Formula on and Evalua on of An -diabe c Polyherbal Capsule

ABSTRACT:
Diabetes mellitus is a chronic metabolic disorder characterized by persistent
hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The
growing prevalence of diabetes and the adverse effects associated with long-term use
of synthetic antidiabetic drugs have increased interest in herbal formulations as safer
and cost-effective alternatives. The present study aimed to formulate and evaluate a
polyherbal antidiabetic capsule containing Gymnema sylvestre (Gudmar) leaves,
Trigonella foenum-graecum (Fenugreek) seeds, and Syzygium cumini (Jamun) seeds,
all of which possess established antidiabetic potential.
The selected plant materials were dried, powdered, and subjected to physicochemical
and phytochemical evaluation. The polyherbal blend was prepared in suitable
proportions and filled into hard gelatin capsules. The formulated capsules were
evaluated for various preformulation and postformulation parameters including angle
of repose, bulk density, tapped density, Carr’s index, Hausner’s ratio, weight variation,
disintegration time, moisture content, and stability studies. Phytochemical screening
confirmed the presence of bioactive constituents such as alkaloids, flavonoids, tannins,
saponins, and glycosides, which are known to contribute to antidiabetic activity.
The synergistic action of Gudmar leaves, Fenugreek seeds, and Jamun seeds may help
in controlling blood glucose levels by enhancing insulin secretion, improving glucose
utilization, and reducing intestinal glucose absorption. The study concludes that the
formulated polyherbal antidiabetic capsule possesses promising pharmaceutical
characteristics and may serve as a potential natural therapeutic option for the
management of diabetes mellitus.

Keywords
Polyherbal formulation; Antidiabetic capsule; Gymnema sylvestre; Trigonella foenum-
graecum; Syzygium cumini; Diabetes mellitus; Herbal medicine; Capsule formulation;
Hypoglycemic activity.

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Chapter No. : 1

INTRODUCTION TO DIABETES MELLITUS :

Diabetes Mellitus is a group of metabolic diseases that are characterized by long-term illness (change)
and high blood sugar (high blood sugar). Only half of the people who are unaware of the disease
receive appropriate treatment. It is caused by insulin deficiency or insulin resistance or both. Insulin
secreted from the beta cells of the pancreas to control blood sugar. Acute hyperglycemia is associated
with long-term damage, dysfunction and failure of many organs, especially the eyes, kidneys, blood
vessels, heart and veins, and therefore involves many different organisms, It contains many
phytochemicals such as various Proteins, calcium, carbohydrates, etc.
More than 230 million people worldwide are affected, and it is expected to reach 350 million by 2025.
Globally the affected people are unaware of the disease and only half receive adequate treatment. It
is caused due to deficiency of insulin or resistance to insulin or both. Insulin is secreted by βcells of
pancreas to control blood sugar level. Blurry visions, excess thirst, fatigue, frequent urination, hunger
and weight loss are some of the symptoms commonly seen in diabetic patients.

TYPES OF DIABETES :
Diabetes results in the impairment of the body’s ability to use food because either the Pancreas does
not make insulin or the body cannot use insulin properly. Hypoglycemia (low Blood glucose) is most
commonly seen in diabetic patients, when the body gets too much Insulin, too little food, a delayed
meal, or more than the usual amount of exercise. When the Body gets too little insulin, too much
food, or too little exercise, it results in hyperglycemia.

Types of Diabetes Mellitus:

1. Type-I or Insulin Dependent Diabetes Mellitus (IDDM)

Juvenile diabetes is an immune-mediated disease and is characterized by destruction of pancreatic
beta cells by T-cell-mediated immunity, which reduces pancreatic cell lifespan by one third, and
ketoacidosis in tissues and fluids.

2. Type-II or Non-insulin Dependent Diabetes Mellitus (NIDDM)

Adult-onset diabetes is characterized by inadequate insulin secretion, with a response to elevated
blood glucose levels indicative of NIDDM. Decreased insulin sensitivity is unusual, and the
hyperglycemia can be reversed by insulin-sensitizing drugs or by reducing hepatic glucose.

3. Gestational diabetes mellitus (GDM)

In pregnant women without diabetes, gestational diabetes occurs almost at the end of the third month
of pregnancy or the beginning of the fourth month of pregnancy. It is characterized by carbohydrate

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

intolerance caused by hormonal changes resulting from pregnancy that prevent the body from using
insulin. Gestational diabetes affects 4% of pregnancies and disappears after birth.

MECHANISM OF ACTION OF HERBAL ANTI-DIABETES

The antidiabetic activity of plants is due to several mechanisms. The mechanisms of herbal
antidiabetic drugs can be divided into:

 Adrenomimetics, pancreatic β-cell potassium channel blockade, cAMP (second messenger)

stimulation.
 Inhibition of renal glucose reabsorption
 Stimulates pancreatic beta cells to secrete insulin or / and insulin
 Inhibits the degradation process
 Reduces insulin resistance
 Provides beta cells with important elements such as calcium, zinc, magnesium, manganese and
Copper.
 Regenerates and / or repairs pancreatic cells beta cells
 Increases the size and composition of islet cells
 Promotes insulin secretion
 Promotes glycogenogenesis and glycolysis
 Anti-inflammatory effects Blocking islet cells destroys beta Cell
 Improves digestion and reduces blood sugar and area.

Signs and symptoms :

Symptoms of untreated diabetes include polyuria, excessive thirst, and weight loss.
Other signs and symptoms also occur, such as fatigue, blurred vision, and genital irritation from
candidiasis. About half of those affected may be asymptomatic. Type 1 occurs soon after the
preclinical stage, while type 2 has a more rapid onset;

Diagnostic Methods of Diabetes :

Diabetes is diagnosed by one of the following

 Fasting blood glucose ≤ 7.0 mmol/L (126 mg/dL).

 Plasma glucose ≤ 11.1 mmol/L (200 mg/dL) < br>Glycated heme (Hb) A1C) ≤ 6.5%Oral Glucose
Tolerance Test (OGTT).

Individuals with fasting blood glucose between 100 and 125 mg/dL are considered to have impaired
diabetes, also called prediabetes. Fasting blood glucose is popular because it is inexpensive and easy
to perform. Diabetes should be confirmed with a second test on a different day.HbA1c is an indicator
of the average blood glucose concentration over the last three months and is recommended as a useful
test for the diagnosis of type 2 diabetes because it overcomes many of the problems associated with
the OGTT. The most commonly used anthropometric measurements to measure obesity are BMI
(body mass index), WC (waist circumference), and WHR (waist-hip ratio). The most commonly used
criteria for the diagnosis of obesity are the National Cholesterol Education Program (NCEP) and ATP

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

III criteria. Regarding sensitivity, Pandya et al. [5] has shown that WC is a better indicator of diabetes
than BMI.

Formulation of Herbal Production:

An herbal "formula" is made up of a carefully chosen combination of unique herbal elements that are
designed to treat a particular disease or group of diseases-conditions. Due to their activating or
catalysing effects on one another, herbs used together become more potent and effective in the body
than a single herb. These mixtures work as potent catalysts to activate each person's unique healing
energies (or vital force), which permeate the entire organism and are present in each and every cell in
our bodies.

WHO Guidelines for Standardization of Herbal Formulation:

The polyherbal formulations, which combine multiple herbs to produce the desired therapeutic effect,
rely on standardisation to maintain and evaluate their quality and safety. Standardisation reduces
batch-to-batch variation and guarantees the polyherbal formulations' acceptability as well as their
safety, effectiveness, and quality.

Standardisation involves:
 Quality control of crude drugs material, plant preparations and finished products: Botanical
evaluation- sensory characters, foreign organic matter, microscopical, histological etc.
 Stability assessment and shell-life: Physicochemical character of drug- Physical and chemical
identity, chromatographic fingerprints, ash values, extractive values, moisture content, volatile oil
and alkaloidal assays etc.
 Safety assessment: Toxicity details- pesticide residues, heavy metals, microbial contamination
pathogens like [Link], Salmonella, [Link], [Link], etc.
 Assessment of efficacy by ethnomedical informations, pharmacological parameters, biological
activity profiles etc.

CAPSULE FORMULATION WITH HERBS

Polyherbal capsules are becoming increasingly popular due to their holistic health benefits, natural
healing properties, and minimal side effects compared to synthetic drugs. arious formulations of
herbal products are possible, including capsules, tablets, syrups, lehiyas, tailas, bhasmas, powders,
etc. The most adaptable form is the capsule, which offers traditional medication delivery for
regulating absorption, improving bioavailability, and precise dose.

The demand is driven by several key factors: Synergistic Therapeutic Effects, Increasing Preference
for Natural & Herbal Medicin, Wide Range of Applications, Ayurveda & Traditional Medicine
Recognition, Rising Demand for Preventive Healthcare, Minimal Side Effects & Better Toleranc &
Convenient Dosage Form. Herbal plants are most important for mankind for treatment and
management of diseases. According to the World Health Organization (WHO), “natural plants are a
plant having more bioactive molecules that have been reported their therapeutic benefits, or which

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

are mother sources of chemo-pharmaceutical semi-synthesis.” Such medicinal plants are in highly
demand by the pharmaceutical companies for their bioactive ingredients Medicinal plants have been
reported worldwide in traditional medicines for the treatment of various chronic diseases. According
to various reports estimated that even modern time approximately 65-75% of the World‟s populations

depend on medicinal plants for treatment and management of diseases. Herbal plants and their parts
are employed in a variety of therapeutic systems for the treatment of ailments, including
homoeopathy, Chinese medicine, Unani medicine, and Ayurvedic medicine.. The quality and purity
of the herbal product must be ensured. These standardised herbal products improve the quality of
plant medicine and raise its acceptability and export quality in the global market. Poly-herbal
formulation is a great idea that is suited and appropriate for the treatment and management of chronic
diseases like cancer. Many studies have been reported with positive findings; however more research
is needed to produce promising natural products. Therefore our goal of our current research was
development and standardization of raw materials used in the poly-herbal formulation based on
organoleptic, powder microscopy and physical property standardization.

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Chapter No. : 2

 PLANT PROFILE:

GUDMAR (Gymnema Sylvestre):

Gudmar is a wood climbing shrub whose leaves are used for medicinal purposes. Gudmar or Gudmar
is considered to be a magical remedy for diabetic patients as it is highly effective in both type I and
type II diabetes mellitus. It reduces blood sugar levels by enhancing the level of insulin in the body.
You can also take Gudmar (Gurmar) churna or kwatha with water to help manage cholesterol by
reducing the levels of bad cholesterol (LDL)Sannageraseham and increasing good cholesterol (HDL).
Applying Gudmar leaves powder along with coconut oil once a day helps to reduce itching, burning
sensations on the skin and also helps in effective wound [Link] Excessive intake of Gudmar
should be avoided as it may cause weakness and excessive sweating with shakiness.

Figure: Gurmar Leaves

What are the synonyms of Gudmar?

Gymnema sylvestrae, Mesha-shringi, Madhunashini, Ajaballi, Avartini, Kavali, Kalikardori, Vakundi,
Dhuleti, Mardashingi, Podapatri, Adigam, Cherukurinja, Sannagerasehambu.

Botanical name :- Gudmar, also called Gymnema Sylvestre,

Family :- Asclepiadaceae.
Part Used: Leaves
Kingdom: Plantae
Subkingdom: Trancheobionta
Superdivision: Spermatophyta
Division: Magnoliophyta

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Class: Magnoliopsida
Genus: Gymnema
Species: Gymnema sylvestrae
Biological sources:- Gymnema is a woody climbing plant found in central and southern India,
tropical Africa, and Australia. It has been used traditionally in Ayurvedic medicine for the treatment
of “honey urine”. Extracts from the leaves contain alkaloids, phenols, tannins, flavonoids, and
saponin.
Chemical constituents :- Gymnemic acid is one of the highly effective chemical constituents of
Gudmar which acts as a cardiovascular stimulant. Other chemical constituents include tartaric acid,
gurmarin, calcium oxalate, glucose, saponins.
Properties of Gudmar:
The beneficial properties of gudmar may include:
 It may have a blood sugar lowering effect.
 It may have a cholesterol-lowering effect.
 It may have anti-inflammatory properties.
 It may benefit in maintaining a healthy weight.
 It may have antimicrobial activity.
 It may have anti-cancer activity.
 It may have antioxidant activity.
 It may have antiarthritic activity.
 It may have an immunomodulatory effect.
 It may benefit stomach health.
 It may benefit liver health.
 It may have anticaries activity (may reduce tooth decay).
 It may have a wound healing effect.

Potential Uses of Gudmar:

Gudmar may have potential uses for various ailments; however, more human studies are needed to
support its true scope in humans.
Gudmar may be used as:
 Powder
 Gudmar extract paste
 Crude plant
 Tablet
 Capsule

JAMUN (Eugenia Jambolana):

Jamun seed powder is an herbal supplement derived from the seeds of the jamun fruit (Syzygium
cumini), also known as black plum or Indian blackberry. The jamun fruit is native to the Indian
subcontinent and is widely grown in various tropical regions around the world.

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Jamun seed powder is made by crushing and grinding the dried seeds of the fruit into a fine powder.
This powder is often used in traditional medicine systems, such as Ayurveda, for its potential health
benefits. The dried and powdered seed of the Jamun is frequently used in India to manage diabetes.
For years, Jamun seed powder has been used as a natural way to maintain a healthy blood sugar level,
as well as treat cardiovascular and gastrointestinal problems. Clinical nutritionist Dr. Lovneet Batra
suggests that you can dry the seeds of jamun and create a powder from it. Consume half a teaspoon
of it with water on an empty stomach daily to deal with diabetes. Jamun seeds contain alkaloids,
which convert starch into energy and helps in reducing diabetes symptoms like constantly feeling
thirsty and frequent urination. Jamun seeds, in powdered form can help in reducing blood sugar levels.

Figure: Jamun Seed

Synonym: Syzygium jambolana, Eugenia jambolana.

Biological Sources :- Jamun is native to the Indian Subcontinent and other regions of Southeast Asia
that includes Sri Lanka, Myanmar and the Andaman Islands. It is commonly known as Indian
blackberry or Jamun.
Botanical name :- Eugenia jambolana.
Common Name: Jamun , Javaplum, Blackplum
Family :- Asclepiadaceae.
Part Used: Seeds
Kingdom: Plantae
Subkingdom: Trancheobionta
Superdivision: Spermatophyta
Division: Magnoliophyta
Class: Magnoliopsida
Genus: Syzygium
Species: Syzygium

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Advantage :- Take a glass of water and add one teaspoon of jamun powder to it. Stir well and drink
this mixture first thing in the morning to reap its benefits. Alternatively, you may also consume it with
low-fat dairy milk or almond milk before meals to maintain healthy blood sugar levels.
Disadvantaged :- As reported in the literature, flatulence, delayed digestion, laryngitis, inflammation
in the lungs, and emphysema are all possible side effects of jamun. Benefits :- Because of its low
glycemic index, diabetic patients should consume Jamun during the summer. It alleviates diabetic
symptoms such as excessive urination or pushing. The extracts of the leaves, seeds, and bark are very
successful in treating diabetes.
Benefits of jamun seed powder:
 Blood Sugar Management: Jamun seed powder is commonly associated with its potential to
help manage blood sugar levels.
 Antioxidant Properties: Jamun seed powder contains antioxidants, such as flavonoids
and polyphenols, which can help neutralize harmful free radicals in the body.
Antioxidants play a crucial role in reducing oxidative stress and inflammation,
potentially lowering the risk of chronic diseases.
 Digestive Health: In traditional medicine, jamun seed powder is used to support
digestive health. It is believed to have a mild astringent property that can help alleviate
diarrhea and other gastrointestinal issues.
 Immune System Support: The powder is thought to boost the immune system due to
its antioxidant content and other bioactive compounds. A strong immune system can
better defend the body against infections and illnesses.
 Oral Health: Some traditional practices suggest that using jamun seed powder as a
mouthwash may help in the treatment of mouth ulcers and improve overall oral hygiene.
 Skin Health: Jamun seed powder may have potential benefits for the skin when applied
topically. It is believed to help manage skin conditions like acne and eczema, possibly
due to its anti-inflammatory and antimicrobial properties.
 Urinary Health: In traditional medicine, jamun seed powder is sometimes used for
urinary disorders due to its diuretic properties, which may help promote urine flow and
cleanse the urinary system.
 Weight Management: Some preliminary studies suggest that jamun seed extract may
have anti-obesity effects and could be beneficial in managing weight.

Fenugreek (Trigonella fornum graecum):

Fenugreek seeds may be helpful for people with diabetes. The seeds contain fiber and other chemicals
that may slow digestion and the body’s absorption of carbohydrates and sugar. The seeds may also
help improve how the body uses sugar and increases the amount of insulin released. Anti-
hyperglycemic effects associated with decreased somatostatin and increased plasma glucagon levels
the anti hyperglycemic effects of fenugreek are thought to be due to amino acids 4-Hydroxysoleucine
works by: Increasing insulin and glucose absorption in peripheral tissues.

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Figure: Frenugreek Seed

Synonyms :- Methinl, deepanl

Family :- Fenugreek Biological sources:- Fenugreek ( Trigonella fornum graecum )
Botanical name :- Gudmar, also called Gymnema Sylvestre
Common Name: Frenugreek (Methi)
Part Used: Seeds
Kingdom: Plantae
Subkingdom: Trancheobionta
Superdivision: Spermatophyta
Division: Magnoliophyta
Class: Magnoliopsida
Genus: Trigonella
Species: Trigonella foenum graecum
Chemical constituents :- steroids sapogenins, isoleucine, and galactomannans.
Uses of Methi in diabetes:
Methi may be helpful in diabetes as it increases insulin sensitivity by controlling the glucose
transporters and signaling transduction in the liver and adipose tissue. According to animal studies,
intake of Methi increased the levels of glucose transporter-2 and 4 in the liver and adipose tissue.
Methi might help improve the condition of insulin resistance. It may also help the liver to perform
better. Diabetes is a serious health condition that requires you to adhere to a doctor’s advice and
treatment.
Health Benefits of Fenugreek Seeds
1. Improves Digestive Health
Fenugreek seeds are rich in soluble fibre, thus aiding healthy digestion and avoiding constipation. It
activates the digestive enzymes in the body, which aids in good digestion and absorption of nutrients.

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

The mucilage contained in this herb soothes the gastrointestinal tract and minimises symptoms such
as acid reflux and indigestion.
2. Regulates Blood Sugar Level
Some of the most prominent Fenugreek seeds benefits include controlling blood sugar. Investigations
have established that Fenugreek seeds can help increase the sensitivity of tissues towards insulin and,
through this mechanism, reduce blood glucose levels, making Fenugreek seeds beneficial for
diabetics.
3. Hair Health Improvement
Fenugreek seeds are extensively used to stimulate hair growth. They contain lecithin, an emulsifier
that strengthens and hydrates the hair strands. Due to their antifungal powers, these seeds may fight
dandruff and prevent scalp infections.
4. Helps in Weight Loss
The Fenugreek seeds assist in managing weight by regulating appetite and giving a feeling of fullness.
Fibres from these seeds, natively found in the seeds, tend to swell inside the stomach, thus stopping
overeating or munching. Many take Methi water in the morning as a weight loss remedy.
5. Hormonal Balance in Women
Fenugreek seeds have compounds that mimic estrogens, so they can balance oestrogen in women.
Fenugreek seeds are extensively used to lighten the pains of menstruation, make periods come
regularly, and also reduce symptoms in menopause. Fenugreek is, therefore, widely consumed by
breastfeeding mothers to increase milk supply.
6. Boosts of Testosterone in Men
Fenugreek seeds have also been known to stimulate testosterone in males, improving sexual function,
enhancing energy, and increasing strength. Additionally, other research studies suggest that
facilitation by seed might be useful for sperm count and motility, thus promoting male fertility.
7. Anti-inflammatory and Antioxidant Properties
Fenugreek seeds have strong anti-inflammatory and antioxidant properties that prevent the body from
falling prey to chronic diseases. The antioxidants in the Fenugreek seed eliminate harmful free
radicals, thus preventing the development of heart disease and cancer-like conditions.
8. Heart Health Support
Though it lowers cholesterol due to its fibre and antioxidants, it contributes even further to heart
health. The daily intake of Fenugreek seeds may decrease LDL or bad cholesterol and triglycerides
while increasing HDL or good cholesterol to showcase better cardiovascular health.

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Chapter No : 3

Literature Review:
SuchitaGokhale, et al, June 2020 :-The Anti- diabetes poly herbal capsule sector is probably the
largest unit sale among the diabetes patient care products since diabetes capsule are one of the Herbal
products used in daily life. The herbal anti- diabetes was Formulated using natural ingredient like
Jamun Seed, Gudmar and Fenugreek with proven efficacy of diabetes patient preparation is prepared.
The combination of several such ingredient of herbal origin has made it possible to secure highly
effective herbal Capsule. The formulation at laboratory scale was done and evaluated for number of
parameters to ensure its safety and efficacy.
Priya D. Gaikwad et.2018-The objective of this study is to formulate and evaluate polyherbal
capsule for diabetes patient purpose from herbal ingredients. Gudmar powder , jamun seed powder
and fenugreek powder. Gudmar powder, Fenugreek powder and Jamun seed powder was procured
from localmarket in powdered form also churna form.
Ayyanar et al., 2008; Di Fabio et al., 2014; Srivastava et al., 2012: Gudmar Leaf; Its mechanism
of action is by inhibiting the glucose absorption in the intestine through the saponin fraction of the
herb.
Chhetri et al., 2005; Srivastava et al., 2013; Tripathi & Kohli, 2014 : Jamun Seed; The excessive
production of ROS having a key role in the development Diabetes. Consequently, neutralization of
ROS by Jamun appears a key mechanisms in Diabetes management. (Molecular level reduction in
glucose level may be associated with Jamun’s having capacity to triggers the PPARα, PPARγ, and
AKT which subssequently downregulate the expression of Foxo-1, PGC1α, Scid 1, ACC1, SREPB1c,
endoplasmic reticulum protein retention receptor (KEDL), and GPR98 leading to decreased activities
of G6Pase, ADA, 5’NTase, PEPCK, and Fas)
Kumar et al., 2012; Xue et al., 2007: Fenugreek Seeds; By reguating insulin secreation from the
pancreatic β-cells. Additionally, a clinical study indicatd that fenugreek’s antidiabetic effect was due
to its ability to enhance insulin sensitivity.
Abdel NS, Fadia SY, Mohamed LA. Medicinal Plants with Potential Antidiabetic Activity and their
Assessment. Med Aromat Plants.
Patel DK, Prasad SK, Kumar R, Hemalatha S. An overview on antidiabetic medicinal plants
having insulin mimetic property.
Da Silva SB, Costa JP, Pintado ME, Ferreira DC, Sarmento B. Antioxidants in the Prevention and
Treatment of Diabetic.
Nagarajan S, Jain HC, Aulakh GS. Indigenous plants used in the control of Diabetes in Cultivation
and Utilization of Medicinal Plants. Jammu regional research laboratory, 1982 584-604.
Doshi G, UneH. Quantification of Quercetin and Rutin from Benincasahispida Seeds and Carissa
Congesta Roots by High- performance Thin Layer Chromatography and High-performance Liquid
Chromatography. Pharmacognosy Research. 2016; v.8(1).

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Chapter No : 4

AIM AND OBJECTIVE

Aim of the study:
The aim of the present study is to design a safe, stable, and effective anti-diabetic polyherbal capsule
by combining multiple medicinal plant and to evaluate its pharmaceutical properties, phytochemical
characteristics, and anti-diabetic potential for the management of diabetes mellitus.

Objectives:

1. To select and prepare medicinal plant materials

 To select Gurmar, Jamun Seed, and Fenugreek based on their anti-diabetic properties and to
process them into suitable powdered form for formulation.

2. To formulate the anti-diabetic polyherbal capsule

 To develop a stable and effective polyherbal capsule using suitable proportions of herbal
ingredients and pharmaceutical excipients.

3. To perform pre-formulation and phytochemical studies

 To evaluate flow properties such as angle of repose, bulk density, tapped density, Carr’s index,
and Hausner ratio, and to carry out phytochemical screening for the identification of active
constituents like alkaloids, flavonoids, tannins, glycosides, and saponins.

4. To evaluate the formulated capsules for quality, stability, and anti-diabetic activity
 To assess parameters including weight variation, disintegration time, content uniformity,
dissolution study, moisture content, stability studies, and anti-diabetic potential of the
formulation.

5. To assess the safety and therapeutic efficacy of the formulation

 To evaluate the effectiveness of the polyherbal capsule in controlling blood glucose levels and to
ensure its safety for therapeutic use.

6. To develop a patient-friendly herbal dosage form

 To prepare an easy-to-administer, stable, and convenient capsule dosage form suitable for long-
term management of diabetes mellitus

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Chapter No: 5
Plan of Work:
1. Literature Review : Collection of Information

2. Collection of Plant Material

3. Authentication of Herbal Plant

4. Evaluation of Herbal Drug

 Perform preliminary phytochemical tests

5. Preformulation studies
a. Organoleptic Evaluation
b. Moisture Content
c. Angle of Repose
d. Bulk density
e. Tapped density
f. Hausner's Ratio

6. Selection of Excipients

7. Development of Formulation Design

8. Formation of Polyherbal Capsule

 Granules Formation (Wet Granulation)

9. Precompressibility Test of Granules

10. Capsule Formation (Direct Granules Filling Method)

11. Formation of Trials Batches (F1 and F2)

12. Evaluation of Capsule

a) General Apperance
b) Weight variation test
c) Moisture content
d) Dissolution Study
e) Disintegration Test

13. Data Analysis

14. Result and Discussion

15. Conclusion

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Chapter No : 6

MATERIALS AND METHODS:

1. MATERIALS

Herbal Ingredients
 Gudmar leaf powder (Gymnema sylvestre)
 Jamun seed powder (Syzygium cumini)
 Fenugreek seed powder (Trigonella foenum-graecum)

 Selection of Excipient :
The majority of materials filled in the tablet are formulated as powders that are typically mixtures
of the active ingredients together with a combination of different types of excipients. Normally,
there are three types of excipients used in tablet formulation i.e. diluents, glidants and lubricants

Diluents:
Diluents/Fillers are added where the quantity of active ingredient is less (or) difficult to filling.
Common tablet/capsule filler include Lactose, Dicalcium phosphate, Microcrystalline
cellulose,etc.

Lubricants:
They reduce friction during the filling process. In addition, they aid in preventing adherence of
capsule material. Magnesium Stearate, Stearic acid, Hydrogenised vegetable oils and talc are
commonly used lubricants.

Glidant:
It is used to improve flow of the powder materials by reducing the friction between the particles.
The most effective glidants are the Colloidal silicon dioxide, Talc and Starch.

Excipients
 Microcrystalline cellulose (MCC) — diluent
 Starch — binder
 Sodium starch glycolate (SSG) — superdisintegrant
 Talc — glidant
 Magnesium stearate — lubricant

Other Materials
 Purified water (for granulation)
 Hard gelatin capsule shells (size 0 or 00)

Equipment Used
 Analytical balance

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

 Mortar and pestle

 Sieve no. 20, 40 and 60
 Hot air oven/tray dryer
 Mixing bowl
 Granulating sieve
 Manual capsule filling machine
 Disintegration apparatus
 Dissolution apparatus
 UV-visible spectrophotometer
 Bulk density apparatus
 Funnel stand for angle of repose

2. METHODOLOGY

1. Preparation of Herbal Powders

Gudmar leaves, Jamun seeds, and Fenugreek seeds were cleaned, dried under shade, and
pulverized separately using a grinder. The powders were passed through sieve no. 40 to obtain
uniform particle size and stored in airtight containers.

3. Formulation table Polyherbal Capsules

[Link]
Ingredients F1 F2 Category
1 Gudmar Powder 150 mg 150 mg Active
ingredient
2 Fenugreek 100 mg 150 mg Active
Powder ingredient
3 Jamun Seed 140 mg 140 mg Active
Powder ingredient
4 Microcrystalline 45 mg 50 mg Diluent
cellulose
5 Talc 5 mg 5 mg Glidant

6 Magnesium 10mg 5mg Lubricant

stearate
Total Weight 500mg 500mg

4. Preparation Method (Wet Granulation Technique)

Step 1: Sieving
All ingredients except talc and magnesium stearate were passed through sieve no. 40/ 80 separately
to ensure uniform particle size.

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 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Step 2: Dry Mixing

The accurately weighed quantities of Gudmar powder, Jamun seed powder, Fenugreek powder,
microcrystalline cellulose, and sodium starch glycolate were mixed thoroughly in a mortar for 10–15
minutes to obtain a uniform powder blend.

Step 3: Preparation of Binder Solution

Starch paste was prepared by dispersing starch in a small quantity of purified water and heating gently
until a translucent paste was formed.

Step 4: Wet Granulation

The starch paste was added slowly to the powder blend with continuous mixing until a coherent wet
mass was obtained.
The wet mass was passed through sieve no. 10/ 12 to produce wet granules.

Step 5: Drying of Granules

The wet granules were dried in a hot air oven at 50–60°C until a constant moisture level was achieved.

Step 6: Sizing of Granules

The dried granules were passed through sieve no. 20 to obtain uniform-sized granules.

Step 7: Lubrication
Talc and magnesium stearate were added to the dried granules and blended gently for 3–5 minutes.

Step 8: Capsule Filling

The lubricated granules were filled manually into hard gelatin capsules (size 0 or 00) using a manual
capsule filling machine.
The filled capsules were cleaned and stored in airtight containers.

Fig: Formulation of Capsule

17
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Chapter No: 7

PRE FORMULATION STUDIES :

Prior to formulation, it is essential that fundamental physical and chemical properties of the drug
molecule and other derived properties of the drug powder are determined.
This information decides many of the subsequent events and approaches in formulation development.
This first learning is known as Preformulation. It aims to optimize the process of turning a drug into
a drug product. During preformulation the physiochemical properties of the drug candidate are
determined. Before beginning the formal preformulation programs the manufacturing scientist must
ensure the following factors:
> The amount of drug available
> The physicochemical properties of the drug already known.
> Therapeutic category and anticipated dose of compound.
> The nature of information, a formulation should have or would like to have.

Physicochemical Evaluation
Bulk density (ρb):
It is decided through measuring the extent of a regarded mass of powder pattern that has been passed
via a screen into a graduated cylinder or via a extent measuring apparatus into a cup. It is expressed
in g/ml and is given through,
ρb = M/Vo
Where, M - is the mass of powder
Vo- is the majority extent of the powder.
The inter particle interactions that have an impact on the bulking houses of a powder are additionally
the interactions that interfere with powder waft, a contrast of the majority and tapped densities can
deliver a degree of the relative significance of these interactions in a given powder. Such a contrast
is regularly used as an index of the capacity of the powder to waft.

Tapped density (ρt):

It is done through robotically tapping a measuring cylinder containing a powder pattern. After looking
at the initial extent, the cylinder is robotically tapped and extent readings are taken till little in addition
extent extrude is observed. The mechanical tapping is done through elevating the cylinder and
permitting it to drop below its very own weight at a selected distance. The tapped extent become
measured through tapping the powder to steady extent. It is expressed in g/ml and is given.
ρt = M/Vt
Where, M - Mass of powder and
Vt- Tapped extent of the powder

18
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Fig: Tapped Density

Compressibility index: (CI):

Compressibility is the capacity of powder to lower in extent below pressure. Compressibility is a
degree that received from density dedication. Weighed amount of granules become transferred to 50
ml graduated cylinder, extent occupied through granules become mentioned down. Then cylinder
become subjected to 500/ 750 and 1250 taps. The distinction among tabs ought to be much less than
2%. The percent Compressibility Index is calculated through the usage of system.

Hausner’s Ratio :
Hausner’s Ratio = Vi / Vo

Where, Vo -Untapped density,

Vi -Tapped density Angle of repose
The tangent of attitude of repose is identical to the coefficient of friction among the particles. Hence
the rougher and more abnormal the floor of particles, the more could be attitude of repose. For
dedication of attitude of repose (θ), the blends had been poured thru the partitions of a funnel which
become constant at a position such that its decrease tip become at a peak of precisely [Link] cm above
a tough floor. The drug or the blends had been poured till the time while top tip of the pile floor
touched the decrease tip of the funnel. Angle of repose become calculated the usage of following
equation.
Tan θ = h/r, θ = tan-1 (h/r)

Where, θ - attitude of repose,

h- peak in cm and
r- radius in cm.

19
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Based on the Angle of repose, Compressibility index and Hausner’s ratio, the waft belongings of the
granules can be characterized [

Determination of Moisture Content:

Using the AACC technique, moisture content was measured. A two gram sample was put
into a glass petriplate that had been heated, weighed, and dried in a hot air oven for two
hours at 130 °C. till construction. After cooling in the dessicator after being weighed after
drying, the glass petriplate was reweighed. Weight loss as a percentage of moisture content
was determined [27].

Moisture content (%)=(w1-w2)/(weight of sample) x 100

W1 = weight of sample before drying

W2 = weight of sample after drying

Fig: Determination of Moisture Content

Determination of Ash Content:

AACC approach was used to quantify and characterize the ash [Link] grams of the
material were put into a pre-weighed crucible, which was then exposed to a muffle furnace's
820°C for four hours before being cooled in a dessicator and weighed [28].

ash(%)= (weight of ash)/(weight of sample ) x 100

Fig: Ash Value

20
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Angle of Repose:
The angle of repose was measured using the stationary funnel technique. A funnel was
positioned above graph paper that was laid out horizontally and fastened with its point at a
specific height (h). The mixture was meticulously poured through the funnel until the
conical pile's peak touched the funnel's tip. The cylindrical pile's base's radius was
calculated. The following method was used to determine the angle of repose :

Tan θ = h/r

Where, θ = Angle of repose,

h = Height of the cone,
r = Radius of the cone base.

Angles of repose values between 25 and 30 show outstanding flow properties, 31 to 35

show good flow properties, 36 to 40 show acceptable flow properties, and 41 to 45 show
passable flow properties. Angles of repose values between 40 and 60 imply a poorly
flowing substance .

Fig: Angle of Repose

Phytochemical Studies
Herb is a biosynthetic laboratory, which contains chemical compounds such as carbohydrates,
proteins and lipids that are utilized as food. It also contains secondary products like glycosides,
alkaloids, flavonoids, tannins etc. The detection of these active principles in medicinal plants plays a
strategic role in the phytochemical investigation of crude drugs and extracts and is very important in
regard to their potential pharmacological effects. These tests facilitate the quantitative estimation and
qualitative separation of pharmacologically active chemical compounds and
subsequently may lead to the drug discovery and development(37)(38).
All the plant raw materials were subjected to preliminary phytochemical screening for
the detection of various plant constituents.

21
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Preliminary phytochemical screening of powder and extracts:

1. Test for Alkaliods (Hager’s test):

For this test procedure, few drops of Hager’s reagent (hydrochloric acid) added to 2 ml of the
respective plant extract. Bright yellow precipitate formation indicated the existence of alkaloids.

2. Test for Saponins (Foam test) :

1ml solution of extract was diluted with distilled water to 10 ml and shaken it vigorously.
Development of stable foam suggests the presence of saponins.

3. Test for Carbohydrates (Molisch's test) :

Few drops of Molisch's reagent was added to each of the portion dissolved in distilled water, this
was then followed by addition of 1 ml of conc. H2SO4 by the side of the test tube. The mixture
was then allowed to stand for two minutes and then diluted with 5 ml of distilled water. Formation
of a red or dull violet colour at the interphase of the two layers was a positive test.

4. Test for Tannins (Ferric Chloride test) :

About 0.5 g each portion was stirred with about 10 ml of distilled water and then filtered. Few
drops of 1% ferric chloride solution were added to 2 ml of the filtrate occurrence of a blue-black,
green or blue-green precipitate indicates the presence of tannins.

5. Test for Proteins (Ninhydrin Test) :

To 1ml of extract few drops of Ninhydrin reagent was added and heated in a boiling water bath.
A purple blue colour indicates the presence of proteins.

6. Test for Flavonoids (Lead acetate test):

Lead acetate test 10 mg of extract was taken and few drops of 10% lead acetate solution was
added. Appearance of yellow colour precipitate indicates the presence of flavonoids.

22
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Fig: Phytochemical test

Post Evaluation Test:

 Weight Variation Test:

1. Step-by-Step Testing Procedure

1. Select the Samples: Gather 20 capsules at random from the targeted production batch.
2. Determine Gross Weight: Measure the exact gross weight (Wf) of each filled capsule
individually via an analytical balance. Keep precise track of each capsule's numbered identity
(1 through 20).
3. Evacuate Capsule Contents: Cut open or carefully separate the shell parts. Remove all inside
powder or liquid granules completely using a brush or clean cloth.
4. Determine Tare Weight: Measure the exact weight (We) of each empty individual capsule
shell.
Find Net Content Weight: Use the formula below to find the net weight of contents (W) for each
sample unit:

W= Wf-We
2. Percentage Variation Calculation
Calculate the Average Net Weight (Wavg) across the entire pool of 20 capsules. Next, compute
the exact percentage deviation for each separate unit using this formula:
Formula:
%Weight Variation= Individual Weight−Average Weight/ Average Weight × 100

3. Pharmacopeial Acceptance Limits

Both USP and BP/IP standards enforce strict acceptance limits depending on the final net mass of
the capsule contents: [1, 2]

23
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Allowed % Deviation (Max Absolute Maximum

Average Mass of Content
2 units) Deviation (No units)
Less than 300 mg ±10% ±20%
Less than 300 mg ±7.5 ±15%

4. Evaluation Criteria
 The batch passes the test if not more than 2 capsules out of the 20 deviate from the average
weight by more than the allowed percentage deviation.
 The batch fails if any single capsule deviates by more than twice the permitted percentage
limit.
If you are currently evaluating a batch, please provide:
 The average weight of your sample capsule contents.
 The individual weights of any units you suspect are failing.

 Disintegration Test
[Link] and Medium Setup
The test is conducted utilizing a specialized regulatory Disintegration Test Apparatus:
 Assembly: A basket-rack unit featuring 6 open-ended glass tubes layered with a #10 mesh
stainless steel screen at the base.
 Immersion Fluid: Fill the beaker with water or 0.1 N HCl, unless a specific anti-diabetic
monograph commands a unique buffer stage.
 Temperature: Maintain the immersion fluid strictly at 37 ± 2 °C throughout the testing
window.
 Frequency: Calibrate the automated drive to move the basket vertically at a steady rate of 28
to 32 cycles per minute

Standard Testing Procedure

1. Load the Capsules: Place 1 anti-diabetic capsule into each of the 6 parallel tubes.
2. Add Appointed Discs: Place a cylindrical plastic disc over each capsule. The disc prevents
the lightweight capsule shell from floating out of the tubes.
3. Initiate Basket Drive: Submerge the loaded basket and activate the up-and-down stroke
cycle.
4. Observe End-Point: Continually monitor the samples. The process stops when no solid mass
or un-ruptured shell fragment remains on the bottom mesh screens.

Fig: Disintegration Test

24
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

 Vitro Dissolution Study:

1. Preparation of the Medium
 Medium Selection: Prepare 900 mL of the specified compendial medium per capsule vessel.
 Common Media: Use 0.1 N Hydrochloric Acid (pH 1.2) for immediate-release formulas, or
Phosphate Buffer (pH 6.8) for sustained-release formulations.
 Deaeration: Heat and filter the medium under a vacuum. This removes dissolved air bubbles
that could alter dissolution rates.
 Temperature Control: Equilibrate the fluid inside the vessel until it reaches 37 ± 0.5 °C to
mimic human core body temperature.

2. Setting Up the Apparatus

 Apparatus Selection: Use USP Apparatus 1 (Basket) or USP Apparatus 2 (Paddle) based on
the monograph guidelines.
 Applying Sinkers: If using a paddle apparatus and the capsule floats, place the capsule inside
a non-reactive wire helix sinker to keep it submerged at the bottom.
 Operating Speed: Set the rotation speed, typically to 50 rpm, 75 rpm, or 100 rpm,
depending on the specific anti-diabetic monograph.

3. Sampling and Sink Conditions

 Run Initialization: Drop one anti-diabetic capsule into each of the six parallel vessels and
immediately start the rotation.
 Aliquots Withdrawal: Draw a specific volume (e.g., 5 mL or 10 mL) from the exact zone
midway between the medium surface and the top of the blade.
 Timing Points: Sample at predefined time intervals, such as 30 minutes for immediate-
release, or up to 12 hours for sustained-release formulations.
 Media Replacement: Instantly replace the withdrawn volume with an equal volume of fresh,
pre-warmed dissolution medium to maintain steady sink conditions.

4. Filtration and Quantification

 Filtration: Filter the collected sample immediately using a 0.45 µm membrane filter to stop
further dissolution of any suspended particles.
 Analysis: Quantify the dissolved anti-diabetic drug fraction using a validated method, such
as UV-Spectrophotometry or Reverse-Phase HPLC.

Fig: Dissolution Test

25
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Chapter No. 8
RESULT AND DISCUSSION:
 Phytochemical Studies Result:

Sr. No Phytochemical Reagent/Test Gudmur Jamun Seed Fenugreek

Test Used Powder Powder Seed Powder

1 Alkaloids Hager’s test Present (+) Present (+) Present (+)

2 Saponins Foam Test Present (+) Absent (-) Present (+)

3 Carbohydrates Molish’s Test Present (+) Present (+) Present (+)

Ferric Chloride
4 Tannins Present (+) Present (+) Present (+)
test

5 Protein Ninhydrin Test Absent (-) Present (+) Present (+)

Lead acetate
6 Flavonoids Present (+) Present (+) Present (+)
test

 Organoleptic Evaluation Result :

Gudmar Jamun Seed Fenugreek Seed

Sr no Parameter
Powder Powder Powder
Light brown to Yellowish-
1 Colour Greenish-Brown
dark brown brown
Characteristic Slightly Strong aromatic
2 Odour
herbal odour astringent odour odour
Dry powder
Dry, Free Smooth dry
3 Apperance with rough
flowing powder powder
particles
Astringent and Bitter and
4 Taste Bitter
slightly bitter slightly pungent
Partially soluble Slightly soluble Swells in water
5 Solubility
in water in water due to mucilage

 Physiochemical Test Result:-

Jamun Seed Fenugreek Seed
Sr. No Parameters Gudmar Powder
Powder Powder
1 Angle of Repose 28.8° 39.8° 36.2°
2 Carr’s Index 16.3% 23.4% 20.8%
3 Hausner Ratio 1.91 1.31 1.26
4 Moisture Content 4.63% 2.72% 7.69%

26
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

 Ash Value Result:

Sr. No Sample Standard Reading Ash Value

1 Gudmar Powder 5-10% 9.67%
2 Jamun Seed Powder 2-8% 5%
3 Jamun Seed Powder 3-5% 4%

 Precompression evaluation test (Granules) F1 and F2 Result:-

Sr, No Test F1 F2

1 Angle of Repose 36.86 37.20

2 Carr’s Index 14.8% 20%

3 Hausner Ratio 1.17 1.25

4 Loss on Drying 8% 5%

5 Tapped Density 0.54 0.55

6 Bulk Density 0.46 o.44

 Post Evaluation Test:

1. Weight Variation:
F1 Formulation:

Capsule No. Weight(mg) %Variation

1 489 -0.38
2 503 +0.62
3 495 -0.98
4 506 +1.22
5 500 +0.02
6 497 -0.58
7 504 +0.82
8 501 +0.22
9 496 -0.78
10 499 -0.18

Average Weight: 499.9mg

Conclusion: All capsules were within the acceptance pharmacopeial limit of ±7.5%. Therefore the
F1 formulation passed the weight variation test.

27
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

F2 Formulation:
Capsule No. Weight (mg) %Variation
1 502 +0.30
2 497 -0.70
3 505 +0.90
4 499 -0.30
5 503 +0.50
6 496 -0.90
7 501 +0.10
8 504 +0.70
9 498 -0.50
10 500 -0.10

Average Weight: 500.5mg

Conclusion: All capsules were within the acceptance pharmacopeial limit of ±7.5%. Therefore the
F2 formulation passed the weight variation test successfully.

Disintegration Study:
Parameter F1 F2
Disintegration Time 6-9 min 7-9 min

Dissolution Study:
Drug Release
Time (in min)
F1 F2
0(Sample) -0.0346 -0.0552
5 0.2250 0.3154
10 0.3384 0.4594
15 0.3554 0.4977
20 0.3652 0.5262
25 0.3684 0.5539
30 0.3754 0.5741
35 0.3794 0.5748
40 0.4221 0.6037
45 0.4324 0.6117
50 0.4356 0.6123
55 0.4641 0.6217
60 0.4648 0.6229

28
Formula on and Evalua on of An -diabe c Polyherbal Capsule

Fig: Graph for F1 (Drug Release)

Fig : Graph for F2 (Drug Release)

29
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

Chapter No. :9

Conclusion:

Herbal remedies have been used to diagnose, prevent, and treat various illnesses. Three herbal
raw materials were chosen for their potential to treat diabetes. The mixtures were combined into
polyherbal capsules and tested for antidiabetic efficacy. The Ayurvedic Pharmacopoeia of India and
WHO’s recommended criteria were used to ensure quality.

Herbal medicines are the oldest form of health care known to mankind. A number of traditional herbal
medicinal practices have been adopted for the diagnostic prevention and treatment of various
diseases. The herbal raw materials were analyzed for identity, quality and purity as per the standards
prescribed by WHO and Ayurvedic Pharmacopeia of India.

The present study successfully developed and evaluated a polyherbal anti-diabetic capsule containing
Gudmar (Gymnema sylvestre), Jamun seed (Syzygium cumini), and Fenugreek (Trigonella foenum-
graecum). These medicinal herbs were selected based on their well-known anti-diabetic, antioxidant,
and insulin-enhancing properties.

The Physiochemical parameters like extractive values were determined, which will help in preventing
variation in quality of the drugs. Phytochemical screening confirmed the presence of important
bioactive constituents such as alkaloids, flavonoids, tannins, carbohydrates, and saponins, which are
responsible for the therapeutic activity of the formulation. Organoleptic and physicochemical
evaluations showed acceptable characteristics of the herbal powders and granules, including good
flow properties, suitable moisture content, and proper density values, indicating their suitability for
capsule formulation.

The prepared formulations (F1 and F2) demonstrated satisfactory pre-compression parameters such
as angle of repose, Carr’s index, Hausner ratio, bulk density, and tapped density, confirming good
flowability and compressibility for capsule filling.

The trials were subjected to preformulation parameters to confirm the uniformity and quality.
The result concludes that the trials was excellent in all parameters and the values were found within
the standard limits and it was used for formulate Polyherbal Capsule. The developed polyherbal
capsule were standardized for its Description, Weight variation, Dissolution, disintegration time,
Physiochemical parameters, and phytochemical studies.

Overall, the formulated polyherbal capsule can be considered a promising, safe, and effective herbal
dosage form for the management of diabetes mellitus. The study supports the potential use of herbal
medicines as an alternative or supportive therapy with minimal side effects. Further pharmacological
and clinical studies are recommended to confirm the long-term anti-diabetic efficacy and safety of
the formulation.

Based on results it is concluded that the formulation and evaluations are good. But still there is need
to do accelerated stability study to determine shelf life of product.

30
 Formula on and Evalua on of An -diabe c Polyherbal Capsule

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