FORMULATION AND EVALUATION OF NANOSUSPENSION OF ROSUVASTATIN FOR SOLUBILITY ENHANCEMENT BY QUALITY BY DESIGN APPROACHAbstract
Rosuvastatin is an antihyperlipidemic agent belonging to BCS class II Drugs with low aqueous solubility and high permeability. Objective: To formulate Rosuvastatin nanosuspension by Emulsification solvent diffusion technique by QbD approach and its evaluation. A 2² factorial design was employed to study the effect of independent variables [SLS (X1) and amount of PVP K -30(X2)] and dependent variables [total drug content (Y1) and PDI (Y2)]. Methods: Four nanosuspensions were prepared and evaluated for their saturation solubility, particle size, zeta potential, SEM, TEM, and in-vitro drug release study. Results: The particle size and PDI of all formulations were in a range of 215-38nm & 0.1-0.9, respectively. The drug content was ranged from 69 %-79%. From the design space F1 (SLS 4mg, PVPK-30, 25mg) and based on the mean particle size of 215nm, PDI of 0.2, drug content of 79%, and cumulative drug release 91%, F1 was selected as an optimum formulation with a zeta potential of -35.2mV. Conclusion: It can be concluded that Rosuvastatin formulated as nanosuspension formulation can enhance the dissolution and bioavailability.
B. Sharannavar * and S. Sawant
KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and Research, JNMC Campus, Nehru Nagar, Belagavi, Karnataka, India.
22 December 2020
05 April 2021
26 May 2021
01 November 2021