chewing gum final

27
P RESENTATION O N Prepared For

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Page 1: Chewing gum final

PRESENTATION ON

Prepared

For

Page 2: Chewing gum final

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

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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.

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Fast onset

of action

Pleasant

taste

Higher

compliance

Ready

for use

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.Water insoluble

chewing gum base .Water soluble bulk portion

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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

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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%

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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.

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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.

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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.

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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.

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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.

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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.

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Plastic container

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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.

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Factors affecting release of API

Contact Time

Physicochemical properties of

API

Formulation factor

Inter individual variability

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Ideal Characteristics

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1 2 3

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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.

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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

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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

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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.

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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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