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Revista Colombiana de Ciencias Químico - Farmacéuticas

versão impressa ISSN 0034-7418versão On-line ISSN 1909-6356

Resumo

BURGUET-LAGO, Nancy et al. Technological development and introduction of the injectable succinylcholine 50 mg/mL in the basic table of national medicines of Cuba. Rev. colomb. cienc. quim. farm. [online]. 2021, vol.50, n.2, pp.339-351.  Epub 29-Out-2021. ISSN 0034-7418.  https://doi.org/10.15446/rcciquifa.v50n2.97915.

Introduction:

The injectable succinylcholine 50 mg/mL is used for rapid tracheal intubations.

Aim:

To develop and introduce the injectable succinylcholine 50 mg/mL into the basic drug table. Three formulation variants were designed: two with antimicrobial and presentation preservatives (6R and 10R bulbs) and one unpreserved (6R bulbs).

Methodology:

The methods used for quality control and stability were validated. Laboratory, pilot and industrial-scale batches with the selected formula were studied for accelerated stability and service life. The designed variants showed adequate quality, selecting the non-preserved, to make batches at different scales. Chromatographic techniques used for the quantification of succinylcholine met established validation criteria.

Results:

The performance of sterility tests and bacterial endotoxin testing was demonstrated. The product under stability study indicated adequate physical and chemical behavior during the period evaluated. The feasibility of technological development was verified, with the formula selected for the injectable succinylcholine 50 mg/mL. Injectable was introduced in the national medicines basic table.

Palavras-chave : Succinylcholine; injectable; development.

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