up to the
final volume with glycerin.
Dispensing : Paracetamol pediatric elixir should be dispensed in a tightly closed,
narrow screw capped ,light resistant bottle
Dose : 5-10ml is according to the age of the patient
Direction : One teaspoonful to be taken, morning and night.
Storage : stored in cool place.
Label : Label must bear all necessary requirements of liquid dosage form, meant
for internal use. In addition, the amount of alcohol content used in the preparation,
should be mentioned on the label.
Uses : Paracetamol pediatric elixir is used as antipyretic and analgesic.
Report :

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Date : Experiment no.:

PIPERAZINE CITRATE ELIXIR IP

Aim : To prepare and submit 20ml of piperazine citrate elixir IP.


Requirements
Apparatus : Beakers, glass rod, measuring cylinder, weighing balance, spatula.
Chemicals : Piperazine citrate, chloroform spirit, glycerin, orange oil ,simple
syrup, water.
Formula :

Ingredients Standard Formula Official formula


Piperazine citrate
chloroform spirit
Glycerin
orange oil
simple syrup
Water

Principle: Piperazine citrate is an anti-helimenth drug. In salt form the drug is


soluble in water. The alcohol present in chloroform spirit is enough to prepare
hydroalcoholic preparation of piperazine citrate. Glycerin act as co-solvent.
Piperazine citrate has unpleasant taste hence sweetening like simple syrup and
flavoring agent like orange oil is used for masking the unpleasant taste.

Procedure : Accurately weigh piperazine citrate and dissolve in purified water.


Dissolve orange oil in chloroform spirit and add this mixture to piperazine citrate
solution. To the above solution add simple syrup and glycerin. mix uniformly and
adjust the volume with purified water.

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Dispensing : This should be dispensed in tightly closed, narrow mouthed, screw
capped,light resistant bottle.

Dose : For the treatment of roundworm a single dosage of is given according to


the age of person.
For children : 9 to12 months – 2.5ml
2 to 3 years – 5ml
4 to 6 years – 7.5 ml
7 to 12 years – 10ml

For treatment of worms 4-15ml daily in divided dosage is given.

Storage : Stored in a cool place, to prevent the volatilization at higher


temperature.
Uses : Piperazine citrate expels the round worms and thread worms from the
intestine, therefore this elixir is used as antihelmintic.

Report :

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LINCTUSES

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LINCTUSES

Liniments are alcoholic or oleaginous solutions or emulsions of various medicinal


substances intended to be rubbed on the skin. Liniments with an alcoholic or
hydroalcoholic vehicle are useful when rubefacient, counterirritant, or penetrating
action is desired; oleaginous liniments are employed primarily when massage is
desired. By their nature, oleaginous liniments are less irritating to the skin than
alcoholic liniments.

Linctuses should be taken as such without dilution with water in small dose and
must be swallowed slowly, in order to have maximum prolonged action of the
drug, on mucous membrane of the throat.

The one dose of linctus is 5ml and supplied in multi dose container, containing
15-20 doses together.

They contain medicament which have demulscent , sedative expectorant action

Formulation:

1) vehicle : invert syrup , glycerine, chloroform , water

2) Stabiliser : syrups, invert syrup.

3) Coloring agent : compound tartarazine solution , amaranth solution

4) Flavouring agent : Fruit flavoured syrup , lemon syrup, Tolu syrup.

5) Preservation : Benzoic acid , chloroform spirit, cinnamic acid

Dispensing : Linctuses should be dispensed in well filled, well closed air tight,
light resistant glass bottle, closed with metallic screw cap.

Directions : TO BE SIPPED SLOWLY IN SMALL DOSES

DO NOT DILUTE WITH WATER BEFORE USE.

Storage : Linctuses should be stored in a cool place away from sunlight .

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Date : Experiment No. :

SIMPLE LINCTUSES BPC

Aim: To prepare and submit 20ml of simple linctuses BPC

Requirements :

Apparatus : Spatula , measuring cylinder, beaker, glass rod

Chemicals:- concentrated anise water, citric acid, amaranth solution, chloroform


spirit, simple syrup

Formula:

Ingredients Standard formulae Working formulae


Citric acid
Concentrated anise
water
Amaranth solution
Chloroform spirit
Simple syrup

Principle:

Citric acid monohydrate and concentrated anise water acts as expectorant and
astringent both are miscible in water. Even though they are soluble in water,.
Simple syrup is used as vehicle to mask the unpleasant taste of citric acid , it also
acts as demulscent. Chloroform spirit and concentrated anise water are used as
flavoring agent, preservative . Amaranth solution is used as coloring agent.

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Procedure : Weigh required quantity of citric acid monohydrate and dissolve in
chloroform spirit . Add all remaining liquid ingredients to above solution and mix
uniformly. Adjust final volume with sufficient quantity of simple syrup.

Dispensing :- Transfer the linctuses to a narrow mouthed, light resistant, glass


bottle, close thoroughly with metallic screw cap, polish and label.

Direction to use: sip 5ml of linctuses and swallow slowly

Dosage: 5ml twice a day

Storage: Linctuses is stored in a cool place and protected from light.

Auxillary label : STORE IN A COOL AND DARK PLACE.

DO NOT DILUTE WITH WATER BEFORE USE.

Uses : Simple linctuses is used as demulcent, expectorant in treatment of cough.

Report:-

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SOLUTIONS

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SOLUTIONS

Solutions are monophasic liquid preparations. They may be stable or unstable.


The solutions are homogenous, one phased system consisting of 2 or more
components. One component is solvent in which the dispersion occurs. The other
is solute which is dispersed as small ions/molecules in solvent. In general, the
solvent part is greater than the solution part (except in some preparations like
simple syrup).

Formation of solution:
The following additives are required for preparation of solution:

 Solvents:
Aqueous - water
Non-aqueous- alcohol, oils
 Buffers: carbonates, citrates, gluconates, lactates
 Density modifiers
 Flavours and perfumes
 Preservatives
 Anti-oxidants and reducing agents

The official solutions are classified as:

1) Solutions for internal administration


i) Solutions used orally either as such or as an ingredient. E.g.:
aqueous iodine solution
ii) Some solutions are used orally which contain medicament. E.g.:
morphine, hydrochloride solution
iii) Some solutions used as additives. E.g.: sorbitol solution, benzoic
acid solution

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2) Solutions for external application: they are used alone or as an ingredient
for other pharmaceutical preparations. E.g.: Ammonium acetate solution,
ferric chloride solution
3) Solutions used as antiseptic and disinfectant. E.g.: cresol soap solution,
strong iodine solution.

Containers: narrow mouthed, screw cap, colorless plain bottle.

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Date : Experiment No. :

STRONG SOLUTION OF AMMONIUM ACETATE

Aim: To prepare and submit 20 ml of strong solution of ammonium


acetate.
Requirements:
Apparatus: Beaker, glass rod, spatula, water bath.
Chemicals: Glacial acetic acid, ammonium bicarbonate, ammonia
solution.
Formula:

Ingredients Standard formula Working formula


Glacial acetic acid
Ammonium
bicarbonate
Strong ammonia
solution
Water

Principle:

Strong ammonium acetate solution contains 51.5% w/w of ammonium


acetate. It is obtained by neutralization reaction between glacial acetic
acid, ammonium bicarbonate and strong ammonia solution. In this
preparation, strong alkali like ammonium bicarbonate and ammonia are
used. For complete neutralization of glacial acetic acid either ammonium
bicarbonate or strong ammonia solution cannot be used in excess quantity.
For the adjustment of pH, two indicators such as bromothymol blue and
thymol blue because they produce different colors at different pH.

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Bromothymol blue gives yellow at pH 6 and blue at pH 7.6.
Thymol blue gives yellow at pH 8 and blue at pH 9.6.
Neutralization points exists between pH 7.6-8

Procedure:
Mix glacial acetic acid with water, Add ammonium bicarbonate to this
solution in small quantities and continuous stirring until everything is
dissolved. Add sufficient quantity of ammonia solution in water so that it
will give blue color with one drop of bromothymol blue or yellow with
thymol blue and then add sufficient amount of water to make up the final
volume.
Dispensing: dispensed in an amber colour bottle tightly closed with screw
cap
Category: Mild expectorant
Storage: store in a cool dry place
Dosage: 1-5 ml
Report :

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Date : Experiment No. :

CRESOL SOAP SOLUTION

Aim: To prepare and submit 20 ml of cresol soap solution.

Requirements:
Apparatus: beaker, glass rod, water bath, spatula
Chemicals: Cresol, Potassium hydroxide, Vegetable oil, Purified water.

Formula :

Ingredients Standard formula Working formula


Cresol
Vegetable oil
Potassium hydroxide
Purified Water

Principle:

Lyzol or cresol soap solution contains 50% v/v of cresol. Cresol has 2%
v/v solubility in water. The solubility of cresol is increased from 2% v/v to
50% v/v by using a solubilizing agent, soap. Vegetable oils contain free
fatty acids which react with sodium hydroxide or potassium hydroxide to
form soap. This soap acts as solubilizing agent and surfactant. Soap forms
lamellar micelle which takes up more o cresol and enhances the solubility
of cresol from 2% v/v to 50% v/v.

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Procedure:
Dissolve potassium hydroxide in 1/4th quantity of purified water. Take
measured quantity of vegetable oil and potassium hydroxide solution. Mix
well and keep the mixture on water bath with occasional stirring until the
completion of saponification. The saponification reaction is tested by
adding 1 drop of reaction mixture to the test tube containing water and
shake well. If the globules aren’t observed in water, it indicates that the
reaction is completed. If there is presence of oil globules, the reaction is
yet to complete. Then continue heating after completion of saponification
reaction, add measured quantity of cresol to the above mixture with
continuous stirring. Adjust final volume with purified water and dispense.

Dispensing:
Transfer the solution into a narrow mouthed, fluted plastic bottle with
screw cap.

Storage: store in a cool place.

Uses: Disinfectant

Report:

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EMULSIONS

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EMULSIONS

An emulsion is liquid preparation containing two immiscible liquids, one of


which is dispersed as globules (dispersed phase is internal phase) in the other
liquid (continuous phase is external phase).
Continuous phase
Dispersed phase

General Types of Pharmaceutical Emulsions:

1) Lotions

2) Liniments

3) Creams

4) Ointments

5) Vitamin drops

Primary and secondary emulsion:

 Primary emulsion containing one internal phase, for example, oil-in-water


emulsion (o/w) and water-in-oil emulsion (w/o).

 Secondary emulsion= multiple-emulsion: it contains two internal phase,


for instance, o/w/o or w/o/w. It can be used to delay release or to increase

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the stability of the active compounds.
Oil
Water

Oil Water

O/W W/O

Water Oil
Oil Water
Oil Water

O/W/O W/O/W

Emulsion Type and Means of Detection : using of naked eye, it is very difficult
to differentiate between o/w or w/o emulsions. Thus, the four following methods
have been used to identify the type if emulsions.

1) Dilution Test: based on the solubility of external phase of emulsion.

- o/w emulsion can be diluted with water.

- w/o emulsion can be diluted with oil.

Few drops
of water Water distribute
uniformly O/W emulsion

Few drops Water separate


of emulsion out as layer W/O emulsion

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2) Conductivity Test: water is good conductor of electricity whereas oil is non-
conductor. Therefore, continuous phase of water runs electricity more than
continuous phase of oil.

Bulb

= Bulb glows with O/W


Electrode
Emulsion = Bulb doesn’t glow with
W/O

3) Dye-Solubility Test:

- Water-soluble dye will dissolve in the aqueous phase.

- Oil-soluble dye will dissolve in the oil phase.

What is look like under the microscope after mixing with suitable dye

Oil-soluble dye (e.g. Scarlet) Water-soluble dye (e.g. Amaranth dye)

W/O O/W O/W W/O

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4-Fluorescence test: oils give fluorescence under UV light, while water doesn’t.
Therefore, O/W emulsion shows spotty pattern while W/O emulsion fluoresces.

Methods of Preparation of Emulsions:

1) Continental or Dry Gum Method:

"4:2:1" Method

4 parts (volumes) of oil [Ansel. 7th ed. page 369]

2 parts of water

1 part of gum

Acacia or other o/w emulsifier is triturated with oil in a perfectly dry Wedgwood
or porcelain mortar until thoroughly mixed. Glass mortar has too smooth a surface
to produce the proper size reduction of the internal phase (Do not use glass
mortar). After the oil and gum have been mixed, the two parts of water are then
added all at once and the mixture is triturated immediately.

2) English or wet Gum Method:

Same proportion of oil, water and gum are used as in the continental or dry gum
method but the order of mixing is different. Mucilage of the gum is prepared by
triturating acacia (or other emulsifier) with water. The oil is then added slowly in
portions, and the mixture is triturated to emulsify the oil. Should the mixture
become too thick during the process, additional water may be blended into the
mixture before another successive portion of oil is added.

3) Bottle or Forbes Bottle Method:

Useful for-

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Extemporaneous preparation of emulsion from volatile oils or oleaginous
substance of low viscosity.

put powdered acacia in a dry bottle

Add 2 parts of oil

Thoroughly shake the mixture in the capped bottle. A volume of water


approximately equal to the oil is then added in portions, the mixture being
thoroughly shaken after each addition.

This method is not suitable for viscous oils (i.e. high viscosity oil).

Formulation of Emulsions :

Emulsifying agents :

1) Carbohydrate Materials:

Acacia, Tragacanth, Agar, Pectin. o/w emulsion.

2) Protein Substances:

Gelatin, Egg yolk, Caesin o/w emulsion.

3) High Molecular Weight Alcohols:

Stearyl Alcohol, Cetyl Alcohol, Glyceryl Mono stearate (o/w emulsion).

Cholesterol ( w/o emulsion)

4) Wetting Agents:

Anionic, Cationic, Nonionic

o/w emulsion

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w/o emulsion

5) Finely divided solids:

Bentonite, Magnesium Hydroxide, Aluminum Hydroxide (o/w emulsion).

Preservatives : Benzoic acid, chloroform, methyl paraben, propyl paraben,


Cetrimide, Sodium benzoate.

Anti Oxidants : Tocopherol, ascorbic acid, citric acid.

Flavoring agents : Vanilin, benzaldehyde spirit, cinnamon water, peppermint


water.

Stability of Emulsion:

An emulsion is considered to be physically unstable if :

Creaming is not an actual breaking but a separation of the emulsion into


two emulsions, one of which (the cream) is richer in the disperse phase than the
other. Creaming is the principal process by which the disperse phase separates
from an emulsion and is typically the precursor to coalescence.

Cracking When
an emulsion separates into its separate ingredients (when the oil and
water are clearly separated and will not recombine) the emulsion is said to have"c
racked" or "broken." Do not confuse a "cracked" emulsion with one that has crea
med.
The most common reason that an emulsion cracks is the addition of too much
or too concentrated alcohol or electrolyte solution. Freezing will also cause an em
ulsion to crack.

Phase Inversion:

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The relative volume of internal and external phases of an emulsion is important.
(increase) internal concentration (increase) viscosity up to a certain point.
Viscosity will decrease after that point. At this point the emulsion has undergone
inversion i.e. it has changed from an o/w to a w/o, or vice versa. In practice,
emulsions may be prepared without inversion with as much as about 75% of the
vol. of the product being internal phase.

Dispensing an emulsion

Container : Emulsions of thick consistency should be dispensed in a wide


mouthed bottle or jar. The very thin emulsions may be dispensed in ordinary
prescription bottles, if they will not become thicker as the emulsifier hydrates on
standing. Thick emulsions cannot be conveniently poured from narrow-mouthed
bottles. Clear bottles are generally preferred to amber ones, unless their contents 
are sensitive to light.

Special Instructions. All emulsions are damaged by excessive heat or cold.
Patients should be instructed to store emulsions away from either extreme. 
Emulsions for internal use should be stored in the refrigerator, but they should be 
protected from freezing. 
All emulsions should bear the "Shake Well Before Using" label. Those for
external use should be so labeled.

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Date : Experiment No. :

TURPENTINE LINIMENT

Aim : To prepare and submit 20ml of turpentine liniment.

Requirements :

Apparatus: weighing balance, beaker, stirrer, measuring cylinder, mortar and


pestle.

Chemicals: Oelic acid, dilute ammonia solution, turpentine oil and water

Formula :

Ingredients Standard formula Working Formula


Soft soap
Camphor
Turpentine oil
Purified water

Principle :

Turpentine oil is an volatile oil obtained on distillation of turpentine which is an


oleic resine obtained from various species of pinus. Turpentine oil misicible in
water and it does not contain any free fatty acids hence it cannot form soap with
alkaline substance. Therefore soft soap has to be used which is a monovalent soap
alkaline in nature and acts as emulsifying agent.

Camphor is a volatile substance it is insoluble in water and soluble in turpentine


hence biphasic system like emulsion can be prepared using soft soap. Which
produces oil in water type of emulsion in this preparation turpentine oil remains
as dispersed phase and water as continous phase. Due to the formation of viscous
emulsion it is easy for rubbing on the skin.

Procedure :
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In a dry container dissolve camphor in turpentine oil. Take a required quantity of
soft soap in a mortar add water and triturate make the soapy solution, to this
solution gradually add the camphor solution with trituration until the thick creamy
emulsion is formed allow it to stand for few minutes for separation of air bubbles.
Add sufficient purified water to make final volume.

Both turpentine oil and camphor volatile in nature. Turpentine oil undergoes rapid
change when come in contact with moisture therefore transfer the preparation to
narrow light resistant glass bottles close it tightly with plastic screw cap polish
label .

Direction to use : to be applied to a part with pain.

Storage : Store in dry place and protect from light.

Uses : turpentine oil acts as counter irritant, hence used as irritant in treatment of
fibrocysts and neuralgia.

It acts as carminative.

Camphor acts as analgesic and rubificient.

Report :

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Date : Experiment No. :

LIQUID PARAFFIN EMULSION

Aim: To prepare and submit 20 ml of liquid paraffin emulsion

Requirements:

Apparatus: weighing balance, beaker, stirrer, measuring cylinder, mortar and


pestle.

Chemicals: liquid paraffin, methyl cellulose 20, benzoic acid solution,


chloroform, vanillin, sodium saccharin.

Formula:

Ingredients Standard formula Working formula


Liquid paraffin
Methyl cellulose 20
Benzoic acid solution
Chloroform
Vanillin
Saccharin sodium
Purified water

Principle:

Liquid paraffin (mineral oil) is a transparent, colourless, odourless oily liquid


composed of saturated hydrocarbons obtained from petroleum. Liquid paraffin
emulsion is oil in water type of emulsion used as lubricant for chronic
constipation. Its acts by softening and lubricating the stools. This helps the stools
to move more easily through the bowel. It is also used to reduce pain associated
with passing stools in people with conditions affecting the anus such as piles or
anal fissure. Methyl cellulose20 is methyl ether of cellulose prepared from wood

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pulp or cotton by treatment with alkali and methylation of alkali-cellulose with
methyl chloride. Methyl cellulose 20 is used as an emulsifying agent. Benzoic
acid is used as preservative. Chloroform is used to dissolve vanillin. This
emulsion is prepared by making methyl cellulose mucilage solution followed by
equal volume of liquid paraffin .

Procedure:

Clean all glassware and dry them properly as per SOP. First prepare
mucilage by mixing the required quantity of methyl cellulose 20 in about
six times its weight of boiling water and allow stand for 30 minutes to
hydrate. Add an equal weight of ice and stir mechanically until
homogenous mucilage is formed. Dissolve vanillin in the benzoic acid
solution and chloroform. Add this mixture to above mucilage and stir for 5
minutes. Prepare saccharin sodium solution by triturating it with water and
add this solution to above mucilage. Make the volume of mucilage up to
10 ml taking care to ensure that there is no entrapped air in the mucilage.
Make the emulsion by mixing together 10 ml of liquid paraffin and 10 l of
the prepared mucilage with constant stirring. As liquid paraffin emulsion
is very coarse in nature, the emulsion is more stable if passed through a
hand homogenizer. Transfer prepared emulsion into narrow mouth amber
coloured bottle and close tightly with child resistant closure. Label and
submit.

Category: lubricant laxative for chronic constipation

Storage: store in a cool, dry place. Do not freeze.

Directions for use: 15ml to be taken twice a day or as directed by the physician

Auxiliary label: Shake well before use. The emulsion should not be taken within
30 minutes of meal times and preferably on empty stomach.

Report:

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POWDERS

POWDERS

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The word "powder" refers to a chemical or mixture that is solid in physical state.
In compounding, "powder" refers to a dosage formulation that is solid in physical
state. But the formulation may be composed of only the active drug or may be a
mixture of the active drug and other ingredients.

Powders offer some unique advantages:

 each dose can contain a different amount of active drug


 can be administered easily to infants and young children who cannot
swallow tablets or capsules
 drug will have a rapid onset of action since disintegration is not required
 can be applied to many body cavities such as ears, nose, tooth socket,
throat
 drugs tend to most stable as a solid
 can be made into many different dosage formulations (capsules, tablets,
powders for reconstitution, dusting powders, bulk powders, powders for
inhalation, etc.)

Classification of Powders

 Bulk Powders

Bulk powders are non potent and can be dosed with acceptable accuracy
and safety using measuring devices such as the teaspoon, cup, or
insufflator. This practically limits the use of orally administered bulk
powders to antacids, dietary supplements, laxatives, and a few analgesics.
Many bulk powders are used topically.

 Dusting Powders

Dusting powders are fine medicinal (bulk) powders intended to be dusted


on the skin by means of sifter-top containers. A single medicinal agent

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may be used as a dusting powder; however, a base is frequently used to
apply a medicinal agent and to protect the skin from irritation and friction.
Bentonite, kaolin, kieselguhr, magnesium carbonate, starch, and talc are
used as inert bases for dusting powders. Powder bases absorb secretions
and exert a drying effect, which relieves congestion and imparts a cooling
sensation. All extemporaneous dusting powders should be passed through
a 100-200 mesh sieve to ensure that they are grit free and will not further
mechanically irritate traumatized areas.

 Douche Powders

Douche powders are used to prepare solutions that cleanse the vagina.
Most douche powders are used for their hygienic effects, but a few contain
antibiotics.

Douche powders are prescribed as a matter of convenience for the patient,


since a powder is more portable than a bulky solution. The formula is
developed so that a teaspoonful or tablespoonful of powder dissolved in a
specified volume of water provides the desired concentration. The pH
usually ranges from 3.5 to 5 when the solution is prepared. Feminine bulb
syringes or fountain syringes are used for vaginal irrigation. Since many of
the ingredients are volatile (e.g., menthol, thymol, and volatile oils),
douche powders should be packaged in glass jars with a wide mouth.
Some commercial douche powders are available in metal foil packets,
which contain the proper amount of powder for a single douche. Many
douches are also available as prepared unit of use solutions in disposable
applicators.

 Insufflations

Insufflations are extremely fine powders to be introduced into body


cavities. To administer an insufflation, the powder is placed in the
insufflator, and when the bulb is squeezed, the air current carries the fine

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particles through the nozzle to the region for which the medication is
intended. All extemporaneously compounded insufflations must be passed
through a 100 mesh sieve. Pressurized packages provide an elegant
approach to the administration of insufflations.

 Powder Sprays

In contrast to dusting powders, powders dispensed under pressure will


deliver targeted and uniform application at the desired site. Also, in an
aerosol container medicated powders may be maintained in a sterile
condition. The powder particles must be a definite size range to prevent
clogging of the valve orifice and to provide uniformity of application. In
general, powders that are to be packaged as powder sprays must not
contain particles greater than 50 microns if they are to be sprayed
successfully.

 Divided Powders (Chartulae; Charts; Powder Papers)

Divided powders or charts are single doses of powdered medicinals


individually wrapped in cellophane, metallic foil, or paper. The divided
powder is a more accurate dosage form than bulk powder because the
patient is not involved in measurement of the dose. Cellophane and foil-
enclosed powders are better protected from the external environment until
the time of administration than paper-enclosed powders.Divided powders
are commercially available in foil, cellophane or paper packs.

Storage: Powders and granules can be filled into sachets or srew capped
wide mouth glass bottle or in self dispensing plastic containers. All
powders and granules should be stored at dry place to prevent
deterioration due to ingress of moisture.

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Label: Powders and granules which are used for internal use should
mention method of reconstitution and administration on its label. Those
which are used for external use are labeled “ For External Use Only” and
“store In Cool And Dry Place”.

Date : Experiment No. :

ORAL REHYDRATION SALT (ORS) POWDER

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Aim: To prepare and submit Oral Rehydration salt (ORS) powder IP 2007 (WHO
2005) for Oral rehydration solution 1liter.

Requirements :

Apparatus : spatula, mortar and pestle, weighing balance

Chemicals: Sodium chloride, Glucose, anhydrous, Potassium chloride, Trisodium


citrate dehydrate

Formula :

Ingredients Standard formula Working formula


Sodium chloride
Glucose (anhydrous)
Potassium chloride
Trisodium citrate dehydrate

Principle :

Oral rehydration therapy (ORT) is a type of fluid replacement used to prevent


and treat dehydration, especially that due to diarrhea. It involves drinking water
with modest amounts of sugar and salts. Oral rehydration therapy can also be
given by a nasogastric tube. Therapy should routinely include the use of zinc
supplements. Use of oral rehydration therapy decreases the risk of death from
diarrhea by about 93%. WHO and UNICEF recommended that the osmolarity of
oral rehydration solution be reduced from 311 to 245 mOsm/L .

ORS is a dry mixture of sodium chloride, sodium citrate, potassium chloride,


and glucose. Glucose may be replaced by sucrose and sodium citrate may be
replaced by sodium bicarbonate, if not available. Oral rehydration therapy was
developed in the 1940s, but did not come into common use until the 1970s. In
2003, WHO and UNICEF recommended that the osmolarity of oral rehydration
solution be reduced from 311 to 245 mOsm/L, These guidelines were also

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updated in 2006. This recommendation was based on multiple clinical trials
showing that the reduced osmolarity solution reduces stool volume in children
with diarrhea by about twenty-five percent and the need for IV therapy by about
thirty percent when compared to standard oral rehydration solution. The incidence
of vomiting is also reduced. The reduced osmolarity oral rehydration solution has
lower concentrations of glucose and sodium chloride than the original solution,
but the concentrations of potassium and citrate are unchanged.

Procedure :

Separately weigh each ingredient properly. Incorporate the powders in order of


bulk starting with potassium chloride, followed by trisodium citrate dihydrate,
then sodium chloride and finally add anhydrous glucose in portions adding each
addition a quantity that approximately doubles the bulk already in the mortar.
Triturate powder mixture properly. Transfer the powder into a packet /sachet.
Label and submit.

Category : Oral rehydration therapy in diarrhea.

Storage : Store in cool and dry place.

Report :

Date : Experiment No. :

SODIUM PHOSPHATE EFFERVESCENT GRANULES


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Aim : To prepare and submit Sodium Phosphate Effervescent Granules USP 20g.

Requirements :

Apparatus: Weighing balance, porcelain dish, stirrer, water bath, mortar and
pestle.

Chemicals : Sodium Phosphate (dried and powdered), Sodium bicarbonate. Citric


acid. Tartaric acid.

Formula:

Ingredients Standard Working Formula


formula
SodiumPhosphate(dried and
powdered)
Sodium bicarbonate
Citric acid
Tartaric acid.

Principle :

An effervescent dosage form, frequently tablets or granules, contains ingredients


that, when in contact with water, rapidly release carbon dioxide. The dosage form
is dissolved or dispersed in water to initiate the effervescence prior to ingestion.
Effervescent salts are granules or coarse to very coarse powders containing a
medicinal agent in a dry mixture usually composed of sodium bicarbonate, citric
acid, and tartaric acid. When added to water, the acids and the base react to
liberate carbon dioxide, resulting in effervescence. The resulting carbonated
solution masks undesirable taste of any medicinal agent.

Using granules or coarse particles of the mixed powders rather than small powder
particles decreases the rate of solution and prevents violent and uncontrollable
effervescence. Sudden and rapid effervescence could overflow the glass and leave

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little residual carbonation in the solution. Using a combination of citric and
tartaric acids rather than either acid alone avoids certain difficulties. When
tartaric acid is used as the sole acid, the resulting granules readily lose their
firmness and crumble. Citric acid alone results in a sticky mixture difficult to
granulate.

It has been found that citric acid monohydrate and tartaric acid used in the ratio
of 1:2, respectively, produces a powder with good effervescent properties. The
amount of sodium bicarbonate to be used may be calculated from the reaction
which occur when the granules come in contact with water.

Dry or Fusion Method In the fusion method, the one molecule of water present in
each molecule of citric acid acts as the binding agent for the powder mixture.
Before mixing the powders, the citric acid crystals are powdered and then mixed
with the other powders of the same sieve size to ensure uniformity of the mixture.
The sieves and the mixing equipment should be made of stainless steel or other
material resistant to the effect of the acids. The mixing of the powders is
performed as rapidly as is practical, preferably in an environment of low humidity
to avoid absorption of moisture and a premature chemical reaction. After mixing,
the powder is placed on a suitable dish in an oven at 34 C to 40 C. During the
heating process, an acid resistant spatula is used to turn the powder. The heat
releases the water of crystallization from the citric acid, which, in turn, dissolves a
portion of the powder mixture, setting the chemical reaction and consequently
releasing some carbon dioxide.

Procedure :

Weigh accurately all ingredients and mix in ascending order of their weights by
trituration. Place porcelain dish on water bath and heat water bath till boiling .
Place powder mixture in pre-heated porcelain dish and mix it throughrly to form
damp or coherent mass of powder. Pass this coherent mass of powder through
sieve 20 by pressing and collect the wet granules on butter paper. Dry these wet

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granules in hot air oven at temperature not exceeding 600C. Fill granules into air
tight wide mouth container. Label and submit.

Category : Purgative

Storage : Store in dry place.

Direction : Add two spoonful of granules to glass of water stirring and drink the
solution while effervescing.

Report :

Date : Experiment No. :

DUSTING POWDER

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Aim : To prepare and submit Zinc Oxide- Salicylic Acid Dusting powder 10g.

Requirements :

Apparatus: Weighing balance, porcelain dish, stirrer, water bath, mortar and
pestle.

Chemicals : Salicylic acid, Starch, Zinc oxide

Formula:

Ingredients Standard Working Formula


formula
Zinc oxide
Salicylic acid
Starch

Principle

Dusting powders are externally used bulk powders for local application, not
intended for systemic action. They are free flowing very fine powders containing
antiseptics, antipruritics, astringents, antiperspirants, absorbants, lubricants etc.

Dusting powders are of two types:

Medicated dusting powders

Surgical dusting powders

Medicated dusting powders are used mainly for superficial skin conditions,
whereas surgical dusting powder is used in body cavities and on major wounds
because of burns and umbilical cords of infants, Surgical dusting powders must be
sterilized before their use, whereas medical dusting powders must be free from
pathogenic micro organisms.

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Dusting powders are generally prepared by mixing two or more ingredients one of
which must be starch, talc or kaolin. Starch, talc or kaolin are more commonly
used in the preparation of dusting powders. However since such ingredients are
readily contaminated with pathogenic bacteria, these must be sterilized by dry
heat method before their use

Zinc oxide- salicylic acid dusting powder is medicated dusting powder and
Intended for application to open wound. This preparation protects wound from
chafing and irritation caused by friction, moisture or chemical irritants. Zinc oxide
in this preparation act as astringent and salicylic acid acts as local anti septic.

Procedure :

Mix salicylic acid with zinc oxide followed by by starch powder by light
trituration in mortar. Mix above powder and pass through sieve 80. Weigh
required quantity of powder and fill into a screw cap wide mouthed glass bottle or
self dispensing plastic container label and submit.

Category : Astringent and local anti septic.

Storage : Store in well closed container.

Label : “ For External Use Only”

Report :

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SUPPOSITORIES

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SUPPOSITORIES
Suppositories are solid dosage forms intended for insertion into body orifices
where they melt, soften, or dissolve and exert localized or systemic effects

Types of Suppositories

a. Rectal suppositories for adults weigh 2 gm and are torpedo shape. ` Children's
suppositories weigh about 1 gm.

b. Vaginal suppositories or Pessaries weigh about 3- 5gm and are molded in


globular or oviform shape or compressed on a tablet press into conical shapes.

c. Urethral suppositories called bougies are pencil shape. Those intended for
males weigh 4 gm each and are 100-150 mm long. ` those for females are 2 gm
each and 60-75 mm in length.

d. Nasal suppositories: called nasal bougies or buginaria meant for introduction in


to nasal cavity. ` They are prepared with glycerogelatin base. ` They weigh about
1 gm and length 9-10 cm.

e. Ear cones: ` Aurinaria and meant for introduction into ear. ` Rarely used `
Theobroma oil is used as base. ` Prepared in urethral bougies mould and cut
according to size.

Advantages: _

Can exert local effect on rectal mucosa.

Used to promote evacuation of bowel.

Avoid any gastrointestinal irritation.

Can be used in unconscious patients (e.g. during fitting).

Can be used for systemic absorption of drugs and avoid first-pass metabolism.

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Babies or old people who cannot swallow oral medication.

Post operative people who cannot be administered oral medication.

People suffering from severe nausea or vomiting.

Disadvantages of suppositories: −

The problem of patient acceptability.

Suppositories are not suitable for patients suffering from diarrhea.

In some cases the total amount of the drug must be given will be either too
irritating or in greater amount than reasonably can be placed into suppository.

Incomplete absorption may be obtained because suppository usually promotes


evacuation of the bowel.

Ideal suppository base:

1. Melts at body temperature or dissolves in body fluids.

2. Non-toxic and non-irritant.

3. Compatible with any medicament.

4. Releases any medicament readily.

5. Easily moulded and removed from the mould.

6. Stable to heating above the melting point.

7. Easy to handle.

8. Stable on storage.

Suppository bases

Fatty bases:

Designed to melt at body temperature.

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1- Theobroma oil (Cocoa butter) ` It is a yellowish-white solid with an odour of
chocolate and is a mixture of glyceryl esters of different unsaturated fatty acids.

Advantages:

a- A melting range of 30 - 36°C (solid at room temperature but melts in the body).

b- Readily melted on warming, rapid setting on cooling.

c- Miscible with many ingredients.

d- Non-irritating.

Disadvantages:

a- Polymorphism: - When melted and cooled it solidifies in different crystalline


forms, depending on the temperature of melting, rate of cooling and the size of the
mass. If melted at not more than 36°C and slowly cooled it forms stable beta
crystals with normal melting point. If over-heated then cooled it produce unstable
gamma crystals which melt at about 15°C or alpha crystals melting at 20°C.
Cocoa butter must be slowly melted over a warm water bath to avoid the
formation of the unstable crystalline form.

b-Adherence to the mould:

c- Softening point too low for hot climates.

d- Melting point reduced by soluble ingredients: Phenol and chloral hydrate have
a tendency to lower the melting point of cocoa butter.- So, solidifying agents like
beeswax (4%) may be incorporated to compensate for the softening effect of the
added substance.

e- Rancidity on storage:

f- Poor water-absorbing ability: Improved by the addition of emulsifying agents.

g- Leakage from the body:

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h- Expensive

Synthetic hard fat: -

For example: Suppocire, witepsol.

Advantages:

a- Their solidifying points are unaffected by overheating.

b- They have good resistance to oxidation because of the lower content of


unsaturated fatty acids.

c- The difference between melting and setting points is small. Hence they set
quickly, the risk of sedimentation of suspended ingredients is low. They are
marketed in a series of grades with different melting point ranges, which can be
chosen to suit particular products and climatic condition.

d-They contain a proportion of w/o emulsifying agents, and therefore, their water-
absorbing capacities are good.

e- No mould lubricant is necessary because they contract significantly on cooling.

Disadvantages:

a- Brittle if cooled rapidly, avoid refrigeration during preparation.

b- The melted fats are less viscous than theobroma oil. As a result greater risk of
drug particles to sediment during preparation lack of uniform drug distribution
give localized irritancy.

Water-soluble and water-miscible bases: `

1- Glycero-gelatin: ` The commonest is Glycerol Suppositories Base B.P., which


has 14% w/w gelatin, and 70% w/w glycerol & water Q.S. to 100%. . ` The

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glycerol-gelatin base U.S.P. consisted of 20% w/w gelatin, and 70% w/w glycerol
& water Q.S. to 100%.

Disadvantages:

a- A physiological effect: osmosis occurs during dissolving in the mucous


secretions of the rectum, producing a laxative effect.

b- Can cause rectal irritation due to small amount of liquid present.

c- Unpredictable solution time.

d- Hygroscopic: So, they should be packaged in tight containers and also have
dehydrating effects on the rectal and vaginal mucosa leading to irritation.

e- Microbial contamination likely.

f- Long preparation time.

g- Lubrication of the mould is essential.

Macrogols (polyethylene glycols): - Polyethylene glycols are polymers of


ethylene oxide and water, prepared to various chain lengths, molecular weights,
and physical states.

The numerical designations refer to the average molecular weights of each of the
polymers. - Polyethylene glycols (PEGs) having average molecular weights of
300, 400, and 600 are clear, colorless liquids, while those with molecular weights
of 600- 1000 are semisolids. - Those having average molecular weights of greater
than 1000 are wax-like, white solids with the hardness increasing with an increase
in the molecular weight.

These polyethylene glycols can be blended together to ` produce suppository


bases with varying: melting points, dissolution rates and physical characteristics. `
Drug release depends on the base dissolving rather than melting. ` The melting
point is often around 50°C. ` Higher proportions of high molecular weight

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polymers ` produce preparations which release the drug slowly and are also
brittle.

Preparation of suppositories: `

Suppositories are prepared by four methods:

I Hand moulding:

-Hand molding is useful when we are preparing a small number of suppositories:

The drug is made into a fine powder. It is incorporated into the suppository base
by kneading with it or by trituration in a mortar. The kneaded mass is rolled
between fingers into rod shaped units The rods are cut into pieces and then one
end is pointed

II Compression molding: `

The cold mass of the base containing the drug is compressed into suppositories
using a hand operated machine.

Advantages:

1.It is a simple method.

2. It gives suppositories that are more elegant than hand moulded suppositories.

3. In this method sedimentation of solids in the base is prevented.

4. Suitable for heat labile medicaments.

Disadvantages:

1.Air entrapment may take place.

2.This air may cause weight variation.

3.The drug and/or the base may be oxidized by this air.

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III Pour moulding: - Using a supp. mould which is made of metal or plastic.
Traditional metal moulds are in two halves which are clamped together with a
screw. `

Steps:

1. The base is melted and precautions are taken not to overheat it.

2. The drug is incorporated in it.

3. The molten liquid mass is poured into chilled(lubricated if cocoa butter or


glycrogelatin is the base)molds.

4. After solidification the cone shaped suppositories

Lubricating the cavities of the mould is helpful in producing elegant suppositories


and free from surface depression. - The lubricant must be different in nature from
the suppository base, otherwise it will be become absorbed and will fail to provide
a buffer film between the mass &the metal. - The water soluble lubricant is useful
for fatty bases while the oily lubricant is useful for water soluble bases. - The
lubricant should be applied on a pledget of gauze or with fairly stiff brush.

IV Automatic Moulding machine: ` All the operations in pour moulding are


done by automatic machines. Using this machine, up to about 10,000
suppositories per hour can be produced.

`Packaging and storage: `

-Suppositories are usually packed in tin or aluminium, paper or plastic. `

-Poorly packed suppositories may give rise to staining, breakage or deformation


by melting. `

-Both cocoa butter and glycerinated gelatin suppositories stored preferably in a


refrigerator. `

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- Polyethylene glycol suppositories stored at usual room temperature without the
requirement of refrigeration

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Date : Experiment No. :

GLYCERO-GELATIN SUPPOSITORIES
Aim : To prepare and submit glycero-gelatin suppositories of 1gram
Requirements
Apparatus : Porcelian dish, Water bath, Measuring cylinder, Weighing balance
Chemicals : Glycerin, Gelatin, Purified water
Formula
Ingredient Standard formula Working formula
Glycerin
Gelatin
Purified water

Principal
Glycero-gelatin base is a mixture of glycerin and water which is made stiff
jelly by addition of gelatin. The composition of glycero-gelatin base is different in
different pharmacopoeias.

Ingredient BP and EP USP BPC


Glycerin 14g 20g 25g
Gelatin 70g 70g 40g
Purified water 100g 100g 100g
Solid drugs and liquids < 20%

Two types of gelatin is used for preparation of glycero-gelatin suppositories:


a) Acidic in nature and used for acidic drugs
b) Alkaline in nature and used for alkaline drugs
The base does not melt at body temperature rather if dissolved in secretions of
body cavity. Solution time is regulated by proportion of gelatin; glycerin: water
used.

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Procedure : Clean all the glassware and dry the properly as per SOP. Weigh
required amount of gelatin and soak it in water until it is softened. Take calculated
amount of glycerin in porcelain dish and heat on water bath at 100 degree Celsius.
Put soaked gelatin to the hot glycerin. Pour the mass while it is hot into the
mould.
Category : laxative
Storage : Stored in cool place
Report :

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Date : Experiment No. :

SOAP GLYCERIN SUPPOSITORIES


Aim : To prepare and submit soap glycerin suppositories
Requirements
Apparatus : measuring cylinder, weighing balance, water bath, beakers
Chemicals : Glycerin, sodium carbonate, stearic acid
Formula

Ingredients Standard Formula Working Formula


Glycerin
Sodium carbonate
Stearic acid

Principle : Soap glycerin suppositories are prepared using glycerin as base. This
promotes peristalsis and evacuation of bowel. In this preparation saponification reaction
takes place between fatty acid or stearic acid and alkali like sodium carbonate produces
soap. Soap is irritant in nature. Hence promotes peristalsis. When soap glycerin base , it
contracts and forms hallow depression at top of suppositories. to avoid this problem the
mould is over filled. During preparation stearic acid should be added slowly into mixture
of glycerin and sodium carbonate with continuous stirring to avoid excessive frothing.

Procedure : Calculate the quantities of ingredients by taking displacement value of


medicament into count. Calculate quantities of ingredients for 3 extra suppositories than
prescribed number. Dissolve calculated amount of sodium carbonate in glycerin on a
water bath with stirring. To the above contents slowly add stearic acid. Heat carefully
with continuous stirring until effervescence seizes and solution is complete. Confirm that
solution is free from air bubbles and add the solution into the mould to over flow and
allow to cool. After setting, trim off the excess base with sharp knife or blade and place
the mould in the refrigerator.

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Dispensing : Glycerin is hygroscopic in nature. Transfer it into air tight container.

Storage : Store in a cool place

Auxillary label : FOR RECTAL USE ONLY


.
Uses : Soap glycerin suppositories are used for easy evacuation of bowels.

Report :

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OINTMENTs

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OINTMENT
Pharmaceutical ointments are semisolid systems that are applied externally,
primarily to the skin and also to mucous membranes, e.g. the rectum, the
vagina/vulva, the eye. Typically, medicated ointments are used for the treatment
of infection, inflammation and pruritus. However, non-medicated ointments are
commonly used due to their emollient/lubricating properties. Pharmaceutical
pastes are generally composed of ointment bases that contain a high concentration
(frequently 50% w/w) of dispersed drug. The viscosity of pharmaceutical pastes is
greater than that of pharmaceutical ointments. The formulation of ointments and
pastes involves the dispersal or dissolution of the selected therapeutic agent into
an ointment base and, therefore, in addition to the physical properties of the
dispersed/dissolved drug, the physicochemical properties of the ointment base are
fundamental to the clinical and non-clinical performance of this type of dosage
form. Advantages and disadvantages of pharmaceutical ointments, and pastes

Advantages:

Pharmaceutical ointments may be easily spread on skin, being retained at the site
of application as an occlusive layer, thereby preventing moisture loss from the
skin.

Pharmaceutical ointments are associated with lubricating/emollient properties,


properties that may be employed to reduce trauma of an affected site upon
spreading.

In general, pharmaceutical ointments persist at the site of application, enabling


the duration of drug release to be greater than for many other topical dosage
forms.

The increased viscosity of pharmaceutical pastes ensures that a thick film of the
dosage form is applied to the site of action, which shows excellent persistence.

This property is particularly useful if protection of an inflamed site is required,


e.g. in eczema, psoriasis. Due to the high solids content, pharmaceutical pastes

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are often porous, allowing moisture 2 loss from the applied site. Furthermore,
pastes may act to absorb moisture and chemicals within the exudates. The opaque
nature of pastes (due to the high solids content) enables this formulation to be
used as a sunblock.

The chemical stability of therapeutic agents that are prone to hydrolysis will be
dramatically enhanced by formulation within pharmaceutical ointments and
pastes.

Disadvantages:

Pharmaceutical ointments are generally greasy and difficult to remove (and are
therefore often cosmetically unacceptable).

Staining of clothes is often associated with the use of pharmaceutical pastes and
ointments.

The viscosity of pharmaceutical ointments, and in particular pastes, may be


problematic in ensuring spreading of the dosage form over the affected site.

Pharmaceutical ointments may not be applied to exuding sites (however, please


note that this does not hold for pastes).

Problems concerning drug release from pharmaceutical ointments may occur if


the drug has limited solubility in the ointment base.

Pharmaceutical pastes are generally not applied to the hair due to difficulties
associated with removal. The choice of ointment base is dependent on several
factors, including:

(1) the site of application;

(2) the required rate of drug release;

(3) the chemical stability of the drug; and

(4) the effect of the therapeutic agent on formulation viscosity.

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1) The site of application In certain clinical conditions the site to which the
ointment will be applied may be dry, e.g. psoriasis, or moist.

If the area is dry, ointments are often used to occlude the site, thereby retaining
moisture. Indeed, this effect is considered to play an important role in the
treatment of certain clinical conditions.

Conversely, occlusive ointment bases are not applied to sites in which there is
fluid exudate.

2) The required rate of drug release Following application, the therapeutic agent
must be released to exert its pharmacological effect, either locally or, after
absorption, systemically. Drug release from the ointment base requires solubility
(albeit partial) of the therapeutic agent within the formulation. This will allow
diffusion of the therapeutic agent (a molecular process) through the ointment base
until it reaches the biological substrate. Therefore the choice of the ointment base
is partially dictated by the physicochemical properties (and in particular the
solubility) of the therapeutic agent.

3) The chemical stability of the drug If a therapeutic agent is prone to hydrolysis,


incorporation into a water-based formulation, e.g. O/W creams, may lead to drug
degradation and hence a shortened shelf-life. This problem may be obviated by
incorporating the drug into a hydrophobic ointment base. For example, the shelf-
life of hydrocortisone is markedly greater in an ointment formulation than in O/W
cream formulation.

4) The effect of the therapeutic agent on formulation viscosity The effect of the
physical incorporation of a therapeutic agent into an ointment base on the
rheological properties of the formulated product will be dependent on the required
drug concentration, the physical properties of the therapeutic agent (e.g. particle
size, shape) and the chemical composition and viscosity of the ointment base.

Therefore, it is important that an ointment base is selected that will produce a


product that may be readily applied to the required site. In light of the high drug

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content, this point is particularly important in the formulation of pastes. Types of
base for ointments and pastes There are four types of base that are used to
formulate pharmaceutical ointments and pastes:

(1) Hydrocarbon

(2) absorption

(3) water-miscible/removable

(4) water-soluble.

1-Hydrocarbon Bases (Oleaginous bases):

They are water-free, and aqueous preparations may be incorporated into them
only in small amounts. They are used chiefly for their emollient effect because
they are retained on the skin for prolonged periods; do not permit the escape of
moisture from the skin to the atmosphere.

As such they act as occlusive dressings.

A-Petrolatum (Yellow Petrolatum, Vaseline). Petrolatum is a mixture of semi-


solid hydrocarbons obtained from petroleum. Petrolatum is varying in color from
yellowish to light amber. It melts at temperatures between 38° and 60°C. It may
be used alone or in combination with other agents as an ointment base.

B-White Petrolatum (White Vaseline). It is petrolatum that has been decolorized;


it differs only in this respect to petrolatum and is used for the same purpose.
White petrolatum is more acceptable to a patient than petrolatum.

C-Yellow Ointment (Simple Ointment) Each 100g of Yellow Ointment contains


5 gm of yellow wax and 95gm of petrolatum.

D-Mineral Oil (Liquid Petrolatum). It is a mixture of liquid hydrocarbons


obtained from petroleum.

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It is useful as a levigating substance to wet and to incorporate solid substances,
e.g., salicylic acid, zinc oxide, into the preparation of ointments that consist of
oleaginous bases as their vehicle.

2-Absorption Bases: -Absorption bases may be of two types:

(1) Those that permit the incorporation of aqueous solutions, resulting in the
formation of W/O emulsions (ex. Hydrophilic Petrolatum and Anhydrous
Lanolin).

(2) Those that are already W/O emulsions (emulsion bases) and permit the
incorporation of small, additional quantities of aqueous solutions (ex. Lanolin and
Cold Cream).

These bases are useful as emollients—although they do not provide the degree of
occlusive afforded by the oleaginous bases. On the other hand, they are also
useful pharmaceutically to incorporate aqueous solutions of drugs, e.g., sodium
sulfacetamide, into oleaginous bases.

(1)a-Hydrophilic Petrolatum

It is composed of cholesterol, stearyl alcohol, white wax, and white petrolatum. It


has the ability to absorb water, with the formation of W/O emulsion.

(1)b- Anhydrous Lanolin

Anhydrous Lanolin is insoluble in water, but mixes without separation with about
twice its weight of water. The incorporation of water results in the formation of a
W/O emulsion. Although its rancid odor is offensive, this base finds particular use
as a vehicle for the application of compound tincture of benzoin and sucrose to
treat bedsores

(2) a- Lanolin Lanolin is a semisolid, fat-like substance obtained from the wool
of sheep. It is a W/O emulsion that contains between 25 and 30 % water.
Additional water may be incorporated into lanolin by mixing.

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(2)-b-Cold Cream . It is a semisolid, white, W/O emulsion prepared with Cetyl
esters wax, white wax, mineral oil, sodium borate, and purified water. The sodium
borate combines with the free fatty acids present in the waxes to form sodium
soaps that act as the emulsifiers and makes the W/O emulsion stable. Cold Cream
is employed as an emollient and ointment base.

3-Water- miscible/removable Bases:

They are O/W emulsions that are capable of being washed from skin or clothing
with water. These bases, which resemble creams in appearance, may be diluted
with water or with aqueous solutions. From a therapeutic viewpoint, they have the
ability to absorb serous discharges in dermatologic conditions. Certain medicinal
agents may be better absorbed by the skin when present in a base of this type than
in other types of bases.

Hydrophilic Ointment

It contains sodium lauryl sulphate as the emulsifying agent, with stearyl alcohol
and white petrolatum representing the oleaginous phase of the emulsion and
propylene glycol and water representing the aqueous phase. Methyl paraben and
propyl paraben are used to preserve the ointment against microbial growth.

4 Water-soluble Bases: Unlike, water-removable bases, which contain both


water-soluble and water-insoluble components, water soluble bases contain only
water-soluble components. They are commonly referred to as "greaseless"
because of the absence of any oleaginous materials. Because they soften greatly
with the addition of water, aqueous solutions are not effectively incorporated into
these bases, thus, they are better used for the incorporation of non-aqueous or
solid substances. They are prepared by blending macrogols (poly ethylene glycol
(PEG)) of high and low molecular weights.

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Date : Experiment No. :

SIMPLE OINTMENT B.P

Aim: To prepare and submit simple ointment

Requirments:

Apparatus: Beaker, water bath, stirrer, glass motar

Chemicals: Wool fat, hard paraffin, cetostearyl alcohol, white soft paraffin

Formula :

Ingredient Standard Formula Working Formula


Wool fat
hard paraffin
cetostearyl alcohol
white soft paraffin

Principle:

Simple ointment is an absorption type ointment base, which is prepared by fusion


method. It consists of hydrophobic fatty bases like hard paraffin, cetostearyl
alcohol and white or yellow soft paraffin, wool fat act as an w/o type of
emulsifying agent, hence it ensures satisfactory emulsification of aqueous solution
of the medicament. Therefore base gets hydrophilic nature and capacity to absorb
large quantity of water.

In this preparation, hard paraffin is used to stiffen the ointment base. Cetostearyl
alcohol improves the stability and emollient property of the ointment. Soft
paraffin gives spreadability and emollient nature to the preparation. If the
medicament is white or colourless then white soft paraffin can be used.

If the simple ointment is used for preparation of ophthalmic ointment, then yellow
soft paraffin should be used instead of white soft paraffin, because white soft

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paraffin is obtained by bleaching of yellow soft paraffin with oxidizing agents and
acids. Hence the traces of oxidizing agents and acids may remain in the white soft
paraffin, and cause irritation to the eyes.

Procedure :

Weigh all the ingredients properly. Melt hard paraffin and cetostearyl alcohol in
porcelain dish kept on water bath. To the above molten mixtures add wool fat and
white soft paraffin and stir it well. After melting all ingredients remove porcelain
dish from water bath and stir it continuously until semisolid base is obtained.

Dispensing: Dispensed in light wide mouthed small glass jar and allow to cool
without stirring, to avoid entrapment of air and makes the product opaque. After
cooling close thoroughly with plastic screw cap, polish and label

Direction: Apply to the affected part , whenever necessary.

Storage: Store in a cool and dark place

Auxillary label: For External Use Only

Uses: This ointment is used as a base for the preparation of other ointments.

Report :

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Date: Experiment No.:

SULPHUR OINTMENT IP

Aim:To prepare and submit Sulphur ointment IP

Requirments:

Apparatus: Beaker, water bath, stirrer, glass mortar

Chemicals: Wool fat, hard paraffin, cetostearyl alcohol, white soft paraffin

Formula :

For Simple Ointment :

Ingredient Standard Formula Working Formula


Wool fat
hard paraffin
cetostearyl alcohol
white soft paraffin

For Sulphur Ointment :

Ingredient Standard Formula Working Formula


Sulphur (precipitated)
Simple Ointment

Principle:

Simple ointment is an absorption type ointment base, which is prepared by fusion


method. It consists of hydrophobic fatty bases like hard paraffin, cetostearyl
alcohol and white or yellow soft paraffin, wool fat act as an w/o type of

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emulsifying agent, hence it ensures satisfactory emulsification of aqueous solution
of the medicament. Therefore base gets hydrophilic nature and capacity to absorb
large quantity of water.

In this preparation, hard paraffin is used to stiffen the ointment base. Cetostearyl
alcohol improves the stability and emollient property of the ointment. Soft
paraffin gives spreadability and emollient nature to the preparation. If the
medicament is white or colourless then white soft paraffin can be used.

If the simple ointment is used for preparation of ophthalmic ointment, then yellow
soft paraffin should be used instead of white soft paraffin, because white soft
paraffin is obtained by bleaching of yellow soft paraffin with oxidizing agents and
acids. Hence the traces of oxidizing agents and acids may remain in the white soft
paraffin, and cause irritation to the eyes.

Sulphur is used for several conditions and avalible in the form of ointment, cream
and lotion. Sulphur ointment has antiseptic, parasitic, and scabicide activity and
used in treatment of scabies and acne. Generally, finely divided precipitated
sulphur is used for preparation of ointment instead of sublimed one. The
precipitated sulphur is amorphous in nature forms smooth ointment.

Procedure :

For Simple ointment :

Weigh all the ingredients properly. Melt hard paraffin and cetostearyl alcohol in
porcelain dish kept on water bath. To the above molten mixtures add wool fat and
white soft paraffin and stir it well. After melting all ingredients remove porcelain
dish from water bath and stir it continuously until semisolid base is obtained.

For Sulphur ointment :

Weigh required quantity of sulphur and simple ointment properly. Place sulphur
on one part of clean ointment slab and simple ointment on other part of slab. Take
small quantity of sulphur and about three times more volume of simple ointment

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at the centre of ointment slab and levigate using ointment spatula until sulphur is
mixed thoroughly in simple ointment base. Continue the process until all quantity
of sulphur is mixed to get a homogeneous mixture.

Dispensing: Transfer the mixed mass into a warm light resistant (greenish or
amber colored) wide mouthed small glass jar and allow to cool without stirring, to
avoid entrapment of air and makes the product opaque. After cooling close
thoroughly with plastic screw cap, polish and label

Direction: Apply to the affected part , whenever necessary.

Storage: Store in a cool and dark place

Auxiliary label: For External Use Only

Uses: This ointment is used for scabies and acne.

Report :

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Date: Experiment No.:

NON-STAINING IODINE OINTMENT I.P/B.P.C

Aim:To prepare and submit non-staining iodine ointment I.P/B.P.C

Requirments:

Apparatus: Beakers, stirrer, water bath, glass mortar

Chemicals: Iodine, oleic acid, castor oil, yellow soft paraffin

Formula :

Ingredients Standard Formula Working formula


Iodine
Oleic Acid
Arachis oil
yellow soft paraffin

Principle:

Non- staining iodine ointment is an ointment prepared by chemical


reaction which is used as an local analgesic and anti-inflammatory. Fixed oils and
fats obtained from vegetable source like arachis oil,castor oil,oleic acid contains
unsaturated fatty acids (i.e fatty acids contain double or triple bond
linkages).Iodine combines with these linkages of fatty acids and form complex

Though the prepared(obtained) ointment is greenish-black in colour , even


these does not leaves stain when rubbed on the skin, due to non availability of free
iodine. Therefore combined iodine ointment is called as “Non-staining iodine
ointment’’

Eg

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CH3(CH2) – CH=CH – (CH2)3 – COOH +I2à CH3(CH2) –CHI – CHI –(CH2)

 For preparation of ointment, arachis oil alone cannot be used, because it


does not contain sufficient unsaturated linkages, to make complex with
iodine. Therefore oleic acid is used along with arachis oil which provides
sufficient unsaturated fatty acids and has oleoginic linkages. These
linkages make complex with iodine and form di-iodo stearic acid.
 Instead of arachis oil, any of paraffin like, hard paraffin, soft paraffin or
liquid paraffin alone cannot be used.
Because they consists almost saturated fatty acids, hence they are unable
to absorb more than 2% of iodine. Therefore paraffin are used as base, for
preparation ointment along with fixed oils
 Under normal conditions employed for preparation of ointment ,the
maximum absorption(complexation) of iodine is not possible. Hence the
amount of oil used is usually much excess than theoretical quantity.
 The addition of yellow soft paraffin in the initial stage i.e along with
arachis oil and oleic acid, slows down the reaction between fatty acids and
iodine. Therefore yellow soft paraffin should be melted separately and
added at end of the preparation
 Iodine is volatile in nature. Therefore ointment should be prepared in
closed vessel and heating should not be done above 500C.
 At room temperature, reaction between oil and iodine is very slow.
Therefore reaction is hastened by heating the reaction mixture. At the
initial stage mixture shows brown colour, but the final stage it turns to
greenish black colour due to complete complexation between fatty acids
and iodine. It may requires several hours (2 to 4 hour)for completion of
reaction

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Procedure:

Since there will be little wastage (loss) of ingredients during weighing


and preparing,to manipulate these practical losses, calculate the
ingredients for at atleast one or two grams extra,than prescribed.
1) Finely powder the iodine in a glass mortar and add the required
amount of iodine to the glass stoppered bottle containing arachis
oil and oleic acid and stir well.
2) Close the bottle with stopper and heat at 50c in a thermo statiscally
controller water bath, with occasional stirring, until brown colour
changes to,greenish black colour (This may make take 2-4 hours)
3) Warm the yellow soft paraffin to 50 C on a water bath. To this
melt, add iodised oil with continuous stirring. (More heating
should not be applied, because it cause deposition of a resinous
substance)

Dispensing: Iodine is sensitive to the light, therefore, pour the mixed mass into a
warm light resistant (greenish or amber coloured)wide mouthed small glass jar
and allow to cool without stirring, to avoid entrapment of air and makes the
product opaque.After cooling close thoroughly with plastic screw cap, polish and
label

Direction: Apply to the affected part , whenever necessary.

Storage: Store in a cool and dark place

Auxiliary label: For External Use Only

Uses: This ointment is used as, local analgesic and anti inflammatory.

Report :

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MOUTHWASHs
&
GARGLES

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MOUTHWASH.

A medicated liquid used for cleaning the oral cavity and treating mucous
membranes of the mouth. May contribute to surface softening and increased wear
of dental resins and composite materials

Types of Mouthwash

Fluoride mouthwashes contain sodium fluoride which helps to strengthen the


teeth as well as adding extra protection against tooth decay.

Cosmetic mouthwashes do not offer the same protection as other types and are
used more as a means of disguising bad breath(halitosis).

Antiseptic mouthwashes contain chlorhexidine gluconate - a chemical which


stops the growth of bacteria and is suitable for people with a mouth infection

Natural mouthwashes are alcohol-free (and contain no fluoride) and work in much
the same way as conventional mouthwashes.They can also treat a mouth infection
or injury. Total care mouthwashes contain anti-bacterial ingredients which help to
reduce the buildup of plaque and prevent gum disease.

Advantages of Mouthwash:

Can boost your oral health.

May prevent plaque from building up.

Rinses with fluoride can help prevent cavities.

Fluoride protects against tooth decay(cavities). Mouthwash can help you target
plaque. Prevents dry mouth.

Disadvantages of Mouthwash:

Some mouth rinses contain high levels of alcohol ranging from 18 to 26 percent.
This may produce a burning sensation in the cheeks, teeth, and gums.

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Detergent

Antiseptic agent – fluoride

Colorants

Sweeteners - sodium saccharine and sucralose.

Vehicle – Water

Preservative- sodium benzoate.

Flavoring - such as eucalyptol or menthol

To prepare mouthwash following ingredients are added

Labeling:

Keep out of reach of children

Away from sunlight

Store at room temperature, narrow mouthed

Storage:

Colorless bottles are used unless protection from light is necessary, plastic screw
caps, fluted

Before using a mouth rinse, brush and floss teeth. Measure the proper amount of
rinse Dilute it before use Thirty seconds is the suggested rinsing time. Do not
rinse, eat, or smoke for thirty minutes after using a mouthwash

Anticavity: Floride rinse

Bactericidal (Cosmetic):Fluoride mouthwash

Analgesic: lidocaine hydrochloride

Antisceptic: Listerene or Phenolic mouthwash

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Gargles

Gargles are aqueous and hydroalcoholic solution which is used to treat or prevent
throat infection.

They are dispensed in concentrated form with directions for dilution with warm
water. They are brought into intimate contact with the mucous membrane of the
throat and allow to remain for few moments

Deodorant effect

• Anti-bacterial

•Astringent

• Mild anesthetic actions

Store away from direct sunlight,heat and moisture

Keep out of the reach of children.

Store at room temperature

The label should include:

(1) the name of the pharmaceutical product

(2) The name(s) of the active ingredients

(3) The amount of active ingredient in a suitable dose-volume

(4) The name and concentration of any antimicrobial preservative and the name of
any other excipient

(5) The batch (lot) number assigned by the manufacturer

(6) The expiry date and, when required, the date of manufacture

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(7) Any special storage conditions or handling precautions that may be necessary

(8) Directions for use, warnings, and precautions that may be necessary;

(9) The name and address of the manufacturer or the person responsible for
placing the product on the market

Dilute 1ml to 20ml with water gargle for 30 seconds, repeat 3 to 4 hourly.

NOT TO BE SWALLOWED

Usage

Avoid contact with the eyes.

Use only as directed.

Always read the label.

Dispensing

Preparation contains volatile ingredients, it should be kept in a tightly closed


container. Containers should be made from material that is sufficiently transparent
to permit the visual inspection of the contents.

The containers should be made of material that will not adversely affect the
quality of the preparation

Strong damp-proof, water-proof packing. Small flip top bottles.

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Date: Experiment No.:

PHENOL GLYCERINE GARGLE

Aim: To prepare and submit 20 ml of phenol glycerin gargle.

Requirements:

Apparatus: Beaker, glass rod, pipette.

Chemicals: Phenol glycerin, amaranth solution, purified water

Formula:

Ingredients Standard formula Working formula


Phenol glycerin
Amaranth solution
Purified water

Principle:

Gargles are aqueous solutions used for the treatment of infections in pharynx and
nasopharynx. They are usually concentrated solutions and must be diluted with
water before use. Phenol gargles should be diluted with equal amount of warm
water before use.

Procedure:

Prepare phenol glycerine and mix it with few ml of purified water and shake. Add
amaranth solution and make up the volume to produce 20 ml of phenol glycerine
gargle with water.

Category: Local analgesic

Storage: Store in well closed container in cool place.

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Auxiliary label: FOR EXTERNAL USE ONLY

DONOT SWALLOW IN LARGE AMOUNTS

Report:

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Date: Experiment No.:

CHLROHEXIDINE MOUTHWASH

Aim : To prepare and submit 100ml of Chlrohexidine mouthwash

Requirements :

Apparatus : Beaker, Glass rod, pipette

Chemicals : Chlrohexidine gluconate, Ethanol, Glycerin, Citric acid, Sodium


citrate, Sodium metabisulfite, Sodium benzoate, Brilliant blue and tartarazine dye,
Mint flavor.

Formula

Ingredients Standard formula Working formula


Chlrohexidine gluconate
Ethanol (96%v/v)
Glycerin
Citric acid
Sodium citrate
Sodium metabisulfite
Sodium benzoate
Brilliant blue and
tartarazine dye
Mint flavor
Purified water q.s

Principle: Chlrohexidine gluconate is a bisguanide antiseptic and disinfectant


which is bactericidal or bateriostatic agaist a wide range of gram –ve and gram
+ve vegetative bacteria, yeast , dermatophyte fungi.

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The anti microbial activity cvers mst of the important species occurring in the
microbe flora. Chlrohexidine gluconate mouth wash is an anti microbial solution
which inhibits the formation of dental plaque. It is indicated as a aid to the
treatment and prevention of gingivitis and in the maintenance of oral hygine,
particularly in situations where tooth brushing cannot be adequately employed. It
is used to promote gingival healing following periodontal sugery. It should be
used as twice daily.

In this preparation Chlrohexidine gluconate is used as an antiseptic and anti


plaque. Ethano (96%v/v) is used as solubilising agaent. It also enhances the flavor
, sharpen the tase and mask unpleasant taste of drug. Glycerin acts as humectants
and increases the viscosity of the product, it also enhances sweetness of the
product and along with ethanol enhances preservation of formulation. Citric acid
and sodium citrate are used to regulate the pH of the preparation. Sodium meta
bisulfate is used to nutrelize the pigmentation activity of chlorohexidine. Brillient
blue and tartarazine yellow are used to get green shade of the preparation.

Procedure:

Clean all the glassware and dry them as per SOP. Dissolve required quantity of
chlorhexidine gluconate, citric acid and sodium citrate in some portion of water
with continuous stirring until clear solution is obtained. Add required quantity of
ethanol to this solution. Add measured quantity of glycerine, sodium
metabisulphite, sodium benzoate, coloring agent, and mint flavour gradually with
continuous stirring. Pour this solution into a measuring cylinder and make up the
volume to 100 ml using purified water. Transfer the prepared mouthwash to
amber coloured bottle and close thoroughly with polypropylene screw cap. The
cap is conical in shape and has 10 ml and a level line engraved on the inside.
Label properly and submit.

Category: In treatment and prevention of gingivitis and in the maintenance of


oral hygiene.

Storage: Store in a cool dry place

Sri Venkateshwara College of Pharmacy Page No. :


Dose: 10 ml twice a day.

For treatment and prevention, swish in your mouth for a minute. Do not rinse, eat
or drink thereafter for 20 minutes. Recommended only under professional
guidance.

Auxiliary label: NOT TO BE SWALLOWED

FOR ORAL USE ONLY

Report:

Sri Venkateshwara College of Pharmacy Page No. :

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