chewing gum 1

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MEDICATED CHEWING GUM :

MEDICATED CHEWING GUM K.V.RAMANA REDDY Asso.Professor srikanth.papa@gmail.com

ADVANTAGES:

ADVANTAGES Fast onset time for a systemic effect Avoidance of gastrointestinal and hepatic first-pass metabolism Local treatment of mouth diseases Systemic effect after absorption through the buccal and sublingual mucosa. To provide less irritation to the stomach Good stability.

ADVANTAGES:

ADVANTAGES Counteracts dry mouth. No need of water. Maximum bioavailability. Duration of action is increased. Sustained action is possible. Patient compliance.

DISADVANTAGES:

DISADVANTAGES 1.Hard chewing gums have caused broken teeth. 2.Extensive chewing for a long period time may cause painful jaw muscles. 3.Extensive use of sugar-alcohol-containing chewing gum may cause diarrhea. 4.Flavors, colors, etc. may cause allergic reactions. 5. Should be kept out of reach of children. 6.Long-term frequent chewing of gum has been reported to cause increased release of mercury vapor from dental amalgam fillings.

FORMULATION:

FORMULATION

VARIOUS EX.OF EXCIPIENTS:

VARIOUS EX.OF EXCIPIENTS Gum Bases : Pv Acetate,chicles,styrene Butadiene Rubber,polyethylene .Smoked Rubber. Elasto mer s :latex Or Natural Gums Like Jelutong, Lechi Caspi,perillo And Chicle. Plasticizers :glycerol Esters Glycerol Esters Of Polymerized Esters, Glycerolesters Of Dimerized Rosin. Α -terpene From Pinene D-limonene .

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Fillers Or Texturizers :magnesium And Calcium Carbonate, Ground Limestone Magnesium And Alumiunium Silicate Clay,alumina,talc,titanium Oxide,mono/Di/Tri Calcium Phosphate. Bulkingagents :polydextrose,oligofructose,insulin,fructooligosaccharides,guargum Hydrolysate, Indigestible Dextrin. Flavouring Agents :Citrus Oil,peppermint Oil ,Wintergreen Oil,spearmint Oil,mint Oil,clove Oil ,

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Sweetners :sorbitol, Corn ,Honey,syrups,sucrose ,Dextrose,Maltose,dextrin,fructose,galactose,sucralase,aspartae, Salt Of Acesulfame, Alitame, Saccharin, Glycerrhizin, Dihydrochalcones. Softners&emulsifiers :glycerin,,lecithin, Tallow, Hydrogenated Tallow,mono/Di/Tri-glyceride, Fatty Acids Like Stearic Acid ,Palmitic Acid ,Oleic Acid ,Linoleic Acid. Colourant And Whiteners :titanium Dioxide,fruit Extracts,fd&c Types Lakes And Dyes

1.Contains Little Water (2–5%). 2.The Water Activity (Aw) In Chewing Gum Is Normally Below 0.6 And Typically 0.4–0.5. 3.Without Water (Less Than 0.2%).It Becomes Hygroscopic And Affects Texture. 4.Antioxidants Are Normally Added With The Gum Base. 5.Low Water Contents Prevents Microbial Growth. 6. Operate The Process At A Lower Temperature To Avoid Stability Issue.:

1.Contains Little Water (2–5%). 2.The Water Activity (Aw) In Chewing Gum Is Normally Below 0.6 And Typically 0.4–0.5. 3.Without Water (Less Than 0.2%).It Becomes Hygroscopic And Affects Texture. 4.Antioxidants Are Normally Added With The Gum Base . 5.Low Water Contents Prevents Microbial Growth. 6. Operate The Process At A Lower Temperature To Avoid Stability Issue . STABILITY PROBLEMS

1.Physicochemical Properties Of The Drug INCLUDE Aqueous Solubility Pka Value, Distribution Between Gum-saliva. 2.Product Properties I.E., Composition, Mass, Manufacturing Process. 3. Process Of Chewing I.E. Chewing Time, Chewing Rate. 4. The Release Rate Of Drug Is Determined By Number Of Factors Related To The Chewer, Drug, And Chewing Gum:

1.Physicochemical Properties Of The Drug INCLUDE Aqueous Solubility Pka Value, Distribution Between Gum-saliva. 2.Product Properties I.E., Composition, Mass, Manufacturing Process. 3. Process Of Chewing I.E. Chewing Time, Chewing Rate. 4 . The Release Rate Of Drug Is Determined By Number Of Factors Related To The Chewer, Drug, And Chewing Gum FACTORS AFFECTING

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5.The chewer-related factors are chewing time, chewing frequency, chewing intensity, and the amount of saliva . 6.Release rate from chewing gum can also be influenced by encapsulation of the drug

1.All gum bases are insoluble in saliva. 2. Gum base that determines the basic characteristics of the product the characteristics that will be influenced by the choice of gum base include texture, release, stability, and the processing. 3.The core weighs 1gm. 4. To obtain a fast systemic effect a release period of 10–15 min is desirable.:

1.All gum bases are insoluble in saliva. 2. Gum base that determines the basic characteristics of the product the characteristics that will be influenced by the choice of gum base include texture, release, stability, and the processing. 3.The core weighs 1gm. 4. To obtain a fast systemic effect a release period of 10–15 min is desirable . POINTS TO BE REMEMBERED

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CHEWING GUM MIXER WITH Z-BLADES

1. Chewing Gum Softens At Temperatures Above 30°C 2. Deformation Of The Gum TAKES IF EXTREME TEMP.In Equipment. 3.Improper Mass And Dimensions Of The Cores During Manufacturing.:

1. Chewing Gum Softens At Temperatures Above 30°C 2. Deformation Of The Gum TAKES IF EXTREME TEMP.In Equipment. 3.Improper Mass And Dimensions Of The Cores During Manufacturing. SCALE UP PROBLEMS

Scientific Rationale For In Vitro Drug Release Determination:

Scientific Rationale For In Vitro Drug Release Determination The basic principle is a simple masticatory movement employed to simulate the chewing action on a piece of gum placed in a small chewing chamber containing a known volume of buffer solution at a given temperature. The drug release rate is influenced by the chewing rate and angle, which provides the necessary shear force to expose new gum surfaces and is a requisite for further drug release.

The transition from the inactive gum to the active dosage form is influenced by mechanical forces temperature wettability and water permeation. As a general rule, under sink conditions, the rate at which the drug is released is directly proportional to the chewing frequency and aqueous solubility of drug substance and is indirectly proportional to the mass of the gum base.:

The transition from the inactive gum to the active dosage form is influenced by mechanical forces temperature wettability and water permeation. As a general rule, under sink conditions, the rate at which the drug is released is directly proportional to the chewing frequency and aqueous solubility of drug substance and is indirectly proportional to the mass of the gum base . APPARATUS I. CHEWING GUM APPARATUS, COMPENDIAL The chewing apparatus for medicated chewing gum was adopted by Ph. Eur. in 2000 (8). shows the construction of the apparatus. The chewing apparatus comprises a chewing chamber, two horizontal pistons, and a third vertical piston (tongue). The vertical piston operates alternatively with the two horizontal pistons and makes sure the gum stays in the right place between chews. If necessary, it is feasible to construct the machine so that at the end of the chew the horizontal pistons rotate around their own axes in opposite directions to each other to obtain maximum chewing. The working procedure of this chewing apparatus is described in Ph. Eur. (8–10).

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Apparatus II. Alternative Chewing Gum Apparatus, Noncompendial—Wennergren(For Drug Release)

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The chewing procedure consists of reciprocations of the lower surface in combination with a shearing (twisting) movement of the upper surface that provides mastication of the chewing gum and at the same time adequate agitation of the test medium. The upper jaw has a flat surface that is parallel to the central part of the lower surface. The small brim of the lower surface is angled upwards (45 degrees) so that the lower surface functions as a small bowl with a flat bottom. This bowl prevents the chewing gum from sliding during mastication PRODUCT QUALITY TEST TO PERFORMEND ON GUM Assay Identification Uniformity of dosage units, content, and mass

1.Test For Uniformity Of Content. 2.Test For Uniformity Of Mass. 3.Drug Release from medicated gum. 4.Stability 5.In-vitro Testing. 6.In-vivo Studies. 7additional test like. Texture Analysis, Product Feel And Consistency, Evaluation Of Flavors And Sweeteners, Tests For Coatings, Impurities, Water Content, Degradation Products, Residual Solvents, Etc.:

1.Test For Uniformity Of Content. 2.Test For Uniformity Of Mass. 3.Drug Release from medicated gum. 4.Stability 5.In-vitro Testing. 6.In-vivo Studies . 7additional test like . Texture Analysis, Product Feel And Consistency, Evaluation Of Flavors And Sweeteners, Tests For Coatings, Impurities, Water Content, Degradation Products, Residual Solvents, Etc . EVALUATION OR QUALITY CONTROL TESTING

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REFERENCES Shah VP, Derdzinski K, Ewing G, et al. A performance test for topical and transdermal dosage Forms. Pharm Forum. 2006;32(5):1586–1589. Shah VP, Ueda CT. USP Advisory Panel on the USP Performance Test for Topical and Transdermal Dosage Forms. Pharm Forum. 2006;32(5):1584–1585. United States Pharmacopeial Convention. USP 30–NF 25. Rockville, MD; United States Pharmacopeial Convention; 2007:2750–2751. United States Pharmacopeial Convention. USP 30–NF 25. United States Pharmacopeial Convention. Rockville, MD; United States Pharmacopeial Convention. 2007:2751.

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