INTRODUCTION

1.1 GUMMIES:

The confectionery industry is one of the most important food sectors worldwide, which has
approximately USD 82.3 billion market value with a growth rate of 3.69 annually, according
to 2018 data. In addition, the candy industry is a 3rd major part of the confectionery industry,
with a high dynamic market on a global scale. [1, 2]iii

The name “gummi” originated in Germany [3] iii with the term jelly sweets more common in
the United Kingdom. The 1st gelatine based shaped candy was the unclaimed babies, sold by
Fryers of Lancashire in 1864 [4] iv In the 1920s, Hans Riegel of Germany started his own
candy company and eventually popularized the fruit flavoured gummy candy with gelatine as
the main ingredient.v[5] The Company was named Haribo and it became a main procedure of
gummy bears.

Gummy Candies are foodstuffs whose main ingredient is gelling agent (gelatine, starch, Agar
agar, carrageenan, gums, and pectin), sweetening agents (sucrose, glucose, stevia and syrups),
acids, aromas and food pigments. [6] viGummies are a popular type of candy that came in a
wide variety of Flavours and shapes.

Numerous categories of gummies are created using alternative ingredients. For example,
sugar free gummies may employ alternative sweeteners like stevia, erythritol instead of
sugars. Vegan gummies, on the other hand, may use alternative gelling agent’s like’s agar-
agar or pectin instead of gelatine. [7]vii

Gummy have been a great way of delivering the active constituents for consumption by
children. Their use for adults has gained acceptance as well. They offer a great variety and a
sense of palatable exhilaration among those who take it as compared to the usual method of
tablets or syrups. [8]viii

1.2 TYPES OF GUMMIES: -

1.2.1 ACCORDING TO SHAPE: -

Gummies come in a variety of shapes, ranging from traditional bears and worms to more
unique and creative shapes. The shapes of the gummy often reflect its Flavours or theme.
Some common types of gummy shapes are: -
1. Bears

2. Worms

3. Rings

4. Cola bottles

5. Sharks

6. Dinosaurs

7. Hearts

8. Gummy snails

9. Snakes

1. Bears: -

Gummy bears are typically made in the shape of a bear, and they came in a variety of
Flavours, including raspberry, orange, lemon and strawberry. Some of the most popular
gummy bear brands include Haribo, Trolli and Black Forest.

2. Worms: -

Gummy worms are long and thin with a wiggly shape that mimics real worms; they often
come in bright colours and flavours like Cherry, Apple, and Grape.

3. Rings: -

Gummy rings are circular and often coated in sugar crystals. They came in a variety of fruit,
flavours, including Peach, Strawberry, and Watermelon.

1.2.2 ACCORDING TO SOURCES: -

On the basis of sources, there are two types of Gummies,

A. Vegan Gummies

B. Non vegan gummies

A. Vegan Gummies: -

Vegan gummies are made without any animal products, such as gelatine, which is derived
from animal collagen. Instead of it plant based alternatives like agar-agar or pectin are used to
create the gummy texture. One of the biggest challenges with making vegan gummies is
achieving the weight texture and consistency. Gelatine is a key ingredient in traditional
gummies because it creates a firm yet chewy texture. Without it, plant-based alternatives can
result in a gummy that is too hard or too soft. However, with the weight combination of
ingredients and techniques, it is possible to create delicious and satisfying vegan gummies.

B. Non vegan Gummies: -

i. Sour gummy

ii. Sugar free gummy

iii. Gluten free gummy

iv. CBD- infused gummy

v. Low-calorie gummy

vi. Chocolate gummy

vii. Halal and Kosher gummy

i. Sour gummy: -

Sour gummies are a variation of the classic gummy candy that offers a tart and tangy twist.
They are coated in a sour sugar mixture that gives them their distinctive taste. Some of the
most popular sour gummies include sour gummy worms, sour gummy bears and sour patch
kids.

ii. Sugar-free Gummy: -

Sugar free gummies are typically made with alternative sweeteners such as stevia or
erythritol. Sugar free gummies offer a guilt free way to enjoy your favourite candy. They are
a great option for those who are watching their sugar intake or who have dietary restrictions.

iii. Gluten free Gummy: -

Gluten is a protein found in wheat barley and rye and is commonly used as a binding agent
in gummies. However, with the growing demand for gluten free products, many gummy
manufactures have started to offer gluten free options. To make gluten free gummies,
manufactures have started to use alternative binding agents such as corn starch, tapioca starch
or potato starch.
1.3 VEGAN GUMMIES: -

As more people turn to veganism for ethical and environmental reason, the demand for vegan
friendly gummies has been steady increasing. [9] ixConventional Gummies are made with
gelatine, which means they aren’t even vegetarian. Gelatine is a powdered thickener derived
from ground bones, hooves and ligaments, often from cows, horses and pigs. Due to its being
derived from an animal source, other vegetarian options are considered its substitute. Algae
could prove to be a good vegan alternative for it. Agar-agar is used as vegan substitute for
gummies.[10] x

Increasing consumer awareness of the impact of nutrition on health and the growing
popularity of vegan diets are causing a need to look for new plant-based formulations of
standard confectionery products with high energy density and low nutritional value,
containing gelatine. Therefore, the development of vegan and sugar free gummies started.
[11] xi

In early 2000, there was a craving for plant-based gummies, without the animal gelatine.
Around 2010, brands started to make plant-based gummies. It was a game changer for
vegetarians, vegans and those with dietary quirks. [12]xii

Vegan gummies are made without any animal products or by products, such as gelatine,
which is derived from animal collagen. Instead, plant-based alternatives like agar-agar or
pectin are used to create the gummy texture.

One of the biggest challenges with making vegan gummies is achieving the right texture and
consistency. Gelatine is a key ingredient in traditional gummies because it creates a firm yet
chewy texture. Without it, plant-based alternatives can result in a gummy that is too hard or
too soft. However, with the right combination of ingredients and techniques, it is possible to
create delicious and satisfying vegan gummies. [13]xiii

DIABETES:

Diabetes mellitus, often known simply as diabetes, is a group of common endocrine diseases
characterized by sustained high blood sugar levels.[11,12] Diabetes is due to either the
pancreas not producing enough insulin, or the cells of the body becoming unresponsive to the
hormone's effects.[13] Insulin and glucagon hormones both are secreted by the pancreas.
Insulin is secreted by the beta (ß) cells and glucagon is secreted by the alpha cells and
glucagon is secreted by the alpha (α) cells both are located in the islets of Langerhans’s.
Insulin decreases the blood glucose level by the glycogenesis and transport glucose
into the muscles, liver and adipose tissue. Neural tissue and erythrocytes do not
required insulin for glucose utilization whereas alpha (α) cells plays an important role
in controlling blood glucose by producing the glucagon and it increases the blood glucose
level by accelerating the glycogenolysis [14, 15]. In addition to increased risk of obesity,
metabolic and cardiovascular disorders, and malignancy in future life of fetus after
delivery.

Classification of Diabetes:

1. Type 1 diabetes:

Type 1 diabetes mellitus (juvenile diabetes) is characterized by beta Cell destruction caused
by an autoimmune process, usually leading to absolute insulin deficiency [20]. Type 1 is
usually characterized by the presence of anti–glutamic acid decarboxylase, islet cell or insulin
antibodies which identify the autoimmune processes that lead to beta cell destruction.
Eventually, all type1 diabetic patients will require Insulin therapy to maintain normglycemia.

2. Type 2 diabetes or adult onset (non-insulin dependent)

More than 90%-95% of diabetes patients belong to this type and most of these patients are
adults. [26] The progressive insulin secretary defect on the background of insulin resistance.
[20] People with this type of diabetes frequently are resistant to the action of insulin [21].
The long-term complications in blood vessels, kidneys, eyes and nerves occur in both types
and are the major causes of morbidity and death from diabetes [1]. The causes are
multifunctional and predisposing factor includes: Obesity, Sedentary lifestyle, increasing
age (affecting middle- aged and older people), Genetic factor such patients are at
increased risk of developing macro vascular and micro vascular complications [ 20,23]
[14]115

LITERATURE REVIEW ON FENUGREEK (TRIGONELLAFOENUM-

GRAECUM)

The English name derives via Middle French fenugreek from Latin faenugraecum, faenum
Graecum meaning "Greek hay".
Biological source: Fenugreek consists of dried ripe seeds of trigonella foenum graecum

Family: Fabaceae

Synonyms: Methi, Methika, chandrika

Taxonomy:x

Kingdom Plantae
Sub-kingdom Tracheobionta (Vascular plants)
Division: Magnoliophyta (Flowering plants)
Class Magnoliopsida (Dicotyledons)
Sub class Rosidae
Order Fabales
Family Fabaceae
Genus Trigonella
Species T. foenum-graecum

Other/Regional Language Names:

Hindi: Methe

Bengali: Methe

Gujarati: Methe

Kannada: Menthya

Malayalam: Ventayan, Uluva

Marathi: Methe

Oriya: Methe

Punjabi: Methe

Sanskrit: Methe

Tamil: Vendayam or Venthiyam

Telugu: Mentulu or Menthulu

Urdu: Methe
Geographical Source:

Fenugreek is a native of South Eastern Europe and West Asia, now cultivated in India,
Argentina, Egypt and Mediterranean countries (Southern France, Morocco and Lebanon). In
India it is grown extensively in Rajasthan, Gujarat, Madhya Pradesh, Uttar Pradesh,
Maharashtra and Punjab. It is a cold season crop and is fairly tolerant to frost and very low
temperature. It is best suited to tracts of moderate to low rainfall and is sown in all types of
soil but perform better in loam and clayey loam with proper drainage. It can also be grown on
black cotton soils.

2.1 DESCRIPTION:

MACROSCOPY:

Fenugreek seed is the ripe fruit of an annual herb. This robust herb has light green leaves, is 30-60
cm tall and produces slender, beaked pods, 10-15 cm long, each pod contains 10-20 small hard
yellowish brown seeds, which are smooth and oblong, about 3mm long, each grooved across one
corner, giving them a hooked [Link][16]

2.2 CHEMICAL CONSTITUENTS:

Fenugreek contains not less than 0.1 %w/w trigonelline on dry basis. Alkaloids such as
trimethylamine, neurin, choline, trigonelliner, gentianine, carpaine and betain are present. Amino
acids such as 4-hydroxy isoleucine, histadine and lysine are present. Saponins such as trigoneosides,
graecunins, fenugrin B and fenugreekine are present. Fenugreek seeds also contain more than 10 mg
of flavonoid per gram of seed, as well as a minor amount of volatile and fixed oils. The oils were rich
in linoleic acid (42.71–42.80%), linoleic acid (26.03–26.15%), and oleic acid (14.24–14.40%).xv [17]
The important constituents that are found to be responsible for generating the anti-diabetic effects are
galactomannan rich soluble fibre fraction, saponin, and an amino acid called 4-hydroxyleucine which
helped in increasing insulin in hyperglycaemic rats and humans. xv[18]

4-hydroxyleucine

2.3 PHARMACOLOGICAL AND THERAPEUTIC BENEFITS OF

FENUGREEK:x

Disease/Disorders Description
Anaemia Prevents red blood cell oxidation
Aging Antioxidants reduces cell death and aging

Polyphenolic compounds from seed possess anti-

Cancer
carcinogenic activities
4-hydroxyisoleucin (amino acid) stimulates insulin
production thereby control blood sugar level. Polyphenolic
Diabetes compounds exhibit anti-diabetic effects. Curative effects of
fenugreek seed powder is a potential neuropathic medicine
in diabetes
Hypercholesterolemia Anti-oxidants from seeds control high blood cholesterol

Natural anti-oxidants help to strengthen immune system

Immunodeficiency
immunomodulatory and immune stimulatory effects
Indigestion and flatulence Fenugreek has been used as laxative. It stimulates appetite

Inflammation Reduces swelling and pain

Protects functional and histopathological abnormalities of
kidney in diabetic patients. Reduces catalase (CAT) and
Kidney disorders superoxide dismutase (SOD0 activity in
hypercholesterolemia patients. Inhibit accumulation of
oxidized DNA to prevent kidney injuries
 Respiratory disorders, bacterial infection, epilepsy, gout,
Others chronic cough, paralysis, dropsy, piles, heavy metal
toxicity, liver disorders and arthritis

2.3.1 PHARMACOLOGICAL REVIEW OF FENUGREEK:

Anti-diabetic activity:[20]

Fenugreek seeds have ant diabetic effect by increasing gastric emptying time and glucose
absorption rate. Fenugreek seeds have greater quantity of fibre which reduces glucose uptake
in small intestine also increase serum insulin level.
Galactomannan, reduces postprandial blood glucose level. When fenugreek seed powder
treatment for 21 days to diabetic rats brought down the high fasting blood glucose levels to
control levels. The enzyme activities were restored to control values in both the kidney and
liver. Fenugreek seeds have saponins and fibre content which are responsible for its ant
diabetic property. The effect of oral administration [5%in the diet] of powder of fenugreek
seeds in alloxan-induced diabetic rats for 21 days were investigated, the glycolytic, NADP
linked lipogenic and gluconeogenic enzymes were determined in the kidney and liver tissues
of rats. The T. foenum graecum saponin fraction significantly modulated the glycogen
enzyme and disaccharides activities in the intestine, it suppressed the increase of blood sugar
level, increased the hepatic glycogen content and improved results in the oral glucose
tolerance test.[22-24]
According to the recent study oral administration of diosgenin to diabetic rats for fourty five
days shows a reduction in hyperglycaemic condition and also an increase in insulin levels.
[33]
Hydroalcholic extracts of fenugreek seeds at different doses was shown to produce increased
body weight and glucose uptake, reduced plasma glucose, glycosylated haemoglobin
(HbA1C).[34]
Clinical trial has shown fenugreek reduced high fasting blood glucose levels in diabetic rats.
The enzyme activities were restored to control value. These effects are due to the activity of
saponins, diosgenin, galactomannan, flavonoids.[6
Lipid Lowering Activity:[21]

Fenugreek seeds lower serum triglycerides, total cholesterol and low-density lipoprotein
cholesterol owing to hypolipidemic effect of fenugreek. Dietary fibre (galactomannan) in
fenugreek seeds is a polysaccharide that consists of a mannose backbone with galactose side
chains, form a viscous gel in the intestine and inhibit lipid and glucose absorption.x

Antioxidant Activity:

Oxidative stress is one of the major health problems in humans, for which several therapies are
utilized and where medicinal plants offer a favourable alternative. Fenugreek contains phenolic and
flavonoid compounds that aid in improving its antioxidant capacity. It has a beneficial effect on the
liver and pancreas; antioxidant properties are associated with health benefits of natural products. Such
properties are studied with germinated fenugreek seeds which are perceived to be more beneficial
than un-germinated seeds because with germination the bioavailability of different components of
fenugreek increases (Balch, 2003). Pulse radiolysis and the deoxyribose system demonstrated The OH
scavenging activity of the seed extract. The fenugreek seeds extract contains antioxidants and protects
cellular structures from oxidative damage. An aqueous methanolic extract of fenugreek was analysed
for its antiradical and in vitro antioxidant action in varied model systems. The results obtained by
different methods present some important factors associated with the antioxidant activity of fenugreek
seeds.x
Overview of pharmaceutical effects of Fenugreek

2.4 MECHANISM OF ACTION OF 4-HYDROXYISOLEUCIN:[22]

The anti-diabetic properties of 4-Hydroxy-isoleucin (4-OHIle) are related to its ability to

stimulate insulin secretion, as observed in human pancreatic islet cells, in isolated perfused
rat pancreas [73] and in in vivo studies [82]. An improvement in glucose and insulin
tolerance, insulin secretion, and reduced hyperglycaemia were observed in diabetic rats and
dogs. 4-OHIle functioned as an insulin secretagogue, but only in the presence of elevated
blood glucose concentrations, in a range of 8.3–16.7 mM [73,82,83].

4-OHIle shows in vitro insulin tropic activity related to the glucose concentration of the
medium in isolated pancreatic beta cells [82,83]. Furthermore, this effect has not been
observed for sulphonylureas, treatment with which has produced hypoglycaemia as an
adverse effect in non-insulin-dependent diabetes mellitus patients. The secretagogue potential
of 4-OHIle is of special interest for various degrees of insulin resistance [97]. In
streptozotocin-treated rats, an improvement of the diabetic state was associated with the
stimulating effect of 4-OHIle on beta cell function, and in normal rats and dogs, 4-OHIle is
able to stimulate insulin secretion and improve glucose tolerance, suggesting its potential in
the treatment of IR and type II diabetes. The molecular mechanism of action of 4-OHIle has
been studied using cell culture models. In rat muscle cells, it has been observed that glucose
uptake and GLUT-4 translocation to the plasma membrane were increased after 16 h
exposure to 4-OHIle [103]. The basal phosphorylation of Akt (Ser-473) increased after
treatment with 4-OHIle, but mRNA expression of total Akt, IRS-1, GLUT-4, and glycogen
synthase kinase-3β (GSK-3β) was unchanged. Treatment of L6 myotubes with 4-OHIle
decreased IR induced by FFAs [104]. In fact, 4-OHIle restored glucose uptake and GLUT-4
translocation to the plasma membrane after palmitate treatment via insulin induction of IRS-1
phosphorylation. 4-OHIle also inhibited both the production of reactive oxygen species
induced by palmitate and the associated inflammation, and it reduced activation of the
JNK1/2 pathway, including the extracellular signal-regulated kinase isoforms 1 and 2
(ERK1/2), p38 MAPK, and NF-κB. The effects of 4-OHIle on 3T3-L1 adipocytes included
increased glucose uptake in insulin-resistant adipocytes in a dose-dependent manner along
with a reduction of TNF-α mRNA expression and secretion, suggesting its anti-inflammatory
[Link]

2.5 LITERATURE REVIEW OF OTHER INGREDIENTS OF

GUMMIES:

Vegan Gummies contains agar-agar, a well-known natural gelling agent used in vegan
gummies production. Agar-agar is a well-known natural gellifying agent that has been used in
manufacturing of gummies alone or in combination with different binding agent to improve
gelling properties of vegan gummies.

1. Agar-Agar:[23]

Agar-agar is a hydrophilic colloid extracted from certain seaweeds of the

Rhodophyceaegroup of algae. It is a heterogeneous mixture of two types of polysaccharides:
agarose and agaropectin. Agarose, the jellifying fraction, is a neutral, essentially sulphate-
free, linear molecule consisting of repeat chains of alternating units of galactose (A) and 3,6
anhydro-L-galactose (B). Agaropectin, the non-gelling fraction, is a sulphated polysaccharide
(3% to 10% sulphate) composed of agarose and varying percentages of sulphate ester,
glucuronic acid and small amounts of pyruvic acid. Agarose represents 70% of the total and
its structure is presented in following figure. [29] The type of agar-agar varies according to
the seaweed where it comes from, and it confers different characteristics to products.[30]
The use of agar-agar in foods is based on its inherent properties (high gelling capacities, wide
pH working range, resistance to heat treatment, large hysteresis, no effect on flavours and
formation of stable reversible gels) .[31]A hot solution with 1.5% agar when is cooled to 34-
43°C, forms a firm gel which does not melt again below 85°C . Relative to the effect of agar
on feed, Lee et al., 2014 stated that agar-agar has excellent anti-obesity and anti-diabetes
effects, and the administration or intake of a composition with agar can effectively prevent,
treat, and remedy obesity and diabetes.

2. Stevia:

Stevia, C20H30O3, is a sweetener and the Stevia plant was discovered by indigenous people
in South America, through Stevia rebaudiana leaves. Its sweet tasting components are called
steviol glycosides and are 200-350 times sweeter than sugar.[16] Initially, FDA did not permit
the use of whole leaf Stevia or crude Stevia extracts because these substances were not
approved for use as a food additive .[17] The preclinical and clinical applications of stevia
were studied and it was concluded that it is not toxic and exhibit several biological activities
such as anti-diabetic, anti-cariogenic, antioxidant, hypotensive, antihypertensive,
antimicrobial, anti-inflammatory, antiplaque and antitumor activities.[18] Some other studies
with rats administered with crude stevia extracts also demonstrated that Steviol, the
sweetener component of stevia, do not poses a reproductive or developmental hazard.
3. Microcrystalline Cellulose:[24]

Microcrystalline cellulose is a partially depolymerized purified cellulose that is presented as a

white, odourless and tasteless crystalline powder composed of porous particles. It is
commercially available in different particle sizes and moisture grades that have different
properties and applications. It is considered a relatively non-toxic and non-irritating material.
Microcrystalline cellulose is used in pharmaceutical products, mainly as a binder and thinner
in tablet and oral formulations. In addition to its use as a binder and thinner, it also has some
lubricating and disintegrating properties that make it useful for forming gummies.

Microcrystalline cellulose

4. Propylene Glycol:[24]

Propylene Glycol (PG) PG is used as a solvent to stabilize substances that are not water
soluble, in parenteral and non-parenteral formulations. It also has moisturizing, antimicrobial
properties and can be used as plasticizer. It is rapidly absorbed through the gastrointestinal
tract and it can damaged skin if high dose. It metabolized in the liver to lactic acid and
pyruvic acid.
5. Water:[24]

Water is the most commonly used agent in paediatric formulations, as liquid preparations are
easier to administrate and allow a more accurate dose adjustment. Water is an ideal medium
for the proliferation of microorganisms (bacteria and fungi) despite their purification, which
is why antimicrobial agents have to be added.

In paediatric oral formulations, the total volume of fluid is of vital importance for the taste
and ability to adequately measure the volume to be administered: in children under 5 years of
age a volume of less than 5 mL should be administered and, in children under 10 years of
age, a volume of less than 10 mL should be administered. xvii

AIM AND OBJECTIVES

3.1 AIM:-To Formulate and Evaluate Anti-diabetic Vegan gummies from
Trigonellafoenum-graecum.
3.2 OBJECTIVES:-

The objectives of vegan gummies for diabetes would typically revolve around providing a
safe and enjoyable way for individuals with diabetes to consume sweets without negatively
impacting their blood sugar levels. Here are some specific objectives:
1. Fenugreek contained gummies has soluble fiber and minerals that may help to slow
down the absorption of sugars in the digestive tract, which lead to more stable blood
sugar levels.

2. By using agar agar, carrageenan, corn starch used in vegan gummies can be produced
without any animal-derived ingredients, making them suitable for individuals
adhering to a vegan diet.

3. The gummies are appealing for sweet taste and proper texture, as enjoyment of food
for pediatric patient which is important for overall satisfaction and compliance with
dietary recommendations.

4. Natural sugar alternatives such as stevia, erythritol, or xylitol to sweeten the gummies
without causing significant spikes in blood sugar levels. These alternatives provide
sweetness with fewer calories and a lesser impact on blood sugar.

5. To support natural insulin production and promote better glucose utilization for type 2
diabetes who still produce insulin but have impaired insulin secretion.

6. To reduce LDL cholesterol in dyslipidemia which is commonly observed in

individuals with diabetes which reduce the risk of cardiovascular complications.

7. High fiber content in fenugreek can promote gastrointestinal health by supporting

regular bowel movements and preventing constipation.

8. Fenugreek's potential role in appetite regulation and weight management is an

important for type 2 diabetes patients.

MATERIAL AND METHOD

4.1 MATERIAL:-
Trigonella Foenum- graecum seeds, Stevia were purchased from local market of Surat.

Agar agar was purchased from Hakeem chichi Pharmacy, Surat.

4.2 METHOD:-

4.2.1 Extraction of herbal drug:

a. Take fenugreek suitably sized powder in an Soxhlet extractor.

b. Add methanol and heat at a temperature between 65-70oc for 72 hours.

c. after extraction period, Filter the extract through filter pepar to a suitable

sized vessel.

d. Concentrate the combined filtrate using rotary vaccum evaporator to get extract.

4.2.2 Preparation of Gummies formation:

a. All the ingredient were weight accurately.

 b. Take a china dish, add agar-agar and water and heat at 55-60ºc with continuous
stirring until it dissolved properly.
c. Add fenugreek extract and stevia in above mixture and melt it.
d. Simultaneously add microcrystalline cellulose (MCC) and propylene glycol.
e. Add sufficient amount of colouring and flavouring agent.
f. transfer it into mould and Allow to cool at room temperature for 10 to 15 minutes.
g. Remove gummies from mould and store it into air tight container in cool place

Total 5 formulations were prepared by varying the concentration of herbal drug extract and
other excipient. The composition of all the 5 formulations were elicited in table:

CONTENTS F1 F2 F3 F4 F5

Agar-agar 3 gm 3 gm 3gm 1.5gm 1.5gm

Water 60ml 70ml 80ml 80ml 60ml

Stevia 1.1gm 1.1gm 1.1gm 0.5gm 0.5gm

Propylene Glycol 0.2ml 0.2ml 0.2ml 0.1ml 0.1ml

Fenugreek Extract 0.5gm 0.5gm 0.5gm 0.5gm 0.5gm

Microcrystalline - 1gm 0.5gm 0.5gm 0.5gm

cellulose
Guar gum 0.1gm - - - -

Citric acid 0.1gm 0.1gm 0.1gm 0.1gm 0.1gm

4.2.3 FORMULATIONS DISCUSSION:

 FORMULATIONS OBSERVATIONS
F1 gummies were too hard to break
F2 proper gelling is not observed
F3 Gummies took more disintegration time than required
F4 gummies were too soft and easily breakable
F5 Almost all problem were overcome in this formulation

Hence, the 5th formulation was used in the preparation of the gummies and all the evaluation
parameters were done on the basis of the 5th formulation.

4.3 EVALUATION OF GUMMIES:

List of Evaluation Parameter to be perform:

1. Physical observation
 Colour
  Odour
 Taste
2. Weight diversity
3. Gummy dimension
4. Disintegration time
5. Swelling ratio
6. Synersis

1. Physical observation: The four vegan gummy formulas were subjected to

physical observations, including color, taste, shape, texture, and smell. Observation of
the texture of the preparation was carried out qualitatively by gently pressing the
surface of the gummy using both fingers. When pressed using both fingers, the
gummy’s elasticity and stickiness were recorded as the texture of the chewable
gummy.

2. Weight diversity: Determination of the variety of vegan gummy weights was

carried out by taking as many as 10 dosage units from each formula. The gummy was
weighed and then calculating an average of 10 gummies was the test results were
declared eligible if there was not one preparation whose weight deviated more than
7.5% from the average weight of the vegan gummy. If one tablet unit is outside the
range, the test is repeated with an additional 10 gummy tablets. Gummy tablets are
declared eligible if no single unit deviates more than 10% from the average weight of
vegan gummy.

3. Disintegration time: Evaluation of the disintegration time of the gummy was

carried out to predict the speed of release of the active ingredient of gummy from the
gummy. This evaluation can provide an overview of the process of absorption of
active ingredients by the body. The test was carried out by placing the gummy in a
beaker glass containing 100 ml of aqua purificata at 37° C., measured , was observed
until the gummy preparation was completely crushed or dispersed using a stopwatch.
 [47] The maximum acceptable disintegration time for vegan gummy is 15 minutes.
[48]

4. Swelling ratio: The gummy development index was measured by weighing the
initial weight of the gummy (Wd). The swelling index determines the absorption
capacity of the liquid in the gummy structure. In the next stage, the gummy
preparation was soaked in 100 ml of aqua purificata for 10 seconds at controlled room
temperature (25-30°C). A gummy that has been soaked is then removed and cleaned
using filter paper to absorb water adhering to the surface of the gummy.
Swelling ratio: - Ws –Wd/Wd*100
Index:-
Ws = weight of chewable gummy after soaking
Wd = weight of chewable gummy before soaking

5. Syneresis: Syneresis is a condition where water molecules are released from the gel
structure [50] Syneresis occurs due to contraction or shrinkage of the gel structure.
[51] The high percentage of gummy syneresis indicated that the preparation’s texture
softened faster, and the instability of the preparation was poor. The measurement of
the syneresis percentage of the preparation was carried out at controlled room
temperature by attaching filter paper to the surface of the gummy. The difference in
weight of gummy before and after contact with a filter paper is calculated as the
percentage of syneresis according to the following equation
Syneresis Percentage: - A– B/A*100
Index:
A =Initial weight of chewable gummy preparation
B = the final Weight of the chewable gummy preparation

RESULTS AND DISCUSSION

 1. Physical observation:
The evaluation of physical observation of gummies involved the measurement
of number of attributes such as gummies color, odour and taste. Table 5.1 shows
the Physical observation of the prepared gummies.
Table 5.1: Physical observation

PARAMETERS RESULTS

Colour Yellow,pink,green

Odour Aromatic

Taste Sweet

elasticity No

stickiness No

PARAMETERS RESULTS
pH 6
Weight diversity 6.626±0.3
Disintegration time 15 min
Swelling ratio 1.46 %
Syneresis 13.01 %
stability Stability is maintain in cool temperature

CONCLUCSION :-
In conclucsion, anti-diabetic vegan gummies offer a promising solution for individuals
managing diabetes who seek enjoyable and convenient ways to support their health goals
while adhering to a vegun lifestyle. These gummies are formulated with carefully selected
ingredients that not only avoid exacerbating blood sugar levels but may also contribute to
better glycemic control and overall well-being. By incorporating natural sweeteners with low
glycemic indexes, such as stevia or erythritol , these gummies can potentially offer additional
benefits, such as improving insulin sensitivity or reducing inflammation associated with
diabetes. Moreover, the absence of animal-derived ingredients ensures that these gummies are
suitable for individuals following vegan diets and those with specific dietary restrictions or
preferences. Overall, anti-diabetic vegan gummies represent a convenient, enjoyable, and
health-conscious option for individuals managing diabetes, providing a delicious way to
support their dietary and wellness needs.
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