Formulation and Statistical Optimization of Pulsatile Drug Delivery System for Terbutaline Sulphate
In the present work it was aimed at developing chrono modulated drug delivery formulation for the treatment of nocturnal asthma. To determine the authenticity of the drug sample (Terbutaline sulphate), various physical, physicochemical and spectrophotometric methods were employed. UV and FTIR spectroscopy were used to verify the authenticity of the sample and the sample was found to be authentic. Drug polymer compatibility studies were conducted and no sign of physical compatibility was seen. The FTIR studies of physical mixture of the drug with different polymers showed no sign of interaction as the spectra of mixtures showed the peaks similar to pure drug spectra. UV spectroscopic method was selected as preferred analytical method for determination of terbutaline sulphate. Trial batches (preliminary) were formulated to study influence of polymer concentration on the physical properties and release profiles of the formulations. The final concentration of the polymers to be used in experimental design was fixed using the preliminary trial batches data.