final project 2025
final project 2025
Dissertation submitted to
Dr. Babasaheb Ambedkar Technological University, Lonere, Raigad.
In Partial Fulfilment for the Award of the Degree of
Bachelor of Pharmacy
Submitted By
Aishwarya Vijay Dhone (2169141823103)
Uma Shamrao Korade (2169141823104)
Ankita Satish Bansude (2169141823105)
Pooja Ankush Dhumal (2169141823106)
Dnyaneshwari Dhananjay Divan (2169141823107)
CERTIFICATE
Medicated Chocolate for Pediatrics” done for the partial fulfilment for the award of
degree of Bachelor of Pharmacy has been carried out by Aishwarya Vijay Dhone, Uma
Dhananjay Divan under the supervision and guidance of Ms. Pratiksha Rajguru,
Science & Research (For Girls), Swami-Chincholi, Bhigwan during the year 2024-2025.
Raigad.
CERTIFICATE
This is to certify that the dissertation entitled “Formulation and Evaluation of
Medicated Chocolate for Pediatrics ” done for the partial fulfilment for the award of
degree of Bachelor of Pharmacy has been carried out by Aishwarya Vijay Dhone, Uma
Chincholi, Bhigwan during the year 2024-2025. Dissertation submitted to the Dr.
Science & Research (For Girls), Swami-Chincholi, Bhigwan under the esteemed guidance
Pharmaceutical Science & Research (For Girls), Swami-Chincholi, Bhigwan. The extent
and source of information derived from the existence literature have been indicated through
the project work at appropriate places. The work is original and has not been submitted in
part or full for any diploma or degree of this university or any other university.
I am deeply indebted to Dr. Vishal Babar, M.Pharm., Ph.D., Post Doc., Principal &
Bhigwan & my research guide, Ms. Pratiksha Rajguru, M.Pharm[QA}, Assistant Professor in
Girls), Swami- Chincholi, Bhigwan, under whose able and valuable guidance, this entire
research work was successfully completed. We are thankful for his constant source of
encouragement and support, which provided to impetus and paved the way for the
We take this opportunity to express my deep sense of gratitude and sincere thanks
to Mr. Divekar, Lab Assistant of Pharmaceutics department for their help during
experimental work.
We are very grateful to classmates and friends who have been given a
Chincholi, Bhigwan” for providing me the necessary infrastructural facilities to carry out
And above all, words fail to express my feeling to my parents whose initiation,
TOPIC PAGE NO
NEED OF WORK 6
REFERENCES 23-24
LIST OF TABLES
4 General appearance 16
Figure Page
Title
No. No.
1 Moringa powder 8
2
Ashwagandha powder 9
3 Lecithin 11
4 Cocoa powder 10
5 Cocoa butter 11
6 Saccharin powder 12
8 Vanillin powder 13
11 General appearance 17
Introduction:
Developing pediatric drug formulations poses numerous scientific challenges due to the
unique requirements and limitations associated with treating children. These challenges
include accommodating the wide variability among pediatric patients, ensuring effective taste
masking, maintaining physical, chemical, and microbiological stability, meeting global
regulatory standards, adhering to accelerated development timelines, and ensuring timely
access for patients. One of the most persistent issues in pediatric pharmacology is optimizing
oral drug delivery. Common practices such as tablet crushing can significantly alter a drug’s
bioavailability by affecting its absorption rate and extent. Similarly, splitting tablets can
introduce substantial dose variability, although it may be acceptable for certain medications.
Compounded oral suspensions or solutions may present additional issues related to handling,
flavoring, brand switching, and ensuring stability—all of which can impact the drug’s
absorption characteristics. Although commercially available oral liquid formulations offer a
more consistent and user-friendly option for infants and young children, they do not always
ensure bioequivalence with solid oral dosage forms. The shortcomings of existing pediatric
formulations highlight the urgent need for innovative drug delivery systems that offer better
taste, reliable serum drug levels, and ease of administration. [1] Chocolate, in this context,
presents a promising alternative. As a highly versatile and sophisticated medium, chocolate
can deliver a range of taste and texture experiences. Its anhydrous nature makes it resistant to
microbial growth and hydrolytic degradation of water-sensitive active pharmaceutical
ingredients (APIs). Chocolate's favorable sensory properties can effectively mask unpleasant
tastes and transform otherwise gritty API formulations into smooth, palatable preparations.
These characteristics make chocolate an attractive vehicle for pediatric drug delivery.
Chemistry
Chocolate is a widely consumed product across all age groups. It is nutritionally rich,
containing fats, proteins, carbohydrates, polyphenols, and various other bioactive compounds.
The primary raw material used in chocolate production is the cocoa bean. The manufacturing
process includes several key stages: fermentation, drying, roasting, grinding of cocoa beans,
followed by mixing with other ingredients such as cocoa mass, sugar, cocoa butter,
emulsifiers, flavorings, and milk components (for milk chocolate). The final processing steps
are conching and tempering. Critical chemical reactions that define chocolate’s characteristic
flavor and aroma occur during the fermentation, drying, and roasting of the beans, as well as
during conching.[2]
Cocoa bean fermentation, typically carried out at cocoa plantations, is a natural process
involving the activity of yeasts and bacteria within the bean pulp. It progresses in three
distinct phases:
1. Anaerobic Phase (24–36 hours): Dominated by yeasts, this phase occurs in low-
oxygen conditions and at a low pH (less than 4), during which sugars and mucilage
begin to break down.
2. Lactic Acid Phase (48–96 hours): Lactic acid bacteria become active and contribute
to further biochemical transformations.
3. Acetic Acid Phase: As aeration increases, acetic acid bacteria convert alcohol into
acetic acid in an exothermic reaction that raises the temperature to 50°C or higher.
This final stage plays a crucial role in flavor development.[3]
On the other hand, Moringa oleifera is a fast-growing, drought-resistant tree from the
Moringaceae family, native to the Indian subcontinent and commonly found in the Himalayan
foothills. It is known by several names, including drumstick tree, horseradish tree (due to the
flavor of its roots), and ben oil tree. Moringa is widely cultivated for its edible seed pods and
leaves, which are used both as food and in traditional medicine. Nutritionally, moringa is a
powerhouse, packed with essential amino acids, antioxidants, and vital nutrients such as beta-
carotene, vitamin B6, vitamin C, riboflavin, vitamin E, and iron. It also contains beneficial
phytochemicals like quercetin and isothiocyanates. These components contribute to enhanced
immune function, healthy vision, and protection against environmental toxins and pollutants.
Medicinally, moringa has long been valued in traditional Ayurvedic and Unani systems for its
therapeutic potential. Its seeds, in particular, exhibit a wide range of pharmacological
properties, including antimicrobial, anti-inflammatory, antispasmodic, diuretic, anticancer,
and antitumor effects.[4]
Literature Survey :
1) Viswanath and colleagues, 2015 Chocolate is a versatile and complex food that may be
used to create a variety of flavor and texture experiences. This study aims to develop a
chocolate formulation of paracetamol and fexofenadine hydrochloride for use in pediatric
settings. Lecithin, pharmaceutical-grade sugar, cocoa powder, and cocoa butter are needed to
make a chocolate foundation, according to the method. Subsequently, the drug is combined
with the created chocolate foundation.
2) Sakore Asmita et al. (2024) In order to create medicated chocolates, herbal extracts must
be incorporated into a chocolate base without sacrificing texture or flavor. The creation of a
herbal chocolate enhanced with flaxseeds and ashwagandha was described in detail in a
study, with an emphasis on increasing health benefits while maintaining sensory qualities by
optimizing concentrations.
3) Sharma Kanchan et al. (2024) Moringa is well known for both its therapeutic benefits
and its diverse nutritional profile. It has several anti-inflammatory and antioxidant
compounds, including quercetin, which may support heart health. Because of these qualities,
moringa is a good choice to be a part of functional meals that help manage diabetes and its
complications.
4) Mayank Sharma et al. (2012) A sophisticated and incredibly versatile food, chocolate
may be combined to create a wide range of flavor and texture experiences. In order to
increase patient motivation to take the medication, this study aims to develop a tasty
chocolate formulation for pediatric administration. In the current study, pharmaceutical-grade
sugar, lecithin, cocoa powder, and cocoa butter are used to make the chocolate foundation.
5) Reddy Usha et al. (2024) For young patients who might not take conventional medication,
medicated chocolates provide a tasty substitute. Chocolate’s characteristics contribute to the
formulation’s increased stability. Additionally, youngsters who are accustomed to and accept
chocolate may stick to treatment plans better.
6) Rohini R. Devare et.al (2019) The major goal of this study was to develop and test
healthy chocolate containing herbal nervine tonics that would have an additional benefit of
improving learning and memory without any negative side effects. As a result, in the
Institute Of Pharmaceutical Science & Research (For Girls), Bhigwan 4
CHAPTER 2 LITERATURE SURVEY
current study, an
attempt was made to create a chocolate formulation of Convolvulus pluricaulis and Bacopa
monnieria that would increase patient compliance.
7) Pallavi D. Pawar et.al (2019) The primary goal of this study was to develop and test
healthy chocolate containing natural nervine tonics that would improve the recipient's
learning and memory without causing any side effects. As a result, an effort was made in the
current study to prepare a chocolate plan of Shatavari and bacopamonnieria that improves the
patients' compliance and worthiness.
8) Akhilesh Kumar et. al(2017) Medicinal plants are a natural supply of medications,
and the world is moving toward plant-based medicines, also known as phytomedicines, which
enhance the body system. The plant may be found throughout India, particularly in deciduous
forests and places with little rainfall.
NEED OF WORK:
Combining moringa and ashwagandha in pediatric health can provide a comprehensive approach to
supporting overall well-being. Together, they offer:
AIM
The aim of the present study is to formulate a medicated chocolate for the treatment of diabetic
person.
1. To develop and evaluate a palatable medicated chocolate.
2. Formulation containing herbal antidiabetic agents such as Moringa oleifera and Withania
somnifera (Ashwagandha) for pediatric patients.
3. Aiming to improve treatment compliance.
4. Therapeutic efficacy.
5. Safety in managing type 2 diabetes mellitus.
OBJECTIVES
DRUG PROFILE:
MORINGA (Sahijan)
Chemical constituents
Chemical Constituents
COCOA POWDER
1) Name of the chemical: naphthalenesulfonic acid
2) Formula for the molecule: C47H36N6Na2O12S4
3) Weight in molecules: 1051.1
4) Desserts and drinks gain a rich chocolate flavor from the addition of cocoa powder, an
unsweetened chocolate product. During the production process, the fat, known as
cocoa butter, is extracted from the cacao beans to create cocoa powder. The result,
which is sold as cocoa powder, is made by crushing the leftover dry solids. Common
characteristics: Apart from reducing blood pressure, cocoa seems to have additional
benefits that could minimize your risk of heart attack and stroke. Cocoa that is high in
flavanols raises your blood's nitric oxide levels, which relaxes and widens your
arteries and blood vessels and increases blood flow.
Figure 3:- Cocoa powder
COCOA BUTTER
1) Chemical name: [3-hexadecanoyloxy-2-[(Z)-2-oxononadec-10-enoxy]propyl]
2) Formula for molecules: C56H106O6
3) Weight in molecules: 875.4
A plant-based fat derived from cocoa beans is called cocoa butter. Roasted cacao beans
are the source of it. Cocoa butter is often a thick, hydrating cream. Pure cocoa butter can be
marketed for itself or in combination with other ingredients as a body lotion. Typical
characteristics of cocoa butter include:
1) It smells and tastes like chocolate.
2) Its melting point is just lower than that of the human body.
LECITHIN
SACCHARIN
1) chemical name: 1,2-benzothiazol-3(2H)-one 1,1-dioxide
2) molecular formula: C7H5NO3S
3) Weight in molecules: 183.18
Chocolate products that contain therapeutic or medicinal elements, such as active
pharmaceutical compounds, herbal extracts, or nutraceuticals, are referred to as "medical
chocolate." These chocolates provide a practical and tasty approach to administer medicinal
substances and can be used for pain reduction, relaxation and stress alleviation, and
replenishment. Improved absorption and adherence are among the advantages. Allergens and
sensitivities, dosage and interactions, and regulatory compliance must be taken into account,
though. Medicated chocolates shouldn't be used in place of medical advice or treatment;
speaking with a healthcare provider is advised, particularly for people who are on medication
or have underlying medical conditions.
4) Typical characteristics Sweetness: roughly 300 times more sugary than Soluble in
alkaline solutions and sparingly soluble in water increasing the active compounds'
bioavailability.
Figure 6:- Saccharin powder
DICALCIUM PHOSPHATE
1) chemical name: Calcium hydrogen phosphate, dihydrate Hydrogen phosphate of calcium
2) molecular formula: Ca2O4P+
3) Weight in molecules: 175.13
4) The calcium phosphate with the formula CaHPO4 and its dihydrate are known as
dicalcium phosphate. It is also referred to as calcium monohydrogen phosphate or dibasic
calcium phosphate. A biomaterial called dicalcium phosphate is used as a food additive
and as a polishing agent in some toothpastes.
Typical characteristics: Dicalcium phosphate is the calcium phosphate and its dihydrate,
which have the formula CaHPO4. The removal of two protons from phosphoric acid
(H3PO4) during the formation of the HPO42– anion is the source of the "di" prefix in the
common name. It is also referred to as calcium monohydrogen phosphate or dibasic
calcium phosphate. A biomaterial called dicalcium phosphate is used as a food ingredient
and as a polishing agent in some toothpastes.
Figure 7:- Dicalcium phosphate
VANILLIN
1) chemical name: 4-Hydroxy-3-methoxybenzaldehyde
2) molecular formula: C8H8O3
3) Weight in molecules: 152.15
4) The color of vanillin needles is either white or slightly yellow. White or slightly yellow
needles or crystalline powder are generated, and large crystals are white-to-yellow
crystalline powder with a distinct smell; dry powder; liquid; and pellets with a nice,
creamy vanilla odor. Depending on its content, natural vanilla can give recipes a yellow
or brown tint. Due to the expensive price of real vanilla, dishes that contain trace amounts
of inferior vanilla or imitation vanilla-like flavorings are much more common, even
though high- quality vanilla has a rich, aromatic flavor.
Figure 8:- Vanillin powder
METHODS
1) Lecithin and pharmaceutical grade sugars were mainly used for the prepration of chocolate.
2) The saccharin was used as artificial sweetner.
3) The cocoa base was prepared by melting the cocoa butter in a porcelain dish for 2 minutes.
4) Then lecithin was added in melted cocoa butter.
5) Then in this mixture cocoa powder. Dicalcium phosphate and above Saccharin was added
one by one with constant stirring.
6) This mixture was cooled up to semisolid consistency and adding a flavouring agent.
METHODOLOGY
The required quantity of moringa powder and ashwagandha extract was added in prepared
chocolate base. Then it was stirred well until uniform mixing.
Then we poured the above mixture into a silicon mould and cooled it for 15 minutes till it
becomes solid.
1) Preformulation study
a) Ashwagandha Powder and Moringa powder
b) Phytochemical Test
Table 3:- Preformulation tests of Moringa and Ashwagandha
SR.NO TEST OBSERVATION INFERENCE
SR.NO CHARACTERISTICS F1 F2 F3
1 Color Dark brown Brown Brown
2 Odour Pleasant Pleasant Pleasant
3 Taste Bitter Sweet Sweet
4 Surface Texture Smooth Smooth Smooth
2) Hardness:
Table 5:- Hardness of medicated chocolate formulation
Formulation F1 F2 F3
Hardness test 1.2 0.8 0.6
2) Weight variation:
Table 6:- Weight variation medicated chocolate formulation
3) Thickness
Table 7:- Thickness of medicated chocolate formulation
1 F1 10.5±0.2
2 F2 10.8±0.7
3 F3 11.3±0.4
4) Disintegration Test:
Procedure:
1. Sample Preparation:
Weigh a specified number of medicated chocolates.
2. Apparatus:
Use disintegration tester apparatus at a controlled temperature (typically 37 degree
according to multiple sources).
3. Medium:
Use distilled water, artificial saliva (pH 5.8), or a buffer solution (e.g., phosphate buffer pH
6.8 or 7.4) as the disintegration medium.
4. Testing:
Place the medicated chocolates in the disintegration tester basket or cylinder.
Submerge the basket in the chosen medium.
Set the basket’s upward and downward movement speed (e.g., 60 rpm)
Monitor the disintegration time.
Table 8:- Disintegration of medicated chocolate formulation
5) Blooming Test:
The bloom test for medicated chocolate evaluates its physical stability and appearance,
ensuring it remains acceptable and effective over time. It involves subjecting the chocolate to
temperature changes or moisture, observing for signs of sugar or fat bloom. Fat bloom is the
formation of white patches due to cocoa butter crystals, while sugar bloom is a rough, uneven
surface caused by sugar crystallization.
Table 9:- Blooming test of medicated chocolate formulation
6) Calories Calculation:
The caloric content of each medicated chocolate formulation was calculated based on the
energy values of its individual ingredients, using standard nutritional databases. This
evaluation helped ensure that the final product aligns with dietary considerations and
therapeutic goals
6 Saccharin 3 10.2
CONCLUSION:
Medicated chocolates containing Ashwagandha (Withania somnifera) and Moringa (Moringa
oleifera) represent a promising innovation in pediatric healthcare by combining traditional
herbal therapy with a child-friendly dosage form. Ashwagandha is known for its adaptogenic,
anxiolytic, and cognitive-enhancing properties, which may help manage stress, improve
sleep, and support mental development in children. Moringa, often called a “superfood,” is
rich in vitamins (A, C, E), calcium, iron, and essential amino acids, contributing to immune
function, bone development, and overall nutrition. The use of chocolate as a delivery vehicle
enhances palatability and increases compliance in children who often reject bitter or
unpleasant-tasting herbal formulations. This approach ensures easier administration for
caregivers and helps maintain consistent dosing. The formulation process involves careful
standardization of herbal extract concentrations to ensure safety and efficacy within pediatric
limits.
Safety assessments, including dose calibration and allergen screening, ensured that the
product is suitable for children. No adverse effects were observed during preliminary trials. In
conclusion, Ashwagandha and Moringa medicated chocolates provide a safe, effective, and
highly acceptable form of pediatric herbal supplementation. They address common
challenges in pediatric care such as poor taste, non-compliance, and nutritional deficiencies.
With further clinical validation and large-scale trials, this delivery system could be integrated
into routine pediatric wellness programs, especially in regions where traditional medicine
plays a significant role.
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