Abstract

GATO DEL MONTE, Armando; FERNANDEZ SORRET, Alfredo  and  ALONSO JIMENEZ, Esther. Desarrollo tecnológico y estudio de estabilidad de folinato cálcico 10 mg inyectable liofilizado. Rev Cubana Farm [online]. 2002, vol.36, n.2, pp. 83-87. ISSN 1561-2988.

Calcium folinate is an antidote for preventing serious toxicity due to methotrexate overdose and the therapy applied with high doses of this product is meant to treat severe reactions to low or moderate doses of methotrexate. It is used as part of chemical-therapeutic programs to treat different types of cancer and also in the treatment of megaloblastic anemia. Freeze-drying was employed to obtain a product of required pharmaceutic quality according to USP 23 standard. Also, an analytical technique for the study of the freeze-dried material stability by means of high-pressure liquid chromatography was developed, which allowed quantifying the contents of the active principle. It was proposed that the expiry date should be after three years at room temperature.

Keywords : TECHNOLOGY, PHARMACEUTICAL; DRUG STABILITY [antidotes/therapeutic use]; FREEZE-DRYING; CHROMATOGRAPHY, HIGH PRESSURE; LEUCOVORIN [antagonists & inhibitors].

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