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Capsule 1 manufacturing and qc test by Kailash Vilegave
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Capsule 1 manufacturing and qc test by Kailash Vilegave

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MANUFACTURING OF HARD GELATIN CAPSULES AND EVALUATION OF CAPSULES …

MANUFACTURING OF HARD GELATIN CAPSULES AND EVALUATION OF CAPSULES



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  • 1. SEMINAR ONMANUFACTURING OF HARD GELATIN CAPSULESAND EVALUATION OF CAPSULES SEMINAR BY :Mr Kailash Vilegave M Pharm. Pragnayraje
  • 2. 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 :1. Gelatin 4. Opaquising Agent2. Plasticizer 5. Preservative3. Colorants 6. Water Pragnayraje
  • 3. GELATIN Properties Types : Type – A Type – B * By Acid Hydrolysis.* By Alkaline Hydrolysis. * Firmness. * Plasticity. Pragnayraje
  • 4. # 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
  • 5. 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
  • 6. OPAQUISING AGENT Eg. Titanium Dioxide (0.5%) PRESERVATIVE WATER-Hot deminearlised water is used in the prepration of dipping solution. Pragnayraje
  • 7. FLOW CHART FOR PREPRATION OF GELATIN FROM RAW MATERIALDry Bone 5% Hcl Lime 10 % Lime Bone meal 10-15 Dicalcium 4-8 hrs Removed days PhosphateCalf Skin Lime 10 % Water Bath Wash 6-12 hrs 10-30 hrsPork skin Acid 1-5 % Acid removal Wash Hcl 10-30 hrs Hot water extractorAir Dry Cool To solidify Vaccum Concn Filter Mill To Size Pragnayraje
  • 8. EVALUATION OF CAPSULESFollowing 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
  • 9. 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
  • 10. REFERENCES* Pharmaceutical dosage forms by Leon Lachman.* Dispensing For Pharmaceutical Students by Cooper and Gunn.* www.google.com Pragnayraje
  • 11. Pragnayraje

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