Estudios de compatibilidad droga-excipiente y de estabilidad de diversas formulaciones de colirios, que contienen como principio activo tobramicina
The solutions developed in this work are similar to those found in the Argentine market. The samples were prepared with a theoretical value of 0.3%. The preparations were analyzed according to USP 41 NF 36. Storage conditions and analysis times were those recommended by ICH. Two software application...
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| Formato: | Tesis doctoral acceptedVersion |
| Lenguaje: | Español |
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Facultad de Farmacia y Bioquímica
2018
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| Acceso en línea: | http://repositoriouba.sisbi.uba.ar/gsdl/cgi-bin/library.cgi?a=d&c=posgraafa&cl=CL1&d=HWA_2771 http://repositoriouba.sisbi.uba.ar/gsdl/collect/posgraafa/index/assoc/HWA_2771.dir/2771.PDF |
| Aporte de: |
| Sumario: | The solutions developed in this work are similar to those found in the Argentine market. The samples were prepared with a theoretical value of 0.3%. The preparations were analyzed according to USP 41 NF 36. Storage conditions and analysis times were those recommended by ICH. Two software applications were used to evaluate the results: Excel and R-software version "stab" 3.0.1. The IFA: excipient compatibility was evaluated by means of DSC, FTIR and DRXp. The thermal stress test in binary mixtures was also analyzed by HPLC and FTIR. Stability studies of tobramycin solution formulas correlate with compatibility tests. These methodologies can be included in preformulation studies. With them, it is possible to reduce the time and consumption of raw materials and inputs needed in the development of pilot batches, required for carrying out stability studies. Based on these results, tobramycin proved to be incompatible with the following excipients: benzalkonium chloride, boric acid, potassium sorbate, sodium phosphate monobasic, disodium EDTA, sodium metabisulfite and thimerosal |
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