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Multiuser equipment approved in grant # 2014/14457-5: PILOT shelf freeze-dryer

Grant number: 14/20224-3
Support type:Multi-user Equipment Program
Duration: February 01, 2015 - January 31, 2017
Field of knowledge:Biological Sciences - Pharmacology
Principal Investigator:Eneida de Paula
Grantee:Eneida de Paula
Home Institution: Instituto de Biologia (IB). Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil
Associated research grant:14/14457-5 - Lipid-based nanocarriers (SLN/NLC and remote-loading liposomes) used to improve the upload and potency of local anesthetics, AP.TEM
EMU web page: Página do Equipamento Multiusuário não informada
Use scheduling: E-mail de agendamento não informado

Abstract

The pilot freeze dryer is essential to the development of lyophilized parenteral formulations that are reproducible, traceable, scalable, without contaminants and stable. Currently there is no pilot freeze dryer available for drug development in Unicamp. The main focus of our research group for years is the parenteral drug formulation, aimed not only at academic research but also the production of patents and collaboration with the industry, in order to convert the knowledge generated in commercial medicines. By the time we had no access to equipment and methodology for characterization of lyophilized formulations, which is more stabl for parenteral drug dosage form. To meet this demand Dra. Laura de Oliveira Nascimento, with experience in lyophilization of vaccines, will perform the thermal characterization of the products developed and define the lyophilization cycles to be used. Without the pilot lyophilizer, it is not possible to control the rates of heating and cooling ramps of pressure or analytically determine the end of primary drying, which often leads to the collapse of the product. Besides the equipment serving the biomembranes laboratory, it will be employed immediately in: - The new Pharmaceutical Technology laboratory of Dr. Laura de Oliveira Nascimento, newly hired in our department, focused on development of parenteral formulations of antimicrobials and vaccines. The laboratory has an ongoing FAPESP project and a submitted CNPq project that would benefit from the equipment. - The biotechnology laboratory of Dr. Marcelo Lancelotti, focused on development of parenteral vaccines to prevent bacterial meningitis. The laboratory also has a FAPESP regular project and a submitted CNPq project that would benefit from the equipment. - The courses graduate of biochemistry and bioactive products, because with this equipment we can offer a practical discipline of theoretical development of parenteral pharmaceutical formulations. No similar matter in any course of Unicamp. - Several groups of developing drug formulations in Unicamp, including the groups that reach the clinical stage and have no way to define process parameters to produce medicines that meet quality requirements. The latter case is even more relevant in the university, because the product development by empirical means generally not scalable in the preclinical phase may invalidate these results for further developments. (AU)