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RSM-Based Design and Optimization of Transdermal Film of Ondansetron HCl

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Abstract

Purpose

The main objective of the present investigation was to develop transdermal films of ondansetron HCl (OS) with polyvinyl alcohol (PVA) using Box-Behnken design and to optimize them employing Derringer’s optimization tool.

Methods

Design-Expert software was used to investigate the effect of independent variables such as concentration (%, w/w) of glycerol and 1,8-cineole, and number of Freeze-Thaw cycle (F-T cycle) on the dependent variables viz. ultimate tensile strength (UTS) and flux. The F-T cycle followed by solvent casting method was employed to develop films. Universal tensile testing machine and Franz diffusion cell were used to measure tensile strength and flux, respectively.

Results

Quadratic model was found to be best fit model and the effect of concentration of glycerol and the number of F-T cycle significantly influences the tensile strength (p < 0.0001), whereas the concentration of 1,8-cineole significantly (p < 0.0001) influenced the flux. The optimized conditions were found to be 10% (w/w) of glycerol, 4.999 number of F-T cycle, and 7.499% (w/w) of 1,8-cineole using Derringer’s optimization tool. Under these conditions, the predicted tensile strength and flux obtained were 18.322 MPa and 30.697 μg/cm2/h, respectively, with desirability of 0.791. Skin irritation potential study on the rat showed a score of 0.44 ± 0.13 on Draize scoring system. The optimized film was found to be stable for 3 months at room temperature and accelerated conditions (40 ± 2 °C temperature and 75 ± 5% RH).

Conclusions

Above results imply that the optimized film of OS is a safe transdermal drug delivery tool which could be used as a potential alternative to oral dosage form.

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Acknowledgements

The authors are thankful to Dr. Sanjay Swain, head of CIF, BIT, Mesra, for performing TGA/DTA and mechanical properties of our samples. The authors also thank the management of GITAM Deemed to be University, Visakhapatnam, for providing necessary facilities to carry out the research work.

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  1. GITAM Institute of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam, Andhra Pradesh, 530045, India

    Rabinarayan Parhi & Tejasri Panchamukhi

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  1. Rabinarayan Parhi
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  2. Tejasri Panchamukhi
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Correspondence to Rabinarayan Parhi.

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Parhi, R., Panchamukhi, T. RSM-Based Design and Optimization of Transdermal Film of Ondansetron HCl. J Pharm Innov 15, 94–109 (2020). https://doi.org/10.1007/s12247-019-09373-9

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