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American Journal of Health-System Pharmacy, Vol. 66, Issue 19, 1722-1725
Copyright © 2009. American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/04/0602-1242$06.00

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Long-term stability of extemporaneously prepared captopril oral liquids in glass bottles

Jørgen Brustugun, Yvonne Elisabeth Lao, Charlotte Fagernæs, Jorunn Brænden and Solveig Kristensen

JORGEN BRUSTUGUN, DR.SCIENT., is Researcher and Hospital Pharmacist, Rikshospitalet Hospital Pharmacy, Rikshospitalet University Hospital, Oslo, Norway. YVONNE ELISABETH LAO, M.SC., is Hospital Pharmacist, Diakonhjemmet Hospital Pharmacy, Oslo. CHARLOTTE FAGERNAS, CHEM.ING., is Head of Analytical Section, Rikshospitalet Hospital Pharmacy, Rikshospitalet University Hospital. JORUNN BRANDEN, M.SC., is Hospital Pharmacist, Lovisenberg Hospital Pharmacy, Oslo. SOLVEIG KRISTENSEN, DR. SCIENT., is Associate Professor of Pharmaceutics, Department of Pharmacy, School of Pharmacy, University of Oslo, Oslo.

Address correspondence to Dr. Brustugun at Sykehusapoteket ved Rikshospitalet, Rikshospitalet-Radiumhospitalet HF, Sognsvannsveien 20, 0027 Oslo, Norway (jorgen.brustugun{at}sykehusapotekene.no).

Purpose. The long-term stability of captopril in extemporaneously prepared oral liquids was studied. Methods. Captopril solutions of 1 and 5 mg/mL were prepared in sterile water for irrigation with sorbitol, disodium edetate, and sodium benzoate. The samples were stored in 100-mL amber glass bottles with a headspace of air at 22 °C for 12 months. The captopril concentration was determined by high-performance liquid chromatography at 0, 3, 6, 9, and 12 months. The pH of the solutions was also measured, and the physical appearance was recorded. The stability of the 1-mg/mL captopril preparation during 1 month of simulated use when stored at 2–8 °C was tested at the start and the end of the 12-month study period. Chemical stability was defined as retention of at least 90% of the initial captopril concentration. The microbiological quality of the preparations was tested at 0, 6, and 12 months (1 mg/mL) and 0 and 12 months (5 mg/mL). Results. Throughout the 12-month study period, the captopril concentration in the oral liquids exceeded 90% of the initial concentration. The lowest concentration (98.5%) was detected in the 5-mg/mL preparation after 3 months of storage. The 1-mg/mL preparation was stable during 1 month of simulated use, both at the start and the end of the 12-month study period. No microbiological growth was observed in any of the samples tested. Conclusion. Extemporaneously prepared oral liquid formulations of captopril 1 and 5 mg/mL were chemically stable when stored in glass bottles at room temperature for 12 months when stabilized with 0.1 mg/ mL disodium edetate at a low pH. Index terms: Angiotensin-converting-enzyme inhibitors; Captopril; Chromatography, liquid; Compounding; Concentration; Contamination; Edetate disodium; Excipients; Hydrogen ion concentration; Sodium benzoate; Solutions; Sorbitol; Stability; Stabilizers; Storage

 

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