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Abstract
The rate limiting factors involved in release of a drug from a tablet are generally accepted to be the disintegration of the tablet followed by the subsequent dissolution of the drug from the dispersed granules.
The development of new potencies of an existing tabletted product by weight multiplication was found to result in non-conformance to established specifications for the product not formulation related.
In addition to a study of the rate limiting factors mentioned above compendial dissolution tests were also compared. Apparatus II was shown to produce more rapid and consistent results than Apparatus I in this investigation and this test is recommended as the one of choice where large volume compacts are involved.