Original Articles
Vasantakumar Pai K, Harsha J,
Abstract
Quality by Design (QbD) approach was employed to formulate Pregabalin Capsules, with the objective of making thee formulation cost effective. The formulated capsules consist of Lactose monohydrate as Diluent, Maize starch as Disintegrant and Talc as Glidant. Capsules were prepared by manual filling. Design of Experimentation (DoE) was employed to evaluate the effect of excipient concentrations in the blend on the various parameters like tapped density, Carr’s index and Disintegration time. Results obtained from DoE suggested that increase in the concentrations of the blend, there is an increase in the responses which are in prescribed limit. In-vitro dissolution study of the optimized formulation had shown 100% release at 45th min whereas marketed formulation had shown 80% release. From this result it can be concluded that formulation of Pregabalin capsules using QbD approach has leaded to a cost effective and stable formulation.