Resumen

COLLADO COELLO, Anna Karelia et al. Technological development of a wide spectrum antiviral agent to parenteral administration: 100 mg/mL Ribavirin. Rev Cubana Farm [online]. 2010, vol.44, n.3, pp.287-296. ISSN 0034-7515.

Development of a formula containing Ribavirin as active principle at a 100 mg/mL concentration maintaining its stable properties from the physical, chemical and microbiological point of view is described. The aim of present formula studies was to determine the suitable formula, the technological procedure and the appropriate package to guarantee stability of end product. Three drugs batches were manufactured, which were packing in colourless glass bulbs with a hydrolytic I quality and stored at room temperature of 30 ± 2 ºC for 12 months; its physical and chemical was studied by accelerated method and shelf life. Its microbiological stability was verified by sterility trial in each of processed batches at study onset and at the end according to USA Pharmacopeia-30 and the regulation established by Cuban State Center for Drug Control with satisfactory results. A toxicology study was conducted of injectable agent showing a wide safety margin to human use. All results obtained fulfilled the quality limits established in official literature for this type of pharmaceutical way thus concluded that the developed drug is properly formulated from the medical point of view with a useful life time of 12 months, stored under study conditions. Finally, the drug was introduced at industrial level without technological problems.

Palabras clave : Technological development; antiviral; injectable solution; Ribavirin.

        · resumen en Español     · texto en Español     · Español ( pdf )