Manufacturing of hard gelatin capsule

1. Pragnayraje
SEMINAR ON
MANUFACTURING OF HARD GELATIN CAPSULES
AND EVALUATION OF CAPSULES
.

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 Agent
2. Plasticizer 5. Preservative
3. Colorants 6. Water
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3. GELATIN
 Properties
 Types :
Type – A Type – B
* By Acid Hydrolysis.* By Alkaline Hydrolysis.
* Firmness. * Plasticity.
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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 )
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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
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6. OPAQUISINGAGENT
Eg.Titanium Dioxide (0.5%)
PRESERVATIVE
WATER
-Hot deminearlised water is used in the
prepration of dipping solution.
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7. 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 CoolTo solidify Vaccum Concn Filter
MillTo Size
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8. EVALUATIONOF 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.
 DisintegrationTest.
 DissolutionTest.
Uniformity of weight :
- 20 intact capsules taken .
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9. Content of the active ingredients in the capsules :
- Generally 20 capsules or such other no as indicated in
the monograph are taken .
DisintegrationTest :
- One one capsule is placed in each of the six tubes of the
basket and temperature is maintained at 37 + 2
DissolutionTest :
- 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%.
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10. REFERENCES
* Pharmaceutical dosage forms by Leon
Lachman.
* Dispensing For Pharmaceutical Students
by Cooper and Gunn.
* www.google.com
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