Captopril oral solution for pediatric use: formulation, stability study and palatability assessment in vivo



Document title: Captopril oral solution for pediatric use: formulation, stability study and palatability assessment in vivo
Journal: Brazilian Journal of Pharmaceutical Sciences
Database: PERIÓDICA
System number: 000452124
ISSN: 1984-8250
Authors: 1
1
2
3
3
3
1
1
1
Institutions: 1Universidade Federal do Rio de Janeiro, Faculdade de Farmacia, Rio de Janeiro. Brasil
2Fundacao Instituto Oswaldo Cruz, Farmanguinhos, Rio de Janeiro. Brasil
3Universidade Federal Fluminense, Faculdade de Farmacia, Niteroi, Rio de Janeiro. Brasil
Year:
Volumen: 58
Country: Brasil
Language: Inglés
Document type: Artículo
Approach: Experimental, aplicado
English abstract The aim of this work was to develop an oral solution of captopril at 5 mg/mL preservative-free. Two formulations were prepared, one containing sweetener (formulation 1) and the other without this excipient (formulation 2). The results found of validation parameters from analytical method performed by HPLC for captopril were, linearity 0.9998, the limit of detection 15.71 µg/mL, the limit of quantification 47.60 µg/mL, repeatability 1.05%, intermediate precision 2.42%, accuracy intraday 101,53%, accuracy inter-day 99.85%. Moreover, the results found for captopril disulfide were, linearity 0.9999, limit of detection 0.65 µg/mL, limit of quantification 1.96 µg/mL, repeatability 2.28%, intermediate precision 1.51%, accuracy intraday 101.36%, accuracy inter-day 100.29%. The appearance of formulations was clear and colorless, pH measures were 3.12 and 3.04, dosage of captopril and captopril disulfide were 99.45% and 99.82%, 0.24% and 0.12% for formulation 1 and formulation 2, respectively. The stability study demonstrated that the concentration of captopril and captopril disulfide in the formulations was > 90% and below 3%, respectively. The in vivo palatability study in animals and humans showed that Formulation 1 containing the sweetener had better acceptance. Thus, the sweetener was able to improve the unpleasant taste of the formulation
Disciplines: Medicina,
Química
Keyword: Química farmacéutica,
Pediatría,
Captopril,
Estabilidad química,
Líquidos orales
Keyword: Medicinal chemistry,
Pediatrics,
Captopril,
Oral liquids,
Chemical stability
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