The development of a stable oral solution of captopril for paediatric patients

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Etat: Public
Version: de l'auteur
ID Serval
serval:BIB_819B7B222822
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
The development of a stable oral solution of captopril for paediatric patients
Périodique
European Journal of Hospital Pharmacy Science
Auteur(s)
Berger-Gryllaki M., Podilsky G., Widmer N., Gloor S., Testa B., Pannatier A.
ISSN
1781-7595
Statut éditorial
Publié
Date de publication
2007
Peer-reviewed
Oui
Volume
13
Numéro
3
Pages
67-72
Langue
anglais
Résumé
Study objectives: Many major drugs are not available in paediatric form. The aim of this study was to develop a stable liquid solution of captopril for oral paediatric use allowing individualised dosage and easy administration to newborn and young patients.
Methods: A specific HPLC-UV method was developed. In a pilot study, a number of formulations described in the literature as affording one-month stability were examined. In the proper long-term study, the formulation that gave the best results was then prepared in large batches and its stability monitored for two years at 5°C and room temperature, and for one year at 40°C.
Results: Most formulations described in the literature were found wanting in our pilot study. A simple solution of the drug (1 mg/mL) in purified water (European Pharmacopeia) containing 0.1% disodium edetate (EDTA-Na) as preservative proved chemically and microbiologically stable at 5°C and room temperature for two years.
Conclusion: The proposed in-house formulation fulfils stringent criteria of purity and stability and is fully acceptable for oral administration to newborn and young patients.
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07/12/2010 14:29
Dernière modification de la notice
20/08/2019 14:41
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