PRESENTATION ON
Prepared
For
Al-Amin Hasan Nirjhar
• ID: 1110333046
Fahima Faroque Archi
• ID: 1111302546
Modhuswiny Mohona
• ID:1110101046
Mustaque Alam Siddique
• ID: 1111329046
Sartaj Zabir Uddin
• ID: 1110136046
Sourabh Paul
• ID: 1110166046
Presented By
Chewing gum has been used worldwide since
ancient times when man experienced the pleasure of
chewing a variety of substances.
Chewing gum can be used as a convenient
modified-release drug delivery system.
Commercially available medicated chewing gums
are currently available for ,
pain relief,
Smoking cessation
travel illness and freshening of breath.
Fast onset
of action
Pleasant
taste
Higher
compliance
Ready
for use
.Water insoluble
chewing gum base .Water soluble bulk portion
Name Functions Examples
Elastomers Provides elasticity and controls gummy mixture
Jelutong,nispero,polysobutylene,isobutylene
Plasticizers Regulates cohesiveness of the product
Natural: Glycerol esters
Synthetic: Terpene resinsFillers or texturizers Provide texture and
improve chewabilityMagnesium and calcium carbonate,talc,limestone
Softners and emulsifiers
Soften the mixture and give required consistency
Glycerin,lecithin,tallow,stearic acid,palmitic acid
Sweeteners Improve the taste of the base gum
Sorbitol,mannitol,glucose,mannose,sucrose,maltose
Flavoring agents To improve flavor in chewing gum
Citrus oil,fruit essences,mint oil,peppermint oil,
Coloring agent Gives desired color of final dosage form
Titanium oxide,natural food colors,dyes
Antioxidants Protects the gum base and flavors from oxidation
Tocopherol,Ascorbic acid.propyl gallate
Ingredient Amount (%)Gum base 20-90%
Softeners 5-35%
Elastomer 10 %
Sweeteners 30 -60%
Texture agent/filler 4-50%
Colorants Up to 1 %
Flavoring agents 2-5 %
Humectants 10 %
Miscellaneous(preservatives, antioxidants)
0.1%
Components of gumbase are softened or melted andplaced in a kettle mixer to which sweeteners, syrups,active ingredients and other excipients are added at adefinite time.
The gum is then sent through a series of rollers that forminto a thin, wide ribbon.
During this process, a light coating of finely powderedsugar or sugar substitutes is added to keep the gum awayfrom sticking and to enhance the flavour.
In a carefully controlled room, the gum is cooled forupto 48 hours. This allows the gum to set properly.Finally the gum is cut to the desired size and cooled at acarefully controlled temperature and humidity.
1. The CG composition (base) is cooled to a temperature at which thecomposition is sufficiently brittle.
2. Amongst the various coolants like liquid nitrogen, hydrocarbonslush use of solid carbon dioxide is preferred as it can givetemperatures as low as -78.5oC
3. The refrigerated composition is then crushed or ground to obtainminute fragments of finely ground pieces of the composition
4. Once the coolant has been removed from the powder, the powdercan be mixed with other ingredients such as binders, lubricants,coating agents, sweeteners etc in a suitable blender such as sigmamixer or a high shearmixer
5. The use of FBR (Fluidized Bed Reactor) is advantageous as itpartially rebuilds the powder into granules, as well as coats thepowder particles or granules with a coating agent therebyminimizing undesirable particle agglomeration.
6. The granules so obtained can be mixed with antiadherents like talc.The mixture can be blended in a V type blender, screened & stagedfor compression.
7. Compression can be carried out by any conventional process likepunching.
1. Direct compression chewing gum can be directly compressed on a traditional tabletting machine, thus enabling rapid and low cost development of a gum delivery system .
2. Directly compressible free flowing powdered gums is obtained by mixtures of polyols and/or sugars with gum base.
3. These can be compacted in to a tablet form using a conventional tablet press.
4. The products are harder than their counter parts and texture analysis shows that they crumble under applied pressure.
5. These chewing gums can include higher levels of active .ingredients than traditional extruded gums, low temperature protects sensitive bioactivity and phytochemical components, moreover lower moisture content also improves shelf life of active molecules. Release is faster than from the conventional gums.
Title in Conventional or traditional method
Freezing, drying &
tableting method
Direct compression method
Manufacturing of
thermolabile may become
challenging as elevated
temperature is required
during melting; If the gum is
highly viscous, accurate
dosing is not possible; Lack of
precise form, shape, weight of
dosage form; Grinding and
compression difficult to
formulate chewing gum as
tablets due to high moisture
content.
High-tech, expensive
equipments are
required. Careful
monitoring of humidity
during manufacturing
process become a
challenge.
The main disadvantage is its
sticking effect to the
punches of the tableting
equipment. The effect is
due to the adhesive nature
of the gum, for this reason,
the procedure is difficult
and needs slower
production speed and
cooling operations to
prevent the tableting
machine damage.
Weight variationTen chewing gums of each formulation are weighed. The average weight and standard deviation are calculated.
Uniformity of contentTen gums are elected randomly. Each gum is first dissolved in 50 ml suitable solvent. The amount of active ingredient is determined by measuring UV absorbance. The experiment is repeated three times.
In vitro drug releaseA mastication device which simulates the mastication ofchewing gum in human is used to perform the drugrelease study. The device consisted of a piston whichstrokes the gum (60 strokes/min) at different points ona random base and a chamber which holds the gum andthe release medium (pH 6.8 phosphate buffer). Water(37°C) was circulated through a jacket around thereceiver chamber to simulate the in vivo temperature.Sample taken at different time interval are analyzed byUV spectroscopy.
OthersColor, shape, fragrance, taste etc are observed.
Plastic container
Nicotine gum
Nicotine gum is a type of chewing gum that deliversnicotine to the body. It is used as an aid in nicotinereplacement therapy (NRT), a process for smokingcessation and quitting smokeless tobacco. The nicotine isdelivered to the bloodstream via absorption by thetissues of the mouth.It is currently available over-the-counter in Europe, the USand elsewhere. The pieces are usually available inindividual foil packages and come in various flavors.Nicotine content is usually either 2 or 4 mg of nicotine,roughly the nicotine content of 1 or 2 cigarettes, with theappropriate content and dosage depending on thesmoking habits of the user.
Factors affecting release of API
Contact Time
Physicochemical properties of
API
Formulation factor
Inter individual variability
Ideal Characteristics
1 2 3
Dose not requires water to swallow. Hence can be take anywhere.
Excellent for acute medication.
Counteracts dry mouth, prevents candidiasis and caries.
Avoids First Pass Metabolism and thus increases the bioavailability of drugs.
Stomach does not suffer from direct contact with high concentrations of active principles, thus reducing the risk of
intolerance of gastric mucosa.
Fast onset due to rapid release of active ingredients in buccal cavity and subsequent absorption in systemic circulation.
Risk of over dosage.
Sorbitol present in MCG formulation may cause flatulence, diarrhea.
Additives in gum like flavouring agent, Cinnamon can cause ulcers in oral cavity and Licorice cause Hypertension.
Prolong chewing on gum may result in pain in facial muscles and earache in children.
Chewing gum have been shown to adhere to different degrees to enamel dentures and fillers.
Chlorhexidine oromucosal application is limited to short term use because of its unpleasant taste and staining properties to teeth and
tongue
Trade Name Active Drugs Use
Nicorette Nicotine Smoking cessation
Nicotinell Nicotine Smoking cessation
NiQuitin CQ Nicotine Smoking cessation
Fluorette Fluoride Dental flourosis
HEXIT Chlorhexidine Prevent tooth decay
Vitaflo CHX Chlorhexidine Prevent tooth decay
Advanced plus Chlorhexidine Prevent tooth decay
Stay Alert Caffeine Stimulant
Travvell Dimenhydrinate Motion sickness
Chooz Calcium carbonate Antacid
Stamil vitamin C Vitamin C Anti-oxidant
Nowadays more and more disease can be treated withNDDS.
Generally it takes time for a new drug delivery system toestablish itself in the market.
But MCG is believed to manifest its position as aconvenient and advantageous drug delivery system as itmeets the high quality standards of PharmaceuticalIndustry and can be formulated to obtain different releaseprofiles of active substances.
In the future we may see that more and more drugsformulated into chewing gum in preference to otherdelivery systems.
The reason is simple that the chewing gum delivery systemis convenient , easy to administer anywhere, anytime andits pleasant taste increases the product acceptability andpatient compliance.
Finally it is concluded that chewing is an
excellent drug delivery system for self
medication and having its own merits.
So in forth coming years it will be a
much more common and popular drug
delivery system.
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