In vitro and in vivo evaluation of guar gum matrix tablets for oral controlled release of water-soluble diltiazem hydrochloride |
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Authors: | Saleh M. Al-Saidan Yellela S. R. Krishnaiah S. Patro Vemulapalli Satyanaryana |
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Affiliation: | (1) Department of Pharmaceutics, Faculty of Pharmacy, Health Science Center, Kuwait University, Kuwait;(2) Department of Pharmaceutical Sciences, Andhra University, 530 003 Visakhapatnam, India;(3) Sipra Labs Pvt. Ltd., 407, Nilgiri, Aditya Enclave, Ameerpet, 500 038 Hyderabad, India;(4) Health Science Center, Kuwait University, PO Box 24923, 13110 SAFAT, Kuwait |
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Abstract: | The objective of the study was to develop guar gum matrix tablets for oral controlled release of water-soluble diltiazem hydrochloride. Matrix tablets of diltiazem hydrochloride, using various viscosity grades of guar gum in 2 proportions, were prepared by wet granulation method and subjected to in vitro drug release studies. Diltiazem hydrochloride matrix tablets containing either 30% wt/wt lowviscosity (LM1), 40% wt/wt medium-viscosity (MM2), or 50% wt/wt high-viscosity (HM2) guar gum showed controlled release. The drug release from all guar gum matrix tablets followed first-order kinetics via Fickian-diffusion. Further, the results of in vitro drug release studies in simulated gastrointestinal and colonic fluids showed that HM2 tablets provided controlled release comparable with marketed sustained release diltiazem hydrochloride tablets (D-SR tablets). Guar gum matrix tablets HM2 showed no change in physical appearance, drug content, or in dissolution pattern after storage at 40°C/relative humidity 75% for 6 months. When subjectd to in vivo pharmacokinetic evaluation in healthy volunteers, the HM2 tablets provided a slow and prolonged drug release when compared with D-SR tablets. Based on the results of in vitro and in vivo studies it was concluded that that guar gum matrix tablets provided oral controlled release of water-soluble diltiazem hydrochloride. Published: June 30, 2005 |
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Keywords: | guar gum matrix tablets oral controlled release diltiazem hydrochloride in vitro drug release in vivo evaluation |
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