Title : Assessment of Quality of Tablets and Capsules
Objectives :
1) To measure the uniformity of diameter,
thickness and hardness of tablets.
2) To determine the tablet friability.
3) To determine the uniformity of weight of
tablets and capsules.
4) To understand the dosage performance test.
5) To discover the content of ibuprofen (assay).
Date of Experiment : 4 December 2014
Introduction :
Tablets and capsules are the example of the
oral dosage form used. They must follow the pharmacopoeial
standards which involve “added substances” that may influence toxicity,
interference with analytical method and many more. The standards that exist in
the British Pharmacopoeia and United Pharmacopoeia including the uniformity of
diameter, weight, content of active ingredient, uniformity of content,
disintegration and dissolution. Uniformity of diameter and weight of a tablet
or capsule may increase the patient compliance because of the uniform size of
appearance. The uniformity of active ingredient and content will make the
dosage supplied to the patients is correct and preventing from overdose cases.
Uniformity in disintegration and dissolution will make sure that each tablet
and capsule will have similar reaction when metabolized in the body. However, there are also
non-pharmacopoeial standards that are not included in the British Pharmacopoeia
and United Pharmacopoeia, but they still influence the properties of the
tablets and capsules. The non-pharmacopoeial standards involve hardness,
friability and bioavailability of the tablets and capsules. 5 different experiments are carried out in order to achieve the 5 main objectives.
Question :
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 tests is used to determine the
consistency in weight, size, and appearance of tablets, while the content test
is used to determine the uniformity of active ingredient in the tablets.
2. State the types of
tablets and capsules that must be tested for uniformity of diameter and
uniformity of content?
Uniformity
of diameter tests involves all the uncoated and coated tablets except 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 the non-compliance may be due to the uneven feeding of granules
into the die. Thus, leads to the
production of tablet with vary in weight. Next may become from the irregular movement of the
lower punch. Since the upper and lower punch did not moving at the same speed. This may cause the variation
in capacity of die space.
5. Explain the difference found in the procedure for dissolution test in the United States Pharmacopeia and the British Pharmacopeia.
4. Why does dissolution
test suitable to be used for batch to batch quality control?
Dissolution testing is to guarantee the
quality of the pharmaceutical product. The dissolution test should highlight a change when it
occurs. This dissolution test ensures both batch to batch consistency and that
the dissolution profiles remain similar to those of pivotal clinical trial
batches. Furthermore, dissolution test can be used to support bioavailability of
a new pharmaceutical product. It gauges quality assurance and bioequivalence.
5. Explain the difference found in the procedure for dissolution test in the United States Pharmacopeia and the British Pharmacopeia.
In British Pharmacopeia,the dissolution test for tablets or
capsules is based on the rotating paddle
system.Tablets or capsules are placed in a basket of wire mesh,the mesh is
being small enough to retain broken
pieces of tablet but large enough to allow entry of solvent without wetting
problems.The basket may be rotated at any suitable aped,but most monographs
specify 50,100 or 1500 rpm.But the United States Pharmacopeia specifies for
solid oral dosage forms,employed with compendially recognised media volumes and
rotation speeds.
Conclusion :
The tablets shoud have desired physical strength to overcome the mechanical shock during handling and packaging.The capsules or tablets produced should give the best therapeutic effect and least side effect.The tablets produced also should follow British Pharmacopeia or United States Pharmacopeia in order to get the desired capsules or tablets.
References :
Aulton, M.E. 2002. Pharmaceutics: The Science of Dosage form Design. Edinburgh Churchill Livingstone.
Martin, A.N. 2006. Physical Pharmacy: Physical Chemistry Principles in Pharmaceutical Sciences. Ed. Ke-5. Philadelphia: Lea & Febiger.
Michael E. Aulton. 2007. 3rd Edition Aulton’s Pharmaceutics : The Design And Manufacture of Medicines. Churchill Livingstone Elsevier.
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