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

Abstract 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,...

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Bibliographic Details
Published in:Journal of microencapsulation 1998, Vol.15 (4), p.445-452
Main Authors: Das, S. K., Das, N. G.
Format: Article
Language:English
Subjects:
Acrylic Resins
Antianginal agents. Coronary vasodilator agents
Biological and medical sciences
Calcium Channel Blockers - administration & dosage
Calcium Channel Blockers - chemistry
Calorimetry, Differential Scanning
Cardiovascular system
Diltiazem - administration & dosage
Diltiazem - chemistry
Diltiazem hydrochloride
Eudragit
General pharmacology
Hydrogen-Ion Concentration
Medical sciences
microparticles
Microspheres
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Polymethacrylic Acids
Solubility
solvent addition technique
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Summary:Abstract 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.
ISSN:0265-2048
1464-5246
DOI:10.3109/02652049809006871