IMPROVEMENT OF EFFICACY AND SAFETY PROFILE OF SIMVASTATIN IN COMPARISON TO REFERENCE PRODUCT (ZOCOR TABLETS) USING NANOPARTICULATE FORMULATION APPROACH


Deepak Gupta, Vinod Mandowara, Shetul Patel, Pragna Shelat

Abstract


Objective: Simvastatin, a HMG-CoA reductase inhibitor widely used in the treatment of Hyper (dys) lipidemia causes myotoxicity and hepatotoxicity. These safety issues limit dose of Simvastatin, lead to additional monitoring of the patients as well as discontinuation of therapy. To alleviate the adverse effects and to improve efficacy and safety profile, Simvastatin was encapsulated in the nanoparticulate formulation and compared with marketed reference formulation (Zocor tablets).Methods: The nano particles (NPs) were prepared using single emulsion diffusion method and optimized for particle size, PDI, zeta potential, encapsulation efficiency.Results: The efficacy and safety of final formulation were evaluated in HFD induced hyperlipidemic albino rats. The results suggested that the NPs have significant improvement of efficacy and reduction of the toxicity in comparison to marketed reference formulation.Conclusion: By encapsulating the Simvastatin in the NPs, the 50% dose reduction can be achieved without compromising efficacy.Keywords: Nanoparticles, Simvastatin, Dose reduction, HFD model, Myopathy, HMG CoA

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About this article

Title

IMPROVEMENT OF EFFICACY AND SAFETY PROFILE OF SIMVASTATIN IN COMPARISON TO REFERENCE PRODUCT (ZOCOR TABLETS) USING NANOPARTICULATE FORMULATION APPROACH

Date

07-04-2016

Additional Links

Manuscript Submission

Journal

International Journal of Current Pharmaceutical Research
Vol 8, Issue 2, 2016 Page: 39-47

Online ISSN

0975-7066

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53 Views | 26 Downloads

Authors & Affiliations

Deepak Gupta
K. B. Institute of Pharmaceutical Education and Research, A-1322, Rajiv Park, Adinath Nagar, Odhav, Ahmedabad 382415 Gujarat, India

Vinod Mandowara
K. B. Institute of Pharmaceutical Education and Research, A-1322, Rajiv Park, Adinath Nagar, Odhav, Ahmedabad 382415 Gujarat, India

Shetul Patel
K. B. Institute of Pharmaceutical Education and Research, A-1322, Rajiv Park, Adinath Nagar, Odhav, Ahmedabad 382415 Gujarat, India

Pragna Shelat
K. B. Institute of Pharmaceutical Education and Research, A-1322, Rajiv Park, Adinath Nagar, Odhav, Ahmedabad 382415 Gujarat, India


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