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Regression analysis a tool for optimization of matrix systems | Abstract
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Abstract

Regression analysis a tool for optimization of matrix systems

Author(s): Koushik Sen Gupta,Lakshmi K. Ghosh

Salbutamol sulphate,a short acting highly selective beta 2 adrenoceptor agonist, used for the treatment of nocturnal asthma. The occurrence of nocturnal asthma is associated with increased morbidity and inadequate asthma control, and has an important negative impact on quality of life. Matrix tablets (Seven formulations F1 – F7) were prepared by direct compression technique using two different grades of hydrophilic polymerMethocel® K4M and K15M in varying ratios.Various rheological and physicochemical parameters were studied and complied with the in-house specifications for tested parameters. Drug excipient compatibility study was performed using Fourier Transform Infra-red spectroscopy and Differential Scanning Calorimetry. In-vitro drug release study was carried out in two different medium (initial 2 hrs in 700 ml 0.1 N HCl, and rest 10hrs add 200 ml 0.2 Mtrisodium phosphate to maintain pH 6.8) and nearly 86 to 96 % drug was released from the system. Scanning Electron Microscopic study was performed to observe the morphological changes of tablets before and after dissolution process. The data obtained from drug release study were fitted into different kinetic models to identify the pattern of drug release from the matrix systems. A linear regression analysis was used to optimize the release of salbutamol sulphate from hydrophilic matrix formulations using Analyse-it + General 1.73 softwaredemo versionto study different responses. On the basis of different equations obtained from the regression analysis, one more formulation (F8) was prepared by taking any combinations of above mentioned polymersfor the optimization of pharmaceutical formulations with desirable performance characteristics