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Sanidad Militar
versión impresa ISSN 1887-8571
Resumen
RODRIGUEZ FERNANDEZ, M.J. et al. Development of the injectable ribavirin solution at the Military Defense Pharmacy Center as an emergency treatment against highly infectious agents. Coverage of a therapeutic lagoon. Sanid. Mil. [online]. 2019, vol.75, n.3, pp.135-142. Epub 20-Ene-2020. ISSN 1887-8571. https://dx.doi.org/10.4321/s1887-85712019000300003.
Background:
Spain, due to its geopolitical situation, is not exempt from the threats and challenges associated with viral infectious diseases such as the «viral hemorrhagic fevers». Implementing actions to reduce these risks with the development of an emergency treatment against these viral agents for intravenous is of great interest.
Objective:
Develop two formulations of Ribavirin 100 mg/ml with different excipients and manufacturing conditions to look for the most stable formulation.
Material and methods:
Ribavirin, various buffers and water for injections have been used. Physical alterations, richness and pH have been evaluated following specifications of European Pharmacopoeia monograp.
Results:
Results of pH and richness of both formulations are exposed with and without terminal sterilization.
Conclusions:
The results obtained meet specifications for both formulations, demonstrating chemical stability after preservation under long-term study conditions for 12 months and accelerated for 6 months. The development of injectable 100 mg/ml ribavirin (10% w/v) satisfies a therapeutic need related to the treatment of first choice in highly contagious viral diseases that lack treatments.
Palabras clave : Ribavirin; Injectable solution; Antiviral; Hemorrhagic fevers.