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2012, Number 4

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Rev Cubana Farm 2012; 46 (4)

Development of Compvit-B® injectable formulation

González GOT, Rodríguez GP, Francis TL, Bergado RJA

Language: Spanish
References: 30
Page:
PDF size: 114.41 Kb.


ABSTRACT

Introduction: at the beginning of the 1990´s, the increased incidence of polyneuropathies in Cuba made it necessary to apply vitamin B group-derived drugs with neuroprotective properties. this kind of drugs was infrequent in the country at that time because of their high prices at the international market.
Objectives: to obtain a formulation containing a combination of high dose of vitamins B1, B6 and B12 which have known positive effects on the treatment of neuropathies.
Methods: comprehensive assessment of eight different variants of injectable formulation, with or without ethylenediaminetetraacetic acid (EDTA) and benzyl alcohol, and of the lyophilization process included in the flow of production or not, in line with the technology suggested by the manufacturer.
Results: the variant number 8 was selected since it meets the set parameters according to the manufacturer's technology and to the Center for the State Quality Control of Drugs. A Cuban-made injectable and lyophilized pharmaceutical called Compvit-B®, made up of 100 mg B1, 100 mg B6 and 5 000 µg B12, was obtained. It meets the established specifications and the requirements by the regulatory bodies for the manufacture of drugs for human use.
Conclusions: the selected variant allowed developing the Compvit-B® pharmaceutical, which is a pharmacologically stable drug of quality, and the health licensing for the general use and the production of this drug was granted by the Center for the State Quality Control of Drugs (CEDMED)


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