Quality Control tests for tablets

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Quality Control tests for tablets

1.11 Quality Control Tests for Tablets

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1.11.1 Official Standards as per I.P. / B.P. / U.S.P.

1.11.2 Non - compendial standards

1.11.3 In - Process Quality Control

1.11.1 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

Uniformity of content

Labeling

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

Uniformity of weight

INDIAN PHARMACOPOEIA

Uncoated tablet

Uniformity of container content

Content of active ingredient

Uniformity of weight

Uniformity of content

Disintegration test

Enteric coated tablet

Disintegration test

Dispersible tablet

Uniformity of dispersion

Disintegration

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Soluble tablet

Disintegration

Effervescent tablet

Disintegration/ Dissolution / Dispersion

test

UNITED STATES PHARMACOPOEIA

Physical tests applicable to tablet formulation

Bulk density /Tapped density of powder

Powder fineness

Loss on drying

Disintegration test

Tablet friability

Dissolution test

Drug release testing

Uniformity of dosage form

Container permeation test

Labeling of inactive ingredients

1.11.2 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.

I.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.

II. 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

1.11.3 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

OUSP mentions some of the quality control tests to be performed before the powder is compressed. e.g., powder fineness, density. etc.

OFriability is official test as per USP.

OAt regular interval (10 - 15minutes) during the course of manufacturing the operator must sample specified number of tablets for testing.

About the Author

Dr.Mukesh Gohel's picture
Author: Dr.Mukesh Gohel

Dr. Mukesh Gohel is principal, professor at the LMCP, Ahmedabad served in academics for more than 40 years. He provides training in leading pharmaceutical industries in the areas of Design of Experiments and Quality by Design. His current areas of interest are direct compression and improvement of drug dissolution.