IN-VITRO DISSOLUTION OF SPARINGLY WATER-SOLUBLE DRUG-DOSAGE FORMS

An in vitro procedure for the evaluation of sparingly water-soluble dr ug products has been developed and tested. The data on several sparing ly water-soluble drug products, such as danazol capsules, megestrol ac etate tablets, prazosin HCl capsules, and quinestrol tablets is presen ted. The procedure allows a systematic approach to evaluate the dissol ution profiles of sparingly water-soluble drug products using various aqueous media including those containing a surfactant such as sodium l auryl sulfate. This approach assists the analyst in developing a sensi tive and specific dissolution methodology to characterize the in vitro release pattern of sparingly water-soluble drug products.