A system is described for developing extended-release products, based upon predicting or simulating the entire plasma level-time curve to be expected from the administration of a controlled-release oral dosage form. Termed "biorelevant dissolution," it employs the product's in vitro dissolution behavior and the drug's pharmacokinetic parameters in conjunction with a classical pharmacokinetic model. The basic system is described along with some pertinent examples.
Povidone (WP)/Polydimethylsiloxane (PDMS) matrices were evaluated as drug delivery devices. hydrophilic component to alter drug release. employed as a rnodel drug substance. a mold and allowing PDMS to cross-link at room temperature. experimental formulations were evaluated for salicylic release via in vitro and in vivo experiments. In vitro experiments were conducted by USP Method 11. In vivo release was determined by monitoring salicylate depletion after subdermal implantation. In vitro and in vivo release rate of salicylic acid was found to be proportional to W P concentration. displayed t " ' relationships for at least 75% of the total release period. Mouse survival was related to salicylic acid release rate. PVP was utilized as a Salicylic acid was Discs were prepared by placing the blended ingredients into The All release rate curves 1217 Copyright 0 1990 by Marcel Dekker, Inc. Drug Dev Ind Pharm Downloaded from informahealthcare.com by University of Sydney on 01/03/15For personal use only.
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