QbD Enabled Development of Press Coated Tablet of Nifedipine: Optimization, In-vitro Release and Stability Studies

Abstract

The study aimed to develop a time-controlled release drug delivery system using the press coating method for chronotherapeutic treatment of hypertension and angina pectoris. The formulation intended to administer the drug at night, with the intention of relieving symptoms in the morning. The research concluded that, the drug's identification test verified it as Nifedipine, demonstrating good flowability. Different polymers, including various viscosity grades of HPC, influenced properties positively. Combining polymers in different ratios yielded distinct release kinetics at specific intervals. Hydrophilic and gellable polymers combined in the outer shell led to productive time release, whereas hydrophilic with erodible polymers extended the release over 6 to 11 hours. Rupturable and gellable polymer combinations achieved release from 6 to 10 hours, while erodible with rupturable polymers ranged from 6 to 8 hours due to composition differences. Excipient concentration impacted release kinetics, with hydrophilic and hydrophobic nature also influencing core tablet release kinetics. pH-independent release demonstrated practicality, especially with non-ionic HPC and EC polymers. The study revealed diverse release kinetics based on polymer and excipient integration in core and outer compositions. Understanding polymeric behaviours improved drug targeting accuracy. Data analysis indicated a mixed release kinetic involving erosion, diffusion, and swelling mechanisms. Overall, the study contributes insights into dosage form behaviour and polymeric influences on drug release.