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Abstract

FORMULATION AND EVALUATION OF CONTROLLED RELEASE TABLETS OF LAMIVUDINE BY 22 FACTORIAL DESIGN

K. P. R. Chowdary*, K. Ravi Shankar and M. Ravi Kumar

ABSTRACT

Lamivudine is a potent antiviral agent used in the treatment of AIDS. Conventional oral formulations of lamivudine are administered multiple times a day because of its moderate biological half-life (t1/2) of 5-7h. Treatment of AIDS using conventional formulations of lamivudine is found to have many drawbacks, such as adverse side effects resulting from accumulation of drug in multidose therapy, poor patient compliance, and high cost. Controlled release formulation of lamivudine can overcome some of these problems. The objective of the present study is development of oral controlled release tablets of Lamivudine employing a combination of hydrophilic polymer, HPMC K 100M and hydrophobic polymer, ethyl cellulose using 22 factorial design. Matrix tablets each containing 120 mg of Lamivudine were formulated employing HPMC K100M and ethyl cellulose as per 22 factorial design and were prepared by wet granulation method and were evaluated. All the CR tablets of lamivudine prepared were of good quality with regard to drug content, hardness, friability, disintegration and were suitable for controlled release. Lamivudine release from the CR tablets prepared was slow and spread over 10 h and depended on the composition of the tablets. The order of increasing release rate (K0) from various formulations was Fab < F1 < Fa < Fb. ANOVA of release rate (K0) values indicated that individual and combined effects of the two factors are highly significant (P < 0.01) in influencing the release rate of drug from the CR matrix tablets. Non-Fickian diffusion was the release mechanism from formulations F1, Fa and Fab which gave relatively slow drug release. Fickian diffusion was the release mechanism in the case of formulation Fb, that gave rapid release of drug. The polynomial equation describing the relationship between the response, Y (percent drug released in 4h) and the variables, X1 (concentration of HPMC K100M) and X2 (concentration of ethyl cellulose) based on the observed data was found to be Y = 83.75 - 6.75 (X1) + 5.75 (X2) – 3.75 (X1 X2). As per the above polynomial equation factor A (HPMC K100M) has greater effect in influencing the drug release from the matrix tablets, followed by factor B (ethyl cellulose) and the combined effect of the two factors (AB) is least. Among all formulation Fab provided lamivudine slowly over 8-10h at a release rate (K0) of 13.50 mg/h which is nearer to the desired release rate (12.5 mg/h) based on its pharmacokinetics and hence it is considered as the best controlled release formulation of lamivudine for b.i.d administration.

Keywords: Lamivudine, Controlled release tablets, HPMC K100M, Ethyl cellulose, Factorial design


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