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Revista Cubana de Farmacia

Print version ISSN 0034-7515

Abstract

GONZALEZ GAY, Olivia Teresa et al. Stability of injectable pharmaceutical Compvit-BÒ. Rev Cubana Farm [online]. 2011, vol.45, n.4, pp.505-514. ISSN 0034-7515.

Compvit-BÒ is a lyophilized injectable polypharmaceutical made up of 100 mg of B1, 100 mg of B6 and 5 000 µg of B12. It is prescribed to treat all types of neuropathies and neurodegenerative diseases. The objective of this paper was the technological development of a stable formulation. For the evaluation of the quality of this drug, three pilot batches were scaled up and were subjected to physical, chemical and microbiological tests; the results were all satisfactory. The stability studies of lyophilized Compvit-BÒ were performed at room temperature. They showed that the pharmaceutical was stable for 3 years and the formulation was regenerated for 72 hours. This drug is registered at the Cuban regulating body called State Center for Drug Control and has been included in the Basic Group of Drugs in Cuba. It has been put on the market by the national drug industry. It is also widely used in the hospital services in Cuba.

Keywords : Vitamin B1; Vitamin B6; Vitamin B2.

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