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Formulation Development and In vitro-Ex vivo Assessment of Simvastatin Niosomal Buccal Films
Sudhakar Beeravelli1, Vyasamurthy Akondi2, Madhavi Nimmathota3
1Airis PHARMA PVT LTD, ALEAP Industrial Area, Gajularamaram, Hyderabad, Telangana, India.
Aim:
The present study aims to develop and characterize simvastatin niosomal film for effective buccal delivery.
Methods:
Simvastatin niosomes were developed by film hydration technique followed by highpressure homogenization using chiller at 5°C. The simvastatin niosomes were characterized for various physicochemical parameters, and simvastatin plain and niosomal films were prepared using PEO as the base by solvent casting technique.
Results:
From the simvastatin niosomes suspension, the percentage assay was found in the range of 96% to 103%, particles size was found in the range of 112nm to 308nm, the zeta potential was found in the range of -9mV to -25.8mV, the %EE was found in the range of 28% to 91% and the in vitro permeation was found in the range of 43.41% to 98% respectively. The niosomal film shown superior results as compared to simvastatin plain film. The FTIR and DSC confirm the compatibility among the existed excipients.
Conclusion:
Niosomes alter the physicochemical properties of simvastatin by the buccal route. The prolonged permeation (96.12% up to 24hrs) of simvastatin was observed from niosomes film across the porcine buccal cavity due to the presence of CPE in the composition, which would be useful for effective buccal delivery.
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