Fast disintegrating pellets: Formulation and evaluation.

Background: Extrusion-spheronization is the most commonly used technology to produce pellets using microcrystalline cellulose as a pelletizing agent. However, it has the major drawbacks of lack of disintegration and prolonged drug release. This study aimed to develop rapidly disintegrating microcrystalline cellulose-based pellets. Methods: Several pellet formulations were prepared via extrusion spheronization using a combination of microcrystalline cellulose, mannitol, polyethylene glycol 400(PEG 400), polyplasdone (PPXL), and croscarmellose sodium (CCS). Subsequently, they were evaluated for their physical characteristics. Results: Process optimization indicated that 500 RPM is the ideal extrusion speed. Furthermore, the best spheronization speed was to start with a speed of 3000 RPM speed to cut off the extrudate at a shorter length and then lower the speed to 1000 RPM to reduce fine production and allow for spherical pellet formation. Increasing the polyethylene glycol content to 20% and maintaining the percentages of croscarmellose sodium (15%), 15%), and polyplasdone xl (5%), respectively, demonstrated a significant improvement in disintegration time (DT). Conclusions: MCC-based pellets with fast-disintegrating characteristics were obtained by extrusion and spheronization. Incorporating the soluble filler mannitol, hydrophilic polymer PEG 400 with super-disintegrant CCS, and PPXL 400 resulted in a more porous matrix that facilitated water entry and rapid swelling of the pellets to explode and disintegrate quickly (2 min).