A quantitative determination method of diclofenac for studying the bioequivalence of transdermal gel preparations of this drug has been validated. It was established that the proposed method is precise, reproducible, and linear in a certain concentration range. The release of diclofenac from transdermal gels with different viscosities and from the reference preparation was studied using the paddle-over-disk technique. Drug release from the transdermal gel preparation was modeled using various mathematical laws including the Higuchi law, first-order kinetics, cube root, and Weibull function. An analysis of the experimental data showed that the release of diclofenac from gels proceeds by diffusion and obeys the Higuchi law. It was found that the rate of drug release from the gel depends significantly on the viscosity. Similarity coefficients were calculated in order to compare diclofenac dissolution profiles and to determine their equivalence. It was concluded that experimental samples of diclofenac gel with medium and high viscosity were equivalent to the reference preparation.
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The work was supported financially by ZAO Natur Produkt Interneshnl (Russia).
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 44, No. 1, pp. 46–49, January, 2010.
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Guseva, S.I., Karlina, M.V., Pozharitskaya, O.N. et al. Validation of a quantitative determination method of diclofenac for in vitro bioequivalence evaluation of transdermal gel preparations. Pharm Chem J 44, 43–46 (2010). https://doi.org/10.1007/s11094-010-0393-x
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DOI: https://doi.org/10.1007/s11094-010-0393-x