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ABSTRACT:
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.
KEYWORDS: COPD, Doxofylline, Montelukast sodium, Polyethylene (oxide), Cros Carmellose Sodium, Hydroxy Propyl Cellulose.
INTRODUCTION:
Oral drug administration has been the predominant route for drug delivery. An ideal drug delivery system provides a therapeutic amount of drug to the proper site in the body to achieve the desired drug concentration. An ideal dosage regimen in the drug therapy of any disease is the one, which immediately attains the desired therapeutic concentration of drug in plasma or at the site of action and maintains the concentration for the entire duration of treatment. In short, managing of spatial placement and temporal delivery is an important criterion for an ideal dosage regimen. Tablets can be defined as solid pharmaceutical dosage form containing the medicament alone or in combination with additive /excipients and prepared either by compression or molding. Sustained release preparation provide an immediate dose required for the normal therapeutic response, followed by the gradual release of drug in amounts sufficient to maintain the therapeutic level for extended period of time. The therapeutic activity of Doxofylline, [7-(l, 3-dioxolane-2-methyl) theophylline] has been evidenced in clinical trials made with asthmatic patients or individuals with Chronic obstructive pulmonary disease (COPD)2.
COPD is defined by its characteristically low airflow on...