Quality By Design (QBD) Approach for the Modification of Poorly Soluble Drugs

Abstract

Quality by Design (QbD) has revolutionized pharmaceutical development by ensuring that quality is designed into processes and products from the outset, rather than relying solely on end-product testing. This systematic approach is particularly valuable in addressing the challenges posed by poorly soluble drugs, which often suffer from low bioavailability. The present work used Liquisolid technology to change the physicochemical characteristics of poorly soluble medicines Olmesartan Medoxomil (OLM) and Ranolazine (RAN) and develop and analyse rapid-release and extended-release liquisolid tablets. Various types of evaluation parameters were studied like thickness, hardness, friability, drug content as well as in-vitro drug release. Liquisolid tablets of OLM and RAN were prepared using Neusilin US as a carrier, Aerosil 200 as a coating material, Primojel as a disintegrant, and PEG 400 as a non-volatile solvent with varying R values and drug concentrations. OLM tablets showed rapid dissolution due to high Neusilin US content, low Aerosil 200, high R value, and low drug concentration. RAN liquisolid tablets were formulated with similar components and ratios. The optimized formulations exhibited enhanced dissolution profiles for both drugs.

Keywords: Quality by Design (QbD), Poorly soluble drugs, Bioavailability, Liquisolid technology, Olmesartan Medoxomil (OLM), Ranolazine (RAN), Rapid-release tablets, Extended-release tablets, Neusilin US, Aerosil 200, Primojel