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Applied Clinical Research, Clinical Trials and Regulatory Affairs

Editor-in-Chief

ISSN (Print): 2213-476X
ISSN (Online): 2213-4778

Research Article

Development and Characterization of Rosuvastatin Loaded Self- Emulsifying Drug Delivery System

Author(s): Divya Bharat, Parijat Pandey, Ravinder Verma and Deepak Kaushik*

Volume 5, Issue 1, 2018

Page: [53 - 62] Pages: 10

DOI: 10.2174/2213476X05666180309160113

Price: $65

Abstract

Background: In the present investigation, a self-emulsifying drug delivery system (SEDDS) has been formulated for enhancing dissolution rate, solubility and bioavailability of drug rosuvastatin belonging to class II of Biopharmaceutical Classification System (BCS).

Methods: Saturation phase solubility studies were performed for selection of a suitable oil, surfactant and co-surfactant. Pseudo ternary phase diagrams were drawn for selecting ratio of oil, surfactant and co-surfactant required for formation of microemulsion.

Results: The optimized rosuvastatin SEDDS formulation contained 46.66% Tween 80, 30% Oleic acid and 23.34% PEG 400 as surfactant, oil and co-surfactant respectively with smallest globule size of 337 nm. The percent transmittance of formulation F-8 was found to be 88.70%.

Conclusion: SEDDS formulation F8 showed a much high drug release (87.25%) in comparison to marketed formulation (42.95%).

Keywords: Self-emulsifying drug delivery system, rosuvastatin, bioavailability, biopharmaceutical classification system, in vitro drug release, pseudo-ternary phase diagram.

Graphical Abstract

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