Protein extrusion-spheronisation

HERBERT, L; PALMA S.; RAVETTI, S; SANCHEZ BRUNI SF; SPARO M

International Journal of Pharma Research & Review

THOMSON REUTERS

Año: 2016 vol. 5 p. 29 - 38

The pelletization techniques have been reviewed in detail in a number of papers, being the most popular methods, solution/suspension layering, powder layering, direct pelletization using high shear mixers and conventional or rotary fluid-bed granulators, and extrusion-spheronization. Pellets that produce by this method have benefits like narrow range of particle size, regular shape, maximizing drug absorption, and reducing risk of dose dumping. There are some variables in this technique like mixing method and time, type and amount of granulation liquid, type of extruder and spheronizer, time of spheronization, etc. Selection of each variable has a great effect on the yielded pellets. An important challenge in the pharmaceutical development of a biologic is the optimization of safety and efficacy while ensuring the ability to manufacture the drug while maintaining quality and stability. The manufacturing process consists of several operational steps referred to as ?unit operations? where the biologic is subjected to different stresses and conditions that may compromise quality and stability. Moreover, recently the requirement for the development of subcutaneous formulations for high dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges for many of the unit operations. These challenges can be mitigated by modification of the manufacturing process and/or development of formulations to prevent degradation. In particular, formulations have been designed to minimize protein aggregation and decrease viscosity, which has led to successful manufacture of the biologic.