QUESTIONS FOR ASSESSMENT OF QUALITY OF TABLETS AND CAPSULES
1) What are the objectives of the tests for uniformity of diameter and uniformity of content?
-The objectives of the tests for uniformity of diameter are to increase the
patient compliance by increasing the quality of product appearance and also to
prevent any confusion towards the patient about the dosage of the medications.
The objectives of the tests for uniformity of content are to ensure uniform
dosage supplied to the patient and prevent from overdose cases due to
non-uniform amount of active ingredients in the capsules or tablets.
- Uniformity of diameter was introduced by the BP in 1958 to remove doubt.
Uniformity of diameter tests involves all the uncoated and coated tablets and
it is not applicable for the enteric tablets, film-coated tablets and
sugar-coated tablets. For uniformity of content tests, it involves all tablets.
3) Give reasons for the non-compliance to test for uniformity of weight.
-The reasons for non-compliance to test for uniformity of weight are uneven
feeding of granules into the die and due to irregular movement of the lower
punch that cause variation in capacity die space.
4) Why does dissolution test suitable to be used for batch to batch quality control?
- Drug absorption from a solid dosage form after oral administration depends on
the release of the drug substance from the drug product, the dissolution or
solubilization of the drug under physiological conditions, and the permeability
across the gastrointestinal tract. Because of the critical nature of the first
two of these steps, in vitro dissolution may be relevant to the prediction of
in vivo performance. Based on this general consideration, in vitro dissolution
tests for immediate release solid oral dosage forms, such as tablets and
capsules, are used to assess the batch to batch quality of a drug product.
5. Explain the difference found in the procedure for dissolution test in the United States Pharmacopoeia and the British Pharmacopoeia.
- In United States Pharmacopoiea (USP) only involved 4 types of apparatus which
are basket type, paddle type, reciprocating cylinder, flow through cell types;
whereas British Pharmacopoeia (BP) involves 3 apparatus which are basket type,
paddle type, and flow through cell type. Besides that, for testing in
conventional-released dosage forms, in USP the thermometer is removed after
dissolution medium is equilibrate to 37°C °C, whereas in BP, the test may also
be carried out with the thermometer in place, provided it is shown that results
equivalent to those obtained without the thermometer are obtained. The
difference in the procedure found in USP and BP could be due to the different
standard of level of dissolution set by the regulation of different countries.
Besides that, the linearity of the test conducted by both countries may be
different
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