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
# 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.
Low viscosity ( 25-35 mp)
High Bloom Strength ( 150-250 gm )
- 5-10 % conc. is used for hard gelatin shell.
- 10-15% conc. is used for soft gelatin shell.
Generally of two types :
a. Soluble dyes.
b. Insoluble Dyes.
Aluminium Lakes Lakes
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
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
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.
Uniformity of weight :
- 20 intact capsules taken .
Content of the active ingredients in the capsules :
- Generally 20 capsules or such other no as indicated in
the monograph are taken .
- One one capsule is placed in each of the six tubes of the
basket and temperature is maintained at 37 + 2
- 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%.