By a News Reporter-Staff News Editor at Drug Week -- Investigators publish new report on Drugs and Therapies. According to news reporting from Havana, Cuba, by NewsRx journalists, research stated, "A successful parenteral formulation can be developed by studying stability and compatibility of biopharmaceuticals as a function of solution composition. Here, we evaluate the influence of pH, buffers, ionic strength, protein concentration and presence of excipients on recombinant human epidermal growth factor (rhEGF) stability."
The news correspondents obtained a quote from the research from Center for Genetic Engineering and Biotechnology, "The stability was accessed by reversed-phase high performance liquid chromatography (RP-HPLC), size exclusion chromatography (SEC-HPLC), enzyme-linked immunosorbent assay (ELISA), Far-UV circular dichroism (CD) and light scattering. The overall maximal stability was obtained in pH near to 7.0 in phosphate, Tris and histidine buffers as the results of the different methods revealed. The CD results revealed that this protein is stable in an extensive pH range. Aggregation of rhEGF was minimized at pH values ranged from 6.0 to 8.0 as indicated the SEC-HPLC and light scattering results. Nor the ionic strength neither the rhEGF concentration had significant effect on the reaction rate constants. Most rhEGF-excipient instability occurs among this protein and reducing sugars. Polymers like poly(ethylene glycol) (PEG) and polysorbates increased methionine oxidation. The rhEGF oxidation and deamidation were the most common degradation pathways."
According to the news reporters, the research concluded: "This research identified critical solution factors to be considered for the development of a successful rhEGF parenteral formulation."
For more information on this research see: Screening for stability and compatibility conditions of recombinant human epidermal growth factor for parenteral formulation: effect of pH, buffers, and excipients. International Journal of Pharmaceutics, 2013;452(1-2):52-62. (Elsevier - www.elsevier.com; International Journal of Pharmaceutics - www.elsevier.com/wps/product/cws_home/505513)
Our news journalists report that additional information may be obtained by contacting H. Santana, Pharmaceutical Development Department, Center for Genetic Engineering and Biotechnology, Ave 31, 158 and 190, PO Box 6162, Havana 10600, Cuba. Additional authors for this research include Y. Gonzalez, P.T. Campana, J. Noda, O. Amarantes, R. Itri, A. Beldarrain and R. Paez (see also Drugs and Therapies).
Keywords for this news article include: Cuba, Havana, Drugs and Therapies, North and Central America.
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