APPLICATION OF PLACKETT–BURMAN DESIGN OF EXPERIMENTS IN THE IDENTIFICATION OF “MAIN FACTORS” IN THE FORMULATION OF DABIGATRAN ETEXILATE MESYLATE IMMEDIATE-RELEASE TABLETSAbstract
The current research paper was focused on exploiting Plackett-Burman design to screen the effect of eight factors Pregelatinised Starch (A), Crospovidone (B), Microcrystalline Cellulose PH 101 (C), Talc (D), Magnesium Stearate (E), Hydroxy Propyl Methyl Cellulose (F), Hydroxy Propyl Cellulose (G) and Lactose Monohydrate (H) on the release of drugs from the Immediate release DEM Cocrystal tablets prepared by direct compression method. The studies were carried out according to a statistical eight-factor 12 model using STATGRAPHICS XVI software and were subjected to a dissolution analysis at 0.1 N HCl pH 1.2 for determination of drug release. The ANOVA and the residual analysis showed the importance of the model. Pareto charts were generated using Design Expert® for visual identification of the effect of excipients on drug release. The drug release percentage was significantly affected by Crospovidone, Hydroxy propylmethyl cellulose, and microcrystalline cellulose. Plackett Burman could guide the process of reducing the number of experiments to a manageable level rationally.
Ashwini Gawade *, Ashwin Kuchekar and Sanjay Boldhane
School of Pharmacy, Dr. Vishwanath Karad, MIT, WPU, Pune, Maharashtra, India.
25 January 2021
29 April 2021
29 May 2021
01 December 2021