Formulation development and evaluation of lamivudine controlled release tablets using cross-linked sago starch.

Autor:	Singh AV; Indian Institute of Science, Department of Materials Engineering, Biomaterials Lab, Bangalore, Karnataka, 560012, India. akhileshvikram@gmail.com, Nath LK
Jazyk:	angličtina
Zdroj:	Expert opinion on drug delivery [Expert Opin Drug Deliv] 2013 Feb; Vol. 10 (2), pp. 173-82. Date of Electronic Publication: 2012 Dec 14.
DOI:	10.1517/17425247.2013.738665
Abstrakt:	Objectives: Modified starches based polymeric substances find utmost applicability in pharmaceutical formulation development. Cross-linked starches showed very promising results in drug delivery application. The present investigation concerns with the development of controlled release tablets of lamivudine using cross-linked sago starch. Methods: The cross-linked derivative was synthesized with phosphorous oxychloride and native sago starch in basic pH medium. The cross-linked sago starch was tested for acute toxicity and drug-excipient compatibility study. The formulated tablets were evaluated for various physical characteristics, in vitro dissolution release study and in vivo pharmacokinetic study in rabbit model. Results: In vitro release study showed that the optimized formulation exhibited highest correlation (R) in case of zero order kinetic model and the release mechanism followed a combination of diffusion and erosion process. There was a significant difference in the pharmacokinetic parameters (T(max), C(max), AUC, V(d), T(1/2), and MDT) of the optimized formulation as compared to the marketed conventional tablet Lamivir®. Conclusion: The cross-linked starch showed promising results in terms of controlling the release behavior of the active drug from the matrix. The hydrophilic matrix synthesized by cross-linking could be used with a variety of active pharmaceutical ingredients for making their controlled/sustained release formulations.
Databáze:	MEDLINE
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