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Variation in captopril formulations in pharmacies across Canada
Mihir Dipakkumar Bhatt1, Jason E Thomas, Tapas Kumar Mondal
1Department of Pediatrics, McMaster University;
Paediatrics & Child Health
|April 3, 2012
Summary
Captopril dosing in children is challenging due to varied liquid formulations from Canadian pharmacies. Lack of bioequivalence data hinders accurate pediatric dosing, necessitating formulation standardization and stability testing.
Area of Science:
- Pharmacology
- Paediatric Medicine
- Pharmaceutical Sciences
Background:
- Captopril is an angiotensin-converting enzyme inhibitor used for pediatric congestive heart failure.
- Limited data exists on captopril's efficacy and safety in children.
- Varied liquid formulations complicate optimal captopril dosing for pediatric patients.
Purpose of the Study:
- To investigate the types of captopril formulations dispensed by Canadian pediatric pharmacies.
- To assess the variability in extemporaneous liquid formulations and their preparation.
- To highlight challenges in pediatric captopril dosing due to formulation inconsistencies.
Main Methods:
- A survey was conducted among fourteen tertiary pediatric center pharmacies in Canada.
- Pharmacies were contacted to determine their dispensed captopril formulations, preparation recipes, and stability data.
- Data on solid vs. liquid formulations and the solutions used for liquid preparations were collected.
Main Results:
- Eight out of fourteen surveyed pharmacies dispensed extemporaneously prepared liquid captopril formulations.
- Significant variety was observed in the solutions used for preparing these liquid formulations.
- The bioequivalence of these diverse captopril preparations has not been studied.
Conclusions:
- Inconsistent captopril formulations in Canadian pediatric pharmacies impede accurate and reliable pediatric dosing.
- Standardization of captopril preparation among pediatric pharmacies is recommended.
- Further studies on the stability and bioequivalence of pediatric captopril formulations are crucial.
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