Capsules

Capsule are the solid unit dosage form of

medicament in which the drug(s) is enclosed in a
practically tasteless, hard or soft soluble container
or shell made up of a suitable form of gelatin. Most
capsules are intended to be swallowed whole.
Generally capsules are of two types viz: Hard
gelatin capsules and Soft gelatin capsules.
 Hard gelatin capsules:

• Made up of a base containing plasticizers and

water. The base may also contain
preservatives, colors, flavors and sugars.
• Capsule shells are made up of two cylindrical
halves, cap and body.
• These capsules are used for filling powders.
Table: Different size of capsule shell
Size Fill volume (ml)
000 (Biggest) 1.40
00 0.95
0 0.68
1 0.50
2 0.37
3 0.30
4 0.21
5 (Smallest) 0.13
 Soft Gelatin Capsules

• These capsules are soft, elastic in nature and have

thicker shells than hard capsule.
• They are prepared from gelatin and water to which
glycerin, sorbitol or propylene glycol has been added as
plasticizers which make the capsules flexible.
• The capsules are used for filling liquids and semisolids.
• These capsules are available in a number of shapes and
sizes e.g. spherical, ovoid, and cylindrical and tubes.
The spherical capsules are also known as "pearls".
• Soft capsules are generally manufactured by two
methods: Rotary die process and plate process.
Quality control test for capsule /compendial requirements for capsule (Hard Gelatin
Capsules)

• 1. General characteristics- Same as discussed

under Tablets.
• 2. Content of Active Ingredient / Absolute
drug content test (Assay) - Same as discussed
under Tablets.
 3. Uniformity of Weight (Weight variation): IP 2018

Average weight of Percentage

capsules deviation (%)
Less than 300 mg ±10 %
300 mg and more ±7.5 %
4. Uniformity of content (CU or C/U) - Same as
discussed under Tablets.
5. Disintegration time test (IP 2018)
Type of capsules Time limit for Disintegration medium Temperature (°C)
disintegration
Hard gelatin capsules 30 minutes Water (Unless otherwise 37±2
specified)

Soft gelatin capsules 60 minutes Water (Unless otherwise 37±2

specified

Enteric coated capsules 60 minutes Mix phosphate buffer of 37±2

(granules)* pH 6.8

*Prior to phosphate buffer the capsules (granules or pellets) are subjected to

the test for two hours using 0.1 M HCl as the medium and no capsules
(granules or pellets) should show any sign of disintegration or rupture
allowing the contents to escape.
6. Dissolution test- Same as discussed
under Tablets.