ABSTRACT:
1Drugs Inspector, CDSCO, FDA Bhawan New Delhi 2Manager, Department of Quality assurance, PAR Formulations Pvt. Ltd, Chennai The aim of the study was to develop a bilayer tablet formulation for the treatment of chronic obstructive pulmonary disease (COPD) using a new polymer Polyethylene (oxide) as a matrix for sustained release layer and Doxofylline and Montelukast sodium as model drugs. The sustained release layer was formulated by direct compression method and the immediate release layer was prepared by wet granulation method. Bilayer tablets were evaluated for hardness, thickness and friability. In-vitro release studies were carried for both the layers. For sustained release layer, water was used as dissolution medium and release pattern of the drug from the new polymer was evaluated by using UV spectrophotometer. For immediate release layer pH6.8 buffer medium was used and the drug release was evaluated by using HPLC. In-vitro release studies reveal that the new polymer releases the drug Doxofylline in a mixed order manner that is swelling, erosion and dissolution. The study reveals that the new polymer Polyethylene (oxide) was used as an alternative to hydroxy propyl methyl cellulose in lower concentration.