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Capsules by Satish

Capsules are solid dosage forms where the drug is enclosed in a tasteless gelatin shell. There are two main types: hard gelatin capsules which are used for powders, and soft gelatin capsules which are used for liquids and semisolids. Quality control tests for capsules include uniformity of weight, content uniformity, and disintegration time.

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sanjeev khanal
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31 views8 pages

Capsules by Satish

Capsules are solid dosage forms where the drug is enclosed in a tasteless gelatin shell. There are two main types: hard gelatin capsules which are used for powders, and soft gelatin capsules which are used for liquids and semisolids. Quality control tests for capsules include uniformity of weight, content uniformity, and disintegration time.

Uploaded by

sanjeev khanal
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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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.

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