Capsule 1 manufacturing and qc test by Kailash Vilegave

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MANUFACTURING OF HARD GELATIN CAPSULES AND EVALUATION OF CAPSULES



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Capsule 1 manufacturing and qc test by Kailash Vilegave

  1. 1. SEMINAR ONMANUFACTURING OF HARD GELATIN CAPSULESAND EVALUATION OF CAPSULES SEMINAR BY :Mr Kailash Vilegave M Pharm. Pragnayraje
  2. 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. 3. GELATIN Properties Types : Type – A Type – B * By Acid Hydrolysis.* By Alkaline Hydrolysis. * Firmness. * Plasticity. Pragnayraje
  4. 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. 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. 6. OPAQUISING AGENT Eg. Titanium Dioxide (0.5%) PRESERVATIVE WATER-Hot deminearlised water is used in the prepration of dipping solution. Pragnayraje
  7. 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. 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. 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. 10. REFERENCES* Pharmaceutical dosage forms by Leon Lachman.* Dispensing For Pharmaceutical Students by Cooper and Gunn.* www.google.com Pragnayraje
  11. 11. Pragnayraje

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