This document discusses medicated chewing gums. It begins with an introduction and then covers the advantages and disadvantages. The main components of chewing gums are described along with their roles. The manufacturing process and factors affecting drug release are summarized. Applications for various medical conditions are provided like dental caries, pain relief, smoking cessation and more. Commonly used commercial products are mentioned. The document concludes by discussing future trends and how chewing gums can be a preferred drug delivery system.
2. INTRODUCTION.
ADVANTAGES AND DISADVANTAGES.
COMPONENTS.
MANUFACTURING PROCESS.
FACTORS AFFECTING RELEASE OF ACTIVE
INGREDIENT.
APPLICATIONS.
COMMERCIAL PRODUCTS.
FUTURE TRENDS.
CONCLUSION.
3. INTRODUCTION
Chewing gum has been used for centuries to
clean the mouth and freshen the breath.
Medicated Chewing Gum (MCG) contains masticatory gum base
with pharmacologically active ingredient .
It is intended to use for local treatment of mouth diseases or
systemic absorption through oral mucosa.
MCG is considered as vehicle or a drug
delivery system to administer active principles and nutrition that
can improve health.
4. 1. Does not require water to swallow.
Hence can
be taken anywhere.
2. Advantageous for patients having difficulty in
swallowing .
4. Counteracts dry mouth, prevents candidiasis
and dental caries.
5. Highly acceptable by children.
ADVANTAGES
5. 6. Avoids First Pass Metabolism and thus
increases the bioavailability of drugs.
7. Drugs that are released from
chewing gum and swallowed, will be
introduced in the gastrointestinal tract either
dissolved or suspended in saliva and thus the
drug will be presented in a readily bioavailable
form.
8. Gum does not reach the stomach.
Hence G.I.T.
suffers less from the effects of excipients.
9. Stomach does not suffer from direct contact
with high concentrations of active principles,
thus reducing the risk of intolerance of gastric
mucosa.
CONT.,
6. 10. Fraction of product reaching the stomach is
conveyed by saliva delivered continuously and
regularly. Duration of action is increased.
11. Aspirin, Dimenhydrinate and Caffeine [9]
shows faster absorption through MCG than
tablets.
12. It may prove to be particularly suitable for the
systemic delivery of drugs, which are
susceptible to metabolism in the gut wall or
liver.
13. The treatment can, if required, be terminated at
any time.
CONT.,
7. 1. Sorbitol present in MCG formulation may
cause flatulence, diarrhea .
2. Additives in gum like flavoring agent,
Cinnamon can cause Ulcers in oral cavity
and Liquorice cause Hypertension.
3. Chlorhexidine oromucosal application is
limited to short term use because of its
unpleasant taste and staining properties to
teeth and tongue
4. Chewing gum has been shown to adhere to
different degrees to enamel dentures and
fillers
5. Prolonged chewing of gum may result in
pain in facial muscles and ear ache in
children.
DISADVANTAGES
8. COMPONENTS OF MCG
Water insoluble chewing gum base. Water soluble bulk portion.
Elastomers
Plasticizer
Fillers
Resins
Sweeteners
Colorants and whiteners
Flavoring agents
Anti caking agent
Grinding agent
Anti oxidant
9. COMPONENT ROLE EXAMPLES
Elastomers They provide elasticity, gummy
texture and cohesion to the chewing
gum.
Natural elastomers
Natural rubbers like Latex or
Natural gums such as Jelutong, Lechi Caspi,
Perillo, and Chicle.
Synthetic elastomers
polyisobutylene and
butyl rubber.
Plasticizers These are used to regulate
cohesiveness of product.
Natural Plasticizers
Glycerol Esters or Partially hydrogenated
Rosin, Glycerol Esters of Polymerized Esters
Synthetic Plastisizers
include Terpene Resins
derived from α-pinene and or d-limonene.
Fillers or
Texturizers
They provide the right
texture, improve chewability, and
provide reasonable size of the gum
lump with low dose
drug for the gum base.
Magnesium and Calcium Carbonate, Ground
Limestone, Magnesium and Aluminum
Silicate, Clay, Alumina, Talc, Titanium Oxide
& Mono/ di/
tri Calcium Phosphate.
Resins They serve two functions. One, as
mastication substance and other as
binding agent between elastomers
and fillers. They contribute to the
balance between the properties of
elasticity and plasticity.
Natural resin
Glycerol esters from pine resins
Synthetic resin
polyvinyl acetate can be used. It reduces the
tendency of the gum to adhere to the teeth.
10. COMPONENT ROLE EXAMPLES
Sweeteners
(Aqueous & Bulk)
To mask the bitter taste.
Aqueous Sweeteners can be
used as softeners to
blend the ingredients and retain
moisture.
Aqueous Sweeteners
Sorbitol, hydrogenated Starch
hydrolysates
and Corn Syrups.
Bulk Sweeteners
Sucrose, Dextrose, Maltose,
Dextrin, Fructose, Galactose,
Corn Syrup.
Colorants & whiteners To give required color . FD & C
type dyes and lakes, fruit and
vegetable extracts,
Titanium Dioxide.
Flavoring agents To improve flavour in chewing
gum .
Essential oils, such as Citrus
oil, fruit
essences, Peppermint oil,
Spearmint oil, Mint oil,
Clove oil & Oil of Wintergreen.
11. COMPONENT ROLE EXAMPLES
Anti-caking agent To prevent
agglomeration of the
subsequently ground
chewing
gum particles.
Precipitated silicon dioxide
can be mixed with
chewing gum composition
and solid carbon dioxide
prior to grinding.
Grinding agents: To prevent the gum from
sticking to the grinding
apparatus.
2-8% w/w of
grinding aid such as
alkaline metal phosphate,
an
alkaline earth metal
phosphate or malto dextrin.
Antioxidants To protect the
gum base and flavors from
oxidation.
Ascorbic
acid, tocopherol,
butylhdroxytoluene.
CONT.,
12. MANUFACTURING PROCESS
Conventional/ traditional Method:
Components of gum base are softened or melted &
placed in a kettle mixer to which sweeteners, syrups,
active ingredients &other excipients are added
at a definite time.
The gum is then sent through a series of rollers
that form into a thin, wide ribbon.
During this process, a light coating of finely powdered sugar or
sugar substitutes is added to keep the gum away from sticking and to
enhance the flavor.
In a carefully controlled room, the gum is cooled for up to 48 hours.
This allows the gum to set properly.
Finally the gum is cut to the desired size and cooled at a carefully
controlled temperature and humidity.
13. FACTORS AFFECTING RELEASE OF ACTIVE INGREDIENT
1. Contact Time: The local or systemic effect is dependent on time of contact of
MCG in oral cavity. In clinical trial chewing time of 30 minutes was considered
close to ordinary use.
2. Physicochemical properties of active ingredient: Physicochemical properties of
active ingredient plays very important role in release of drug from MCG. The
saliva soluble ingredients will be immediately released within few minutes
whereas lipid soluble drugs are released first into the gum base and then
released slowly.
3. Inter individual variability: The chewing frequency and chewing intensity
which affect the drug release from MCG may vary from person to person. In-
vitro study prescribed by European Pharmacopoeia suggest 60 cycles per
minute chewing rate for proper release of active ingredient.
4. Formulation factor: Composition and amount of gum base affect rate of
release of active ingredient. If lipophilic fraction of gum is increased, the release
rate is decreased.
14. Applications
The MCGs can also be used as an alternative tool to buccal
and sublingual tablets which are intended to act systemically
because active ingredient is released more uniformly and cover
greater area of absorption in oral cavity.
Oral diseases are prevented or cured with MCG.
MCGs can be used for systemic effect in conditions like
vitamin C deficiency, pain & fever, alertness, motion sickness,
smoking cessation, as well as for local effect in conditions like
plaque acid neutralization, fresh breath, dental caries,
antiplaque, fungal, and bacterial infections
Prevention and cure of oral diseases is a prime target for
chewing gum formulations.
15. 1. Dental caries:
Fluoride containing gums have been useful
in preventing dental caries in children and
in adults with. Xerostomia(dry mouth)
Chlorhexidine chewing gum can be used to
treat gingivitis, periodontitis, oral and
pharyngeal infections.
It can also be used for inhibition of plaque
growth.
Chlorhexidine chewing gum offers large flexibility
in its formulation as it gives less staining of the
teeth and is distributed evenly in the oral cavity.[42]
The bitter taste of chlorhexidine can be
masked quite well in a chewing gum
formulation.
16. 2. Systemic therapy:
Pain- chewing gum can be used in treatment of minor pains, headache and
muscular aches.
Smoking cessation- Chewing gum formulation containing nicotine and
lobeline have been clinically tested as aids to smoking cessation.
Obesity- Active substances like chromium, guaran and caffeine are proved to
be efficient in treating obesity. Chromium is claimed to reduce craving for
food due to an improved blood-glucose balance.
Caffeine and guaran stimulate lipolysis and have a thermogenic effect
(increased energy expenditure) and reduce feeling of hunger.
Other indications- Xerostomia, Allergy, Motion sickness, Acidity, etc are all
indications for which chewing gum is a means of drug delivery.
17.
18.
19. Chewing gum is no longer seen simply as confectionary. It not
only offers clinical benefits but also is an attractive, discrete and
efficient drug delivery system.
A few decades ago, the only treatment for some diseases was
surgical procedure but now more and more diseases can be treated
with Novel Drug Delivery Systems.
Dental health chewing gum is here to stay, as is medicated gum
for smoking cessation and travel sickness. A bright future for a
preparation with a long history.
20. Finally, in the future, we may see drugs
formulated into chewing gum
in preference to other delivery systems to
deliver drugs locally to the oral cavity.
The reason is simple - that the chewing gum
delivery system is convenient, easy to
administer - anywhere, anytime and its
pleasant taste improves patient compliance.
22. A review article published in journal
of Indian drugs- volume 43(3).
http://www.ijrpbsonline.com
Journal of pharmacy research
2011,4(3),848-851.
http://www.fertin.com
Google images.