A PROJECT ON PHARMACY PRACTICE SCHOOL
TOPIC- NUTRACEUTICAL : TO PREPARE TRANSDERMAL PATCH
OF CAFFEINE
BACHELOR OF PHARMACY
BY
PARAS SHUKLA
B.PHARM 4th YEAR
ROLL NO – 2102030500068
UNDER SUPERVISION OF
MR AWINISH SHRIVASTAW
(ASSISTANT PROFESSOR)
RAMESHWARAM INSTITUTE OF TECHNOLOGY AND
MANAGEMENT,LUCKNOW
(AFFILATED TO DR. A.P.J ABDUL KALAM TECHNICAL
UNIVERSITY, LUCKNOW)
SESSION 2024 - 2025
ACKNOWLEDGEMENT
On this great occasion of accomplishment of our project on
NUTRACEUTICAL TO PREPARE TRANSDERMAL PATCH OF
CAFFEINE we would like to sincerely express our gratitude to MR
AWINISH SHRIVASTAW SIR who has been supported through the
completion of this project.
We would also be thankful to our Director Dr. UMESH PRATAP
SINGH of our college for providing all the required facilities in
completion of this project.
Finally I would like to thank my family and friends who helped me
a lot to complete the project .
PARAS SHUKLA
th
B. PHARM 4 YEAR
2102030500068
INDEX
S No. CONTENT
1 NUTRACEUTICAL
2 BENEFITS OF
NUTRACEUTICAL
3 CLASSIFIACTION
4 TRANSDERMAL PATCH OF
CAFFEINE
5 INTRODUCTION OF CAFFEINE
6 INTRODUCTION OF
TRANSDERMAL PATCH
7 METHOD OF PREPARATION
OF TRANSDERMAL PATCH OF
CAFFEINE
NUTRACEUTICAL
“Nutraceutical” is a term coined in 1979 by Stephen
DeFelice.
It is defined as “a food or parts of food that provide medical
or health benefits, including the prevention and treatment of
disease.”
Nutraceuticals may range from isolated nutrients, herbal
products, dietary supplements, and diets to genetically
engineered “designer” foods, and processed products such
as cereals, soups, and beverages. A nutraceutical is any non-
toxic food extract supplement that has scientifically proven
health benefits for both the treatment and prevention of
disease.
Nutraceuticals also refer to natural functional/medical foods
or bioactive phytochemicals that have health
promotingdiseasepreventing or medicinal properties.
These nutraceuticals in general contain vitamins, lipids,
proteins, carbohydrates, minerals, or other necessary
nutrients, depending on their emphases.
These nutraceuticals are used in nutritional therapy based
upon their chemical structures and biological functions.
The other components of our definition of nutraceutical
include the statements “for disease treatment and
prevention” and “administered with the intent of improving
the health and wellbeing of animals”.
Important function of Regulation Bodies In
Nutraceuticals
To test: safety, purity & potency of products.
To develop: effective & capable of producing ingredients use
in products.
To develop: new products either by combining existing
ingredients used in nutritional supplements or determining
new ingredients.
To develop: testing methods for ensuring the uniformity of
the ingredients in the company’s products.
In that products included vitamins, lipids, carbohydrate,
minerals & other nutrients.
These products are also used with health benefits & reduce
the risk of cancer, BP, high cholesterol, excessive weight,
diabetes, arthritis, cataracts, menopausal symptoms,
insomnia, digestive upsets, constipation etc.
Many other benefits like:
To help us live longer.
To stay away from particular medical conditions.
Increases the health value of our diet.
Its not produce unpleasant side effects.
Increases the health value of our diet.
It also help doing personally for psychological benefits.
Benefits of Nutraceuticals
The benefits of nutraceuticals are limitless and new uses for
them are being discovered every day. From physiological to
psychological health, nutraceuticals have the potential to treat a
wide array of illnesses and ailments. Nutraceuticals have been
used to:
improve overall health
boost energy
relieve anxiety
improve mental clarity
enhance sleep quality and quantity
prevent chronic diseases
reduce drug cravings
delay the aging process
increase life expectancy
support and regulate bodily functions
In addition to these health benefits, recent studies have shown
promising results for the effectiveness of herbal nutraceuticals on
disorders related to oxidative stress including allergies,
Alzheimer’s, cardiovascular disorders, cancer, diabetes,
inflammatory diseases, Parkinson’s disease, and obesity.
CLASSIFIACTION OF NUTRACEUTICALS
Nutraceuticals are non-specific biological therapies used to
promote wellness, prevent malignant processes and control
symptoms.
They are categorized as follows based on their chemical
constituents
(a) Nutrients : Substances which have established Nutritional
functions e.g. Vitamins, Minerals, Amino Acids, Fatty acids, etc.
(b) Herbals or Phytochemical : Herbs or Botanical
productsProducts of herbs of botanical products in the form of
concentrates or extracts.
Examples: Aloe vera, wheat grass, ginger, garlic, etc
(c) Dietary supplements : Probiotics, Prebiotics, Antioxidents,
Enzymes, etc.
Nutraceuticals are categorized on the basis of foods available in
the market -
1. Traditional nutraceuticals
2. Non-traditional nutraceuticals
1. TRADITIONAL NUTRACEUTICALS:
These are natural substances with no changes to the foodstuff.
They are grouped on the basis of
I. Chemical Constituents
a) Nutrients b) Herbals c) Phytochemicals
II. Probiotic Microorganisms
NUTRIENTS
VITAMINS - A vitamin is an organic molecule (or a set of
molecules closely related chemically, i.e. vitamers) that is an
essential micronutrient that an organism needs in small
quantities for the proper functioning of its metabolism. Essential
nutrients cannot be synthesized in the organism, either at all or
not in sufficient quantities, and therefore must be obtained
through the diet.
Fat Soluble Vitamins
Vitamin A: Acts as antioxidant, essential for growth and
development, maintains healthy vision, skin and mucous
membranes, may aid in the prevention and treatment of certain
cancers and in the treatment of certain skin disorders.
Vitamin D: Essential for formation of bones and teeth, helps the
body to absorb and use calcium.
Vitamin E: Antioxidant, helps to form blood cells, boost immune
system.
Vitamin K: Essential for blood clotting .
Water soluble vitamins
Vitamin C: Antioxidant, necessary for healthy bones, gums, teeth
and skin. Helps in wound healing, prevent from common cold.
Vitamin B1: Helps in carbohydrate metabolism, essential for
neurological function.
Vitamin B2: Energy metabolism, maintain healthy eye, skin and
nerve function.
Vitamin B3: Energy metabolism, brain function.
Vitamin B6: Helps to produce essential proteins, convert proteins
to energy.
Vitamin B12: Help in producing genetic material, formation of RBC,
maintenance of CNS, synthesis of amino acids, involved in
metabolism of protein, fat and carbohydrate.
MINERALS
Calcium
Magnesium
Manganese
Boron
Copper
Zinc
Phosphorus
Calcium: Essential for bone and teeth, maintaining bone strength,
nerve, muscle and glandular function, blood clotting. Iron:
Energy production, Hb, oxygen transport.
Magnesium: For healthy nerve and muscle function, bone
formation.
Phosphorous: Energy production, phosphorylation process, bone
and teeth, for genetic material.
Cobalt: Component of vit. B 12 and B 12 coenzymes.
Copper: Hb and collagen production, function of heart, energy
production, absorption of iron.
Iodine: Proper function of thyroid gland.
Zinc: Essential for cell reproduction, for development in Neonates,
wound healing, production of sperm and testosterone hormone,
Herbals - Examples include willow bark (Salix nigra),
having active component salicin, which is anti-inflammatory,
analgesic, antipyretic, astringent and antiarthritic.
Parsley (Petroselinum cripsum) contains flavonoids (apiol,
psSoralen) and is diuretic, carminative and antipyretic.
Peppermint (Mentha piperita) contains menthol as an active
and cures cold and flu. Lavender (Lavendula angustifolia)
contains tannin which is helpful in curing depression,
hypertension, stress, cold, coughand asthma.
Cranberries (Vaccinium erythrocarpum) contain
proanthocyanadin and found to be useful in cancers, ulcers
and urinary tract infections.
Phytochemicals
These are classified on the basis of chemical name given
according to their phytochemical properties.Examples
include carotenoids (isoprenoids), legumes (chickpeas and
soybeans), etc.
Flavonoid polyphenolics are found in berries, fruits,
vegetables and legumes which are potent antioxidants,
phytoestrogens, prevent breast cancer, prostate cancer, and
control diabetes.
Non-flavonoid polyphenolics are present in dark grapes,
raisins, berries, peanuts, turmeric roots; are strong anti-
inflammatory, antioxidants, anticlotting agents and reduce
cholesterol.
Spirulina and chlorella also used as food supplements
Probiotic Microorganisms.
“Probiotics” mean “for life” and are defines as live
microorganisms, which when consumed in adequate
amounts, ss
Features: They are friendly bacteria that promote healthy
digestion and absorption of nutrients.- They act to crowd out
pathogens such as yeasts, other bacteria and viruses that
may otherwise cause disease and develop a mutually
advantageous symbiosis with the human gastrointestinal
tract
Probiotics can cure lactose intolerance bythe psroduction of
the specific enzyme (B-galactosidase) that can hydrolyse the
offending lactose into its component sugars.
Prebiotics are a more recent addition to our vocabulary and
are substances which when consumed are not digested by
us. Instead, they act as a nutrient source for good probiotic.
Nutraceutical Enzymes
These enzymes are derived from microbial, plant or animal
sources.
NON-TRADITIONAL NUTRACEUTICALS
These are artificial foods prepared with the aid of biotechnology.
Food samples contain bioactive components which are
engineered to produce products for human wellness.
They are divided into:
a) Fortified nutraceuticals
b) Recombinant nutraceuticals
a) Fortified nutraceuticals - It constitutes fortified food
from agricultural breeding or added nutrients and/or ingredients .
e.g. Orange juice fortified with calcium, cereals with added
vitamins or minerals and flour with added folic acid. Also, milk
fortified with cholecalciferol used in vitamin D deficiency.
b) Recombinant nutraceuticals - As the word itself
denotes; these are energy providing foodstuffs formed by
“recombination”, with the help of biotechnology.
e.g.: bread, alcohol, fermented starch, yogurt, cheese, vinegar.
NUTRACEUTICALS AS THERAPEUTIC AGENTS
The majority of the nutraceuticals do possess multiple
therapeutic benefits and have been claimed to have physiological
benefits or provide protection against various diseases as the
following products:
Cardiovascular agents
Anti-obese agents
Anti-diabetic agents
Anti-cancer agents
Immune boosters
Substances that manage chronic inflammatory disorders
Formulations to cure degenerative diseases
TRANSDERMAL PATCH OF CAFFEINE
INTRODUCTION OF CAFFEINE
Caffeine is a naturally occurring alkaloid found in various
plants, including coffee beans, tea leaves, and cacao pods. It
acts as a central nervous system stimulant, reducing fatigue
and drowsiness1. Here's a brief introduction based on
research papers:
1. Chemical Structure and Properties: Chemically known as
1,3,7-trimethylxanthine, caffeine has the molecular formula
C8H10N4O2. It belongs to the methylxanthine class of
alkaloids2.
2. Sources: Caffeine is widely consumed worldwide, primarily
through coffee, tea, soft drinks, energy drinks, and certain
medications.
3. Mechanism of Action: Caffeine works by antagonizing
adenosine receptors in the brain, which prevents the onset of
drowsiness. It also increases the release of
neurotransmitters like dopamine and norepinephrine,
enhancing alertness and cognitive function3.
4. Health Effects: Research has shown that caffeine can have
both positive and negative effects on health. It can improve
athletic performance, cognitive function, and mood, but
excessive consumption may lead to anxiety, insomnia, and
other health issues1.
5. Current Research: Recent studies focus on caffeine's
potential health benefits, such as its antioxidant, anti-
inflammatory, and neuroprotective properties. Researchers
are also exploring novel delivery methods to enhance its
bioavailability and therapeutic effects
INTRODUCTION OF TRANSDERMAL PATCHES
Transdermal patches are a non-invasive method of delivering
medication through the skin directly into the bloodstream. Here's
a brief introduction:
1. Definition and Mechanism: Transdermal drug delivery
involves applying a patch to the skin, which releases a
controlled amount of medication over time. The medication
then penetrates the skin layers and enters the circulatory
system1.
2. Advantages: Transdermal patches offer several benefits
over traditional oral or injectable methods. They provide a
steady release of medication, reduce the risk of
gastrointestinal side effects, improve patient compliance,
and avoid the first-pass effect (where the liver metabolizes a
significant portion of the drug before it enters systemic
circulation)2.
3. Applications: These patches are used for various medical
conditions, including pain management, nicotine
replacement therapy, hormone replacement therapy, and
treatment of angina3.
4. Challenges: One of the main challenges is the skin's barrier
function, particularly the stratum corneum, which limits the
types of drugs that can be effectively delivered transdermally.
Researchers are exploring methods to enhance drug
permeation, such as using chemical enhancers,
microneedles, and iontophoresis1.
5. Recent Advances: Advances in transdermal patch
technology include the development of new materials and
formulations to improve drug delivery efficiency and patient
comfort. There is ongoing research to expand the range of
drugs that can be delivered transdermally and to optimize
patch design for better therapeutic outcomes1
The preparation of a transdermal patch containing caffeine
involves several steps to ensure proper drug delivery and
adhesion. Here's a general method based on research
papers:
Transdermal patches are a convenient and discreet way to
deliver medication directly into the bloodstream through the
skin. They are particularly useful for medications that are
difficult to take orally or that require a consistent, steady
dose.
How they work:
A transdermal patch consists of several layers:
* Backing layer: This is the outer layer that protects the
patch and provides a surface for application.
* Adhesive layer: This layer sticks to the skin and holds the
patch in place.
* Drug reservoir: This layer contains the medication that is
to be delivered.
* Rate-controlling membrane: This layer controls the rate at
which the medication is released from the reservoir.
* Liner: This layer protects the adhesive layer until the patch
is ready to be applied.
When the patch is applied to the skin, the medication is
slowly released from the reservoir through the rate-
controlling membrane. The medication then passes through
the skin and into the bloodstream.
Advantages of transdermal patches:
* Convenience: Transdermal patches are easy to apply and
can be worn for several days at a time.
* Consistency: They provide a consistent, steady dose of
medication, which can be helpful for conditions that require
long-term treatment.
* Avoidance of first-pass metabolism: Some medications
are broken down by the liver before they reach the
bloodstream. Transdermal patches bypass the liver, which
can lead to higher blood levels of the medication.
* Reduced side effects: Because transdermal patches
deliver medication directly into the bloodstream, they can
cause fewer side effects than other methods of
administration, such as oral pills or injections.
Disadvantages of transdermal patches:
* Skin irritation: Some people may experience skin irritation
at the site of application.
* Cost: Transdermal patches can be more expensive than
other forms of medication.
* Limited number of medications available: Not all
medications are available in transdermal patch form.
Common uses of transdermal patches:
Transdermal patches are used to treat a variety of
conditions, including:
* Pain
* Nausea and vomiting
* Motion sickness
* Hormone replacement therapy
* Nicotine addiction
* Smoking cessation
* Heart disease
*Hypertension
* Migraine headaches
METHOD OF PREPARATION OF TRANSDERMAL
PTACH OF CAFFEINE
1. Materials Preparation:
o Active Pharmaceutical Ingredient (API): Caffeine
o Polymers: Hydroxypropyl methylcellulose (HPMC),
Tamarind, Moringa (natural polymers)
o Solvent: Distilled water
o Permeation Enhancer: Tween-80 (5% w/w)
o Backing Layer: To protect the patch
2. Formulation:
o Dissolve caffeine and other polymers in distilled water
to create a homogeneous solution.
o Add the permeation enhancer to improve drug
absorption through the skin.
3. Coating:
o Use a modified solvent evaporation method to coat the
solution onto a suitable backing layer.
o Ensure uniform distribution of caffeine and polymers on
the backing layer.
4. Drying:
o Allow the coated patches to dry completely to form a
solid matrix.
o Ensure the patches are free from any solvent residues.
5. Cutting and Packaging:
o Cut the dried patches into desired sizes.
o Package the patches in airtight containers to maintain
their stability and efficacy.
This method ensures that the caffeine is evenly distributed
within the patch and can be effectively delivered through the skin
BIBLIOGRAPHY
Bagchi D. Nutraceuticals and functional foods
regulations in the United States and around the world.
Toxicology 2006 International Journal of Health & Allied
Sciences www.ijhas.in
Rodak, K., Kokot, I., & Kratz, E. M. (2023). Caffeine as a
factor influencing the functioning of the human body-
friend or foe?. PMC PubMed Central®. Retrieved
December 9, 2024, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC107909
93/
Khan, Z., Kakkar, S., Ghag, S., Shah, S., Patil, S., & Gupta,
A. D. (2018). Recycling of tea waste for extraction of
caffeine and production of a transdermal patch. World
Journal of Pharmaceutical Research.
Nowaczewska, M., Wiciński, M., & Kaźmierczak, W.
(2020). The Ambiguous Role of Caffeine in Migraine
Headache: From Trigger to Treatment. Nutrients.
Puri, V., Nagpal, M., Singh, I., Singh, M., Dhingra, G. A.,
Huanbutta, K., Dheer, D., Sharma, A., & Sangnim, T. (2023).
Nutraceuticals: Therapy Support and Formulation
Challenges.
