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Formulation Development And In Vitro-Ex Vivo Assessment Of Simvastatin Niosomal Buccal Films

Author(s):

Sudhakar Beeravelli, Vyasamurthy Akondi and Madhavi Nimmathota*  

Abstract:


Aim: Aim of the present study is to develop and characterize simvastatin niosomal film for effective buccal delivery.

Methods: Simvastatin niosomes were developed by film hydration technique followed by high-pressure 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 -9 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 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.

Keywords:

Niosomes, Span 60, Cholesterol, Permeation, buccal films, and Chemical permeation enhancer.

Affiliation:

Airis PHARMA PVT LTD, ALEAP Industrial Area, Gajularamaram, Hyderabad, Telangana, Department of Pharmacy & Pharmacology, School of medicine, University of Tasmania, Hobart, Department of Pharmaceutics, CMR College of Pharmacy, Hyderabad, Telangana



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