Abstract

A QBD APPROACH IN SPRAY DRIED SOLID DISPERSION TECHNOLOGY

Snehal Eknath Bhusare*, Anandrao Dayaram Savkare, Pallavi Tanaji Kare, Neha Jalindra Bhor

Abstract

Most of the New Chemical Entities (NCEs) discovered are poorly soluble or lipophilic in nature which can cause poor bioavailability after oral administration. Poor solubility and bioavailability posechallenge in the development of efficient pharmaceutical formulation. The application of solid dispersions is a useful method to increase the dissolution rate of these drugs and thereby improve their bioavailability. Numerous technologies canbe used for development of solid dispersion, among them spray dryingtechnology can be successfully useful for development of product from lab scale to commercial scale dueto rapid solvent evaporation during the process, cost effectiveness,possibility of continuous manufacturing and ease of scalability. In recent time, there is an increased demand from regulatory authorities to implement Quality by Design (QbD) approach in product development stage. Objective behind this is to understand the manufacturing process together to achieve final product within predefined excellence. This review covers the theoretical framework for QbD approach in spray dryingtechnology, the effect of process parameters such as feed flow rate, inlet temperature, outlet temperatureand formulation parameters such as feed composition and feed concentration on critical quality attributes.

Keywords: Spray drying, solid dispersion, Quality by design (QbD), solubility enhancement, selection of polymer and solvent.