Abstract

OPTIMIZATION OF DELAMINATION TENDANCY IN BILAYER TABLETS BY QUALITY BY DESIGN AND FORMULATION OF DUAL RELEASE SYSTEM OF ANTI-ASHTHMATIC API’S.

Suhas H. Lahane*

ABSTRACT

Purpose behind developing this system is to get two different release rates i.e. dual release of one or two different drugs from a single dosage form. As bilayer tablets is prone to lamination, here delamination tendency is optimized by using Quality by design (QbD). Release like dual release systems can be obtained via bilayer tableting technology that combines an immediate-release granulate and a controlled release hydrophilic matrix complex within the one tablet. Batches were made with the aid of factorial design using design expert 12.0 trial software. In the present study, effects of three independent variables were considered i.e. Tampered first layer thickness (mm) (X1) or (A), Turret Speed (rpm) (X2) or (B), and total hardness (N)(X3) or (C). Delamination tendency was evaluated by using friability test as a strength checking for layer separation in bilayer tablet. No. of counts up to when layer separate i.e. laminate in friabilaor was considered as response. Significant effects of interaction and polynomial variables on the investigated characteristics of process of bilayer tablet compression and on delaminating tendency were verified using 23 full factorial designs. The results obtained with optimized the process parameter permitted for high scale up production. The final formulation was evaluated as per pharmacopoeia, in-house test and found to be complying with predetermined specifications. The stability study data interpreted the stable formulation.

Keywords: QbD (Quality by design), Dual release system, Bilayer Tablet, Delamination tendency, API I - Leukotriene inhibitor and antagonists, API II – Xanthine etc.