Revista Cubana de Farmacia
versión On-line ISSN 1561-2988
GATO DEL MONTE, Armando et al. Formulation of metotrexate 50 mg injectable solution. Rev Cubana Farm [online]. 2006, vol.40, n.2, pp. 0-0. ISSN 1561-2988.
Metotrexate is an antimetabolite that groups itslef among the folic acid antagonists for the treatment of gestational choriocarcinoma, destructive choriocarcinoma, lunar hydatidiform choriocarcinoma, acute lymphocytic leukemia, prophylaxis and treatment of meningeal leukemias and maintenance therapy combined with other chemotherapeutic agents in different solid tumors and non-Hodgkin lymphomas, as well as in arthritis and psoriasis. To develop this product, preliminary trials were made in the preformulation stage, and the organoleptic characteristics, pH, and the active principle concentration were determined. By these studies, it was possible to obtain a formulation of metotrexate 50 mg injectable solution with adequate characteristics, and physical, chemical, biological and microbiological stability. The formulation was industrially escalated and was bottled in ampuls that meet the established quality parameters satisfactorily. The quality parameters of the finished product that appear in the USP 26 were proved by the stability study of these batches. An expiration date of 2 years was established under the conditions of controlled temperature 2-8 ºC and protected from light
Palabras llave : Metotrexate; cytostatic; antineoplastic; high resolution liquid chromatography; stability; antimetabolites; cancer.