Tablet:Quality control tests for tablets
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Contents |
Official Standards as per I.P. / B.P. / U.S.P.
(65-67)
TABLE: 54. COMPARISON OF DIFFERENT PHARMACOPOEIAL QUALITY CONTROL TESTS
|
PHARMACOPOEIAS |
TYPE OF TABLET |
TESTS TO BE PERFORMED |
| BRITISH PHARMACOPOEIA | For all tablets | Content of active ingredients Disintegration |
| Uncoated tablet |
Disintegration test Uniformity of weight |
|
| Effervescent tablet | Disintegration test Uniformity of weight |
|
| Coated tablet |
Disintegration test Uniformity of weight |
|
| Gastro resistant tablet |
Disintegration test |
|
| Modified release tablet |
Uniformity of weight | |
| Tablet for use in mouth |
Uniformity of weight | |
| Soluble tablet |
Disintegration test Uniformity of weight |
|
| Dispersible tablet | Disintegration test Uniformity of dispersion |
|
| INDIAN PHARMACOPOEIA | Uncoated tablet | Uniformity of container content Content of active ingredient |
| Enteric coated tablet |
Disintegration test | |
| Dispersible tablet | Uniformity of dispersion Disintegration |
|
| Soluble tablet | Disintegration test | |
| Effervescent tablet | Disintegration/ Dissolution / Dispersion test |
|
| UNITED STATES PHARMACOPOEIA | Physical tests applicable to tablet formulation | Bulk density /Tapped density of powder Powder fineness |
Non – compendial standards
(2,13)
Measurement of mechanical properties is not covered pharmacopoeial monograph. There are also a number of tests frequently applied to tablets for which there are no pharmacopoeial requirement but will form a part of a manufacturer’s own product specification.
Hardness tests/ Crushing strength
The test measures crushing strength property defined as the compressional force applied diametrically to a tablet which just fractures it. Among a large number of measuring devices, the most favored ones are Monsanto tester, Pfizer tester, and Strong cobb hardness tester. All are manually used. So, strain rate depends on the operator. Heberlein Schleuniger, Erweka, Casburt hardness testers are motor driven.
Friability
(Official in USP)
The tablet may well be subjected to a tumbling motion. For example, Coating, packaging, transport, which are not severe enough to break the tablet, but may abrade the small particle from tablet surface. To examine this, tablets are subjected to a uniform tumbling motion for specified time and weight loss is measured. Roche friabilator is most frequently used for this purpose.
Tests for coated tablets
I. Water vapor permeability
II. Film tensile strength
III. Coated tablet evaluations:
i)Adhesion test with tensile-strength tester: Measures force required toe peel the film from the tablet surface.
ii)Diametral crushing strength of coated tablet: Tablet hardness testers are used. This test gives information on the relative increase in crushing strength provided by the film and the contribution made by changes in the film composition.
iii) Temperature and humidity may cause film defects. Hence studies are to be carried out.
iv) Quantification of film surface roughness, hardness, & colour uniformity. Visual inspection or instruments are used. Resistance of coated tablet on a white sheet of paper. Resisilient films remain intact, & no colour is transferred to the paper; very soft coating are readily “erased” from the tablet surface to the paper.
In – Process Quality Control
(13)
The control of the tableting process in production is concerned with the following :
I. Weight of tablet – Single pan electric balance.
II. Crushing strength – Controls friability and disintegration time.
III. Tablet thickness – Very thick tablet affect packaging particularly into blisters.
IV. Disintegration time.
V. Friability
As a part of Current Good Manufacturing Practice (cGMP), the production run is monitored under control chart. At regular interval (10 – 15minutes) the operator must sample specified number of tablets, weigh them individually, check thickness, crushing strength and all the properties as mentioned above. The process can be automated and interfaced with printer. Such data promotes process improvement.
Key Phrases
- USP mentions some of the quality control tests to be performed before the powder is compressed. e.g., powder fineness, density. etc.
- Friability is official test as per USP.
- At regular interval (10 – 15minutes) during the course of manufacturing the operator must sample specified number of tablets for testing
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