MEDICATED CHEWING GUMS

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MEDICATED CHEWING GUMS,AIMST

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MEDICATED CHEWING GUMS K.JAYA RAJ KUMAR AMIST UNIVERSITY MALAYSIA

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INDRODUCTION Chewing gums are mobile drug delivery systems. It is a potentially useful means of administering drugs either locally or systemically via, the oral cavity. The medicated chewing gum has through the years gained increasing acceptance as a drug delivery system. Several ingredients are now incorporated in medicated chewing gum, e.g. Fluoride for prophylaxis of dental caries, chlorhexidine as local disinfectant, nicotine for smoking cessation, aspirin as an analgesic, and caffeine as a stay alert preparation. MCGs are solid, single dose preparations with a base consisting mainly of gums that are intended to be chewed but not swallowed. They contain one or more active substances which are released by chewing and are intended to be used for local treatment of mouth diseases or systemic delivery after absorption through the buccal mucosa.

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Pharmacological Active Agents or Drugs are formulated into variety of dosage forms like Tablets, Capsules, Injectables, Inhalers, Ointments etc considering Physicochemical properties, Pharmacokinetic&Pharmacodynamic parameters and Biopharmaceutical aspects of Drugs. In addition to its confectionary role, Chewing Gum (CG) also has proven value as a delivery vehicle for pharmaceutical and nutraceutical ingredients Today CG is convenient drug delivery system which is appropriate for a wide range of active substances. Many therapeutic agents are absorbed in the oral cavity. For the drugs having significant buccal absorption, dosage forms such as Lozenges, Chewable tablets and Chewing Gum permits more rapid therapeutic action compared to per-oral dosage forms. Conti…

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Chewable tablets and chewing gum have been very well received by the parents for use in children with full dentition. Children in articularmay consider chewing gum as a more preferred method of drug administration compared with oral liquids and tablets. The use of MCG is feasible in local treatment of diseases of oral cavity as well as treatment of systemic conditions. Chewing gum has been used for centuries to clean the mouth and freshen the breath. Conti…

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ADVANTAGES OF MCGS Dose not requires water to swallow. Hence can be take anywhere. Advantageous for patients having difficulty in swallowing. Excellent for acute medication. Counteracts dry mouth, prevents candidiasis and caries. Highly acceptable by children. Avoids First Pass Metabolism and thus increases the bioavailability of drugs F Fast onset due to rapid release of active ingredients in buccal cavity and subsequent absorption in systemic circulation.5 Gum does not reach the stomach. Hence G.I.T. suffers less from the effects of excipients . Stomach does not suffer from direct contact with high concentrations of active principles, thus reducing the risk of intolerance of gastric mucosa

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Fraction of product reaching the stomach is conveyed by saliva delivered continuously and regularly. Duration of action is increased. Aspirin, Dimenhydrinate and Caffeine shows faster absorption through MCG than tablets. Conti…

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DISADVANTAGES OF MCGS Risk of over dosage with MCG compared with chewable tablets or lozenges that can be consumed in a considerable number and within much shorter period of time. 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. 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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Chewing gum have been shown to adhere to different degrees to enamel dentures and fillers. Prolong chewing on gum may result in pain in facial muscles and earache in children. Conti…

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COMPOSITION OF MCGS Chewing gum is a mixture of natural or synthetic gums and resins, sweetened with sugar, corn syrup, artificial sweetners and may also contain coloring agents and flavor. The basic raw material for all CG is natural gum Chicle , obtained from the sapodilla tree. Chicle is very expensive and difficult to procure therefore other natural gum or synthetic materials like polyvinylacetate and similar polymers can be used as gum base. Typically Chewing Gum comprises two parts 1. Water insoluble chewable gum base Portion. 2. Water-soluble bulk portion.

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Water insoluble gum base a) Elstomers : Natural elastomer : Natural rubbers like Latex or Natural gums such as Jelutong , Lechi Caspi,Perillo , Chicle . b) Plastisizers : Natural Plastisizers include Natural rosin esters like Glycerol Esters or Partially hydrogenated Rosin, Glycerol Esters of Polymerized Esters, Glycerol Esters of Partially dimerized Rosin & Pentaerythritol Esters of Rosin. Synthetic Plastisizers include Terpene Resins derived from α- pinene and/or d-limonene.

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c) Fillers or Texturizers Magnesium and Calcium Carbonate, Ground Limestone, Magnesium and Aluminium Silicate, Clay, Alumina, Talc, Titanium Oxide & Mono/ di/ tri Calcium Phosphate. Conti…

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Water soluble portions contains Bulk Sweetners a) Softners and Emulsifiers : Softners include Glycerin, Lecithin, Tallow, Hydrogenated Tallow, Mono/ di/ tri-Glycerides, Fatty acids like Stearic acid, Palmitic acid, Oleic acid and Linoleic acid. b) Colourants and Whiteners dyes and lakes, fruit and vegetable extracts, Titanium Dioxide. c) sweetners Aqueous Sweetners ; Sorbitol , hydrogenated Starch hydrolysates and Corn Syrups. Corn syrup keeps gum fresh and flexible

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Bulk Sweetners Saccharides like Sucrose, Dextrose, Maltose,Dextrin , Fructose, Galactose , Corn Syrup Sugarless Components Sorbitol , Manitol , Xylitol , hydrogenated Starch hydrolysate Sucralose , Aspartame, salt of Acesulfame,Alitame , Saccharin, Glycerrhizin,Dihydrochalcones . d) Bulking agents: d) Bulking agents: Polydextrose,Oligofructose , Inulin , Fructooligosaccharides , Guargum hydrolysate , Indigestible Dextrin. Conti…

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e) Flavouring Agents: Citrus oil,fruit essences, Peppermint oil, Spearmint oil, Mint oil, Clove oil & Oil of Wintergreen. Artificial flavouring agents can also be used. f) Active Component: In medicated chewing gum active pharmacological agent may be present in core or coat or in both. The proportion of which may vary from 0.5-30% of final gum weight. A small, unionized, lipophilic and enzymatically stable active agent is likely to be absorbed more readily. A saliva soluble ingredient will be completely released within 10- 15 minutes of chewing whereas lipid soluble ingredient will dissolve in the gum base and thereafter be slowly and completely absorbed Conti…

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MANUFACTURING PROCESSES 1. Conventional/ traditional Method: Components of gumbase are softened or melted and placed in a kettle mixer to which sweetners , syrups, active ingredients and other excipients are added at a definte 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 flavour . In a carefully controlled room, the gum is cooled for upto 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.

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2. Cooling, Grinding and Tabletting Method: Cooling and Grinding: The CG composition (base) is cooled to a temperature at which the composition is sufficiently brittle and would remain brittle during the subsequent grinding step without adhesion to the grinding apparatus. The temperature required for cooling is determined in part by the composition of the CG and is easily determined empirically by observing the properties of the cooled chewing gum composition. Generally the temperatures of the refrigerated mixture are around -15oC or lower. Amongst the various coolants like liquid nitrogen, hydrocarbon slush use of solid carbon dioxide is preferred as it can give temperatures as low as -78.5oC, it sublimes readily on warming the mixture, is not absorbed by the chewing gum composition, does not interact adversely with the processing apparatus and does not leave behind any residue which may be undesirable or potentially hazardous. The refrigerated composition is then crushed or ground to obtain minute fragments of finely ground pieces of the composition. Conti…

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Use of anti-caking agent: An anti-caking agent such as precipitated silicon dioxide can be mixed with chewing gum composition and solid carbon dioxide prior to grinding. This helps to prevent agglomeration of the subsequently ground chewing gum particles. Use of grinding agents: To prevent the gum from sticking to the grinding apparatus, 2-8% by weight of grinding aid such as alkaline metal phosphate, an alkaline earth metal phosphate or malto dextrin can be incorporated. Conti…

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Tabletting : Once the coolant has been removed from the powder, the powder can be mixed with other ingredients such as binders, lubricants, coating agents ,sweeteners etc, all of which are compatible with the components of the chewing gum base in a suitable blender such as sigma mill or a high shear mixer. Alternatively a Fluidized Bed Reactor (FBR) can be used. The use of FBR is advantageous as it partially rebuilds the powder into granules, as well as coats the powder particles or granules with a coating agent thereby minimizing undesirable particle agglomeration. The granules so obtained can be mixed with antiadherents like talc. The mixture can be blended in a V type blender, screened & staged for compression. Compression can be carried out by any conventional process like punching. Conti…

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APPLICATIONS 1).Dental caries: Prevention and cure of oral disease are obvious targets for chewing gum formulations. It can control the release rate of active substances providing a prolonged local effect. It also reelevates plaque pH which lowers intensity and frequency of dental caries. Fluoride containing gums have been useful in preventing dental caries in children and in adults with xerostomia . Chlorhexidine chewing gum can be used to treat gingivitis, periodontitis , oral and pharyngeal infections. It can also be used for inhibition of plaque growth

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2.) Systemic therapy: (a) Pain- Treatment of minor pains, headache, muscular aches can be successfully accomplished (b) Smoking cessation- Chewing gum formulation containing nicotine49, lobeline and silver acetate have been clinically tested as aids to smoking cessation. Nicotine is a natural alkaloid occurring in the leaves of tobacco plant. It is a therapeutic agent intended to help smokers break the psychological habit of smoking by reducing the nicotine withdrawal symptoms normally experienced when smoking is stopped. Conti…

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(c) 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 d)Other indications- xerostomia , Allergy,Motion sickness, Acidity, Cold and Cough45, Diabetes, Anxiety etc are allindications for which chewing gum as drug delivery system could be beneficial Conti…

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