FORMULATION AND EVALUATION OF MEDICATED

CHEWING GUM USING CAFFEINE FOR ALERTNESS

PROJECT REPORT

SUBMITTED IN THE PARTIAL FULFILMENT OF THE REQUIREMENT

OF THE DEGREE OF

BACHELOR OF PHARMACY

SUBMITTED TO: SUBMITTED BY:

MRS. RIMI CHAUDHARY ATUL KUMAR
ASSISTANT PROFESSOR REG. NO. 2015365

DEPARTMENT OF PHARMACY
GOVT. POLYTECHNIC COLLEGE
AMRITSAR-143005
PUNJAB-INDIA
[DECEMBER 2023]
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 CERTIFICATE

This is to certify that the work contained in this project report entitled “Formulation and
Evaluation of Medicated Chewing Gum using Caffeine for Alertness” submitted in partial
fulfilment for the degree of BACHELOR OF PHARMACY, embodies the original research
work carried out by Mr. Atul Kumar himself under my supervision and guidance at the
Department of Pharmacy, Govt. Polytechnic College, Amritsar.

Mrs. Rimi Chaudhary

Assistant Professor

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 DECLARATION

I Atul Kumar, hereby declare that the work embodied in the project report entitled
“Formulation and Evaluation of Medicated Chewing Gum using Caffeine for Alertness”
submitted to the Department of Pharmacy, Amritsar, is result of my investigation and this
dissertation is composed by me. All the results reported in this study are original results of
experiments undertaken by me and text has been written by me. I also declare that nothing in
part or full has been submitted for the award of any other degree, diploma or fellowship to
any institute or University. All the ideas and references have been duly acknowledged. If
anything, wrong is detected in the future, I shall be held responsible for the same.

Place: Amritsar Atul Kumar

Date: 03/12/2023 Reg. No. 2015365

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 ACKNOWLEDGEMENT

First and foremost, I would like to thank “Almighty God’’ for giving me the courage to
pursue my dreams and believe in my passion. It would not have been possible without my
trust in God. By God’s grace, I have made efforts on this project.

I felt lack of vocabulary to express my gratitude and respect towards my teacher and
supervisor Mrs. Rimi Chaudhary, Assistant Professor, Department of Pharmacy, Amritsar
who devoted her precious time in guiding and solving my difficulties. From the depth of heart
and soul, I am very thankful to God for permitting me to work under her guidance.

I am grateful to express my sincere thanks to Dr. Shelly Khurana, Head, Department of

Pharmacy, Amritsar for providing me all the necessary facilities for the completion of this
project.

I would like to extend my deepest regards to highly regarded faculty members Dr. Balwinder
Singh, Mrs. Harinder Kaur, Mr. Harjeet Singh, Mr. Supreet Tuli and Mr. Manjinder Singh
for their help and encouragement.

I would like to extend my sincere thanks from core of heart to my batch-mates Mr. Imtiyaz
Ahmad Sheikh, Mr. Akash Kori, Ms. Tisha, Ms. Tina Thakur and Ms. Sunita Kaur their
help, support and encouragement throughout my course work.

Above all, heartiest veneration goes to my parents, my father Mr. Ramesh Chander and my
mother Mrs. Asha who put me on the path and taught me how to take the first step into the
journey of my life and over showed me with love and protection as I continue to go further.
They are my pillar of strength. I would also like to thanks my sister Ms. Kamna for their help
and support.

ATUL KUMAR

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 LIST OF CONTENT

Introduction…………………………………………………………….6

Review of literature……………………………………………………9

Materials and methods………………………………………………..17

Work Done so far…………………………………………………………

Summary and Conclusion…………………………………………….

References……………………………………………………………...

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 [Link]

For the delivery of drugs, a variety of dosage forms are available, including tablets, capsules,
gels, injectables, inhalers, pastes, creams, ointments, and more. In addition, Gums are also
utilised in addition to these dose forms for medication administration. Gum chewing is
among the most common confectionary items that are used globally.

A little bit of chewing gum products intended to transport medications are well-known as
MCG, or "medicated chewing gum." chewing medicine gum is regarded as an innovative
method of delivering drugs with stable and a single-dose supplement with a chewing gum
base are satisfied by the pharmacologically active component. Typically, it is utilised to treat
local gum diseases or for further purposes involving systemic absorption via means of the
oral mucosa. Chewing gum with medication only to avoid being ingested.

These days, medicated chewing gum is frequently utilised to provide medications for tooth
care and quitting smoking. wherein fluoride or carbamide compounds and nicotine
comprising goods that are correspondingly offered for the same. Chewing gum with
medication is the newest form of delivery. It has a variety of possible applications in
pharmaceutical over-the-counter medications and supplements. Almost Each year, 80–100
million pieces of medicated chewing gum are sold. Of them, 55% were offered with gum that
is sugar-free. Among all Teenagers make up 70% of customers.

An investigation carried out demonstrated that the higher amount of medicated chewing
more girls than boys chew gum. 79% or so of sugar-free In Switzerland, chewing gum with
medication is sold. Chewing gums typically consist of two phases: a continuous, water-
soluble phase and a discontinuous phase made up of the gum base (core), which is blended in
a ratio of 1:3. Chewing gum with medication has less water content with absolutely no
preservative residue. Gum core could be or might not have a sugar or polyol compound
coating. It is possible to include flavouring substances in the chewing gum recipes to improve
patient adherence in dose formulations for children.

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Chewing medication as a pharmaceutical dosage form gum received approval from the
European Commission. Council's recommendations for the dosage of pharmaceuticals shape.

Advantages

1. It is useful due to the convenient route of administration.

2. It is advantageous for patients with dysphagia because there are no requirements for the
swallowing of chewing gum.

3. There is no requirement of water to take this medicament. Therefore, it can be

administered anywhere.

4. It has higher patient compliance.

5. It helps in counteracting dry mouth (xerostomia) through the stimulation of salivary

secretion. It also prevents caries and candidiasis.

6. It is highly accepted by children because of its confectionery like appearance and taste.

7. It is one of the best options for acute medication.

8. It is not allowed to be swallowed. Thus, it increases the bioavailability of the drug by

avoiding first-pass metabolism.

9. There is a rapid release of active ingredients in the buccal cavity. Hence, the fast onset of
action can be achieved with greater availability.

10. It reduces the risk of intolerance of the gastric mucosa because the stomach does not get
in direct contact with a higher concentration of active pharmaceutical ingredients.

Disadvantages

1. Medicated chewing gums may show side effects due to the presence of different
excipients in it. For example, Sorbitol – Flatulence; Flavoring agents – Ulcer formation in the
oral cavity; Liquorice – Hypertension.

2. The unpleasant taste of chlorohexidine and its staining ability to the teeth and tongue
limits its use in or mucosal application.

3. This delivery system may adhere to the enamel dentures and fillers.

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 4. It may result in pain in facial muscles and earache in children because of prolonging
chewing of gums.

5. There may be a risk of overdosing in medicated chewing gums than that of chewable
tablets or lozenges.

6. It causes side effects if administered in more quantity within a short period.

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[Link] of literature
Medicated chewing gums
This type of chewing gums contains pharmaceutical or nutraceutical compounds that are
released in a controlled manner during mastication. So, these gums are accepted as drug
delivery systems. It has many potential applications like smoking cessation, treatment of
motion sickness, anti-oxidant, oral antifungal, alertness, antinausea, anti-emetic, antiseptic,
freshening of the oral cavity, healing, etc.

Figure 2.1 Subtypes of Chewing Gum

Common varieties of chewing gum

Gums with sugar

It's made out of 80 percent sugar and glucose syrup combined with gum foundation. Chewing
gum without sugar. This kind of gum uses polyol in place of sugar. substances and strong
sweeteners for sugar and glucose syrup.

Gums with coating

The chewing gum's coatings improve its appearance. impact of the product, which therefore
raises patient adherence. The coating aids in water control activity and product shelf life.

Gums filled in the centre

Some chewing gums are known as center-filled gums because they include flavoured liquid
in the middle in the shape of a soft mass.

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Gums that work

Certain chewing gums are designed to satisfy specific functions based on the demands of
human resources. These are referred to as useful gums. For instance, the inclusion of minerals
or vitamins in the gum to offer a useful function to it. According to shape Chewing gum
comes in a variety of forms based on forms such as ball, stick, tube, and wrap gum Dragee
gum, tab gum, and ribbon gum.

Composition

The essential ingredient of chewing gums is neutral, tasteless masticatory gum base, which is
created by employing a gum base that is insoluble in water and several additions such as
preservatives, food colouring, softeners, and sweeteners, flavourings, antioxidants, etc. Gum
chewing Composed of two stages: the gum phase that is insoluble in water and the phase that
is soluble in water (sugar or sugar alcohol). An announcement on the third stage of the
covered gums for chewing. Compound substance regarded as third stage inside it.. The
coating might include : active ingredient, flavourings, colorings, and sweeteners agents. Each
and every component needs to be biocompatible and compostable characteristic. Since it
needs to demonstrate clinical effectiveness and possible safety if a certain dosage may be
enlarged due to chewing gum with medication.

Water-insoluble gum phase

The components of chewing gum in this phase include fillers, elastomers, plasticizer, and
gum base. This phase's primary ingredients are gum base (20–30%), Fillers (0-), Plasticizer
(20-35%), and Elastomer (10-30%) 0.5%. Regular chewing gum typically contains 20–30%
of gum phase, while chewing gum without sugar has that sum up to an average of 50%. Gum
composition phase influences chewing gums' ideal qualities, such as chewiness, stickiness,
flavouring compound binding, Chewing gum releases scent, etc.
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Gum base

It is the essential component used to make chewing gum. It might have synthetic or natural
origins. Chicle-isolated natural gum derived from sapodilla trees . It has a botanical name and
is a member of the Sapotaceae family. Van Royen's Manilkara Zapota (L.). It is gathered
during the wet season of Belize and Mexico, which runs from July to February, and
Guatemala. The polyterpene-based chicle This chicle gum is pricey and hard to Acquire.
Consequently, over time, it was replaced with artificial gums such polyvinyl acetate,
butadiene-styrene copolymer, isobutylene-isoprene copolymer, and so on. Gum base (number
five, eight) is an insoluble, non-edible, non-nutritive substance that helps chewing gum-based
medication administration.

Elastomers

These are meant to give the chewing gums their elastic quality. It also regulates chewing
gum's gummy texture. Elastomers that are utilised to make chewing Gums made of natural
elastomers include Jelutong, Latex, and Chicle, Lechi, Caspi, and Puerile. Artificial
elastomers polyisobutylene, butadiene, styrene copolymers, polyethylene mixes and
isobutylene-isoprene copolymers as well as harmless vinyl polymers such as polyvinyl
alcohols. It's also possible to utilise standard elastomer solvents in the degradation of
elastomers. Six elastomer solvents are made up of terpinene resins, including methyl, α-
pinene, and polymer Pentaerythritol or glycerol esters of resins gums and resins, such as
mixes of hydrogenated, dimerized, or polymerized resins. Concentrations of the elastomer
solvents ranging from 5 to 75% by weight of gum may be used base. Gum manufacturers'
elastomer selection formulation is crucial to the release of the scent of gum chewing. For
every formulation of chewing gum, it is crucial to keep the chewing gum's flavour for an
extended period of time. Should there be a strong affinity between the elastomer and
flavouring ingredient, after which the taste will be noticed for a greater period of time spent
chewing and masticating gum. If the elastomer solvent concentration rose, then the chewing
gum that was produced seems sticky to the tooth surface, and should the concentration drop,
Mastication characteristics were adversely impacted.

Plasticizer

These are employed to control the product's cohesion. For improved mouthfeel, it offers a
great deal of softness during mastication. Two categories exist for plasticizers included in
chewing gum composition, i.e. both synthetic and natural. Organic plasticizers include
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glycerol. esters, resins that are partly hydrogenated, polymerized glycerol esters, partly
dimerized glycerol esters resins, glycerin, lecithin, pentaerythritol esters of resins, oils such
as oleic acid, palmitic acid, stearic acid, and Vitamin L. Sodium stearate is one type of
synthetic plasticizer. Glyceryl lecithin, Glyceryl triacetate, and Glyceryl monoglyceride and
acetylated monostearate.

Fillers
These are used to change the gum's texture. It is one of the inexpensive processing-assistant
substances. It further enhances the ability to chew gum. It offers the size needed to create a
gum lump using a small amount of the medication. As an illustration, talc, alumina, and
titanium oxide clay, magnesium carbonate, and crushed limestone tri-calcium magnesium and
aluminium silica tetri-calcium phosphate, calcium carbonate, six bentonite Phosphoryl.

Water-soluble gum phase

This phase of chewing gum contains bulk as well as high intensity sweeteners, softeners,
emulsifiers, flavors , colors , anti-oxidants.

Sweeteners

There are two types of sweeteners used in the fabrication of chewing gum, viz. aqueous and
bulk. The sensory properties of the final product may get affected due to the particle size of
sweeteners. The large particle of sweeteners may give a gritty texture to the final product.

Aqueous sweeteners
These are used to retain the moisture of formulation for freshening purpose and also to soften
the blend of gum. These consist of sugars like sorbitol, hydrogenated starch hydrolysates, and
corn syrups. Corn syrup helps to keep gum fresh and flexible.

Bulk sweeteners

These contain sugar and sugarless components. 30-75% of these sweeteners used in the
fabrication of the chewing gum. These bulk sweeteners are further classified into two types,
viz. nutritive sweetener and non-nutritive sweeteners.

Emulsifiers and softeners

These ingredients are added to chewing gum to make it more chewable and improve its
mouthfeel. usually utilised in the concentration range of 0.5–15%. Glycerin, lecithin, stearic

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acid, and palmitic acid, for instance hydrogenated tallow, oleic acid, linoleic acid, tallow, tri-,
di-, or mono-glycerides.

Flavoring agents

These agents are used to improve the flavor in chewing gum. Generally, they mask the bitter
taste of the drug by incorporating flavor in it. Several flavoring agent presents are used such
as citrus oil, fruit essence, essential oils, peppermint oil, spearmint oil, mint oil, clove oil and
oil of wintergreen.

Table 2.1 Flavouring agents

Active element
This might be found in the chewing gum's coat, core, or both. It might be included in the ratio
of 0.5- 30% of the chewing gum's total weight after medication. A lipophilic active ingredient
with tiny particle size characteristic, a unionised and enzymatically stable form easily turns
into bioavailable material. A dynamic element containing more soluble material in saliva will
be fully released ten to fifteen minutes after chewing. However, lipid-soluble medications
first dissolve in the gum base, where they get thoroughly and gradually absorbed. The
inclusion of coatings, solubilizing agents, buffering agents, or Encapsulation accelerates and
broadens the release of the part that is in motion.

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Marketed Products of Medicated Chewing Gum

Table 2.2 lists a number of marketed medicinal chewing gum products

Applications of Medicated Chewing Gum

The medicated chewing gum can also be used as an alternative tool for buccal and sublingual
tablets. It acts locally as well as systemically because the drug is released more uniformly and
covers a maximum area of absorption in the oral cavity. Medicated chewing gum widely used
for local effects in various conditions (plaque acid neutralization, fresh breath, dental caries,

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antiplaque, fungal, and bacterial infections) and systemic effects in various conditions
(vitamin C deficiency, pain & fever, alertness, motion sickness, and smoking cessation).

Pain

In therapeutic settings, NSAID-containing chewing gum formulations have been used to treat
mild headaches, muscle aches, and minor pains. The original chewing gum for medicinal
purposes Aspergum, a chewing gum that is available, contains sulfuric acid acetylated.

Smoking Cessation

Clinical trials have been conducted on nicotine, silver acetate, and lobeline-containing
formulations as aids in quitting smoking. In 2012, Aslani developed chewing gum with
nicotine by direct compression a method to help people stop smoking. The outcome shown
that the finished product had the best chewing plumpness, sticking to teeth, and hardness
qualities, in addition to the most delectable flavour and maximum acceptance among
smokers. chewing gum with nicotine is said to be a practical formula for breaking a "oral
habit" such as tobacco use

Dental Caries

[Link] primary goal is to prevent and treat oral illness.

ii. To regulate the pace at which active ingredients are released and to produce a long-lasting
local impact.

iii. Reduces dental caries' incidence and severity by Plaque pH should be reduced.

iv. Chewing gum containing fluoride can help prevent dental caries in young people.

v. Chewing gum containing chlorhexidine is used to treat a number of illnesses (oral,

periodontal, and infections of the pharynx) and result in reduced discoloration of the teeth.

vi. To cover up the unpleasant taste of some medications, including Chlorhexidine.

Oral Candidiasis

Fungal infections are becoming one of the leading causes of morbidity. Because
microorganisms resistant to standard therapy are growing more common, researchers are
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searching for new and improved medications reduced side effects and enhanced therapeutic
benefits. Research is being done to develop a chewing gum with medication using a blend of
essential oils as the active components to successfully cure oral candidiasis.

Obesity

It has been demonstrated that active ingredients such guarana, chromium, and caffeine-
containing formulations are effective in treating obesity. Studies have shown that guarana and
caffeine can speed up the metabolic rate and decrease the sensation of hunger and increase
lipolysis. In 2012, Aslani and Jalilian made caffeine-containing chewing gum to reduce
weariness and boost alertness. Because chromium improves blood flow, it lowers obesity
glucose equilibrium.

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 1. Materials and methods

Chemicals

Powdered Sugar, Cinnamon oil, Caffeine, Dextrose, Acacia gum, Glycerol, Di-calcium
phosphate, Glycerin and Ascorbic acid.

Figure 3.1 Procedure to prepare Chewing Gum

Evaluation Parameters

To evaluate the qualities of the medication product, two different evaluation test types are
used: quality parameters and physical evaluation parameters.

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Physical examination of the medicated chewing gum

Content Uniformity Test

2 mg or less than 2% of the gum's total mass is present fulfil the requirements of this exam.

Uniformity of Mass

Both coated and uncoated med-chew gum are compliant using the single-dose mass
uniformity test getting ready.

Weight Variation

The purpose of this test is to ascertain the weight fluctuation included in a single product
batch. Ten medicated weights Gum was removed from one batch. Average mass computed,
and the standard deviation was derived from there.

Adhesion

On a level surface, chewing gum with medication was placed. Pillar hammer colloids on
prescription chewing gum thirty strokes per minute in frequency. This procedure completed
in 10 minutes. Following mass adhesion to it was noted and the hammered surface was
examined.

Plasticity / Hardness

A Monsanto-style hardness tester was used to conduct this test on all varieties of medicated
chewing gum composition.

Stability Analysis

The synthetic gum base (10 gm) was kept in the container at 30°C ± 2°C/65% RH ± 5% RH
for six months, as per WHO recommendations. We looked for indications of physically
deformed and ageing.

Parameters of quality

1. Texture; 2. Taste; 3. Perceptual

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[Link] Done so Far

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Summary and Conclusion

In comparison to chewable pills, lozenges, and other medication delivery methods, medicated
chewing gum is a superior method. Other formulas that are similar. Because it's different
features, it may be determined that the medication. Chewing gums can serve as a vehicle for a
variety of several medications were both long-acting and capable of producing both impacts
on the mouth cavity that are both local and systemic. Medicated chewing gum is said to
demonstrate its status as a suitable and advantageous medication delivery device since it
meets Pharm. Industry's exacting criteria for quality and may be adjusted to provide various
release patterns in terms of active ingredients. Lastly, we could observe in the future Chewing
gum with medication has been the standard option as a in contrast to alternative medication
delivery methods regionally inside the mouth.

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References

1. Rassing MR, Chewing gum as a drug delivery, Advanced drug delivery reviews, 13, 1994,
89-121.

2. Konar N, Palabiyik I, Tocker OS, Sagdic O, Chewing Gum: Production, Quality

Parameters and Opportunities for Delivering Bioactive Compounds, Trends in Food Science
& Technology, 2016, 1-39. DOI: 10.1016/[Link].2016.07.003.

3. Garg T, Goyal AK, Medicated Chewing Gum: Patient Compliance Oral Drug Delivery
System, Drug Delivery Letters, 4, 2014, 72-78.

4. Jain N, Jadhav M, Annigeri RG, Pipaliya PR, Medicated Chewing Gums - A Novel
Targeted Drug Delivery, Journal of Indian Academy of Oral Medicine & Radiology, 31, 2019,
625.

5. Kumar R, Solanki P, Chandra A, Medicated Chewing Gum- A Novel Drug Delivery

System: An Updated Review, American Journal of Advanced Drug Delivery, 2014, 434-450.

6. Biswal PK, Anant kumar, An Updated Review on Medicated Chewing Gum, International
journal of advances in pharmacy, biology and chemistry, 2(2), 2013, 351-359.

7. Patel Y, Shukla A, Saini V, Shrimal N, Sharma P, Chewing gum as a drug delivery system,
International journal of pharmaceutical sciences and research, 2(4), 2011, 748-757.

8. Gadhavi AG, Patel BN, Patel DM, Patel CN, Medicated Chewing Gum - A 21st Century
Drug Delivery System, International journal of pharmaceutical science and research, 2(8),
2011, 1961-1974.

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