Kamma Jitendranath Chowdary1, M Pradeep Kumar*2
1M.Pharm Student, Department of pharmaceutics, Vasavi institute of pharmaceutical sciences, Andhra Pradesh, India
2Professor, Department of Pharmaceutics, Vasavi institute of Pharmaceutical sciences, Andhra Pradesh, India
A b s t r a c t
Our aim with this study was to develop and evaluate a sustained-release matrix tablet formulation for Miglitol, and to assess its effectiveness. The pre-formulation studies were carried out and the results were found to be favorable. The appropriate excipients were selected for formulation development. In accordance with the flow characteristics of the API, the experiment was carried out utilizing simultaneously dry and wet granulation procedures. Wet granulation was used to enhance the formulation in order to increase the flow quality of the tablets and turned out to be effective. During the formula’s development, the beginning evaluations which included the bulk density, tapped density, Carr’s index, Hausner’s ratio, and angle of repose were reviewed for granules and hardness, friability, weight fluctuation, and thickness. In-vitro dissolution trials on Miglitol sustained release matrix tablets exhibited drug release in the range of 22.15% to 98.65% at the end of the 10th hour. In view of extended drug release, formulation F9 was picked as the most effective formulation. All hardness, friability, weight fluctuation, thickness, assay, drug content, and dissolution properties of the finished goods were examined. The kinetic release technique proved that the drug is released by zero-order kinetics (R2 value of 0.9491), and the Korsmeyer equations provided a value that was close to one and indicated that the drug had been released by zero-order kinetics (R2= 0.8449). Three months of testing for stability at 45°C/75% RH. Stability samples were examined at both the beginning and after three months. The resulting results were assessed in relation to the predefined requirements. All of the results have been deemed effective.
Keywords: Miglitol, assay, drug content, Korsmeyer equations, Carr’s index