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

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 pe...

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Bibliographic Details
Published in:	Brazilian Journal of Pharmaceutical Sciences Vol. 58
Main Authors:	Dysarz, Leticia Pereira, Tavares, Melanie, Viçosa, Alessandra Lifsitch, Ribeiro, Mara Fernandes, Teixeira, Rafaela Gomes de Silva, Elias, Sabrina Calil, Silva, Márcio Robert Mattos da, Santos, Elisabete Pereira dos, Ricci-Júnior, Eduardo
Format:	Journal Article
Language:	English
Published:	Universidade de São Paulo, Faculdade de Ciências Farmacêuticas 2022 Universidade de São Paulo
Subjects:	Captopril Drug stability Oral liquid Pediatrics PHARMACOLOGY & PHARMACY Taste Pediatrics Oral liquid Taste Captopril Drug stability
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Summary:	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.
ISSN:	2175-9790 2175-9790
DOI:	10.1590/s2175-97902021000419175