Abstract

FORMULATION, OPTIMIZATION AND EVALUATION OF CONTROLLED POROSITY OSMOTIC PUMP DELIVERY OF LOVASTATIN

*R. Sunitha, G. Rajesh, Malothu Narender, Madhavi Latha Samala

ABSTRACT

The porous osmotic pump tablets were designed using D‐Optimal design and numerical optimization technique was applied to find out the best formulation. Osmotic agent sodium chloride and pore former PEG 400 was considered as independent variables. Drug release rate at 2 h, 4 h, 8 h, 12 h, T50% and release exponent (n) were taken as responses. The increase in concentration of pore former and osmotic agent after a limit, changes the release from zero order to Higuchi based release. The optimized formulation follows non‐Fickian release mechanism. The FT‐IR and DSC studies revealed that no physicochemical interaction between excipients and drug. The influence of pH and agitation intensity on the release of drug was studied and the release mechanism was throug hosmosis. Stability studies revealed that optimized formulation was stable. The result of D‐ Optimal design and ANOVA studies reveals that osmotic agent and pore former have significant effect on the drug release up to 12 h. The observed independent variables were found to be very close to predicted values of most satisfactory formulation which demonstrates the feasibility of the optimization procedure in successful development of porous osmotic pump tablets containing diclofenac sodium by using sodium chloride and PEG 400 as key excipients.

Keywords: Lovastatin, Optimal optimization, Porous osmotic pump, Poly ethylene glycol 400, Sodium chloride.