Validación del proceso de formulación del inyectable amikacina 500 mg

Alain Herrada-Céspedes; Marylin Pérez-Calixto; Mirna Fernández-Cervera; Ivón Castro-Rodríguez

Alain Herrada-Céspedes Unidad Empresarial de Base (UEB) aica productiva (Planta de Bulbos), Empresa Laboratorios aica+, La Habana, Cuba https://orcid.org/0000-0002-1742-6679
Marylin Pérez-Calixto Unidad Empresarial de Base (UEB) aica productiva (Planta de Bulbos), Empresa Laboratorios aica+, La Habana, Cuba https://orcid.org/0000-0003-1588-7014
Mirna Fernández-Cervera Instituto de Farmacia y Alimentos, Universidad de La Habana. La Habana, Cuba https://orcid.org/0000-0001-6537-3367
Ivón Castro-Rodríguez Unidad Empresarial de Base (UEB) aica productiva, Empresa Laboratorios aica+, La Habana, Cuba https://orcid.org/0000-0003-0414-3888

Keywords: amikacin sulphate; injection; process validation

Abstract

Amikacin is the aminoglycoside with the broadest antibacterial spectrum. It was
a product transferred to the Aica Laboratories Company, developing a small
volume injection solution. The objective of the work was to validate the
formulation process of the injection amikacin 500 mg. Three consecutive
industrial batches were evaluated. The operating parameters, the operation
qualification and performance were verified. Before and after the filtration
process, the organoleptic characteristics, pH and assay were evaluated. The
shelf life stability of the three batches was evaluated for 24 months. The
working pressures and stirring speed met the established criteria,
demonstrating the operation reproducibility. The verification of the weighing of
each component of the injection and the integrity test of the filter media, in the
three batches, demonstrated compliance with established specifications in the
manufacturing process. Adherence with the quality specifications set for the
product was evidenced, before and after filtration. The validated status of the
manufacturing process of the injectable amikacin sulphate is demonstrated
according to the existing conditions in the Aica Laboratories Company. The
industrial batches of the selected formulation were physically, chemically and
microbiologically stable for 24 months, stored at 30 ºC ± 2 ºC and 70 ± 5 % of
relative humidity

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Validation of the formulation process of the injection amikacin 500 mg

Abstract

References