J Pharm Pharmacogn Res 2(Suppl. 1): S32, 2014
Special supplement with the abstract book of LATINFARMA 2013
CO 052: CRITICAL POINTS TO CONSIDER WHEN DEVELOPING PHARMACEUTICAL PRODUCTS BASED ON MICROSPHERES CONTAINING PROTEINS
Nowadays peptides and proteins are commonly used as the active principle of many pharmaceutical products. However the design of dosage forms with these biomolecules has some limitations related to the adverse events and the relatively short elimination half-life. Consequently novel protein administration systems have been investigated to exploit the therapeutic potential of them while simultaneously avoiding the limitations. Biodegradable microspheres are one of the most widely explored because they could (i) reduce the administration frequency of the product, (ii) maintain appropriate protein levels in the blood for an adequate period of time, (iii) decrease adverse events and hence (iv) improve the compliance of patients during the treatments. In the last decades numerous investigations about the encapsulation of therapeutic proteins have been developed but only a few products are already under clinical application. This is because the protein microencapsulation is a complex process governed by multiple factors that should be optimized in order to program the properties desired for a specific protein-loaded microsphere preparation. In addition, the properties of the encapsulated protein are often modified as a result of the encapsulation process, thus they should be carefully evaluated in order to demonstrate the ability of the protein to exert its biological function. On the other hand, microspheres are typically manufactured by an aseptic process because terminal sterilization (heat sterilization and gamma irradiation) results in premature degradation of the particles. Due to the complexity in the development and manufacturing process for microsphere drug products an appropriate quality control strategy should be designed. This talk reviews through practical examples, the current state of microspheres containing therapeutic proteins from basic research to its clinical application and debate controversial aspects related to the development of pharmaceutical products based on these novel drug delivery systems. Regulatory topics associated with these products are also discussed.