PRACTICAL 4 : Experiment 2 - Table friability
PRACTICAL 4 : Experiment 3 - Uniformity of weight of tablets and capsules
PRACTICAL 4 : Experiment 4 – Dosage performance tests
Practical 4 : Experiment 5 -Content of ibuprofen (assay)
Questions:
1. What are the objective of the tests for uniformity of diameter and uniformity of content?
1. What are the objective of the tests for uniformity of diameter and uniformity of content?
The test for uniformity of diameter is
done to determine the consistency in size and appearance of tablets, while the test
for uniformity of content test is done to
ensure the consistency of dosage units, each unit in a given batch should
contain the active drug within a narrow range around the label claim.
2. State the types of
tablets and capsules that must be tested for uniformity of diameter and
uniformity of content?
The test for diameter involves all the uncoated and coated tablets except for the enteric
tablets, film-coated tablets and sugar-coated tablets. The
test for content uniformity is required for all dosage forms.
3. Give reasons for the
non-compliance to test for uniformity of weight.
The
reasons for the non-compliance may be due to the uneven feeding of granules
into the die. Furthermore, it might be from the irregular movement of the
lower punch. This may cause the variation in capacity of die space.
4. Why does dissolution test suitable to be used for batch
to batch quality control?
Dissolution
testing is used to formulate the drug dosage form and to develop quality
control specifications for its manufacturing process This dissolution test ensures both batch to batch
consistency and that the dissolution profiles remain similar to those of
pivotal clinical trial batches. The test is used to identify any potential
problem that may occur in the bioavailability of the product over a period of
time Furthermore, dissolution test is used to obtain clinical results for the
support of the product specification in the product quality control and to
obtain information on the ability of test batches to dissolve in the
bioequivalence studies. .
5. Explain the difference found in the
procedure for dissolution test in the United States Pharmacopeia and the
British Pharmacopeia.
In USP, the dissolution procedure consists of
three stages, in which the next stage is proceeded only if the previous stage
is failed.
In BP, the test is carried out with 6 units of tablets or capsules and the result should be, for each unit tested, the amount dissolved is not less than 70% of the active ingredient within 45 minutes. If one unit fails to meet this requirement, a retest of another 6 units are carried out and the requirement is the same for all unit but one of the total units.
Thank you for sharing this blog. It is very important and very nice. I like the content and the information you have shared. I loved your explanation. I would like to suggest you about Dissolution Profile
ReplyDeleteCompany in Mumbai, India It is outstanding amongst other company of disintegration profile and it has best arrangement organization with best and diverse solution. The company provides best services with best deals of best dossiers products. It is also a Stability Study Company in Mumbai, India The organization has best specialists to indentify every one of the items with best fixing of pharmaceuticals .The company pharma products are been quality assured by the experts and it also has one of best customers satisfaction among the other companies in India.