Stability Study of fast Disintegrating tablets of Nisoldipine as per ICH Guidelines

Abstract

The stability study is a critical parameter to be evaluated in a pharmaceutical product development cycle. A pharmaceutical scientist pays a great deal of heed in testing a product stability. The present research work focused on conducting stability study of fast disintegrating tablet batch of Nisoldipine (NFDT). The various parameters evaluated were weight, hardness, friability, disintegration time, drug content and % drug released. The stability study of optimized fast disintegrating tablet batch NFDT was performed according to ICH guidelines. For the study plan, fast disintegrating tablet batch was placed in a wide mouth air tight containers, which were charged into the stability chamber. The temperature was adjusted at 40°C ± 2°C and relative humidity of 75% ± 5%. The study period was of 6 months. The fast disintegrating tablet batch NFDT did not showed any significant difference in weight, hardness, % friability and disintegration time. The drug content was also reported to be in limits of acceptance. The % drug released at various time intervals was insignificantly changed during its storage period. Hence, the prepared tablets were stable during their storage period.