Desarrollo y evaluación de una formulación oftálmica de atropina al 0,01%
[EN]Introduction: Topical use of low concentration atropine (0.01%) has proved to be the most effective treatment for controlling the progression of myopia in children. However, it is not commercialized as such and therefore the formulation of individualized drugs is an alternative to approach such...
| Autores: | , , |
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| Tipo de recurso: | artículo |
| Fecha de publicación: | 2018 |
| País: | España |
| Institución: | Universidad de Salamanca (USAL) |
| Repositorio: | GREDOS. Repositorio Institucional de la Universidad de Salamanca |
| OAI Identifier: | oai:gredos.usal.es:10366/137748 |
| Acceso en línea: | http://hdl.handle.net/10366/137748 |
| Access Level: | acceso abierto |
| Palabra clave: | Atropina Colirio Miopía UPLC Atropine Eye drop Myopia |
| Sumario: | [EN]Introduction: Topical use of low concentration atropine (0.01%) has proved to be the most effective treatment for controlling the progression of myopia in children. However, it is not commercialized as such and therefore the formulation of individualized drugs is an alternative to approach such treatment. Objectives: Galenic development of a 0.01% atropine sulfate formula, stability study and validation of the analytical method for the quantification of atropine sulfate in elaborated ophthalmic solutions. Material and Methods: Bibliographic study, development and elaboration of various formulas, controls and study of stability during two months at 25 ºC / 60 %RH and 5 ºC. Discussion and Results: The analytical method has proved to be selective, linear, accurate both inter and intraday. The pH and osmolarity of the proposed formulations were not modified after two months in any of them; no statistically significant differences were observed either in the richness of atropine or the preservative during the stability study. Conclusion: The results obtained recommend a formulation with phosphate buffer, since its pH is more similar to the physiological pH and, considering that it is a chronic use eye drops, it is advisable, and without preservative. |
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