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AN OVERVIEW ON COMPARISON OF DRUG RELEASE FROM DOSAGE FORMS IN SINGLE BUFFER VERSUS A pH GRADIENT DISSOLUTION TEST. Renuka, Sachin Kumar Singh, Yashwant, Surajpal Verma

AN OVERVIEW ON COMPARISON OF DRUG RELEASE FROM DOSAGE FORMS IN SINGLE BUFFER VERSUS A pH GRADIENT DISSOLUTION TEST.

Renuka, Sachin Kumar Singh, Yashwant, Surajpal Verma


International Journal of Natural Product Science 2012: Spl Issue 1:66.

Abstract (RBIP-66)

The dissolution test is utilized as either a research tool for optimizing new formulations or a quality control test to routinely monitor the uniformity and reproducibility of production batches. The dissolution test should reflect significant differences in bioavailability arising from differences in dissolution and discriminate formulation factors such as polymers, particle surface area, or physical and chemical characteristics of the drug. The recent Pharmacopoeial methods state only about the use of a single buffer system in order to evaluate dissolution performance of the drug either in its immediate release or in its modified release dosage forms. The present study is an overview of advantages of the use of a pH gradient dissolution testing over the use of a single buffer system. Moreover, recent Pharmacopoeial test methods prescribe the use of USP Apparatus 1 or 2 and simple dissolution media like pH 1.2 or phosphate buffer pH 6.8. Such methods may be useful for quality control purposes in terms of batch-to-batch conformity. However, they do not comprehensively reflect conditions to which a dosage form moving through the human GI tract will be exposed and therefore cannot be used to predict drug release during the course of GI passage. In view of the properties of drug and the release mechanisms of the various formulations on the market, it was deemed both necessary and sufficient to establish a simple pH-gradient method with elements of standard methods such as these described in the USP, but additionally reflecting the changing pH conditions as the dosage form proceeds through the human GI tract, in order to predict any differences in in vivo performance.
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