CAPSULES: DEFINITION TYPES AND STANDARD TESTS:

CAPSULES:  A small container, A pill in the form of a small rounded gelatinous container with medicine inside

 DEFINITION TYPES AND STANDARD TESTS:

Capsules are solid dosage forms in which the drug or a mixture of drugs is enclosed in hard gelatin capsule shells in soft soluble shells or gelatin or in hard or soft shell of any other suitable material of various shapes and capacities.

Following are the Types of Capsules:

1. Hard Capsules. 2. Soft Capsules. 3. Modified release Capsules. 4. Enteric Capsules.

Empty Gelatin Capsules Sizes.

HARD GELATIN CAPSULES: - These sizes are designated by numbers.

1. 000(Triple Zero) --- Biggest Size

2. 00(Double Zero) 

3. 0(Zero)

4. 1(One)

5. 2(Two)

6. 3(Three)

7. 4(Four)

8. 5(Five) --- Smallest Size 

SOFT GELATIN CAPSULES: These are classified depending upon the shapes, sizes and capacities.

The numbers represents capacities in minims.

1. Round - 1, 2, 3, 4, 5, 6, 7, 8, 9, 28, 40T, 80T and 90.

2. Oval - 1, 2, 3, 4, 5, 6, 7.5, 10, 12, 16, 20, 40, 60, 80, 85 and 110. 

3. Oblong - 3, 4, 5, 6, 8, 9.5, 11, 14, 16, 20, 90 and 360.

4. Tube - 5, 6, 8, 17.5, 30A, 30B, 35, 45, 55, 65, 90, 160, 250, 320 and 480. 

5. Misc. - 6, 17, 30, 35, 60 and 80. 

CAPSULES: Standards and Limits:

1. Description: It should comply with Specifications of Product.

2. Content of Active Ingredients.

Limit: 90 to 110% of label claim. 

3. Uniformity of Weight.

Average weight of Capsules content Less than 300 mg

Percentage Deviation 10%

Average weight of Capsules content 300 mg and more

Percentage Deviation 7.50%

4. Disintegration Test.

Hard Capsules - Disintegration time shall not be more than 30 minutes.

Soft Capsules - Disintegration time shall not be more than 60 minutes.

Enteric Capsules - Acidic Medium – Shall not disintegrate for 2 hours and in alkaline 

Medium capsules shall disintegrate within 30 minutes.