level: Level 5
Questions and Answers List
CAPSULE
level questions: Level 5
| Question | Answer |
|---|---|
| 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. | Dissolution test |
| The dissolution medium is held in a covered 1000ml glass vessel and maintained at __ TEMPERATURE by means of a constant temperature suitable water bath. | 37 °C ±0.5 °C |
| TESTING OF CAPSULES DISSOLUTION | Six capsules are tested and are accepted if each of them is not less than monograph specified i.e., p +5% If it fails then additional six capsules are tested the result is accepted if the avg. of 12 capsules is greater than or equal to p and none of them is less than p-15% If the capsule still fails the test the additional 12 capsules are tested and are accepted if the avg. of 24 is greater than to p, if not more than two less than p-15% and none of them is less than p-25% |
| Dissolution test apparatus: | 1 Apparatus-1 (rotating basket dissolution apparatus) 2 Apparatus-2 (rotating paddle dissolution apparatus) |
| Small wire mesh size basket-22 Temperature 37 15°c Rotated speed-25-150rpm Dissolution medium height from the bottom of the vessel -23-27mm. | Apparatus-1 (rotating basket dissolution apparatus) |
| Small wire mesh size: 22 Dissolution medium height from the bottom of the vessel -23-27mm Temperature 37+5°c Rotated speed-25-150rpm | Apparatus-2 (rotating paddle dissolution apparatus) |
| This test is carried out to assure the suitability of containers for packaging of capsules. | moisture permeation test |
| Moisture permeation test PACKAGING OF CAPSULES | 1 Single unit containers-blister pack or strip pack. 2 Unit dose containers-glass or plastic bottle is to be determined. |