INVESTIGADORES
RAMIREZ RIGO Maria Veronica
congresos y reuniones científicas
Título:
Solid State Characterization of Sulbactam Pivoxil
Autor/es:
GALLO LC; ´GONZALEZ VIDAL N; RAMIREZ RIGO MV
Lugar:
Rosario
Reunión:
Congreso; 4ta Reunión Internacional de Ciencias Farmacéuticas (RICiFa 2016); 2016
Institución organizadora:
Universidad Nacional de Rosario
Resumen:
Amoxicillin (AM) is a widely used broad-spectrum bactericidal agent, susceptible to β-lactamases. Combined formulations of AM and Sulbactam Pivoxil (SP), an irreversible -lactamase inhibitor, can be used to improve antibacterial therapy and counteract bacterial resistance. In the context of a project involving the development of a new pediatric extemporaneous suspension of AM/SP, drug preformulation data is needed. To the best of our knowledge, there is not information available about the physical properties of SP. Therefore, the aim of the present study was to perform a solid-state characterization of SP.Particle size distribution (laser diffraction), optical microscopy, flow properties (Carr Index-CI- and repose angle-), X-ray powder diffraction (XRPD), FT-IR spectroscopy, thermal analysis (differential scanning calorimetry-DSC- and thermogravimetric measurement-TGA), moisture content (MC) and water activity (aw) measurements were performed. SP particles exhibited a mean diameter of 343.1 µm. Irregular crystals could be observed, with similar size to the obtained by laser diffraction. The powder showed a reasonable flowability with a CI of 18.8% and α of 38°. The XRDP exhibited a crystalline pattern. FT-IR results showed the characteristics bands of the aliphatic hydrocarbons (2979 cm-1) and ester (1802-1757, 1323 cm-1) functional groups. In the DSC curve, a sharp endothermic peak occurred at 108.7 °C, corresponding to melting of SP. The TGA curve exhibited a mass loss at 183.6 °C, which was associated with a decomposition process. SP showed a MC value of 0.34 % and aw of 0.463. The information obtained in the present study is relevant for development, processing and storage of formulations that include SP. Acknowledgment: This work was funded by the Secretaría de Políticas Universitarias, Argentina (SPU 4508/14). The authors thank Monica Murrie (Laboratorio de Especialidades Medicinales Provinciales Nº 3) and Fernanda Cabrera (PLAPIQUI) for their collaboration.