Spherical Agglomeration Formulation Development of Bilastine for Particle Engineering by Plackett-Burman Design

Abstract

Purpose: The ambition of the present work was to development of Bilastine (BIL) spherical agglomeration (SA), BIL, peripheral histamine H1-antagonist used to treat seasonal allergic rhinitis and chronic spontaneous urticaria, which conceptualizes with certain technology based on principles of Quasi Emulsion Solvent Diffusion (QESD) method, to improve the Solubility, Absorbance of drug and micromeritic properties.

Method: Spherical agglomeration were developed by using different solvent system, Methanol as good solvent, water as poor solvent (bad solvent) and DCM as bridging liquid. Plackett-Burman design (PBD) could stimulate an economical experimental scheme that focuses on developing and determining the much relative significance. A Plackett-Burman (PB) screening design approach was utilized in which 7 factors at 3 levels were trial out at 12 runs to study the main effect of process and formulation variables on Saturated Solubility (SS), Particle Size (PS) and Angle of Repose(AR) of Spherical Agglomerates.

Result: Results show that of (GS-BL)-PS, Concentration of Polymer and stirring speed were the most fundamental factors that affect the saturated solubility (SS), particle size (PS) and angle of repose (AR). The surface morphology and crystalline nature of Agglomerates were also characterized by SEM, DSC and XRPD.

Conclusion: This study come to an closure and concluded with Plackett-Burman design (PBD) was a well systematized tool for screening of process and formulation variables which affecting the characteristic parameters of Bilastine Spherical agglomerates.