通过流体动力学预测溶出度：流动池法测定水杨酸片的溶出度

Predicting dissolution via hydrodynamics: salicylic acid tablets in flow through cell dissolution.

作者信息

Cammarn S R, Sakr A

机构信息

Procter & Gamble Pharmaceuticals, PO Box 191, Norwich, NY 13815, USA.

出版信息

Int J Pharm. 2000 May 25;201(2):199-209. doi: 10.1016/s0378-5173(00)00415-4.

DOI:10.1016/s0378-5173(00)00415-4

PMID:10878326

Abstract

A model was established for the dissolution of non-disintegrating salicylic acid tablets as a function of hydrodynamic conditions in the Flow Through Cell system (USP Apparatus 4). The approach was to model the dissolution rate of the material as a function of the Reynold's number, the dimensionless engineering term that describes the degree of turbulence. The dissolution rate of USP calibrator salicylic acid tablets was measured as a function of tablet size, orientation within the cell, dissolution media flow rate, and cell size. All of these variables were found to have an effect on dissolution rate, consistent with theory. An equation to predict this dissolution was established as: N(SH)=-21.1+12.6xN(RE)(0.5), R(2)=0.99; 10<N(re)<292.

摘要

建立了一个模型，用于研究在流通池系统（美国药典装置4）中，非崩解型水杨酸片的溶出度与流体动力学条件的关系。方法是将材料的溶出速率建模为雷诺数的函数，雷诺数是描述湍流程度的无量纲工程术语。测定了美国药典校准水杨酸片的溶出速率与片剂尺寸、在溶出池中方位、溶出介质流速和溶出池尺寸的关系。结果发现，所有这些变量均对溶出速率有影响，这与理论相符。建立了一个预测该溶出度的方程：N(SH)=-21.1+12.6xN(RE)(0.5)，R(2)=0.99；10<N(re)<292。