Level a in Vitro/in Vivo Correlations: A Quality Control Tool or Bioequivalence Predictor for Extended-Release Solid Oral Dosage Forms?

摘要: AbstractAttempts to establish and utilize in vitro/in vivo correlations for the assessment of extended-release (ER) solid oral dosage forms was reemphasized at a recent International Congress. In 1988 United States Pharmacopeial's (USP) Subcommittee on Biopharmaceutics proposed 3 levels such correlations, A, B C decreasing order importance. The highest order, level is assumed when successful prediction complete drug serum/plasma concentrations versus time profile using dissolution data achieved. This report describes establishment Level A 2 different ER theophylline “Biorelevant” technique first by Leeson et al 1985. Dissolution studies were undertaken formulations, namely, Theodur ® 300 mg tablets, Retafyllin tablets. performed USP Apparatus (paddle) buffered media over pH range 3.0 7.5. These subsequently us...