A Project Work Report Entitled

FORMULATION OF HERBAL GUMMIES FOR

PCOS (SUPPLEMENT)
Submitted To

Dr. Babasaheb Ambedkar Technological University,

Lonere, Raigad
In partial fulfilment for the degree of
Bachelor of Pharmacy
by

Mr. Rohit Raju Rathod

Under The Guidance of

Mr. N. B. Chougule
Principal

Ashokrao Mane Institute of Pharmacy, Ambap

2023-2024
 Ashokrao Mane Institute of Pharmacy, Ambap

DECLARATION

I hereby declare that the report of Practice School entitled

FORMULATION OF HERBAL GUMMIES FOR PCOS (SUPPLEMENT) has
been prepared by me at Ashokrao Mane Institute of Pharmacy, Ambap in
partial fulfilment of the requirement for the award of the degree of Bachelor
of Pharmacy. I further declare that I have not submitted this report
previously for the award of any degree or diploma of any other university or
examination body.

Date:

Place: Ambap

Rohit Raju Rathod

(PRN:2069573823054)
Final Year B. Pharm. (Sem-VIII)
Ashokrao Mane Institute of Pharmacy, Ambap
 Ashokrao Mane Institute of Pharmacy, Ambap

CERTIFICATE

This is to certify that the report of Practice School entitled

“FORMULATION OF HERBAL GUMMIES FOR PCOS (SUPPLEMENT)”
submitted by Mr. Rohit Raju Rathod Final Year B. Pharm. (Sem-VIII) in the
partial fulfilment for the award of degree of Bachelor of Pharmacy, through
Ashokrao Mane Institute of Pharmacy, Ambap has been carried out under
my guidance, supervision and Instructions. The project is now ready for
examination.

Date:
Place: Ambap

Mr. N. B. Chougule
Principal
Ashokrao Mane Institute of Pharmacy, Ambap
 Ashokrao Mane Institute of Pharmacy, Ambap

CERTIFICATE

This is to certify that the report of Practice School entitled

“FORMULATION OF HERBAL GUMMIES FOR PCOS (SUPPLEMENT)”
submitted by Mr. Rohit Raju Rathod Final Year B. Pharm. (Sem-VIII) in the
partial fulfilment for the award of degree of Bachelor of Pharmacy, through
Ashokrao Mane Institute of Pharmacy, Ambap. This project is now ready for
examination.

Date:
Place: Ambap

Dr. N. B. Chougule
 Acknowledgement

ACKNOWLEDGMENT

“Acknowledging the debt is not easy for us as I am indebted to so many people.” I take
this opportunity in expressing the fact that this report writing is the result of incredible
amount of encouragement co-operation, and moral support that I have received from
others.

I would like to express my deep gratitude to our respected principal Dr. N. B. Chougule
sir, academic coordinator Mr. Abhishek V. Desai sir. I would also like to express my
gratitude from the core of my heart to my guide Mr. N. B. Chougule sir who helped me
and coordinating my entire report writing. Their consistent support and co-operation
should the way towards the successful completion of project.

I am also grateful to all other faculty and staff members for their kind of cooperation
and help. Lastly, I would like to express my deep appreciation towards my classmates
and in deftness to my parents for providing me moral support and encouragement.

Mr. Rohit Raju Rathod

Ashokrao Mane Institute of Pharmacy, Ambap

INDEX

INDEX
Chapter no Title Page No

Abstract

1 Introduction 1-2

2 Literature of review 3-4

3 Aim and Objectives 5-6

4 Plan of work 7

5 Plant Profile 8-14

6 Materials and Methods 15-17

7 Evaluation of Gummies 18

8 Result and Discussion 19-21

9 Conclusion 22

10 References 23-24

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Ashokrao Mane Institue of Pharmacy,Ambap
ABSTRACT

ABSTRACT

Polycystic Ovary Syndrome (PCOS) is a complex endocrine disorder affecting

millions of women worldwide, characterized by hormonal imbalances, irregular
menstrual cycles, insulin resistance, and other associated symptoms. Conventional
treatments often involve pharmacological interventions, but there is growing interest
in natural remedies due to concerns about side effects and long-term safety. In this
context, the formulation of herbal gummies for the treatment of PCOS emerges as a
novel and promising approach.This abstract outlines the rationale, methodology, and
potential benefits of developing herbal gummies tailored specifically for PCOS
management. By leveraging the therapeutic properties of herbs known to address the
underlying hormonal dysregulation and symptomatology of PCOS, such as
chasteberry, cinnamon, and spearmint, these gummies offer a convenient, palatable,
and potentially effective alternative to traditional treatments.

Key considerations in the formulation process include the selection of herbs with
evidence-based efficacy, optimization of dosages for maximum therapeutic benefit,
and formulation of gummies free from common allergens and artificial additives to
ensure safety and tolerability. Furthermore, the development of herbal gummies
allows for enhanced compliance and adherence to treatment regimens, particularly
among individuals who may find traditional medications challenging to tolerate or
administer.

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Ashokrao Mane Institue of Pharmacy,Ambap
Chapter 1
INTRODUCTION

INTRODUCTION

Polycystic Ovary Syndrome (PCOS) is a common hormonal disorder

affecting women of reproductive age. It is characterized by the presence
of multiple small cysts on the ovaries and the hormonal imbalances that
occur as a result. The exact cause of PCOS is not fully understood, but it
is believed to be a combination of genetic and environmental factors that
contribute to the condition. Insulin resistance, which is when the body is
unable to use insulin effectively, is also a common feature of PCOS.
Symptoms of PCOS can vary, but often include irregular menstrual
periods, excessive hair growth, acne, and weight gain. PCOS can also
cause fertility issues, as the hormonal imbalances can prevent ovulation
from occurring regularly. PCOS is a chronic condition that requires
ongoing management, but there are treatments available to help manage
the symptoms and reduce the risk of long-term health complications

PCOS (Polycystic Ovary Syndrome) is a hormonal disorder that

affects many women of reproductive age. It can cause a range of
symptoms, including irregular periods, excessive hair growth, acne,
weight gain, and infertility. While there is no cure for PCOS, there are
various ways to manage its symptoms. One such method is through the
use of PCOS gummies supplements. These supplements contain a
combination of herbs that are believed to help improve the symptoms of
PCOS.

Reasons why using PCOS gummies supplements

✓ Regulation of menstrual cycles

✓ Management of insulin resistance
✓ Support for fertility
✓ Reduction of androgen levels
✓ Improve Insulin Sensitivity
✓ Regulate Hormone Levels
✓ Support Ovarian Health
✓ Reduce Inflammation
✓ Support Weight Management
✓ Convenience: Gummies can be a convenient way to take
supplements.
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Chapter 1
INTRODUCTION

✓ Hormonal Imbalances

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Chapter 2
LITERATURE

LITERATURE OF REVIEW

1. Gayathri Kalidoss et. Al(2021): In this article, the author discussed

about the Polycystic Ovarian Syndrome(PCOS). Also discussed about the
herbal supplements which cure this syndrome.

2. Lakshmi-Chandra Mishra et.al (2000): In this article, author studied

about the therapeutic uses of drugs. And discussed about the chemistry.

3. P. Pradhan et.al (2009): The author studied the pharmacognostical

studies and phytochemical screening of ashoka. It also studied
pharmacological activities like anti-inflammatory, wound healing, and
anticancer activity. This review focuses on the wide phytochemical and
pharmacological activities of Ashoka.

4. Shantaram Gajanan Khanage et.al (2019): The author discuss about

the herbs which are effectively use for the treatment of Cystic Syndrome
(PCOS).

5. Priyanka Kantivan Goswami et.al(2012): In this article, Author

studied about the causes of the PCOS. Also studied about the various
herbal medicine which are effective in Polycystic Ovarian
Syndrome(PCOS).

6. Gina Aulia et.al (2023): Author works on the formulation of herbal

gummies by using Jatropa Curcas L.as anthalmentics. The study was
observed that the prepared gummies showed significant anti helminths
activities.
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Chapter 2
LITERATURE

7. Aleksandra Vojvodi´c Cebin et.al(2024): In this article, author studied

about formulation and evaluation of gummies using natural ingredients.
Author explains the procedure briefly.

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Chapter 3
AIM AND OBJECTIVES

AIM

Formulation of Auyurvedic gummies for PCOS (Suppliment).

Objective for pcos gummies

PCOS (Polycystic Ovary Syndrome) gummies can have several

objectives, such as:

1) Improve Insulin Sensitivity: Insulin resistance is a common issue for

women with PCOS. PCOS gummies can contain ingredients like
chromium and cinnamon that can help improve insulin sensitivity.

2) Regulate Hormone Levels: PCOS is caused by hormonal imbalances,

particularly high levels of androgens. PCOS gummies can contain
ingredients like myo-inositol and d- chiro-inositol, which have been
shown to help regulate hormone levels in women with PCOS.

3) Support Ovarian Health: Women with PCOS often have cysts on their
ovaries, which can affect fertility. PCOS gummies can contain nutrients
like vitamin D and antioxidants that can support ovarian health.

4) Reduce Inflammation: Inflammation is a common issue in women with

PCOS. PCOS gummies can contain ingredients like omega-3 fatty acids
and turmeric that have anti- inflammatory properties.

5) Support Weight Management: Many women with PCOS struggle with

weight management due to insulin resistance and other hormonal
imbalances. PCOS gummies can contain ingredients like fiber and
chromium that can help support healthy weight management.

6) Convenience: Gummies can be a convenient way to take supplements,

especially for those who struggle with swallowing pills or dislike the taste
of liquid supplements.

7) Nutrient Deficiencies: Women with PCOS may have certain nutrient

deficiencies that can be addressed with supplements. For example,
vitamin D deficiency is common in women with PCOS, and PCOS
gummies can contain vitamin D to support bone health and other
functions.

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Chapter 3
AIM AND OBJECTIVES

8) Hormonal Imbalances: PCOS gummies can contain ingredients like

myoinositol and d- chiro-inositol, which have been shown to help
regulate hormone levels in women with PCOS.

9) Weight Management: PCOS gummies can contain ingredients like

fiber anchromium that can help support healthy weight management,
which is often a struggle for women with PCOS.

10) Overall Health: PCOS gummies can contain antioxidants, omega-3

fatty acids, and other nutrients that can support overall health and well-
being, which is especially important for women with PCOS who may be
at increased risk for certain health conditions.

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Chapter 4
PLAN OF WORK

Plan of Work
Sr. no Title of work

1 Selection of Subject

2 Literature Review

3 Selection of herbal drug

4 Gathering of raw materials

5 Selection of appropriate method for formulation

6 Experimental Procedures
I Extraction of Active constituents

II Preparation of gummies

III Evaluation test

A Physical evaluation, Colour, Odour,
pH
B Osmosis

C Moisture Content

D Anti-oxidant

7 Result and Discussion

8 Conclusion

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Chapter 5
PLANT PROFILE

1) Aswagandha

Scientific name: Whithania Somnifera

Biological source: Dried roots and stem bases of Whithania Somnifera.

Family: Solanaceae

Chemical constituents: It consist alkaloids and whitanolides(steroidal

lactones).

Uses:

1. It may help stabilize and adjust menstrual cycles.

2. It stimulates blood flow.
3. It fights against the infection.

2) Ashoka

Scientific name: Saraca asoca

Biological source: Dried stem bark of plant Saraca Indica Linn.

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Chapter 5
PLANT PROFILE

Family: Fabaceae

Chemical constituents: It contains tannins (0.57%-7.85%), Ash(2.43%-

6.69%), Flavonoids, Alkanes.

Uses:

1. It is useful to manage female disorders like dysmenorrhea and

menorrhagia due to its vata balancing property.
2. It helps in alleviating pain.

3) Dashamoola

Scientific name: Aegle marmelo

Biological source: Dried stem bark of plant Aegle marmelo.

Family: Fabaceae

Chemical constituents: It contains tannins, Flavonoids, alkaloids,

glycosides, terpenoids

Uses:

1. Treating various types of fever.

2. It reduces pain.
3. It improve impaired digestion.

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Chapter 5
PLANT PROFILE

4) Lodhara :

Scientific name: Symplocos racemose Roxb.

Biological source: Dried stem bark of plant Symplocos racemose Roxb.

Family: Symplocaceae

Chemical constituents: It contains flavonoids, cardiac glycosides,

saponins, tannins, triterpenes and Phytosterols. Flavonoids exhibited the
highest antimicrobial potential whereas tannins, triterpenes and
phytosterols were completely inactive.

Uses:

1. It helps to cure acne, blemishes.

2. It also helps in gynaecological or female disorders.

5) Guduchi

Scientific name: Tinospora cordifolia

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Chapter 5
PLANT PROFILE

Biological source: Dried stem of plant Tinospora cordifolia.

Family: Menispermaceae

Chemical constituents: It contains Diterpene compunds, polyphenols,

polysaccharides including arabinogalactinan polysaccharide.

Uses:

1. It boosts the body defense mechanism(immunity).

2. Helps regularizes and normalizes menstrual cycle.

6) Kakamachi:

Scientific name: Solanum Nigrum Linn.

Family: Solanaceae

Chemical constituents: It consist of alkaloid, steroid, carbohydrate,

tannin, saponins

Uses:

1. It effective in heart disease.

2. It relives pain.

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Chapter 5
PLANT PROFILE

7) Aloe Vera

Scientific name: Aloe barbadensis

Biological source: Aloe is the dried juice collected by incision, from the
bases of the leaves of various species of Aloe. Aloe vera Linn or Aloe
barbadensis

Family: Liliaceae

Chemical constituents: chemical constituents in Aloe vera are

Anthraquinones, saccharides, prostaglandins, and fatty acids.

Uses:

Analgesic

Antibacterial

Antiviral

Antifungal

Anti-oxidant immune modulator

Antiseptic

Anti-inflammatory

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Chapter 5
PLANT PROFILE

8) Punarnava

Scientific name: Boerhavia diffusa

Family: Nyctaginaceae

Chemical constituents: It contains sterols, beta sitosterol and alkaloid.

Uses:

1. It uses as diuretic
2. It helps to manage symptoms of spleen enlargement.
3. Useful to control obesity.

9) Shatavari

Scientific name: Asparagus racemosus

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Chapter 5
PLANT PROFILE

Biological source: It is a dried root and leaves of plant Asparagus

racemosus.

Family: Liliaceae

Chemical constituents: It contains steroids, alkaloids, mucilage. Saponine

also present.

Uses:

1. It treats conditions related to hormone imbalance such as polycystic

ovarian syndrome and infertility.

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Chapter 6
MATERIALS AND METHODS

Materials

Each gummies contains

Sr.no Ingredients Quantity

1 Ashwagandha 19.8mg

2 Ashoka 30mg

3 Dashamoola 19.8mg

4 Lodhra 19.8mg

5 Guduchi 19.8mg

6 Kakamachi 19.8mg

7 Aloevera 15mg

8 Punarnava 19.2mg

9 Shatavari 19.2mg

Excepients

Ingredients Role Quantity

Gelatine Binding Agent 5gm

Carmosine Colouring agent 2-3drops

Strawberry Extract Flavouring agent 4-6 drops

Sucrose Sweetning agent 10 gm

Water Vehicle 50 ml

Herbal Extract 4.56 ml

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Chapter 6
MATERIALS AND METHODS

METHOD

• Appropriate amount of agar should be dislove in 50 ml of hot

water on moderate agitation.
• Extract of all herbs added into above solution.
• Add 10 mg of Sucrose as sweetning agent .
• Add colouring and Flavouring agent with continuous stirring.
• Then cool above solution at room temperature and transfer it into
any shape of
• silicon mould .
• After 2 days remove gummies from mould.
• Store in air tight container.

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Chapter 6
MATERIALS AND METHODS

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Chapter 7
EVALUATION PARAMETERS

Evaluation Parameters:

1. Sensory evaluation: Colour, Odour, Taste, Hardness, Chewing

2. Moisture Content: Take Weight of 1 gummie then put it in hot air oven
for 2 hours for drying .After 2 hours again take weight of that gummie and
calculate moisture content

3. Osmosis: Take Weight of 1 gummie then deep it in water for 2 hours

for osmosis .After 2 hours again take weight of that gummie and calculate
weight of gummie after osmosis.

4. pH of gummies: Blending a gummies into invariant paste. Calibrating

the pH cadence and conforming the sample temperature to room
temperature before measuring the pH. Irrigating the pH electrode with
distilled water.Immersing the electrode to the gummy paste and measuring
the p.

5. Friability Testing: Constantly dropping a sample of gummies over a

fixed time, using arotating barrel with a baffle. The result is examining for
broken tablets, and the chance of tablet mass lost through dicing.

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Chapter 8
RESULT AND DISCUSSION

1.Sensory Evaluation: Observation is done by sensory organs.

Sr no Sesnsory evaluation Result

1 Colour Reddish Brown

2 Odour Pleasant

3 Taste Sweet

4 Texture Smooth Gelatinous

2. Moisture Content:

Take Weight of 1 gummie then put it in hot air oven for 2 hours for drying
.After 2 hours again take weight of that gummie and calculate moisture
content and it was found to be ,0.84gm.

(Before moisture removing) (After moisture removing content)

3. Osmosis:

Take Weight of 1 gummie then deep it in water for 2 hours for osmosis
.After 2 hours again take weight of that gummie and calculate weight of
gummie after osmosis and it was found to be ,0.67gm.

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Chapter 8
RESULT AND DISCUSSION

(Before osmosis) (After osmosis)

4. pH of Gummie : pH of Gummie should be 4.5-5.0 pH.

5. Concentration of solution :

To calculate the concentration of the solution of gummies, we need to

determine the total mass of the ingredients and the volume of the solution.

First, let's calculate the total mass of the ingredients:

Total Mass = Ashwagandha + Ashoka + Dashamoola + Lodhra + Guduchi

+

Kakamachi + Shatavari + Purnarnava + Aloe vera + Agar

Total Mass = 19.8 mg + 30 mg + 19.8 mg + 19.8 mg + 19.8 mg + 19.8 mg

+ 19.2 mg + 19.2 mg + 15 mg + 5 mg

Total Mass = 188.6 mg

Next, we need to convert the volume of water from milliliters to liters:

Volume = 50 ml = 50/1000 L = 0.05 L

Finally, we can calculate the concentration of the solution using the

formula:

Concentration = (Total Mass of Ingredients) / (Volume of Solution)

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Ashokrao Mane Institute of Pharmacy, Ambap
Chapter 8
RESULT AND DISCUSSION

Concentration = 188.6 mg / 0.05 L

Concentration = 3772 mg/L

Therefore, the concentration of the solution of gummies is 3772 mg/L

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Ashokrao Mane Institute of Pharmacy, Ambap
Chapter 9
CONCLUSION

CONCLUSION:

the formulation of herbal gummies for the treatment of Polycystic Ovary Syndrome
(PCOS) holds significant promise in providing a natural and convenient approach to
managing this complex hormonal disorder. By harnessing the therapeutic properties
of herbs known to regulate hormonal balance, reduce insulin resistance, and alleviate
symptoms associated with PCOS, such as irregular menstrual cycles and hirsutism,
these gummies offer a holistic alternative to traditional pharmaceutical interventions.

The synergistic combination of carefully selected herbs, such as Ashoka, Cinnamon,

and Shatavari, in a palatable gummy format not only enhances compliance but also
ensures optimal absorption and bioavailability of the active compounds. Moreover,
the absence of common allergens and artificial additives makes these herbal gummies
suitable for a wide range of individuals seeking natural remedies for PCOS
management.

However, it is essential to underscore the importance of further research and clinical

trials to validate the efficacy, safety, and long-term effects of herbal gummies in the
management of PCOS. Additionally, healthcare professionals should play a pivotal
role in guiding patients on the appropriate use and integration of herbal supplements
into their treatment regimens, considering individual health profiles and potential
interactions with other medications.

Overall, the formulation of herbal gummies represents a promising avenue in the

holistic management of PCOS, offering patients a convenient, natural, and potentially
effective approach to addressing the multifaceted aspects of this common endocrine
disorder.

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Chapter 10
REFERENCES

REFERENCE:

1. Azziz R. PCOS: a diagnostic challenge. Reproductive biomedicine online. 2004 Jan

1;8(6):644-8.

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polycystic ovary syndrome: A review of phytomedicine research. Int J Herb Med.
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Chapter 10
REFERENCES

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17. Knochenhauer ES, Key TJ, Kahsar-Miller M, Waggoner W, Boots LR, Azziz R.
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properties of gummy candies enriched with pineapple and papaya peel powders. Food and
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