Sid Report
Sid Report
Sid Report
INTRODUCTION
Our goal in this Internship is to gain a knowledge about pharmacy and drug formulation.
The safe and efficient use of pharmaceuticals is the main emphasis of the vital healthcare field of
pharmacy. It includes a range of activities, including drug development and discovery,
distribution, and patient outcome monitoring. Pharmacists are essential in making sure that drugs
are given correctly, taken by patients in a safe manner, and have the desired therapeutic effects.
Pharmacists are qualified experts who offer invaluable knowledge in areas like drug interactions,
dose modifications, and patient education in addition to administering prescriptions. They
collaborate closely with patients and healthcare professionals to manage chronic illnesses,
enhance treatment regimens, and advance general wellness. Pharmacy is a dynamic and essential
profession that is always changing due to developments in pharmaceutical research, technology,
and healthcare procedures. There are 3000 pharmaceutical industry and India has highest number
of US-FDA complaint Pharma plants outside of USA. In India, Sun Pharmaceutical company is
#1 rank which is situated at Mumbai, Maharashtra.
Year of establishment:1988
Website: www.Sbcollegeofpharmacy.com
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B) HISTORY OF THE COLLEGE
C) ABOUT SBCP
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within the pharmaceutical industry. Moreover, the college is committed to community service
and outreach programs, aiming to make a positive impact on society through pharmaceutical
education, healthcare awareness campaigns, and collaborative initiatives with healthcare
institutions.
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E) STUDENT’S WORK ASSESSMENT
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2. INTERSHIP OBJECTIVE
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3. TECHINAL REPORT
Pharmacy encompasses a wide range of topics that are essential for understanding
medications, their effects, and their role in healthcare. Here are some key topics in pharmacy
are
PHARMACEUTICAL CHEMISTRY
PHARMACEUTICS
PHARMACOLOGY
Pharmacology is a branch of medicine and biology concerned with the study of drug
action. It involves examining how drugs interact with biological systems, understanding their
mechanisms of action, therapeutic uses, and potential side effects. Pharmacologists explore the
effects of drugs on humans, animals, and even at the cellular and molecular levels.
PHARMACOGNOSY
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3.2 PHARMACEUTICAL CHEMISTRY
Biologically active molecule synthesis and drug design are the focus of pharmaceutical
(medical) chemistry. The goal of pharmaceutical chemistry is to create new chemical compounds
that may aid in the search for novel pharmaceuticals or enhance the structures of already existing
drugs, thus increasing the number of chemical drugs in existence. While organic chemistry is
important, only highly skilled pharmaceutical chemists can function well in an extremely
interdisciplinary setting and collaborate with researchers in other fields, including toxicology,
molecular biology, structural biology, pharmacology, physical chemistry, biochemistry,
pharmacokinetics, pharmaceutical technology, and pharmacology.
Aspects of pharmaceutical chemistry include:
1. Drug development
2. Drug design
3. Drug delivery system
1. Drug development
The process of developing a novel medication or medical device and introducing it to the
market is referred to as drug development. Drug development, chemistry, pharmacology, non-
clinical safety testing, manufacturing, clinical trials, and regulatory submissions are all included
in this integrated, interdisciplinary effort. This report, which was recently presented at the 39th
annual meeting of the American College of Toxicology in West Palm Beach, Florida, outlines
the workshop titled "Drug Development 101." The purpose of this session is to educate
participants about drug development. medication design is the first step in the medication
development process.
2. Drug design
Drug design, sometimes referred to as rational drug design, is the process of identifying
and creating novel medications by taking into account biological target information. Creating
compounds that preferentially interact with a particular target in the body, like a protein or
enzyme, is the aim of drug design in order to produce therapeutic effects with a minimum
number of adverse effects.
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3.21 Process of drug design
A) Target identification and validation
(i)Identification
Finding a target molecule or pathway connected to a disease process is the first
stage in the drug design process. This could be a nucleic acid, protein, enzyme, or
receptor that is involved in the pathophysiology of the illness.
(ii)Validation
Upon identification of a prospective target, further validation is required to
ascertain the target's significance in the disease and its appropriateness for
pharmacological intervention. This entails a variety of experimental methods and
frequently entails analyzing the composition and functionality of the target.
B) Lead discovery
A novel medicine is designed starting with a lead molecule. The main chemical
ought to possess the therapeutical qualities that are crucial for the medicine. Lead
compounds can be found in both synthetic and natural sources.
X-ray crystallography and NMR spectroscopy are two methods that are utilized
to ascertain the targets and its lead compound complexes' three-dimensional structure.
This data aids in the comprehension of binding interactions and directs logical design.
(ii)Molecular modeling
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Potential therapeutic candidates and the target molecule are simulated using
computational methods by QSAR (Quantitative Structure-Activity Relationship)
modeling, molecular docking, and molecular dynamics simulations.
(iii)QSAR modeling
QSAR models are useful for predicting the biological activity of novel compounds
because they establish a correlation between a compound's chemical structure and activity.
D) Preclinical development
(i)Preclinical studies
Before lead compounds enter clinical trials, preclinical studies are essential for
assessing their safety, effectiveness, and pharmacokinetic characteristics. To obtain
complete information on a medication candidate, these investigations are usually carried
out in vivo (in animal models) and in vitro (in cell cultures).
The important in preclinical studies is
Pharmacokinetics
The ADME process is part of the pharmacokinetics process.
Absorption
Analyze the drug’s absorption into the bloodstream following delivery.
Distribution
Examine the drug’s distribution over the body’s tissues.
Metabolism
Know the drug’s metabolism, which is mostly carried out by liver enzymes.
Excretion
Examine the drugs and its metabolites excretion from the body, which usually happens in
the form of feces or urine.
pharmacodynamics
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pharmacodynamics is the study of mechanism of action of drugs and explain what
drug does to body and how do they do it.
Biochemistry of drug action
The study of how medications interact with biological molecules to
produce their desired effects or unwanted side effects is known as the
biochemistry of drug action. Usually, drugs work by attaching themselves to
particular target molecules in the body, including enzymes, transport proteins, or
receptors. This binding event modifies the target molecule's function, resulting in
physiological modifications that have positive therapeutic effects.
Example
The use of beta-blockers in cardiovascular therapy is a prime illustration of this drug action.
Beta-blockers are medications that are used to treat cardiac arrhythmias, or irregular heartbeats,
and hypertension, or elevated blood pressure. These medications function by attaching
themselves to the surface of cardiac muscle cells' beta-adrenergic receptors. Beta-blockers inhibit
the activity of stress hormones such as adrenaline (epinephrine) and others by binding to these
receptors, which would otherwise cause the heart to beat more rapidly and forcefully.
Consequently, beta-blockers lower blood pressure and heart rate, enhancing cardiac
performance. Commonly used beta blockers like Tenormin, Cardicor, Betaloc, Angilol,
Lopresor.In this example:
E) Toxicology
Evaluate the drug's immediate hazardous effects following a single dosage, also known as
acute toxicity.
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F) Clinical studies
Phase I, II, and III clinical studies involving people are carried out to evaluate safety,
efficacy, dose, and adverse effects. The outcomes of these trials are used to seek regulatory
permission.
We learned that Instead of doing clinical studies on animal, Bureau for Health and
Education Status Upliftment introduce a software call Ex pharma – software. It is a computer
assisted learning software containing various programs which stimulate animal experiments in
pharmacology. This software can be used to demonstrate the effect od drugs on different animal
system without using real animals.
G) Formulation development
H) Quality control
Throughout their entire lifecycles, from initial design to manufacture and distribution,
pharmaceutical goods must adhere to specified quality standards, which are ensured by quality
control in drug design and development.
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The quality control includes:
(i)Chemical and analytical testing
Identity: Ensuring that techniques like mass spectrometry, chromatography (HPLC),
spectroscopy (IR, NMR), and spectroscopy are used to accurately identify the drug
substance and excipients.
Purity: Measuring the amount of contaminants in the drug ingredients.
Uniformity: Ensuring that the active components in the formulations are distributed
uniformly.
Appearance: Examining the medication product's outward features, including its color,
shape, and texture.
Dissolution: Measuring how long it takes for the active components in tablets or
capsules to dissolve and release.
Microbial limits: Checking for the presence of dangerous bacteria in the medication
product.
We learned that by using Friability tester we find out the stability of the tablets.
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(vi) Quality risk managements
Risk assessment
Recognizing possible threats to patient safety and product quality at every stage of
the drug's lifecycle and putting mitigation strategies in place.
To guarantee that pharmaceutical products are high-quality, safe, and effective, quality
control is essential in medication design. Good quality control helps to better healthcare
outcomes and facilitates the successful creation of new medications.
During the drug design process, drug delivery systems are essential. Enhancing the
therapeutic efficacy, safety, and patient compliance of pharmaceutical chemicals is the goal of
the drug delivery system. These systems are made to target particular bodily locations, regulate
the release profile, and increase the bioavailability of medications. Drug delivery system types
include:
(i) Extended-release tablet with controlled release system
Advantages
Drug release that is sustained: Extended-release tablets are designed to release the
medication gradually and steadily over a longer amount of time.
Enhanced patient adherence: Through a decrease in the daily dosage requirements.
Patients' adherence is improved by this kind of pill, particularly for long-term diseases.
Steady blood levels: By reducing swings that may happen with instant release
formulations, they aid in maintaining a steady plasma drug content.
Systems with coatings: A polymer membrane coats tablets to regulate the rate of
release.
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Applications
These oral dosage forms are made to release the active ingredient in pharmaceuticals
quickly after consumption, giving a prompt onset of action.
Advantages
Quick start of action:The medication is designed in such a way that immediate release
pellets enter the bloodstream swiftly, enabling quick therapeutic benefits.
Convenience:Depending on the drug's pharmacokinetics and dosage regimens, they are
usually taken many times a day.
Examples:Paracetamol (acetaminophen) for fever and Cetirizine tablet for relief of
allergy symptoms.
3.3 PHARMACEUTICS
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The first step in the procedure is choosing the active pharmaceutical ingredient
(API) in accordance with its intended pharmacological effects and therapeutic
qualities.
2. Choice of Excipients
Excipients are inert ingredients that are added to a formulation to improve
solubility, stability, convenience of administration, or alter the drug's release. They
are picked with care to guarantee compliance with legal requirements and API
compatibility.
3. Formulation Design
Excipients are inert ingredients that are added to a formulation to improve
solubility, stability, convenience of administration, or alter the drug's release. They
are picked with care to guarantee compliance with legal requirements and API
compatibility.
4. Manufacturing Process
We learned that manufacturing procedures are created once the formulation is
created to guarantee the product's uniformity and repeatability.The machine used to
punch the tablet is tablet punching machine.
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We learned that Tablet coating is a critical process in pharmaceutical
manufacturing, involving the application of a thin layer of coating material to the surface of a
tablet.
Film Coating
Controlled-Release Coating
Protection: Shields the drug from moisture, light, and air, enhancing stability.
Controlled Release: Enables sustained or delayed release of the drug.
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The packaging materials are chosen to preserve the stability of the formulation
and shield it from external influences. To find out how well the formulation holds up
over time under different storage circumstances, stability testing is done.
1. Physical Characteristics
To guarantee consistency and quality, the external look, homogeneity of dosage
units, hardness, disintegration time (for tablets), and viscosity (for liquids) are
assessed.
We learned that the dissolution testing apparatus plays a major role in
pharmaceutical manufacturing. It measures the rate at which a drug is released from
its dosage form (e.g., tablet) into a solution, which simulates the drug's behavior in
the gastrointestinal tract. This test helps ensure consistency and predict the drug's
bioavailability.
o Use: Commonly used for capsules and tablets that tends to float.
o Use: Widely used for tablets and capsules, especially those that sink.
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2. Chemical Analysis
Methods including titration, spectroscopy, and chromatography are employed to
confirm the identity, concentration, and purity of the medicinal ingredient in the
formulation.
3. Biological Evaluation
This entails evaluating the drug's pharmacological activity to make sure the
intended therapeutic impact is achieved. Studies may be carried out both in vivo
(using animal models) and in vitro (using cells or tissues).
4. In vivo Pharmacokinetics
Pharmacokinetic investigations ascertain the drug's mode of absorption,
distribution, metabolization, and excretion from the body. This aids in determining
dosage schedules and forecasts human drug behavior.
6. Clinical Trials
Following the completion of preclinical research and the receipt of regulatory
approval, clinical trials involving human participants are carried out to assess safety,
effectiveness, and tolerability in a regulated setting.
7. Regulatory Approval
To ascertain whether a medicine satisfies safety and efficacy requirements for
commercialization, regulatory bodies like the European Medicines Agency (EMA) in
Europe and the Food and Drug Administration (FDA) in the United States examine
all data from formulation and evaluation trials.
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3.33 PARACETAMOL DRUG FORMULATION
Procedure
1. Dissolution of p-Aminophenol
In a beaker, dissolve 10 grams of p-aminophenol in 100 milliliters of distilled water.
To guarantee total disintegration, you might need to reheat the mixture a little.
2. Preparation of Acetylation Reaction
Stirring constantly, add 15 mL of acetic anhydride to the p-aminophenol solution.
Add a few drops of strong sulfuric or hydrochloric acid to the mixture if a catalyst is
needed.
3. Reaction and Cooling
Stir the reaction mixture for approximately fifteen minutes at room temperature. After
that, chill the solution in the beaker by submerging it in an ice bath, which will aid in
the product's precipitation.
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4. Precipitation of Paracetamol
The paracetamol will separate from the solution as it cools. In order to neutralize any
leftover acetic acid and encourage crystallization, add a tiny amount of sodium
acetate if the precipitation is going slowly.
5. Filtration
After the paracetamol has completely precipitated, strain the mixture and gather the
solid result with a funnel and filter paper.
7. Recrystallization (Optional)
Re-crystallize the paracetamol for maximum purity by dissolving it in a small amount
of hot water, letting it drop to room temperature, and then chilling it even further in
an ice bath. The product has been recrystallized; filter and dry.
Safety and Precautions
• Use the proper personal protection equipment (gloves, goggles, lab coat) when handling
• Concentrated acids and acetic anhydride should be handled carefully since they are
corrosive.
Uses
It works well as an analgesic and antipyretic. The antipyretic effect of the medication is
attributed to its activity on the hypothalamus heat-regulating center, whereas analgesia is
demonstrated as a result of an increase in pain threshold.
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3.34 Evaluation of Paracetamol Tablets
1. Physical Tests
Tablet Hardness
To make sure the tablet can tolerate handling, its hardness can be measured with a
hardness tester.
Friability
Using a friabilator (Fig 3), determines how resistant the tablet is to abrasion.
Weight Variation
Preserves consistency in the tablet weights within a batch. The disintegration test
measures how long it takes for a tablet to start disintegrating into smaller pieces.
2. Chemical Tests
Assay of Active Ingredient
Quantifies the amount of paracetamol in the tablet using techniques like HPLC
(High-Performance Liquid Chromatography) or UV spectrophotometry.
Dissolution Test
Using Dissolution Testing Apparatus (Fig.6) Measures the rate and extent of drug
release from the tablet in a specified medium.
3. Stability Testing
Accelerated Stability Testing
Tablets are stored under elevated temperature and humidity conditions to predict shelf
life.
Long-term Stability Testing
Tablets are stored under normal conditions to monitor changes over time.
4. Microbial Testing
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Ensures that the tablets are free from harmful microorganisms. Common tests include
total microbial count and specific pathogen testing.
3.4 PHARMACOLOGY
PHARMACOLOGY
Jonathan Pereira is known as the father of pharmacology. Pharmacology is the derived from the
Greek words: Pharmakon means drug and Logos means study. Pharmacology is the study of
action of drugs on living organisms or tissues and how those drugs help to diagnose, treat, cure
and prevent disease. Clinical Pharmacology is the study of drugs in humans. It includes the
substance origin, composition, therapeutic use and toxicology, pharmacokinetics and
pharmacodynamic studies of drugs in humans. The two main areas of pharmacology are
pharmacokinetics and pharmacodynamics. It is useful for rational prescription of drugs. Drug is
defined as an agent used for diagnosis, treatment, or prevention of diseases in humans and
animals.
PHARMACOKINETICS
PHARMACODYNAMICS
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The assignment they had given to me during my holiday was to take notes on the topics of
mechanism of action of anti-bacterial drug, anti-diabetic drug, anti-ulcer drug, anti-cancer drug.
The above mentioned topics are discussed below:
There are six major modes of action i) interference with cell wall synthesis, ii) inhibition of
protein synthesis, iii) interference with nucleic acid synthesis, iv) inhibition of a metabolic
pathway, v) inhibition of membrane function, vi) inhibition of ATP synthase. According to its
mechanism of action, the targets of antibacterial drugs include cell membrane, cell wall, protein
synthesis, nucleic acid synthesis and biological metabolic compound synthesis. The six main
modes of action of antimicrobial and support target and phenotypic discovery, including:
The mechanism of action of anti-diabetic drugs are described by their pharmacologic names and
their actions:
i)METFORMIN
It improves the response of cells to insulin, by promoting glucose uptake by the cells which in
turn bring down the blood sugar levels. It also suppresses appetite. It is the most tested drug for
diabetes which usually does not cause low sugars.
It is the most potent drug for diabetes. It drives blood glucose into the cells. Hypo glycemia
(low sugar) is the only complication if used inappropriately. It can be used in conditions like
renal, cardiac, hepatic impairments, sepsis and pregnancy where most oral drugs cannot be used.
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3.43 MECHANISM OF ACTION OF ANTI-CANCER DRUG
The anti-cancer drug may be divided into two groups. i) cell cycle specific (CCS), it act
mainly in dividing cell. ii) Cell cycle non specific (CCNS), it act mainly in dividing cell as well
as resting cell.
ALKYLATING AGENT
Anti-ulcer drug works through various mechanisms to reduce stomach acid, protect the stomach
lining and promote healing of ulcers. The modes of action of drugs are:
These drugs such as omeprazole and esomeprazole, block the enzyme H+ /K+
ATPase in the stomach lining, which is responsible for the final step in acid production.
ii) Antacids
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3.45 DETERMINATION OF BLOOD CLOTTING TIME
During my internship I had learned to determine the blood clotting time of blood by wrights
capillary method.
Clotting or coagulation is a complex process in which clotting factors activate each other
and form a gel like substance of insoluble fibrin threads. This process is very important as it
prevents excessive blood loss irrespective of reason for bleeding. The process occurs in three
stages
Clotting time of interval between entry of blood into glass capillary tube and
formation of thin fibrin thread.
We had discussed some points about the clotting time of blood and they are mentioned below:
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Coagulation of blood is a chemical process in which the soluble fibrinogen is
converted into an insoluble fibrin threads.
It is due to reaction among various coagulation factors in the blood.
There are 13 clotting factors in the blood.
The time taken for this conversion is known as clotting or coagulation time.
Finally The clotting time of blood was found to be 1 minute and 30 seconds.
During my internship I had learned to determine the bleeding time of blood by Duke’s method.
Haemostasis (‘Haem’ means blood, stasis means ‘to stop’) refers to the process of stoppage of
bleeding within specified duration (usually 1-5 minutes) after blood vessels are punctured, cut or
damaged. It prevents excess loss of blood and thereby avoids further complications. This process
involves multiple processes like vasoconstriction, platelet plug formation and blood clotting.
Bleeding time is the time interval between the onset of bleeding and spontaneous unassisted
stoppage of bleeding.
A finger is pricked after aseptic precaution and the time was noted.
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The bleeding point was touched gently by a filter paper for every 30 seconds
without pressing the finger.
Number the blood spot one onwards(30,60,90,…)
Note the tone when bleeding stops (when there is no trace of blood spot on
filter paper as end point).
The blood spots were counted and the bleeding time was calculated.
The normal bleeding time is 1-5 minutes.
We had discussed some points about the bleeding time of blood they are mentioned below:
Finally The bleeding time of blood was found to be 1 minute and 30 seconds.
3.5 PHARMACOGNOSY
Pharmacognosy is the study of the medicinal use of crude drugs obtained from plants
and natural resources. Crude drugs are the dried, raw material of plant, animal or mineral origin,
used for the medicinal purpose.The American society of pharmacognosy defines
Pharmacognosy as “the study of the physical, chemical, biochemical and biological properties
of drugs, drug substances or potential drugs or drug substances of natural sources”.
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Easy availability of drugs and their low cost.
2.blackpepper 4.Cotton
The solvent used for the extraction of medicinal plants. The choice of solvent depends on
the type of plant, part of plant to be extracted, nature of the bioactive compounds, and the
availability of solvent. In general, polar solvents such as water, methanol, and ethanol are used in
extraction of polar compound, whereas non polar solvents such as hexane and dichloromethane
are used in extraction of non-polar compounds. During liquid–liquid extraction, the conventional
way is to select two miscible solvents such as water–dichloromethane, water–ether, and water–
hexane. In all the combinations, water is present because of its high polarity and miscibility with
organic solvent.
Solvents Polarity
n-Hexane 0.009
Petroleum ether 0.117
During fractionation, the selected solvent is added according to the order of increasing
polarity, starting from n-hexane, the least polar to water with the highest polarity.
3.54 TEST FOR ALKALOIDS
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EXAMPES
a) Morphine
Morphine is the most abundant opiate found in Papaver somniferum (the opium poppy).
It has a role as an opioid analgesic, a mu-opioid receptor agonist, a plant metabolite, an
environmental contaminant, a xenobiotic, a vasodilator agent, an anaesthetic, a drug allergen and
a neuroprotector.
USES
Morphine is used to treat severe pain severe. Morphine belongs to the group of medicines
called narcotic analgesics (pain medicines).
b) Papaverine
USES
Papaverine is an alkaloid used to treat many types of smooth muscle spasms such as
"vascular spasms”.
To detect the presence of flavonoids, 1mL of extract was taken and placed into a test
tube. Then few drops of lead acetate added and shaken. Formation of yellow precipitate signifies
the presence of flavonoids.
Uses
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Flavonoids possess a number of medicinal benefits such as anticancer,anti-oxidant,anti-
inflammatory and antiviral properties.
EXAMPLES
Citrus fruit
Citrus fruits are notably rich in flavonoid compounds and represent an important source
of dietary flavonoids, including hesperidin, hesperidin, naringin, naringenin, diosmin, quercetin,
rutin, nobiletin, tangeretin.
Uses
Vitamin C is the best and natural exfoliator of our skin, and citrus fruits are rich in
it. Citrus fruits help clear your clogged pores and dead skin to make your pores shrink.
Orange peels are here to rescue your skin-related problems.
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4. CONCLUSION
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5. BIBLOGRAPHY
3.Pharmaceuticalformulation
https://www.ncbi.nlm.nih.gov/books/NBK562239/#:~:text=Pharmaceutical%20formulation
%20is%20the%20multistep,the%20final%20beneficial%20medicinal%20product.
https://www.ncbi.nlm.nih.gov/books/NBK13703/
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