PHARM125_Capsules_S2014 - CAPSULES PHARM 125 Spring 2014 Readings Ansels Pharmaceutical Dosage Forms 8th Ed Chapter 7 Aultons Pharmaceutics 3rd Chapters

PHARM125_Capsules_S2014 - CAPSULES PHARM 125 Spring 2014...

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CAPSULESPHARM 125 - Spring 2014
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Readings°Ansel’s Pharmaceutical Dosage Forms: 8thEd, Chapter 7°Aulton’s Pharmaceutics, 3rd: Chapters 34-35°Remington, 21sted. Chapter 45 (Capsules: pages 918-928)2
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Learning objectives°Hard gelatin capsules±Advantages and disadvantages±Production of hard gelatin capsules±Industrial filling Methods±Excipients°Soft Gelatin Capsules±Advantages and disadvantages±Manufacture of soft gelatin capsules±Quality control of capsules°Content and weight uniformity°Stability testing°Disintegration°Dissolution°Moisture permeability test3
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Introduction°Capsules are defined as a solid dosage form in which API and/or inert substances are enclosed in a small shell of gelatin4
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Advantages of Capsules°Mask unpleasant taste, odor or appearance of a drug°Allow powders to be dispensed in an uncompressed form°Versatility for multiple filling of diverse systems°May be easier for some people to swallow°May be easier for some people to swallow°Better bioavailability than tablets5
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Disadvantages°Easily tampered°Easily affected by humidity and microbial contamination°May be difficult to swallow (hard capsules)°Highly soluble salts generally should not be dispensed in hard gelatin capsulesdispensed in hard gelatin capsules6
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Source of GelatinGelatinGelatin: Is a translucent, colorless, brittle, nearly tasteless solid substance, derived from the collagen inside animals' skin and bones7
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Preparation of GelatinCollagen8
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Hard Gelatin Capsules°Why gelatin commonly used?°Non-toxic°Readily soluble in biological fluids at body temperature°Forms a strong flexible film°Consists of a body and a shorter cap that fits firmly over the body°Capsules are made of gelatin, sugar, water, colorants and opacifying agent (TiO2).opacifying agent (TiO2).°Can be filled with dry powders, granules, tablets, semi-solids and non-aqueous liquids°Gelatin:±Prepared by hydrolysis of collagen±Type A: Acid hydrolysis, uses pork skin as starting material±Type B: Basic hydrolysis, uses bovine bones9
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Manufacture of Empty Gelatin Capsules10Sequence of two-piece hard gelatin capsule shell manufacture1.Concentrated gelatin (35-40% in water) is prepared at 60-70 ºC2.Vacuum applied to remove any air bubbles3.Aliquots of this solution dispensed in suitable containers4.Capsules formed by dipping moulds (22ºC) into conc gelatin (gelatin temp. 45-55ºC DippingQ-U6QQ
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Sizes (for human use)11
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Industrial Machine Filling12Use capsule body to measure powder
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Industrial Machine Filling13
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