Medicated Chewing Gum - A Review
Medicated Chewing Gum - A Review
Medicated Chewing Gum - A Review
Review Article
Medicated Chewing Gum – A Review.
Ms. Neha Vinod Motwani* and Mr. Kiran A. Suryavanshi
SMBT Institute of D. Pharmacy, Dhamangaon, Tal. Igatpuri, Nashik-433403, MS (India).
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tablets. Particularly, for children this is very Elimination of gum at any time as termination
convenient method of administration when of drug delivery.
compared to tablets, liquids, Helps to reduce risk of overdosing while it is
Improved technology and extended know how swallowed.
have made it possible to develop and It does not Require water to drink
manufacture convenient drug delivery system It protect the susceptible drugs consist of
which is appropriate for a wide range of chemical or enzymatic attack in gastrointestinal
active substances. Medicated chewing gum (GI) tract.
offers advantages in comparison to conventional It has systemic and local drug delivery.
oral mucosal and oral dosage forms both for; Chewing gum is highly trendy by children
(a) Local treatment and teenagers
(b) Systemic effect
It has Low first-pass effect so reduced dose is
After absorption through the buccal and formulated in chewing gum compared to other
sublingual mucosal and from the oral delivery systems
gastrointestinal tract .Chewing gum can be
Chewing gum is good for speedy delivery
retained in the oral cavity for a long period and,
Chewing rarely have side effects
if the drug is readily absorbed across oral
mucosa, chewing gum can provide a fast onset Reduced risk of intolerance to gastric mucosa
time for a systemic effect and the pass Chewing gum has excellent stability against
metabolism of susceptible drugs. Generally, light, oxygen, and moisture
medicated chewing gum has a good stability, Rapid bowel healing after GI surgery.
the medicine can be taken potential for Disadvantages of medicated chewing gums
avoidance of gastrointestinal and hepatic first – (Surana, A.S., 2010)
easily and directly without the prerequisite of Chewing gum causes problems like jaw pain
water, and if required, prompt Discontinuation and headaches if used continuously.
of medicament is possible. This drug delivery leads to disappearing of
Dosage forms such as mouthwashes, erodible/ drug in oral cavity followed by dilution in saliva.
chewable buccal tablets, and chewing gums It has Different releasing profiles as of chewing
allow release of drugs for only a short period and style differences
thus the reproducibility of drugs absorption is There is Short time of administration due to
comparatively poor. Application of bioadhesive eating, speaking, and drinking.
semisolid gels creates considerable technical Simultaneous stress on jaws that may cause
problems in the buccal absorption. Although temporomandibular joint disorder
medicated chewing gums pose difficulties in It causes Teeth decay because coated by sugar.
regulating the dose administered, they still Chewing gum can cause Stomach irritations,
have some advantages as drug delivery devices, aches, gastric ulcer through continuous
particularly in the treatment of diseases the oral swallowing of saliva and even flatulence as it
cavity and in nicotine replacement therapy. include presence of sorbitol in some formulations
Some commercially available chewing gums are As it is not suitable for under-aged child will
Caffeine chewing gum, and Nicotine chewing causes chocking by swallowing gum in under-
gums (e.g. Nicorette ® and Nicotine®). The aged children.
permeability of nicotine across the buccal Problems Occurred During Manufacturing of
mucosa is faster than across the skin. (B. D. Chewing Gums
Ingole, et al) As chewing gum contains adhesive
Advantages of Medicated chewing gum ingredients that will jam the grinding machine,
(Imfeld, T. et al,1999) sticking to blades, screens and other surfaces if
Chewing gum is Healthy treat after a meal. the moisture level is not controlled.
It helps to Increase rate of efficiency rather Another problem associated with the above
than other oral delivery systems methods is that the gum base is heated to a fluid
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mass to facilitate mixing of other ingredients. softening the elastomers base constituent. Such
Such elevated Temperatures can cause elastomers solvents may contain terpinene
degradation of heat sensitive compounds, resins such as polymers of alpha-pinene or
including active agents and flavors. beta-pinene, methyl, glycerol or pentaerythritol
In manufacturing of chewing gum, for gum esters of resins or modified resins and gums,
bases or gum core organic solvents are used to such as hydrogenated, dimerized or polymerized
dissolve the active agents. It is difficult to resins or mixtures. The elastomers solvents are
eliminate these organic solvents from the final employed in amounts from 5.0% to 75.0%, by
product and may present certain health risks if weight of the gum base, and preferably from
even trace amounts remain in the final dosage 45.0% to 70.0%, by weight of the gum base
forms. Synthetic elastomers such as butadiene; styrene
It is hard to provide sanitary condition while copolymers, polyisobutylene, isobutylene
manufacturing medicated chewing gum. (Patel, isoprene copolymers, polyethylene mixtures, and
V.P. 2011). non-toxic vinyl polymer, such as polyvinyl
Composition alcohol are widely used bases. The molecular
The composition of chewing gum consists of weight of the vinyl polymer may range from
gum base which are composed of an insoluble 3,000 to 94,000. The amount of gum base
resins, humcetants, elastomers, fillers, waxes, employed varies greatly depending upon various
antioxidants and softners. Chewing gum is a factors such as the type of base used, the
mixture of natural or synthetic gums and resins, consistency of the gum desired and the other
sweetened with sugar, corn syrup, artificial components used in the composition to make the
sweeteners and may also contain coloring agents final chewing gum product. In general, the gum
and flavor. The main ingredients in modern base will be present in amount from 5% to 94%,
chewing gum are Gum Base. The basic raw by weight of the final chewing gum composition.
material for all CG is natural gum chicle, Preferably, the gum base is used in amounts from
obtained from the sapodilla tree. Chicle is very 15% to 45% and more preferably in amounts
expensive and difficult to procure therefore other from 15% to 35% weight of the final chewing
natural gum or synthetic materials like polyvinyl gum composition.
acetate and similar polymers can be used as gum Plasticizers
base. For years gum base was made from chicle Waxes, vegetable oils, glycerines, Plasticizers
which was the ingredient in chewing gum. or softeners such as lanolin, palmitic acid, oleic
(Kumar, R. et al). acid, stearic acid, sodium stearate, potassium
stearate, acetylated monoglyceride, glycerine,
MANUFACTURING (Gadhavi, G. et al, 2011) natural and synthetic waxes, hydrogenated
Following Are the Constituents used in vegetable oils, polyurethane waxes, paraffin
Manufacturing Process waxes, microcrystalline waxes, fatty waxes,
Gum Base propylene glycol may be included into the gum
Gum base is an static and insoluble non nutritive base to gain a variety of advantageous textures
product used as a support for the edible and consistency properties.
Department of Pharmaceutical Sciences and Adjuvants
Technology, near Arvind Baug, Shri Sarvajanik Calcium carbonate, talc, or other charging
Pharmacy College, Mehsana 384001, Gujarat, agents are used. Mineral adjuvant such as
India and easily soluble of the chewing gum calcium carbonate, magnesium carbonate,
(sugar, glucose, polyoils and flavours) Other raw aluminium hydroxide, aluminum silicate, talc,
materials are generally Grouped in following tricalcium phosphate, dicalcium phosphate serves
Classes. up as fillers and textural agents.
Elastomers Antioxidants
The gum base composition may include An anti- oxidant such as butylated
conventional elastomeric solvents to aid in hydroxytoluene, butylated hydroxyanisole,
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propyl gallate and mixtures thereof, may be b. Water-soluble artificial sweeteners: soluble
incorporated as antioxidants. saccharin salts, i.e. sodium or calcium
Compression adjutants saccharin salts, cyclamate salts.
Appropriate compression adjuvant such as c. Dipeptide based sweeteners: L- aspartic acid
silicon dioxide, magnesium stearate, calcium derived sweeteners such as Aspartame,
stearate and talc can be used in medicated Alitame, methyl esters of L-aspartyl-
chewing gum for ease of compression. The Lphyenyl-glycerine and Laspartyl- L 2,5-
alkali metal phosphates prevent caking and dihyrophenylglycine, L-aspartyl 2,5-
balling of “High”. Additionally, it has been dihydro-L phenylalanine – L aspartyl – L (1-
discovered that malt dextrin enhances the cyclohexen) alanine.
grinding of “high” moisture-containing chewing d. Water-soluble sweeteners: derived from
gum compositions by absorbing moisture to naturally occurring water soluble
allow lubrication in the gum as it separates into sweeteners, chlorinated derivatives of
granules. If oil lubricants are used, it is preferred ordinary sugar (sucrose, known as Sucralose)
to be 0.4% to 1% by weight of the tableted e. Protein based sweeteners: such as
chewing gum composition. The amount of thaumaoccousdanielli (Thaumatin I and II)
glidants present in the tableted chewing gum In general an effective amount of sweetener
composition is from 0.5% to 5% by weight of is utilized to provide the level of sweetness
the tableted chewing gum composition. Those desired, and this amount will vary with the
glidants useful are selected from the group sweetener selected and are present in
consisting of alkali metal salts, talc, starch, amounts from 0.0025% to 90% by weight of
polyhydric alcohols and mixtures. Anti-adherents the gum composition.
function to prevent tablet granulations from Coloring agents
sticking to the faces of the punches and the die The colouring agents comprise pigments,
walls, but most importantly, prevent adherence which may be incorporated in amounts up to
of chewing gum granules from adhering to one about 6% by weight of the gum composition,
another, a phenomenon known as blocking. titanium dioxide may be incorporated in
Anti- adherents may be added to the chewing amounts up to about 2%. The colorants may
gum composition while the composition is in also include natural food colors and dyes suitable
the hoppers, or subsequent to grinding and are for food drug and cosmetic applications.
selected from the group consisting of Flavouring agents
silicates, silicon dioxide, talc and mixtures Flavouring agents suitable for use are essential
thereof present in amount of 0.2% to 1% by oils and synthetic flavours such as citrus oils,
weight of the tableted chewing gum composition fruit essences, peppermint oil, spearmint oil,
and preferably about 0.3 to about 0.6% by clove oil wintergreen oil, and anise oil.
weight. Generally anti-adherent is a finely Bulking agents
divided low bulk density powder, which is If low calorie gum is desired then they are used.
preferably water insoluble. The preferred anti- Examples of low down calorie bulking agents
adherents are fumed silica and talc. The term- include Polydextrose, Oligofructose, Inulin,
fumed silica is meant to include pyrogenic Guargum hydrolysate, heavy Dextrin.
silica’s; micron sized silica’s and hydrated
silica’s. Manufacturing Process
Sweeteners Fusion method
a. Water-soluble sweetening agents: xylose, Most chewing gum are made using the
ribulose, glucose, mannose, galactose, conventional gum process (i.e fusion
fructose, sucrose, maltose, invert sugar method).The first step of this method for
partially hydrolyzed starch, dihyrochalcones, manufacturing chewing gum is to melt and soften
monellin, steviosides, glycyrrhizin, and the gum base at about 60°C and place it in a
sugar alcohols such as sorbitol, kettle mixer or Z-blade mixer in which blades
mannitol,hydrogenated starch hydrolsates. soften the base, then other ingredients such as
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sugar, glycerin, sweeteners, taste-masking agent After the grinding step, we can let the coolant (if
are added to the softened base, After this the used) evaporate and disappear from our desired
flavoring agent is added in the mixing procedure composition. The minute particles may be coated
at 40°C, then cooling and rolling steps would be by edible substances or premixed with powdery
done, and finally the rolled chewing gum would materials. For stabilization, compressing punches
then be cut into pieces of required shapes and may be needed but anti-adherent agent should be
sizes and packaged as unit doses. To make a added to prevent sticking. (Athanikar, N.K. et al
coated gum tablet, a coating agent should be 2001 .)
sprayed to form a uniform surface. Second type Direct compression
of this method is somehow different: The New technology to make a chewing gum tablet is
primary step of preparation is to set up a mixer direct compression and tableting. This cost-
(the mixer could be sigma blade or other types of effective method involves compression of gum
mixers), if a sugar-containing gum is needed, the bases mixed with active ingredients. At high-
first step is to add corn syrup to the mixer, and speed standard machine, but as explained in a
then finely powdered sugar is added gradually. patent, this way of forming chewing gum tablets
Sugar, used in this step, could be powdered provides a quickly dissociable chewing gum, but
sucrose, dextrose, fructose, corn syrup solids or after a few seconds of chewing, particles adhere
combination of them. together to form a uniform and homogenous
After adding these sweeteners, plasticizers are mass. In this method; we need a granulating
added to modify the texture and regulate the agent, most preferably that is sorbitol which can
cohesiveness. Glycerine is the most preferably also act as a sweetener. A lubricant such as
plasticizer used. The mechanical forces of mixer, magnesium stearate, talc, stearic acid,
that is, compressive and shear and heat can ease hydrogenated vegetable oils, and sodium stearyl
the softening process. When no heat is applied, a fumarate is added to formulation before
higher power is demanded. The mixing process tableting. First step of this method is dry mixing
continues until a homogenous mass is formed. of gum base, granulating agent and at least one
(Rassing MR et al 1994) processing material then adding active
Cooling, grinding, and tableting method ingredient, sweeteners, and other needed
This method has been developed with an attempt ingredients to the formulation in free flowing
to lower the moisture content. In manufacturing form of materials then directly compressing the
of medicated chewing it is used to Provide a chewing gum into tablets. In the first step, the
chewing gum with desired taste, color, and temperature should not raise higher than the
flavour is to mix gum base with favourable and melting point of the gum base. After obtaining a
suitable sweeteners, corn syrups, starches, uniform and slick mass, the temperature would
flavouring agents, and colorants, and then lower to add other ingredients.
refrigerate and cool it by a freezer apparatus or Other significant benefits of this method are as
by contacting with a coolant like carbon dioxide follows- fast release, fast absorption and high
to a temperature below −15°C which is therefore content uniformity.
crushed and pulverized with a cutter or grinding Medicated chewing gums by direct compression
apparatus to obtain minute particles then these method are 10 times harder and crumble when
finely ground particles are heated to a pressure is applied resulting in faster release than
temperature which makes them adhere to each medicated chewing gum formed by fusion
other and form a slick and uniform bulk with method (Heema, N. et al 2010).
consistent texture and low specific gravity. If the Packaging
fragments are such that they do not self-adhere, The advantages of chewing gum packaging are
low pressure would be applied manually or clear to the world since it extends shelf-life of the
mechanically before they are warmed to the product by preventing aroma and flavour to
normal room temperature to thereby promote disappear. It also provides moisture retention and
self-adhesion. The cooling and grinding steps can gum stability. There are too many packaging
be combined by cooling the grinding apparatus. methods with a wide range of options. In almost
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all of packaging types, we need a wrapping It has been observed commercially that the
machine that receives and wraps the sticks of drug release from medicated chewing gum as per
gums; in some cases, the wrapper machine seals the specification given in European
the end of the package. In the following, a Pharmacopoeia and is determined by applying a
formed blister pack may be used then a foil will mechanical kneading procedure to a piece of
be heat-sealed at the back or a traditional gum placed in a small chewing chamber
packaging may be applied by lining the pellets containing a known volume of buffer solution.
up in a row and wrapping then sealing the both (Asija, R., et al, 2012)
ends .The manufacturing and packing steps
should be performed at about 20-25°C and SAFETY ASPECTS
relative humidity of 57%. Packaging has a Different commercial chewing gums have been
substantial portion in the whole process both in shown to stick on to dissimilar degree to
terms of cost and time. Undoubtedly, packaging dentures, fillers and crowns. Over chewing
influences attraction of product among causes painful jaw muscles. Chewing gum
consumers, thus a well-flavoured and stylish appears to offer a slighter risk of overdosing by
design can attract more consumers to buy the inaccuracy or misuse than flavored chewable
specific product. Therefore, besides protecting tablets. Medicated chewing gums should, like
the content, avoiding impurity, expediting other medicaments, be kept out of reach of
transport and improving storage, packaging can children and it would be wise to advice
influence consumers’ willingness to buy the people prone to allergic response to confirm
product and capture his attention during purchase the flavoring and sweetening agents incorporated
competition. (Bahoshy BJ, et al US Patent No. in the chewing gum formulations.
4,000, 320.)
Limitations (Ritesh Kumar et al, 2014) FUTURE TRENDS
High temperature used in melting restricts the Future of chewing gum will reveal all the
utilize of this method for thermo labile drugs. scientists efforts for the development of chewing
Melting and mixing of extremely viscous gum gum as a modern drug delivery system and
mass makes controlling of accuracy and progress of chewing gum as it not only offers
uniformity of drug dose complicated. clinical benefits but also convenient easy to
Lack of accurate form, shape or weight of administer. A few decades ago, the only
dosage form. treatment for some disease was surgical
Technology not so easily adaptable to integrate procedure but now more and more disease can be
the stringent manufacturing conditions essential treated with Novel Drug Delivery Systems.
for production of pharmaceutical products Generally, it takes time for a new drug delivery
system to establish itself in the market and gain
QUALITY CONTROL acceptance by patients, however chewing gum is
As per specifications given in European believed to manifest its position as a
Pharmacopoeia. convenient and advantageous drug delivery
Test for Uniformity of Content system as it meets the high quality standards of
If not or else prescribed or justified and pharmaceutical industry and
authorized medicated chewing gum with content can be formulated to obtain different release
of 2 mg or less than 2 percent of the total mass of profiles of active substances. The potential of
gum comply with test. MCG for buccal delivery, fast onset of action
Uniformity of mass and the opportunity for product line extension
Uncoated medicated chewing gum and if not or makes it an attractive delivery form.
else justified and authorized coated medicated Reformulation of an existing product is
chewing gum comply with the test for uniformity required for patent protection, additional
of mass of single- dose preparations. patient benefits and conservation of revenues.
Drug release from medicated chewing gum The potential of medicated chewing gum for
buccal delivery, fast onset of action and the
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opportunity for product line extension makes it chewing gum: A review. J Drug Delivery Ther.
attractive delivery form. (2), 90–95.
4. Aslani, A., and Rafiei, S. (2012). formulation
ACKNOWLEDGEMENT and evaluation of nicotine chewing gum. Adv
Authors are thankful to the Principal and Biomed Res.,1,57.
management of SMBT Institute of D. Pharmacy, 5. Athanikar, N.K., and Gubler, S.A. (2001).
Nashik-422401, India. Process for Manufacturing a Pharmaceutical
Chewing Gum. US Patent. No. 6, 322, 828.
FUNDING SUPPORT 6. Bahoshy, B.J., Klose, R.E., Sjonvall, R.E.,
None. and Szczesniak, A.S. (1976). Chewing gum with
improved storage qualities. US Patent No. 4,000,
CONFLICT OF INTEREST 320.
The authors declare that there is no conflict of 7. Chaudhary, S.A., and Shahiwala, A.F.
interest. (2012). Directly compressible medicated
chewing gum formulation for quick relief from
CONCLUSION common cold. Int J Pharm Investig,2, 123.
According to the advantages of chewing gum as 8. Cherukuri, S.R., and Bikkina, K. (1988).
a novel drug delivery ,like simultaneously Tabletted Chewing Gum Composition and
supporting both local and systemic delivery Method of Preparation. US Patent No. 4753805.
,protection against acids and enzymes ,low first 9. Cherukuri, S.R., Hriscisce, F., and Wei, Y.C.
pass metabolism ,uplifting alertness and (1988). Reduced Calorie Chewing Gums and
cognitive function , excellent stability, taste Method. US Patent No. 4,765,991.
masking of certain drug and a lot more; we can 10. Heema, N., and Stuti, G. (2010). Medicated
conclude that chewing gum will be much more chewing gums-updated review. Int J Pharm Res
familiar to patient, and market in next few years . Dev.2,66–76
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used without water, at any time. Medicated pQ1rK3ZM
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Scientist and researchers should also consider fiction: A review of gum-chewing and oral
new formulations for chewing gums for health. Crit Rev Oral Biol Med. 10, 405–19.
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