alexa Abstract | Challenges in Protein Formulation Focused on Extrusion-Spheronization Process

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Biotechnology revolution had led the overcoming of different types of therapeutic protein because of their chemical 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 therapeutic and 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 system for oral pharmaceutical proteins and peptides is still in development stage. There are number of limitations to oral delivery of proteins such as barriers to peptide bioavailability after oral administration, intestinal membrane permeability, size, intestinal and hepatic metabolism and solubility. Pellets have shown great potential in the delivery of proteins/peptidal drugs. Some strategies of development of oral protein and peptides has always been challenged, optimizing the safety and efficacy while ensuring the ability to manufacture the drug while maintaining quality and stability. The pelletization techniques have been reviewed in numerous papers, is a technique that enables the formation of spherical beads or pellets with a mean diameter usually ranging from 0.5-2.0 mm. Pellets are prepared by different techniques, such as extrusion and spheronization. This review discusses challenges in protein formulation that have been used to prepare pelletized dosage forms using the extrusion-spheronization process

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Author(s): S. Ravetti, L.Y. Hergert, M. Sparo, S.F. Sanchez Bruni, S.D. Palma

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