EXCIPIENTS

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PHARMACEUTICAL EXCIPIENTS Presented by: Akshay Mundhe Guided by: Mrs.S.N fuloria DEPARTMENT OF PHARMACEUTICS

Pharmaceutical excipients::

Pharmaceutical excipients : Excipients are those substances which are added to the formulation other than pharmacologically active drug Excipients have slight or no action and added to formulation to get the desired properties . According to IPEC “ Excipients are those product having slight or no action and intended to added in formulation to make formulayion more effective

IDEAL PROPERTIES OF EXCIPIENTS :

IDEAL PROPERTIES OF EXCIPIENTS EXCIPIENTS Pharmacologically Inert No Interaction with Drug Cost effective Feasible Stable for handling

Functionalities of Excipients :

Functionalities of Excipients Excipients have different kinds of properties depending on its properties different concentrations are used to get desired use and all this thing depend upon physicochemical properties of excipients Same excipient can be use for different purpose at different concentration Use of excipients defines Dosage form Drug release Stability acceptibility

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EXCIPIENTS FUCTIONAL CATEGORY PROPERTIES STARCH Binder Lubricant disintegrants Density-0.45-0.55 g/cm3 pH range-4.0-8 Solubility in Ethanol 95% Swelling temprature -64C GELATINS Coating agents Binders Thikening agents Viscosity modifiers Density 1.32g/cm3 pH range -3.8-8.0 solubility in glycerin Swelling temprature-68C HPMC Binder Coating agent Thickening agents Density ~_ 0.5g/cm3 pH range -3.0-6.0 Solubility in acetone LACTOSE Diluents Sweetening agents Density-1.589g/cm3 Brittle fracture index-0658 Soluble in water PROPERTIES OF SOME IMPORTNT EXCIPIENTS

EXCIPIENTS USED IN SOLID DOSAGE FORM:

EXCIPIENTS USED IN SOLID DOSAGE FORM EXCIPIENTS USE EXAMPLE Diluents Comprise the bulk of tablet or other dosage form Calcium phosphate (10-15%) Starch(5-10%) Calcium sulphate (5-10%) Microcrystalline cellulose (5-15%) Binders They are the glue to hold the granules or particle together Gelatin (6-18%) Starch paste(3-20%) HPMC(2-6%) Acacia(1-5%) Disintegrants The purpose of causing the compressed tablet to break when placed in aqueous medium some tablet doesnot need disintegrants such as chewable tablets Avicel pH 101 (3-9%) Starch1500 (10-15%) Alginic acid (1-5%)

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Excipients USE Examples Super disintegrants They are strong disintegrants causing rapid breakage of tablet In case of dispersible tablets Crosspovidone (2-5%) Cross carmalose Sodium (0.5-5%) Lubricants To ease the ejection of tablet from the die To prevention sticking of tablet to the punches Metal stearates (1-5%) Light mineral oil(2-6%) Sodium benzoate (1-5%) Sodium lauryl sulphate (1-2%) Glidants They reduce interparticular friction Sillica aerogels (1-5%) Calcium sillicate (1-3%) Antiadharants Avoid the sticking of powder or granule to the punch or die Magnesium stearates (0.25-5%) Calcium stearates (0.5-1%)

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Excipients USE Exmples Sweetners To background flavor and mouthfeel ( chewable tablets) Aspartame (2-8%) Cyclamate (2-5%) Lactose (5-10%) Flavors For consumer acceptance taste and mouthfeel Vanilla (2-5%) Liquorice (0.5-3%) Rosemary Colorants [ F&D,D&C,External D&C ] Asthetic appeal to consumer - product identification complimeny match to flavor Erythrosine(40) Sunset yellow ( 3) Tatrazine Indigotine

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Excipients USE Example Adsorbents These mainly use for adsorption of dosage form on gastric surface Kaolin (0.5-2%) Talc(1-3%) Opaquing agents Opaquing agents may provide protection against light( capsule) Titanium Dioxide(1-4%) Surfectants To increasethe wetting of the mass and enhance drug dissolution Sodium stearyl -2-lactylate Poloxamers( 2-5%) Sodium lauryl sulphate (5-10%)

EXCIPIENTS USED IN SEMISOLIDS:

EXCIPIENTS USED IN SEMISOLIDS Excipients Uses Examples Ointment bases Oleogenous base Adsorption bases Emusifying bases Medium for drug Form a occlusive layer on skin increse penetrtion Adsorption of water Contain hydrophillic surfactant Increse contact with skin Liquid parafin Fixed oil Wool fat Wool alcohole PEG 200 PEG1000 Buffer Compatibility with skin drug solubility and stability barrier effect ionisation Phosphate buffer (2-5%) Hydrochloride buffer

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Excipients USE Example Antioxidants prevent the oxidation in case of unsaturated oily phase Tocopherol Propyl gallate Methyl gallate Preservatives Water containing semisolid need protection against microbial growth Sodium benzoate Propyl paraben Methyl paraben Colorants Pleasant color provide asset for acceptance of consumer D&c 11(eosin) D&C Yelliw no; 7 Thickening agent Maintain liquid and solid constituent together Sodium CMC (5-10%) Tragacanth (5-15%) Gelling agent To form gel with high optical clarity Natural polymers (5-10%) Semisynthetic polymers (2-8%) Up to 1% } Up to 0.30%

EXCIPIENTS USED IN LQUID PREPRATION :

EXCIPIENTS USED IN LQUID PREPRATION Excipient Uses Example Vehicle Dissolution or carry out drug to intended route Purified water Water for injection Sterile WFI Cosolvants Increase solubility of water minimize chemical degradation Glycerin PEG Antimicrobial preservative Prevent solution from microbial reaction Bezalkonium chloride (0.25-1%) Thiomersals ( 0.3-0.5%) Mercurials (0.03-0.5%)

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Excipients Uses Example Antioxidants Prevent degradatin of drug Prevent rancidity of vegetble oil Sodium sulphate (0.5-1%) Sodium bisulphate(0.3-0.7%) Ascorbic acid (up to 1%) Thioglycerols (up to 0.5%) Buffers Adjusting and maintainng PH of the formulation Acetate Buffer -;3-6 Citrate Buffer ;- 3-6 Phosphate buffer 6-8 Glutamate Buffer ;- 8-10 Tonicity Adjuster To make the solution tsotonic i.e. have equal osmotic pressure as to blood Nacl-0.9% Manitol Sorbitol surfactants They act as wettig agent in suspention for miscellar solublization Polysorbate -80 ( 10-15%) Poloxy ethelyne –poloxypropylyne ether (5-15%) Up to 2%

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EXCIPIENTS Uses Example Suspending agents They impart viscosity to formulation and slowdown setting Methyl cellulose (5-10%) CMC 5-15% PVP ( up to 10%) Emulsifier To promote emulsification to maintain stability of emusification Ethylene glycol (3-15%) Sorbitan distearate( 5-10%) Amerocol Lecithin (3-10%) Chelating agents They bind to the heavy metal which catalyse oxidative degradatio Disodium EDTA (0.5-2%)

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Excipients Uses Examples Complexing agents They increse solubility by complexation 2-oH propyl cyclodextrine Protein stabilizer Stabilize protein ,drug form aggregation Glycine 0.5-1% Lysine 0.3-0.5% PVP0.5-1% Bulking agents Increse the bulk of freez dried product Manitol 10-15% Lactose 5-20%

EXCIPIENTS USED IN COSMETICS:

EXCIPIENTS USED IN COSMETICS Excipients Uses Examples Ointment bases Oleaginous base Adsorption bases Emulsifying bases Medium for drug Form occlusive layer on skin increase penetration Adsorption of water Contain hydrophilic surfactant Increase contact with skin Liquid paraffin Fixed oil Wool fat Wool alcohol PEG 200 PEG1000 Buffer Compatibility with skin drug solubility and stability barrier effect ionization Phosphate buffer Hydrochloride buffer

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Excipients uses Example Surfectants Reduce the interfacial tension between oil and water IONIC- sodium lauryl sulphate NON IONIC- cetyl alcohole Humectants Prevent the loss of moisture retain the natural moisture of skin Calcium chloride Sodium lactate glycerin Preservatives Water containing semisolid need protection against microbial growth Sodium benzoate 0.5-2% Benzalkonium chloride 0.5-1% Thiomersals Antioxidants prevent the oxidation in case of unsaturated oily phase Tocopherol 0.03-0.5% Propyl gallate0.5-1% Methyl gallate

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Excipients Use Examples Colorants [ F&D,D&C,External D&C ] Asthetic appeal to consumer - product identification complimeny match to flavor Erythrosine(40) Sunset yellow ( 3) Tatrazine Indigotine Emulsifying agents To promote emulsification to maintain stability of emusification Ethylene glycol Sorbitan distearate Amerocol lecithin opacifiers In transparent cosmetic product to render them opaque Titanium, dioxide Zinc oxide PEG400

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EXCIPIENTS USES EXAMPLE Detrgents For wetting ,foaming emulsifying, Removal of Dirt Monoethylamine Diethyl SLS Binders For cohesion of solids CMC Sodium alginate Tragacanth Adsorbent To take up the water and oil soluble substance Bentonite Calcium carbonate starch Abrasive To remove material from body surfaces and to produce gloss Calcium carbonate Dicalcium phosphate

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Excipients Uses Examples Sweetening agents To make the taste more acceptable Sodium sacchrin 2-5% Cyclamate (up to 5%) dextran Sesquetering agents Ability to form complex metal ion Disodium EDTA (0.5-1%) Foam boosters To improve foaming charecterstics Xanthin gum 0.5-1% Lauramide DEA Sarcosinates Thickening agents They increase the viscosity make the flow more plastic HPMC (3-10%) CMC(5-10%) Carbopol 934

Refernces:

Refernces Pharmaceuticeutical dosage form : Tablets Volume1 by Herbert liberman and Leon Lachman Pharmaceutical dosage form of drug delivary by Ansel Textbook of cosmetic and herbal technilogy by Shobha Rani Hiremath Modern pharmceutics by Gilbert and Banker Handbook of pharmaceutical Excipients by Ramond C Row , Paul J sheskey , Marian E Quin

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