Evaluation of capules

Evaluation tests for capsules

1. Evaluation of capsules By Shaik Sana Banu , Third year. Rao’s college of pharmacy, Nellore.

2. Capsule Definition : Capsule is a solid dosage form in which the drug is enclosed in a hard or soft soluble container, usually of a form of gelatin .

3. Evaluation tests for capsules Evaluation tests for capsules are listed below: Stability tests Shell integrity test Determination of shelf life Invariability tests weight variation Content uniformity Disintegration test Dissolution test Moisture permeation test

4. I . Stability tests Stability tests for capsules are performed to know the integrity of gelatin capsule shell (but not to known the stability of therapeutically active agent) and for determining the shelf life of capsules. The test helps in improving the quality of contents of capsule shell and for choosing the appropriate retail package.

5. Contd …. Before actually performing the tests following fact : The capsule shell are to be stabilized to know atmospheric condition with relative humidity about 20-30% and temperature about 21-24⁰c. a) Shell integrity test: This test is performed to find out the integrity of capsule shell. The standard capsule shells kept at the room temperature 40⁰c and 80% RH becomes more soft, sticky and swollen. b) Determination of shelf life: Shelf life or the expiry date of packed capsules is determined under normal storage conditions.

6. II . Invariability tests The invariability in the medicaments packed in the capsule shells can be determined by performing the following tests: Weight variation test Content uniformity test

7. III. Disintegration test Disintegration test is a method to evaluate the rate of disintegration of solid dosage forms. Disintegration is defined as the breakdown of solid dosage form into small particles after it is ingested. The shell pieces after disintegration may agglomerate forming large mass of gelatin taking more time to dissolve and may adhere to the mesh thus, blocking the holes. According to USP, place one dosage unit in each of the tubes of the basket with water or any other specified medium (depends on individual monograph) maintained at 37.3°C.

8. Contd … Attach a removable wire cloth with a plain square weave of 1.8-2.2 mm of mesh aperture and a wire diameter of 0.6-0.655mm to the surface of upper rack of the basket assembly. Observe the capsules for a time limit , at the end of prescribed time, all of the capsules must have been disintegrated excluding the fragments from the capsule shell. If 1 or 2 capsules fail, the test should be repeated on additional of 12 capsules. Then, not fewer than 16 of the total 18 capsules tested should disintegrate completely.

9. Disintegration apparatus

10. IV. Dissolution test Dissolution test is an official method to determine the dissolution rate of a solid dosage form. Dissolution rate is defined as the rate at which the drug is released into the systemic circulation from the dosage form.

11. Contd … Dissolution test apparatus:- Apparatus-I (rotating basket dissolution apparatus ): Small wire mesh size basket – 22 Temperature - 37±5⁰c Rotated speed – 25-150rpm Dissolution medium height from the bottom of the vessel – 23-27mm.

12. Contd … Apparatus-2 (rotating paddle dissolution apparatus): Small wire mesh size: 22 Dissolution medium height from the bottom of the vessel – 23-27mm Temperature - 37±5⁰c Rotated speed – 25-150rpm

13. V. Moisture permeation test This test is carried out to assure the suitability of containers for packaging of capsules. The moisture permeating feature of capsules packaged in Single unit containers-blister pack or strip pack. Unit dose containers glass or plastic bottle is to be determined.