Questions for practice of Assessment of Quality of Tablets and Capsules

1. What are the objectives of the tests for uniformity of diameter and uniformity of

content ?

The objective of the test for uniformity of diameter is to determine the diameter, thickness and hardness of the tablet. On the other hand, the objective of the test of uniformity of content is to standarlised the contents are within limits set with reference to the average content of the sample. So that the dose of the drugs are uniform.

2. State the types of tablets and capsules that must be tested for uniformity of diameter and uniformity of content.

For tablets                   : uncoated and coated, effervescent, enteric-coated and modified-release

For capsules                : hard, soft, enteric-coated, and modified-release

3. Give reasons for the non-compliance to test for uniformity of weight.

The uniformity of weight can be due to uneven feeding of granules into the die by hopper shoe due to uneven powder flow. Granules with poor flowability may affect the weight uniformity also. Besides that, powders may stick or adhere to the punch which will directly affects uniformity of tablets and capsules.

4. Why does dissolution test suitable to be used for batch to batch quality control?

The dissolution test is suitable to be used for batch to batch quality control as the dissolution instrument used consists of eight dissolution flasks. Seven tablets of the same kind and type but from different batches can be tested simultaneously. One of the dissolution flask contains only dissolution medium without any tested tablet. Here, the dissolution medium is used to replace the volume of aliquot withdrawn for analysis.

5. Explain the difference found in the procedure for dissolution test in the United States Pharmacopoeia and the British pharmacopoeia.

United States Pharmacopoeia	British Pharmacopoeia
Uses both rotating-basket method and paddle method.	Uses rotating-basket method, paddle method and flow-through cell method.
The flask used is cylindrical with spherical bottom, which is made of plastic or glass.	The flask used is cylindrical with flat bottom, which is made of glass.
In basket method, the basket position is 2.5±0.2cm from the bottom of the flask.	In basket method, the basket position is 2.0±0.2cm from the bottom of the flask.
The speed used is 25-150rmp ± 4%.	The speed used is 25-150rmp ± 5%.
In dissolution medium where water is not specified, addition of purified pepsin to acidic media or pancreatin for media at or above pH6.8.	Dissolution medium is 4g/L solution of NaOH is not deaerated prior to testing.
Consist of 3 stages, S1, S2 and S3. The test is continued through the 3 stages if the result cannot be comfirmed at either S1 or S2.	-If one fails this requirement, a further 6 may be tested individually and all must comply. No retesting is permitted.
To determine compliance in the dissolution requirements where stated in the individual monograph for a tablet or a capsule dosage form.	-To determine the dissolution rate of active ingredient of solid dosage forms.
Dissolution amount is Q. There is an Acceptance table. In this practical, it is not less than 75% in 30 minutes.	Dissolution amount not less than 70% of the prescribed at stated amount.