Polyester based polymeric nano and microparticles for pharmaceutical purposes: A review on formulation approaches.

The novel polymeric particulate systems show high potential in their clinical effectiveness. Nevertheless, many of the drug delivery systems developed in the research laboratories have not found their way to clinics. The lack of therapeutic efficacy and safety, due to the use of some materials unapproved by the FDA, seems to be an important reason behind the unsuitability of the developed polymeric systems for the clinical application. Through specific design, choice of proper approach and excipients, the zero order linear release is highly achievable. The aim of this review was to explain the challenges associated with formulation development for several therapeutic agents in polymeric particulate system by scientific evidences. Growing interest in biotechnology and application of therapeutic proteins and peptides in various pathogenic disorders caused our special focus on their quality and preparation challenges. In this review, all formulation development issues i.e. choice of material, the amount of their use and regulatory policies were discussed. In the rest, other formulation development parameters such as effect of particle size, pH, drug loading as well as production method difficulties, dosage form qualities and route of administration to reach high quality particles were reviewed. Generally, this review tried to address an overview on how to solve the difficulties in the path of development of the polymeric particles for the pharmaceutical purposes.