PLACKETT-BURMAN SCREENING OF OLMESARTAN MEDOXOMIL LIQUISOLID TABLETS: QUALITY BY DESIGN APPROACHAbstract
Solubility is considered as the important parameters to achieve desired concentration of drug in systemic circulation for achieving required pharmacological response. Olmesartan medoxomil (OLM) is poorly soluble belongs to BCS class II. The drug is rapidly absorbed following oral administration, with a bioavailability approximately 26%. Liquisolid technique was used to enhance the aqueous solubility and dissolution rate to obtain faster on set of action, minimize the variability in absorption, and improve its oral bioavailability. The aim of the present study was to develop Olmesartan medoxomil liquisolid tablets using Quality by Design (QbD) approach to screen the effect of four formulation and process factors on the formulation. OLM liquisolid tablets were prepared by Liquisolid technique. Plackett-Burman (PB) design was used to screen the effect of four formulation and process factors to improve solubility and bioavailability. The liquisolid formulation were characterized by pre and post compression parameters, DSC, XRD, SEM, and in-vitro drug release. Excipients like Neusilin US2, Aerosil 200, PEG 400 and Primojel showed an influential effect on the selected responses angle of repose, thickness and hardness as observed in pareto charts of PB design. Hence Liquisolid technique was selected to develop the liquisolid compacts of Olmesartan medoxomil, to obtain fast dissolving effect which enhances the solubility and bioavailability. PB design was proved to be appropriate tool to study effect of Neusilin US2, Aerosil 200, PEG 400 and Primojel on the response variables and to recognize the most influencing factor by using Liquisolid technique.
Shantanu B. Kuchekar * and Shrinivas K. Mohite
Department of Pharmaceutics, Rajarambapu College of Pharmacy, Kasegaon , Maharshtra, India
21 March, 2015
02 May, 2015
23 September, 2015
01 October, 2015