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Formulation, optimization and evaluation of microemulsion based gel of Butenafine Hydrochloride for topical delivery by using simplex lattice mixture design

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Abstract

The aim of the present investigation was to develop and evaluate Butenafine Hydrochloride loaded microemulsion based gel for treatment of fungal infection. Pseudo ternary phase diagrams were constructed for different microemulsion formulations composed of Capmul MCM as oil, Cremophor RH 40 as surfactant and Transcutol HP as co-surfactant. Composition of microemulsion system was optimized using simplex lattice mixture design including the concentration of oil, Surfactant co-surfactant ratio (Smix) and water (independent variables) and the  % transmittance and globule size of microemulsion (response variables). The physicochemical properties of the optimized microemulsion were investigated. Microemulsion was incorporated into 1 % carbopol 934P gel and the ex vivo drug permeation of gel was also investigated. The results showed that the optimized microemulsion formulation was composed of Capmul MCM oil (5 %, w/w), Cremophor RH 40/Transcutol HP (43.333 %, w/w) and water (51.667 %, w/w). The mean globule diameter was 108.8 nm. The conclusion was that the release controlling ability of microemulsion containing gel formulation was significantly improved in comparison to commercial cream. Skin irritation study was also performed and it shows no irritation on rat skin after 24 h of application. Microbiological assay of Butenafine Hydrochloride was performed where it shows better zone of inhibition than marketed formulation.

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Acknowledgements

I would also like to thank to Parul Institute of Pharmacy, Vadodara for providing all other requirements and supportive environment for research work. I would like to thank to Glenmark Pharmaceutical Ltd. for providing Butenafine Hydrochloride as a gift sample. For animals used in the study, preapproval of animal ethical committee was taken. These authors (Shruti Rao, Tularam Barot, Dr. Bhupendra Prajapati, Mrs. Lalit Lata Jha) declare that they have no conflict of interest.

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Authors and Affiliations

  1. Department of Pharmaceutics, ROFEL Shri G M Bilakhia College of Pharmacy, Vapi, India

    Shruti Rao, Tularam Barot, K. S. Rajesh & Lalit Lata Jha

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  1. Shruti Rao
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  2. Tularam Barot
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  3. K. S. Rajesh
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  4. Lalit Lata Jha
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Correspondence to Shruti Rao.

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Rao, S., Barot, T., Rajesh, K.S. et al. Formulation, optimization and evaluation of microemulsion based gel of Butenafine Hydrochloride for topical delivery by using simplex lattice mixture design. Journal of Pharmaceutical Investigation 46, 1–12 (2016). https://doi.org/10.1007/s40005-015-0207-y

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  • DOI: https://doi.org/10.1007/s40005-015-0207-y

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