Abstract

SCREENING OF FORMULATION VARIABLES IN DRUG RELEASE PATTERN OF EXTENDED RELEASE MATRIX TABLET BY TAKING CHITOSAN & EUDRAGIT-L POLYMER USING PLACKETT-BURMAN DESIGN.

Amaresh Prusty*, Bijon Kumar Gupta and Amiya Kanta Mishra

ABSTRACT

The present topic involves development and optimization of extended-release (ER) tablets of Tramadol Hydrochloride (TH) by using a 3-factor, 2-level Plackett-Burman (PB) statistical design. During our study we consider different independent factors like Chitosan conc., Eudragit Conc., MCC Conc. and Hardness at their low, high levels. So we have prepared extended release matrix tablets by taking polymers like CS, Eudragit-L-55 and MCC and studied how these factors affects the drug release pattern for extended release matrix tablet of TH using Plackett Burman Design by considering independent variables at two levels. By using Design Expert software the effect of different factors were studied and we found Chitosan (CS) and MCC conc are two responsible factors for drug release. To check drug interaction with ingredients Fourier transform infrared spectroscopy (FTIR) study was conducted. From our experimental we found that the statistical design is now days very much important for identifying factors which affects drug release and also helps in selecting the best formulation. Stability studies (40ºC and 75±5%RH) are conducted for 3 months showing stability of prepared matrix tablets.

Keywords: Chitosan; Eudragit-L100; Tramadol Hydrochloride (TH); Matrix Tablet; Plackett Burman design.