RSM-Based Design and Optimization of Transdermal Film of Ondansetron HCl
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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.
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.
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).
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.
KeywordsTransdermal film Ondansetron HCl Tensile strength Flux Box-Behnken design
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.
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflict of interest.
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