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Revista Cubana de Farmacia

versión impresa ISSN 0034-7515versión On-line ISSN 1561-2988

Resumen

COLLADO COELLO, Anna Karelia et al. Technological development of an injectable formulation of dihydroergotoxine mesylate 0.3 mg/mL . Rev Cubana Farm [online]. 2008, vol.42, n.2. ISSN 0034-7515.

Cerebral and peripheral vasodilators are a group of very heterogeneous drugs that have in common the capacity to produce cerebral or peripheral vasodilatation by different mechanisms. The drug that gave rise to this paper, dihydroergotoxine mesylate, is within this group. It stimulates the rhythm of the electroencephalogram and increases the utilization of glucose in the brain. A sterile injectable formulation composed of dihydroergotoxine mesylate powder and enough amount of aqueous vehicle was developed and bottled in ampoules of 1 mL. An analytical technique was developed and validated by high resolution liquid chromatography to study the stability of the formulation and to determine its expiration date. The quality of the microbiological preparation was proved, and a product that satisfactorily meets all the specifications established for sterile preparations was obtained. The technology obtained was easily scalable

Palabras clave : Dihydroergotoxine; dihydroergotoxine mesylate; injectable solution; stability study; quality control.

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