Compatibility study of tobramycin and pharmaceutical excipients using differential scanning calorimetry, FTIR, DRX, and HPLC

Autor: Silvina L. Bonafede, Adriana Ines Segall, María Ana Rosasco, Sonia Nerina Faudone
Rok vydání: 2018
Předmět:
Zdroj: Journal of Thermal Analysis and Calorimetry. 134:1929-1941
ISSN: 1588-2926
1388-6150
Popis: Differential scanning calorimetry (DSC), isothermal stress testing–Fourier transform infrared spectroscopy (IST–FTIR), isothermal stress testing–high-performance liquid chromatography, and powder X-ray diffraction (PDRX) were used as screening techniques for assessing the compatibility of tobramycin with some currently employed ophthalmic excipients. In the first phase of the study, DSC was used as a tool to detect any interaction. The absolute value of the difference between the enthalpy of the pure tobramycin melting peak and that of its melting peak in the different analyzed mixtures was chosen as a parameter of the drug–excipient interaction degree. DSC results demonstrated that benzalkonium chloride, monobasic sodium phosphate, boric acid, edetate disodium, sodium metabisulfite, thimerosal, and potassium sorbate interact with tobramycin. Taking into account these results, it could be suggested that some of the changes observed in the IST–FTIR spectra of binary blends of tobramycin and some of the excipients would account for a possible interaction between the mixture component. In this study, PDRX did not provide much information, since only tobramycin–thimerosal interactions could be detected. DSC and IST–FTIR are suitable and simple methods for the detection of potential incompatibilities between active pharmaceutical ingredient (API) and excipients. Fil: Rosasco, María Ana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina Fil: Bonafede, Silvina Laura. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina Fil: Faudone, Sonia Nerina. Provincia de Córdoba. Ministerio de Ciencia y Técnica. Centro de Excelencia en Productos y Procesos de Córdoba; Argentina Fil: Segall, Adriana Ines. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Databáze: OpenAIRE
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