Challenges in Protein Formulation Focused on Extrusion-Spheronization Process

Abstract

Biotechnology revolution had led the overcoming of different types of therapeutic protein because of theirchemical structure can perform specific reactions in the body, increasing efficacy and decreasing side effects.Numerous efforts were made to optimize the physicochemical properties of the proteins used for therapeuticand studied different methods for an effective administration of the protein contained in the medicine,evaluating different routes of administration to achieve the desired therapeutic effects. The delivery systemfor oral pharmaceutical proteins and peptides is still in development stage. There are number of limitationsto oral delivery of proteins such as barriers to peptide bioavailability after oral administration, intestinalmembrane permeability, size, intestinal and hepatic metabolism and solubility. Pellets have shown greatpotential in the delivery of proteins/peptidal drugs. Some strategies of development of oral protein andpeptides has always been challenged, optimizing the safety and efficacy while ensuring the ability tomanufacture the drug while maintaining quality and stability. The pelletization techniques have beenreviewed in numerous papers, is a technique that enables the formation of spherical beads or pellets with amean diameter usually ranging from 0.5-2.0 mm. Pellets are prepared by different techniques, such asextrusion and spheronization. This review discusses challenges in protein formulation that have been used toprepare pelletized dosage forms using the extrusion-spheronization process.