Yu K, Gebert M, Altaf S A, Wong D, Friend D R
Cibus Pharmaceutical Inc., Burlingame, CA 94010, USA.
J Pharm Pharmacol. 1998 Aug;50(8):845-50. doi: 10.1111/j.2042-7158.1998.tb03998.x.
In-vitro/in-vivo correlations (IVIVC) are useful for predicting in-vivo results from in-vitro data. An IVIVC has been used to optimize a hydrocolloidal-based matrix tablet designed to be bioequivalent to an existing once-daily diltiazem HC1 product (Dilacor XR 240mg; Rhone-Poulenc Rorer). Data from a preliminary formulation dosed to fasted and fed subjects were used to establish the IVIVC. The correlation was then used during reformulation of the dosage forms to predict changes in the maximum plasma concentration (Cmax) and the area under the plasma-concentration-time curve (AUC) for fasted and fed subjects using in-vitro dissolution data. The IVIVC adequately predicted plasma profiles of two optimized formulations in studies with fasted and fed subjects.
体外/体内相关性（IVIVC）有助于根据体外数据预测体内结果。IVIVC已被用于优化一种基于水胶体的骨架片，该骨架片旨在与现有的每日一次盐酸地尔硫䓬产品（Dilacor XR 240mg；罗纳-普朗克-罗雷尔公司）具有生物等效性。来自初步制剂给予禁食和进食受试者的数据用于建立IVIVC。然后，在剂型重新设计过程中使用该相关性，利用体外溶出数据预测禁食和进食受试者的最大血浆浓度（Cmax）和血浆浓度-时间曲线下面积（AUC）的变化。在禁食和进食受试者的研究中，IVIVC充分预测了两种优化制剂的血浆曲线。
