Formulation and Evaluation of Extended Release Dosage Form Using Principles of Quality By Design (QbD)

Abstract

A QbD approach (DOE approach) was applied to obtain the targeted profile for Drug Ganciclovir (GCR), Lopinavir (LPR). The excipients used in the preparation process of liquisolid formulation has an enormous impact on dry free flowing powder, and this results in significant variation in flow properties, compressibility during preparation. To study the impact of those excipients on flow properties, compressibility and in vitro dissolution use of experimental design approach need to be implemented. Many statistical designs of experiment (DOE) are used. First, application of Plackett–Burman screening design helps to identify the most significant factors affecting flow properties. Next, a Factorial design achieves the exact relationship between the post compression parameters and two factors (that have been identified in the screening study). The factorial design is a technique that allows identification of interaction between factors which affects the post compression parameters. Hence to solve the problems associated with BCS Class II drugs there is a need to modify flow properties, particle size, solubility and finally dissolution rate using Quality by design (QbD) approach.