Formulation Development and Optimization of Immidiate Rellease (IR) Tablet of BCS Class I Drug using Quality by Design Approach

Abstract

The aim of the project is to prepare immediate release (IR) tablet of BCS class I drug.Immediate release dosage forms are those in which ≥85% of labeled amount dissolves within 30 min. Different approaches like direct compression, wet granulation and dry granulation were attempted but to obtain the desire criteria of formulation and API dry granulation was only option. The immediate release of BCS class 1 drug was achieved by dry granulation in Roller compactor followed by compression. Coating was done with opadry blue (nonfunctional coating) since it is a generic formulation the tablets were formulated in such a way so as to achieve similar drug release pattern as that of innovator product. The formulations were evaluated and optimized by comparing with RLD (Reference listed Drug).The preformulation studies like, bulk density, tapped density, moisture content, forced degradation study and compatibility of all excipients with API were carried out. The stability testing of one of the developed formulation was also carried out at different condition for 1 month as per ICH guideline.