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final project 2025

The dissertation titled 'Formulation and Evaluation of Medicated Chocolate for Pediatrics' explores the development of pediatric drug formulations using chocolate as a delivery medium due to its favorable sensory properties and stability. The research addresses challenges in pediatric pharmacology, such as taste masking and bioavailability, and incorporates ingredients like Moringa and Ashwagandha for their nutritional and medicinal benefits. This work was conducted by a group of students under the guidance of Ms. Pratiksha Rajguru at the Institute of Pharmaceutical Science & Research, aiming to innovate pediatric drug delivery systems.

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0% found this document useful (0 votes)
7 views47 pages

final project 2025

The dissertation titled 'Formulation and Evaluation of Medicated Chocolate for Pediatrics' explores the development of pediatric drug formulations using chocolate as a delivery medium due to its favorable sensory properties and stability. The research addresses challenges in pediatric pharmacology, such as taste masking and bioavailability, and incorporates ingredients like Moringa and Ashwagandha for their nutritional and medicinal benefits. This work was conducted by a group of students under the guidance of Ms. Pratiksha Rajguru at the Institute of Pharmaceutical Science & Research, aiming to innovate pediatric drug delivery systems.

Uploaded by

Aishwarya
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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FORMULATION AND EVALUATION OF MEDICATED

CHOCOLATE FOR PEDIATRICS

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)

Under the Guidance of


Ms. PRATIKSHA RAJGURU, M.Pharm[QA}
ASSISTANT PROFESSOR
DEPARTMENT OF PHARMACEUTICS

Dattakala Shikshan Sanstha’s


INSTITUTE OF PHARMACEUTICAL SCIENCE & RESEARCH (For Girls)
Swami-Chincholi, Bhigwan, Pune-Dist, Pin-413130.
2024-25
Dattakala Shikshan Sanstha’s
Institute of Pharmaceutical Science & Research (For Girls)
Approved by PCI - New Delhi, DTE - Mumbai, Recognized by Govt. of Maharashtra
Affiliated to Dr. Babasaheb Ambedkar Technological University, Lonere, Raigad & MSBTE, Mumbai
| DTE Code: 6914 | MSBTE Code: 1891 | PCI ID: 909 | AISHE Code: C - 60003 |

Mr. Rana Suryawanshi Mrs. Maya Zol Prof. Ramdas M. Zol


Vice – President Secretary Founder – President

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

Shamrao Korade, Ankita Satish Bansude, Pooja Ankush Dhumal, Dnyaneshwari

Dhananjay Divan under the supervision and guidance of Ms. Pratiksha Rajguru,

Assistant Professor in the Department of Pharmaceutics at Institute of Pharmaceutical

Science & Research (For Girls), Swami-Chincholi, Bhigwan during the year 2024-2025.

Dissertation submitted to the Dr. Babasaheb Ambedkar Technological University, Lonere,

Raigad.

Place: Swami-Chincholi Dr. VISHAL BABAR, M.Pharm., Ph.D., Post. Doc.


Date: PRINCIPAL
Dattakala Shikshan Sanstha’s
Institute of Pharmaceutical Science & Research (For Girls)
Approved by PCI - New Delhi, DTE - Mumbai, Recognized by Govt. of Maharashtra
Affiliated to Dr. Babasaheb Ambedkar Technological University, Lonere, Raigad & MSBTE, Mumbai
| DTE Code: 6914 | MSBTE Code: 1891 | PCI ID: 909 | AISHE Code: C - 60003 |

Mr. Rana Suryawanshi Mrs. Maya Zol Prof. Ramdas M. Zol


Vice – President Secretary Founder – President

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

Shamrao Korade, Ankita Satish Bansude, Pooja Ankush Dhumal, Dnyaneshwari

Dhananjay Divan under my supervision and guidance in the Department of

Pharmaceutics at Institute of Pharmaceutical Science & Research (For Girls), Swami-

Chincholi, Bhigwan during the year 2024-2025. Dissertation submitted to the Dr.

Babasaheb Ambedkar Technological University, Lonere, Raigad.

Place: Swami-Chincholi MS. PRATIKSHA RAJGURU, M.Pharm[QA}.


Date: RESEARCH GUIDE
DECLARATION

We hereby declare that the dissertation entitled “Formulation and Evaluation of

Medicated Chocolate for Pediatrics” was carried out by us at Institute of Pharmaceutical

Science & Research (For Girls), Swami-Chincholi, Bhigwan under the esteemed guidance

of Ms. Pratiksha Rajguru, Assistant Professor, Department of Pharmaceutics, Institute of

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.

Aishwarya Vijay Dhone (216914182103)

Uma Shamrao Korade(2169141823104)

Ankita Satish Bansude (2169141823105)

Pooja Ankush Dhumal (2169141823106)

Dnyaneshwari Dhananjay Divan (2169141823107)


ACKNOWLEDGMENTS

I am deeply indebted to Dr. Vishal Babar, M.Pharm., Ph.D., Post Doc., Principal &

Professor, Institute of Pharmaceutical Science & Research (For Girls), Swami-Chincholi,

Bhigwan & my research guide, Ms. Pratiksha Rajguru, M.Pharm[QA}, Assistant Professor in

Department of Pharmaceutics at Institute of Pharmaceutical Science & Research (For

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

successful completion of the research work.

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

constant inspiration which enabled me to reach this exuberant moment of my life.

We are indebted to the management “Dattakala Sikshan Sanstha, Swami-

Chincholi, Bhigwan” for providing me the necessary infrastructural facilities to carry out

the project work.

And above all, words fail to express my feeling to my parents whose initiation,

constant source of inspiration and encouragement throughout this course.

Aishwarya Vijay Dhone (2169141823103)


Uma Shamrao Korade (2169141823104)
Ankita Satish Bansude (2169141823105)
Pooja Ankush Dhumal (2169141823106)
Dnyaneshwari Dhananjay Divan (2169141823107)
DEDICATED TO
MY BELOVED PARENTS
CONTENTS

TOPIC PAGE NO

GENERAL INTRODUCTION 1-3

LITERATURE SURVEY 4-5

NEED OF WORK 6

AIM AND OBJECTIVE 7

DRUG PROFILE 8-13

MATERIALS AND METHODS 14-15

RESULTS AND DISCUSSION 16-21

SUMMARY AND CONCLUSION 22

REFERENCES 23-24
LIST OF TABLES

Table Title Page No.


No.

1 Ingredients and their uses 14

2 Formulation of medicated chocolates batches 15

3 Performulation test of moringa and ashwagandha 16

4 General appearance 16

5 Hardness of medicated chocolate formulation 17

6 Weight variation of medicated chocolate formulation 17

7 Thickness of medicated chocolate formulation 18

8 Disintegration of medicated chocolate formulation 18

9 Blooming test of medicated chocolate formulation 19

10 Calories calculation of medicated chocolate formulation 20

11 In vitro drug release studies of medicated chocolate formulation 21


LIST OF FIGURES

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

7 Dicalcium phosphate powder 13

8 Vanillin powder 13

9 Formulation of medicated chocolate 15

10 Preformulation test of moringa and ashwagandha 16

11 General appearance 17

12 Hardness testing using Pfizer tester 17

13 Dissolution of medicated chocolate formulation 19

14 In vitro studies drug release graph representation 21


ABBREVIATIONS

API - Active Pharmaceuctical


Ingredients RTM - Ready to Mix
DT - Disintegration
time HDT - Hardness test
INVO - In-vitro Study
UD - Unit dose
GSP - Good Sensory
Profile Cal - Calories
CHAPTER 1:
INTRODUCTION
CHAPTER 1 INTRODUCTION

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]

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CHAPTER 1 INTRODUCTION

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]

Ashwagandha (Withania somnifera) is a highly valued herb in Ayurvedic medicine, known


for its adaptogenic properties that help the body cope with physical and emotional stress. In
paediatrics care, Ashwagandha has shown promise in supporting a range of developmental
and health needs. It may help enhance cognitive functions such as memory, attention span,
and learning ability, which are critical during school-age years. Additionally, Ashwagandha
is believed to promote emotional balance by reducing anxiety and irritability, making it
beneficial for children dealing with behavioural challenges or stress-related symptoms. It also
supports the immune system, helping children better resist infections and recover from
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CHAPTER 1 INTRODUCTION
illness more

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CHAPTER 1 INTRODUCTION

quickly. Ashwagandha’s nourishing properties are thought to aid in promoting healthy


appetite, physical strength, and stamina, which can be particularly useful for children who are
underweight or fatigued. Furthermore, it may help regulate sleep cycles, contributing to better
rest and recovery in growing children. While traditional use and emerging research suggest
its safety and effectiveness, paediatrics use of Ashwagandha should always be supervised by
a qualified healthcare provider to ensure appropriate dosing and suitability for the child’s
specific health needs.[5]

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CHAPTER 2:
LITERATURE
SURVEY
CHAPTER 2 LITERATURE SURVEY

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
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CHAPTER 2 LITERATURE SURVEY
current study, an

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CHAPTER 1 INTRODUCTION

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.

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CHAPTER 3:
NEED OF WORK
CHAPTER 3 NEED OF WORK

NEED OF WORK:

Why Use Both Moringa and Ashwagandha in Pediatric Care?

Combining moringa and ashwagandha in pediatric health can provide a comprehensive approach to
supporting overall well-being. Together, they offer:

1) Blood sugar regulation:


It has been demonstrated that ashwagandha and moringa can help reduce blood glucose levels.
According to studies, moringa may have antidiabetic properties because of its high concentration of
kaempferol, quercetin, and chlorogenic acid, all of which have been shown to control glucose
metabolism. These substances can aid in the management of insulin resistance, a prevalent issue in
type 2 diabetes.
Using ashwagandha and moringa in pediatric medicated chocolate presents a novel way to provide
therapeutic advantages in a way that kids may easily accept and enjoy. The following are the
reasons why moringa and ashwagandha are used to make medicated chocolate for pediatric care:
Both are natural herbs with well-established health benefits, and incorporating them into chocolate
offers a fun way to give them to kids.
a) Immunity boost.
b) Moringa have rich nutrients profile.
c)Digestive benefits include
constipation.
d) Palatability for children.
e) Ashwagandha reduced the stress and anxiety.
2) Nutritional Support: Ashwagandha's capacity to boost immunity and energy is complemented by
moringa's abundance of vitamins and minerals.
3) Stress Reduction and Emotional Well-Being: Ashwagandha aids in the management of stress
and anxiety, and the nutritional benefits of moringa improve the body's ability to adapt to both
mental and physical demands.
4) Cognitive and Physical Development: Ashwagandha and moringa both promote mental
clarity and attention, as well as physical health.

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Bhigwan
CHAPTER 3 NEED OF WORK

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Bhigwan
CHAPTER 4:
AIM AND
OBJECTIVES
CHAPTER 4 AIM AND OBJECTIVES

AIM AND OBJECTIVES:

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

1. To formulate herbal medicated chocolate incorporating Moringa and Ashwagandha,


known for their antidiabetic properties.
2. To enhance acceptability and compliance among pediatric patients using chocolate as a
palatable delivery system.
3. To evaluate physicochemical parameters such as appearance, texture, melting point, and
uniformity
4. To conduct disintegration and drug release studies to ensure appropriate delivery of active
herbal ingredients.
5. To assess the antidiabetic activity of the formulation using in vitro assays.
6. To perform stability testing under various conditions to ensure the shelf life and
effectiveness of the formulation.
7. To perform the stability study.

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CHAPTER 5:
DRUG PROFILE
CHAPTER 5 DRUG PROFILE

DRUG PROFILE:

 MORINGA (Sahijan)
Chemical constituents

1. Flavonoids: Quercetin, which is present in Moringa leaves, has been


demonstrated to have anti-diabetic effects by lowering inflammation and
oxidative stress.
2. Phenolic acids: The antioxidant and anti-inflammatory properties of O-coumaric
acid, myricetin, and ellagic acid, which are found in Moringa leaves, can aid in
the management of diabetes.
3. Glucosinolates: Research has demonstrated that the antioxidant and anti-
inflammatory qualities of glucomoringin, which is present in Moringa seeds,
can lessen the difficulties associated with diabetes.
4. Fatty Acids: Research has demonstrated that oleic acid, a significant constituent
of Moringa seed oil, has anti-diabetic effects by lowering blood pressure and
enhancing insulin sensitivity.

Benefits in Medicated Chocolates:


1. Increase Bioavailability: The bioactive substances in moringa may increase
the bioavailability of other therapeutic ingredients in the chocolate.
2. Enhanced Antioxidant Activity: The antioxidants in moringa may have a
synergistic effect with the antioxidant activity of cocoa flavonoids.
3. Better Palatability: The nutty flavor of moringa can improve the medicated
chocolates' flavor and scent.
4. Enhanced Nutritional Value: The health advantages of moringa can raise the
total nutritional content of medicated chocolates.
Figure 1:- Moringa powder

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CHAPTER 5 DRUG PROFILE

 ASHWAGANDHA (Withania somnifera)

Chemical Constituents

1. Withanolides: The main active ingredients in ashwagandha are steroidal lactones.


2. Alkaloids: Ashwagandha has sedative and relaxing properties that support its
involvement in stress reduction and mental relaxation. Alkaloids including
somniferine, withanine, and anaferine contribute to these effects.
3. Saponins: Saponins, such as withanosides and sitoindosides, are adaptogenic
substances that enhance endurance and cognitive function while assisting the body in
managing stress.
4. Flavonoids: These antioxidants boost heart and brain health by lowering oxidative
stress and scavenging free radicals.
5. Amino Acids: Tryptophan and other amino acids included in ashwagandha influence
serotonin levels, which helps to produce its relaxing and mood-enhancing effects.

Potential Health Benefits:

1. Adaptogenic properties: Assist the body in adjusting to stressful situations.


2. Decreased stress and anxiety: It elevates mood and lowers cortisol levels.
3. Better cognitive function: Boost focus and memory.
4. Support the immune system for improved immunological function.
5. Greater strength and muscular mass: Promote muscle growth and repair.
Figure 2:- Ashwagandha powder

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CHAPTER 5 DRUG PROFILE

 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.

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CHAPTER 5 DRUG PROFILE

Figure 4:- Cocoa butter

 LECITHIN

1) Chemical name: 1-palmitoyl-2-linoleoylphosphatidylcholine


2) Formula for molecules: C42H80NO8P
3) molecular weight: 758.1
The body's cells need a lipid called lecithin. It is found in many foods, such as soybeans and
egg yolks. One material that can be used as medicine is lecithin, which is also employed in
the manufacturing of medications. Lecithin is used to treat memory issues, such as dementia
and Alzheimer's disease.
Figure 5:- Lecthin

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CHAPTER 5 DRUG PROFILE

 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.

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CHAPTER 5 DRUG PROFILE

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CHAPTER 5 DRUG PROFILE

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

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CHAPTER 6:
MATERIALS AND
METHODS
CHAPTER 6 MATERIALS AND METHODS

MATERIALS AND METHODS :


Table 1:- Ingredients and their uses

SR.NO INGREDIENTS HERBAL USE


1. Moringa Antidiabetic
2. Ashwagandha Antidiabetic and Antihypertensive
3. Lecithin Emulsifier
4. Cocoa butter Solidifying agent
5. Cocoa powder Principal ingredient
6. Saccharin Sweetening agent
7. Dicalcium phosphate Adsorbent
8. Vanilla Flavouring agent

METHODS

Preparation of chocolate base

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.

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CHAPTER 1 INTRODUCTION

Figure :- Formulation of medicated chocolate

Table 2:- Formulation of medicated chocolate batches

SR.NO INGREDIENTS F1 (gm) F2 (gm) F3 (gm)


1. Moringa 0.25 0.25 0.25
2. Ashwangandha 0.25 0.25 0.25
3. Lecithin 0.60 0.60 0.60
4. Cocoa butter 4.80 5.00 5.30
5. Cocoa powder 1.30 1.00 0.85
6. Saccharin 3.80 2.95 3.15
7. Dicalcium phosphate 0.54 0.54 0.54
8. Vanillin q.s q.s q.s

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CHAPTER 7:
RESULT
AND
DISCUSSION
CHAPTER 7 RESULT AND DISCUSSION

RESULT AND DICUSSION:

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

1 Ferric chloride test positive Green color

2 Lead acetate test positive White ppt

3 Alkaloids test (wagners positive Reddish brown


reagent) ppt

4 Reducing sugar (fehling positive Brick red ppt


solution A and B)

Figure:- Preformulation test of moringa and ashwagandha

2) Evaluation study of formulation


1) General Appearance:
Table 4:-General Appearance

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

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CHAPTER 7 RESULT AND DISCUSSION

Figure:- General appearance of medicated chocolate formulation

2) Hardness:
Table 5:- Hardness of medicated chocolate formulation
Formulation F1 F2 F3
Hardness test 1.2 0.8 0.6

Figure :- Hardness testing using Pfizer tester

2) Weight variation:
Table 6:- Weight variation medicated chocolate formulation

Sr.No Weight Variation


1 7.85
2 7.52
3 7.98
4 8.04
5 8.10
Total weight 39.49
Average weight 7.89

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CHAPTER 7 RESULT AND DISCUSSION

3) Thickness
Table 7:- Thickness of medicated chocolate formulation

Sr.No. Formulation Thickness(cm)

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

Formulation Disintegration (min)


F1 23±3
F2 22±5
F3 19±2

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CHAPTER 7 RESULT AND DISCUSSION

Figure:-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

SR.NO TEST RESULT


1 Fat Bloom No
2 Sugar Bloom No
3 Texture Bloom No

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

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CHAPTER 7 RESULT AND DISCUSSION

Table 10:- Calories count of medicated chocolate formulation

Sr.No Contents Quanity (gm) Calories (per serving)

1 Moringa 0.25 0.715

2 Ashwagandha 0.25 0.775

3 Lecthin 0.60 4.2

4 Cocoa butter 5 44.2

5 Cocoa powder 1 4.2

6 Saccharin 3 10.2

7 Dicalcium phosphate 0.54 0

Total count Calories: 62.37

7) In Vitro study release of Medicated Chocolate


To evaluate the dissolution and release characteristics of medicated chocolates, a dissolution
apparatus and UV spectroscopy can be employed.
The process involves preparing medicated chocolate samples and conducting dissolution
testing using a calibrated apparatus, such as the USP Dissolution Apparatus, in a phosphate
buffer medium (pH 6.8).
Samples are withdrawn at specified time points (0,5, 10, 20, 30, 40, 50, and 60 minutes) to
assess the release profile of active ingredients.
The collected samples are then analyzed using UV spectroscopy to measure the absorbance
and quantify the concentration of released active ingredients.
This method provides accurate release profiles and precise quantification of active
ingredients, helping to understand the dissolution behavior of medicated chocolates.

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0
CHAPTER 7 RESULT AND DISCUSSION

Table 11:- In vitro drug release studies of medicated chocolate formulation


Sr.No Time (min ) F1 F2 F3

1 0 0.000 0.000 0.000

2 5 0.228±0.002 0.278±0.002 0.319±0.002

3 10 0.359±0.002 0.394±0.002 0.418±0.002

4 20 0.677±0.002 0.769±0.002 0.779±0.002

5 30 0.821±0.002 0.902±0.002 0.920±0.002

6 40 0.890±0.002 0.965±0.002 0.975±0.002

7 50 0.960±0.002 0.995±0.002 0.977±0.002

8 60 1.000±0.002 1.005±0.002 0.987±0.002

Figure 14:- In vitro studies drug release graph representation

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CHAPTER : 10
CONCLUSION
CHAPTER 10 CONCLUSION

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.

Phytochemical screening confirmed the presence of key bioactive compounds such as


alkaloids, flavonoids, and saponins. Organoleptic evaluation and acceptability testing
indicated high levels of satisfaction among pediatric users in terms of taste, texture, and
willingness to consume the product regularly.

The chocolates also offer advantages such as:

 Ease of storage and transport


 Reduced gastrointestinal irritation compared to tablets or syrups
 Improved bioavailability when fats in chocolate aid in absorption

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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CHAPTER : 11
REFERENCE
CHAPTER 11 REFERENCE

REFERENCE :
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containing cefpodoxime proxetil: a novel solid dosage form for paediatric patient. In
Proceedings of RK University’s First International Conference on Research &
Entrepreneurship, 2016.
2. Ithape PR, Ghadage PD, Gadhve JK, Mali AS. Oral drug delivery system challenges to
pediatrics and current approaches. Pharma Tutor., 2018; 6(6): 9-13.
3. Pareek, A., Pant, M., Gupta, M. M., Kashania, P., Ratan, Y., Jain, V., Pareek, A., &
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pharmacological activities, ethnomedicinal, phytopharmaceutical formulation, clinical,
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chocolates containing guaifenesin. European Journal of Pharmaceutical and Medical
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Ashwagandha: A Review of Clinical Studies. Phytotherapy Research, 35(3), 752-760.
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14. Viswanath V, Narasimharao B, Purushothaman M, Sireesha S. Formulation and
evaluation of fexofenadine hydrochloride and paracetamol chocolate for pediatrics. heart
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Somnifera (Ashwagandha) and Asparagus Racemosus (Shatavari). International Journal
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