Capsule 1 manufacturing and QC test by Kailash Vilegave

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MANUFACTURING OF HARD GELATIN CAPSULES AND EVALUATION OF CAPSULES Capsule

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Pragnayraje SEMINAR ON MANUFACTURING OF HARD GELATIN CAPSULES AND EVALUATION OF CAPSULES SEMINAR BY : Mr Kailash Vilegave M Pharm.

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INTRODUCTION – Mothes and Dublane was first patent one piece capsule made from gelatin in 1834 . James Murdock was first person to get British Patent of two piece hard gelatin capsule in 1848. MANUFACTURING OF HARD GELATIN CAPSULES : Gelatin 4. Opaquising Agent Plasticizer 5. Preservative Colorants 6. Water Pragnayraje

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GELATIN Properties Types : Type – A Type – B * By Acid Hydrolysis.* By Alkaline Hydrolysis. * Firmness. * Plasticity. Pragnayraje

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# BLOOM STRENGTH : It measures weight in grams required to move a standard plunger (dia – 0.5 inches to a fixed distance ) into a surface of 6.66% w/w held at 10 for 17 hrs. # VISCOSITY : Low viscosity ( 25-35 mp) High Bloom Strength ( 150-250 gm ) Pragnayraje

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PLASTICIZER 5-10 % conc. is used for hard gelatin shell. 10-15% conc. is used for soft gelatin shell. COLORANTS Generally of two types : a. Soluble dyes. b. Insoluble Dyes. Aluminium Lakes Lakes Pragnayraje

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OPAQUISING AGENT Eg. Titanium Dioxide (0.5%) PRESERVATIVE WATER -Hot deminearlised water is used in the prepration of dipping solution. Pragnayraje

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FLOW CHART FOR PREPRATION OF GELATIN FROM RAW MATERIAL Dry Bone 5% Hcl Lime 10 % Lime Bone meal 10-15 Dicalcium 4-8 hrs Removed days Phosphate Calf Skin Lime 10 % Water Bath Wash 6-12 hrs 10-30 hrs Pork skin Acid 1-5 % Acid removal Wash Hcl 10-30 hrs Hot water extractor Air Dry Cool To solidify Vaccum Concn Filter Mill To Size Pragnayraje

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EVALUATION OF CAPSULES Following are the tests that should be carried out for evaluation of the capsules : Uniformity of weight. Content of the active ingredients in the capsules. Disintegration Test. Dissolution Test. Uniformity of weight : - 20 intact capsules taken . Pragnayraje

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Content of the active ingredients in the capsules : - Generally 20 capsules or such other no as indicated in the monograph are taken . Disintegration Test : - One one capsule is placed in each of the six tubes of the basket and temperature is maintained at 37 + 2 Dissolution Test : 1000 ml of water of 36.5 to 37.5. The sample passes the test if the amount of active ingredients in the soln. is not less than 70%. Pragnayraje

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REFERENCES * Pharmaceutical dosage forms by Leon Lachman. * Dispensing For Pharmaceutical Students by Cooper and Gunn. * www.google.com Pragnayraje

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