Topographical Dissolution Characterization for Controlled Release Products - a New Technique

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Abstract
With most controlled release oral drug dosage forms, dissolution is the rate limiting step in drug release. While in vivo drug absorption and elimination involve a number of complex factors, characterization of in vitro dissolution rate under controlled conditions (pH, solvent, speed, etc.) should be able to provide valuable insights into in vivo drug bioavailability Frequently, the analysis of these factors becomes obscured when a variety of data are presented in conventional two dimensional plots. The choice of approval or disapproval of a new drug product based on such data becomes difficult. We have therefore examined the characteristics of drug product dissolution using a multi-dimensional technique available in SAS as a means of more effectively delineating properties of dissolution rate. The results of our studies show that more definitive information can be discerned in a multi-dimensional topographic image which has been shown to be predictive of in vivo drug plasma concentrations