QUESTIONS

Question: 

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

The uniformity of diameter should be achieved for the appearance of the tablet should be elegant and its weight, size and appearance should be consistent, also to remove any doubt arisen. The content uniformity test is used to ensure that every tablet contains the amount of drug substance intended with little variation among tablets within a batch.

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

All coated and uncoated tablets and all capsules intended for oral administration where the range of size of the dosage form available include 50mg or smaller sizes.

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

i. The test is limits for the average weight of uncoated compressed tablets only.

ii. The weight of every single tablets is varies among each other. 

iii. The human error may occurred especially during weighting the tablets. 

4.  why does dissolution test suitable to be used for batch to batch quality control?
Dissolution of taste-masked bulk drug is an important test method for both product development and quality control.  This process is suitable to batch-to-batch quality control as the consistency can be assured, and dissolution data on the taste-masked drug is frequently predictive of dissolution of the tableted product.The USP 2 paddle apparatus at 50-100 rpm suitable for dissolution testing of taste-masked drug as well.The media used for the taste-masked drug should match that of the finished product to maximize the value of the test.  Dissolution test is an essential part of drug development,where information on test batches used in bioavailability/bioequivalence studies and pivotal clinical studies to support specifications for quality control can be obtained.

5. Explain the difference found in the procedure for dissolution test in United States Pharmacopoeia and the British pharmacopoeia.
For the ‘ sink conditions’ the British Pharmacopoeia(BP) define as a volume of test fluid at least 5 to 10 times saturation volume while United Stated Pharmacopoeia(USP) define as not less than three times that required to form a saturated solution of the drug substances.

Test conditions are chosen to provide a ‘gentle hydrodynamic regimen’. Test fluids that are closer to physiological media are preferred to those composed of mixtures of water and organic solvents or to solutions containing surfactants. BP consider that the limits applied to this test offer an acceptable of assurance of total dissolution while USP use a pragmatic approach to try and find compromise conditions that satisfied all cases.