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Information about Excipients

Published on December 31, 2011

Author: dnyaneshwalunj

Source: authorstream.com

Slide 1: 1 WALUNJ DNYANESH R. Ist sem M. Pharm Department of Pharmaceutics. S.N.D College of pharmacy Bhabulgaon ,Yeola. EXCIPIENTS Slide 2: Contents: Introduction Excipients Excipients interaction Surfactant micell Formation Cyclodextrins Ion Exchange Resines Super disintegrants Thickners Film coating material Standardisation of Excipients Slide 3: Introduction: . An excipient is generally a pharmacologically inactive substance used as a carrier for the active ingredients of a medication In addition to their use in the single-dosage quantity, excipients can be used in the manufacturing process to aid in the handling of the active substance concerned . Depending on the route of administration, and form of medication, different excipients may be used. DILUENTS : DILUENTS Diluents are fillers used to increase the bulk volume of a tablet. By combining a diluent with the active pharmaceutical ingredients, the final product is given adequate weight and size to assist in production and handling. Lactose Types Spray dried lactose Fast-Flo lactose Tabletose Slide 5: Starch Can be corn, wheat or potato source USP grade of starch has poor flow & compression characteristics Specially dried starches also have standard moisture level of 2-4% Therefore not used in wet granulation Dextrose Available both anhydrous and a hydrate product Excellent compressibility and good flow Largest particle size, therefore blending problem may occur :  Mannitol Slow solubility Less sensitive to humidity Use as a filler in chewable tablets Sorbitol Widely used in sugar-free mints and as a vehicle in chewable tablets Maltodextrin Highly compressible Completely soluble Very low hygroscopic :  Sucrose Good flow properties and needs a glidant only when atmospheric moisture levels are high Excellent colour stability on aging Cellulose Microcrystalline cellulose The most important tablet excipient developed in modern times Inorganic calcium salts Inexpensive and possesses a high degree of physical and chemical stability Dicalcium phosphate Slide 8: Binders and Adhesives Binders hold the ingredients in a tablet together and their derivatives Disaccharides: sucrose, lactose starches, cellulose or modified cellulose such as microcrystalline cellulose and cellulose ethers such as hydroxypropyl cellulose (HPC) For granulation, solutions of adhesive materials like acacia, gelatin, liquid glucose, sucrose syrup, starch paste etc are employed to appropriate extents Slide 9: Disintegrants Disintegrants, an important excipient of the tablet formulation, are always added to tablet to induce breakup or disintegration of tablet when it comes in contact with gastro intestinal fluid. crospovidone, sodium carboxymethyl cellulose The modified starch , sodium starch glycolate... Preservatives Antioxidants like vitamin A, vitamin E, vitamin C, retinyl palmitate, and selenium The amino acids cysteine and methionine Citric acid and sodium citrate Synthetic preservatives like the parabens: methyl paraben and propyl paraben Slide 10: Lubricants, Antiadherents & Glidants Lubricants are the substance which prevent adhesion of the tablet material to the surface of the dies and punches, reduce interparticle friction, facilitate an easy ejection of tablets from the die cavity and improves rate of flow of tablet granulation. Commonly used lubricants are talc, magnesium stearate, calcium stearate, stearic acid, hydrogenated vegetable oil and PEG Glidant is a substance that improves the flow characteristics of a powder mixture. These materials are always added in the dry state just prior to compression. The most commonly used glidants are colloidal silicon dioxide and talc Slide 11: Antiadherents which prevent sticking to punches and die walls.Talc, magnesium stearate and corn starch have excellent antiadherent properties. Slide 12: Colours, flavours and sweeteners Colours Product identification Elegant look Natural vegetable colors – limited availability & unstable FD&C and D&C approved dyes are used. Flavors Rasberry, Pineapple, Peppermint, Blackcurrant, Orange, Mango, Strawbery – Slide 13: Sweeteners Earlier saccharin was the only artificial sweetener used. Its is 500 times sweeter than sucrose but has a bitter after taste and also carcinogenic properties Aspartame is the new sweetener- disadvantage is its instability in the presence of moisture. Glycerin,mannitol,dextrose, sorbitol Humactant Use to prevent drying out of preparation like creams and ointment. Eg. Glycerin, propylene glycol Slide 14: Acidifying Agents Used in liquid preparations to provide acidic medium for product stability Eg.citric acid , acetic acid.fumaric acid , nitric acid Adsorbants Holding other molecules on its surface Examples: cellulose, activated charcoal Aerosol propellant Agents responsible for producing pressure in container Examples: Dichlorodifluoromethane, Dichlorotetrafluroethane Carbon dioxide. Slide 15: Suspending agents They are used to reduce the rate of sedimentation of particles suspended. Examples: Agar, bentonite,hydroxymethyl cellulose,hydroxypropyl cellulose plasticizer Used as a component of film coating solution to enhance the coat over tablets ,beads, granules Examples:Glycerin,diethyl phthalate Slide 16: Surfactant Substance that absorb surfaces or interfaces to reduce surface tension. Examples: Benzolkonium chloride,polysorbate80 Solvents An agent used to dissolve another pharmaceutical substance or drug in preparation of solution Examples: Glycerin,alcohol,corn oil, cottonseed oil ,mineral oil, purified water, water for injection Viscosity increasing agents Used to enhance contact time, and thickness of topical creams Examples: Alginic acid, bentonite,sodium alginate, tragacanth, methylcellulose Surfactant Micelle Formation : Surfactant Micelle Formation NEWER EXCIPIENTS : NEWER EXCIPIENTS CYCLODEXTRINS : CYCLODEXTRINS Cyclodextrins (CDs) have been used in drug development only since the mid-1970s. In general, the parent CDs were introduced as food additives, and the modified CDs were introduced as proprietary pharmaceutical ingredients CDs are enabling excipients used to address solubility, stability, and bioavailability issues in a manner not possible with other inactive ingredients. ION EXCHANGE RESINS : ION EXCHANGE RESINS Ion-exchange resins are used as excipients in pharmaceutical formulations such as tablets, capsules, and suspensions. In these uses the ion-exchange resin can have several different functions, including taste-masking, extended release, tablet disintegration, and improving the chemical stability of the active ingredients. There are four main types differing in their functional groups 1)strongly acidic sulfonic acid groups 2) strongly basic quaternary amino groups Slide 21: 3)weakly basic carboxylic acid groups 4)weakly acidic primary, secondary, and/or ternary amino groups, e.g. polyethylene amine THICKNERS : THICKNERS Thickening agents, or thickeners, are substances which, when added to an aqueous mixture, increase its viscosity without substantially modifying its other properties, such as taste The agents are materials used to thicken and stabilize liquid solutions, emulsions, and suspensions. They dissolve in the liquid phase as a colloid mixture that forms a weakly cohesive internal structure. Examples are: Alginic acid (E400), sodium alginate (E401), potassium alginate (E402 ), Agar ,Pectin (E440),Gelatin FILM COATING MATERIAL : FILM COATING MATERIAL A film coating is a thin polymer-based coat applied to a solid dosage form such as a tablet, granule or other particle. The thickness of such a coating is usually between 20 and 100 μm. The vast majority of the polymers used in film coating are either cellulose derivatives, such as the cellulose ethers, or acrylic polymers and copolymers. Examples: Occasionally high molecular weight polyethylene glycols, polyvinyl pyrrolidone, polyvinyl alcohol and waxy materials use. SUPERDISINTEGRANTS : SUPERDISINTEGRANTS superdisintegrants are used in tablets and capsules to ensure that these comparts are rapidly broken down into the primary particles to facilitate the dissolution or release of the active ingredients.     Superdisintegrants which provide improved compressibility and which does not negatively impact the compressibility of formulations which include high dose drugs Examples: Crospovidone L-HPC: (Low substituted hydroxy propyl cellulose) Sodium starch glycolate Slide 25: Standardisation Aspects Identification of the substance : Product ID Product name Chemical name Chemical formula Manufacturer Distributor Composition/Information on ingredient : Hazards identification : Target organs Chronic helth hazard Slide 26: First aid measures : Eye contact Skin contact Inhalation Ingestion Fire fighting measures : Media to be used for fire fighting. Unusual fire Special protective equipments Slide 27: Handling and storage : Exposure controls : Engineering control: Information about the area usea. Respiratory protection: Information like used in ventilated area. Hand protection: Hand protection equipments Eye protection: Eye protection equipments Slide 28: Physicochemical properties : Stability and reactivity : Chemical stability Hazardous polymerisation Conditions to avoid Materials to avoid Compatibility factors : Slide 29: Toxicological information : Acute oral LD50 Sencitisation Mutagenicity Teratogenicity Carcinogenicity Skin irritation Eye irritation Ecological information : Biodegradability Aquatic toxicity. Disposal consideration : Slide 30: REFERENCES Howard C. Ansel, Pharmaceutical dosage form and drug delivery system,B.I publication,7th edition,page no-87-95 Leon Lachman, Herbert T. Liebermann , “ The Theory & Practice of Industrial pharmacy”, 3, 764-801. http://en..wikipedia.org/wiki/excipients Slide 31: 31 THANK YOU

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