QUESTIONS

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 make sure the tablets produced are all uniform in size. This is important in the later process of tablet packaging either blister packaging or plastic container. The test for uniformity of content is to ensure that each tablet contains the similar amount of active ingredients and excipients so that each tablet contains correct dose of drugs. Hence, the bioavailability and efficacy carried out by the drug is the same for each of the tablet taken orally.

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

Enteric coated tablets, film coated tablets and sugar coated tablets must be tested for tests for uniformity of diameter meanwhile the uniformity of content tests is done on uncoated tablets and compression coated tablets.

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

The reason for non-compliance to test for uniformity of weight is the uneven feeding of granules into the die. Although the weight calculated is uniform, it does not determine the uniformity of amount of active ingredient in each tablet or capsule. Besides that, the irregular movement of the lower punch will cause the variation in capacity of die.

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

Dissolution test is suitable in QC to assess batch to batch consistency and detect deviations of manufacturing, to identify critical manufacturing variables like Binder effects, Mixing effects, Granulation Procedure, Coating Parameters, to assess excipients role in different dosage forms, and to study the non-traditional production effects associated with NDDS.

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
The tools used for dissolution test is are Spinning basket similar to the British Pharmacopoeia and paddle that spin in the liquid solvents	The tool used for dissolution test is a ‘Cylindrical Steel Basket’ where tablets are placed inside the basket and spin in a solvent liquid
Dissolution process should be done to all solid dosage forms unless it is unsuitable to be conducted to the solid dosage form	Dissolution should only be done when there is dissolution problem predicted to occur in solid dosage form