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Abstract

FORMULATION AND EVALUATION OF ACYCLOVIR CR TABLETS: OPTIMIZATION BY 22 FACTORIALSTUDY

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

ABSTRACT

Acyclovir is a potent antiviral drug useful in the treatment of Herpes simplex, Herpes zoster, Chicken pox and HIV infection. Acyclovir has a short biological half life 2.5h and also dosing frequency of 200mg/400mg 5 times a day depending upon type of infection. An alternative dose of 800 mg leads to plasma fluctuations. Controlled release formulation is needed for acyclovir because of its short biological half life and also to overcome adverse side effects, poor patient compliance, reduce dose and maintain uniform drug levels. The objective of the present study is development of oral controlled release tablets of Acyclovir employing a combination of hydrophilic polymer, sodium CMC and hydrophobic polymer, ethyl cellulose using 22 factorial design. The drug release data were fitted into a polynomial equation to establish the relationship between the response, percent drug release (Y) and concentration of the two polymers, sodium CMC (X1) and ethyl cellulose (X2), based on which optimization of acyclovir CR tables was done to achieve 45% drug release in 4 h. Matrix tablets each containing 120 mg of Acyclovir were formulated employing sodium CMC and ethyl cellulose as per 22 factorial design and were prepared by wet granulation method and were evaluated. All the prepared CR tablets were of good quality with regard to drug content, hardness, friability, disintegration and were suitable for controlled release. Acyclovir release from the CR tablets prepared was slow and spread over 8 h and depended on the composition of the tablets. The order of increasing drug release rate (K0) from various formulations was Fab < Fb < Fa < F1. Drug release from all the CR tablets prepared was diffusion controlled and ‘non-Fickian diffusion’was the release mechanism from these CR tablets. The polynomial equation describing the relationship between the response, Y and the variables, X1 and X 2 based on the observed data was found to be Y = 55.1 - 6.1 (X1) – 7.45 (X2) – 2.85 (X1 X2). The coefficients in above polynomial equation indicate the magnitude of the effect of the factors involved. The increasing order of the coefficients of the two factors was 7.45 (X2) > 6.1 (X1) > 2.85 (X1 X2). Hence the factor B (ethyl cellulose) has greater effect in influencing the drug release from the matrix tablets, followed by factor A (Sodium CMC) and the combined effect of the two factors (AB) is least. Based on the above polynomial equation, the optimized acyclovir CR tablet formulation with 45% drug release in 4 h (desired drug release based on pharmacokinetics) could be formulated employing sodium CMC at 116.25% of drug content and ethyl cellulose at 15% of drug content. The optimized acyclovir CR tablet formulation gave 45.75% drug release in 4 h fulfilling the target release set. Hence formulation of acyclovir CR tablets with desired drug release could be optimized by 22 factorial design.

Keywords: Acyclovir, Controlled release tablets, Sodium CMC, Ethyl cellulose, Factorial design.


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