Preparation and in vitro dissolution profile of dual polymer (Eudragit™ RS100 and RL100) microparticles of diltiazem hydrochloride

被引:32
作者
Das, SK [1 ]
Das, NG
机构
[1] Nova SE Univ, Coll Pharm, 3200 S Univ Dr, Ft Lauderdale, FL 33328 USA
[2] Univ Pittsburgh, Sch Pharm, Pittsburgh, PA 15261 USA
关键词
diltiazem hydrochloride; microparticles; Eudragit; solvent addition technique;
D O I
10.3109/02652049809006871
中图分类号
O69 [应用化学];
学科分类号
081704 ;
摘要
A microparticulate dosage form for a highly soluble drug, diltiazem hydrochloride, was formulated with Eudragit RS100 and RL100 using a novel dual polymer technique. A mixture of diltiazem with Eudragit RS100 (low water permeability) in acetone was coacervated into soft polymer microdrops, following which a mixture of diltiazem and RL100 (high water permeability) was added to produce microparticles consisting of both polymers with diltiazem dispersed in the matrix. A second formulation was developed using the same method except using Eudragit RS100 for both steps. For a comparative study, diltiazem, Eudrait RS100 and RL100 were combined together in a single matrix and formulated into microparticles. In vitro drug release profiles using USP paddle dissolution apparatus 2 revealed that dual polymer matrix microparticles containing Eudragit RS100 in the inner and Eudragit RL100 in the outer core exhibit a suitable release profile with an initial release of the drug followed by a plateau level for the test period of 5 h. Differential scanning calorimetric analysis showed no interaction of the drug with the polymers.
引用
收藏
页码:445 / 452
页数:8
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