Development of Sustained Release Pellets of Nifedipine by Extrusion-Spheronization Method

Nifedipine is an antihypertensive drug used for the treatment of hypertension. Nifedipine is Biopharmaceutical Classification system (BCS) class-II drug having low solubility and high permeability. The sustained release pellets were formulated to reduce the side effects, decrease the administration frequency, and maintain plasma concentration within a therapeutic range to provide a consistent drug concentration at absorption site. These pellets in the size range of 650 to 900 µm that they tend to disperse more effectively in the gastrointestinal tract, enhancing drug absorption and minimizing local irritation. The sustained release pellets were prepared by extrusion-spheronization method using microcrystalline cellulose as filler, hydroxypropyl methyl cellulose as the release polymer and isopropyl alcohol as binder. The sustained release pellets of Nifedipine were characterized for Pellet size analysis, Drug content, micrometric properties. The best formulation was characterized for the In-vitro release studies and stability studies. The F2 batch had the particle size of 750µm, drug release of 82.12±0.05% after 8 hours. Accelerated stability studies and long term stability studies was performed and found to be satisfactory. Thus, it can be concluded that the developed formulation would be a promising delivery system with potential dissolution, patient compliance and sustained release of the drug.