Emerging challenges in the security and quality of large volume parenteral solutions

• Grant number: 13/18186-3
• Support type: Regular Research Grants
• Duration: March 01, 2014 - July 31, 2016
• Field of knowledge: Health Sciences - Pharmacy - Medicines Analysis and Control
• Principal researcher: Terezinha de Jesus Andreoli Pinto
• Grantee: Terezinha de Jesus Andreoli Pinto
• Home Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Assoc. researchers: Adriana Bugno

Abstract

The parenteral solutions are responsible for saving a countless number of lives worldwide. Their inherent characteristics, as well as its demand for public health and universal tendencies are responsible to boost the use of new technology to the process, with support of rapid, sensitive and reliable techniques applied to quality control of pharmaceuticals. Considering this, the project was designed with the aim of developing researches to innovate the quality control of large volume parenteral solutions (LVPS), furthermore making use of new techniques for the LVPS be available in the market in a fast, safe, and effective way and with the desired quality. The parenteral solutions are composed essentially of water. Thus, the first stage of the project is to evaluate the water, main input of the pharmaceutical product on the risk of biofilm formation; the second step, in order to evaluate the polymeric packaging materials for the presence of impurities such as leachable; and the third step in order to develop rapid methods for quality control in the process and finished product. Results from the project will allow responses to emerging challenges, contributing to research, education and, in particular, to public health of the country. (AU)