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Long‐term Stability of a Compounded Suspension of Torsemide (5 mg/mL) for Oral Administration
BACKGROUND: Torsemide use for congestive heart failure (CHF) has been reported, but prescription frequency is unknown. Commercially available tablet sizes in North America limit dosing precision, indicating a need to evaluate its strength and stability in suspension. OBJECTIVES: To determine the fre...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5697182/ https://www.ncbi.nlm.nih.gov/pubmed/28913839 http://dx.doi.org/10.1111/jvim.14819 |
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author | Adin, D. Johnson, P.R. Kim, C.H. Nguyenba, T. Rosen, S. |
author_facet | Adin, D. Johnson, P.R. Kim, C.H. Nguyenba, T. Rosen, S. |
author_sort | Adin, D. |
collection | PubMed |
description | BACKGROUND: Torsemide use for congestive heart failure (CHF) has been reported, but prescription frequency is unknown. Commercially available tablet sizes in North America limit dosing precision, indicating a need to evaluate its strength and stability in suspension. OBJECTIVES: To determine the frequency of torsemide prescriptions and to determine a beyond use date (BUD) of a compounded suspension of torsemide for oral administration stored under 2 temperature conditions for 90 days. ANIMALS: No animals used. METHODS: Pharmacy records were retrospectively reviewed for torsemide and furosemide prescriptions from 2008 to 2015 at 2 veterinary referral centers. After preliminary strength testing, compounded torsemide suspension (5 mg/mL) for oral administration was prepared using torsemide tablets suspended in OraPlus:OraSweet 1:1, buffered to a pH of 8.3 and stored at refrigeration (2–8°C) and room temperature (20–25°C) in 2 oz amber plastic bottles. Samples were analyzed by reverse phase high‐performance liquid chromatography (RP‐HPLC) on days 0, 14, 30, 60, and 90. RESULTS: Prescriptions for torsemide increased from 2008 to 2015. Analysis of the torsemide 5 mg/mL suspension for oral administration at each time point met United States Pharmacopeia (USP) requirements for torsemide content of 90–110% of label claim. The average strength at 90 days decreased to 92 ± 3% at 2–8°C and 95 ± 2% at 20–25°C. Stability testing did not detect unknown impurities. CONCLUSIONS: Increasing torsemide use warrants availability of a validated and stable compounded formulation. Our results support the assignment of a 90‐day BUD for torsemide 5 mg/mL suspension for oral administration compounded in OraPlus:Sweet 1:1 buffered to a pH of 8.3. |
format | Online Article Text |
id | pubmed-5697182 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-56971822017-11-29 Long‐term Stability of a Compounded Suspension of Torsemide (5 mg/mL) for Oral Administration Adin, D. Johnson, P.R. Kim, C.H. Nguyenba, T. Rosen, S. J Vet Intern Med SMALL ANIMAL BACKGROUND: Torsemide use for congestive heart failure (CHF) has been reported, but prescription frequency is unknown. Commercially available tablet sizes in North America limit dosing precision, indicating a need to evaluate its strength and stability in suspension. OBJECTIVES: To determine the frequency of torsemide prescriptions and to determine a beyond use date (BUD) of a compounded suspension of torsemide for oral administration stored under 2 temperature conditions for 90 days. ANIMALS: No animals used. METHODS: Pharmacy records were retrospectively reviewed for torsemide and furosemide prescriptions from 2008 to 2015 at 2 veterinary referral centers. After preliminary strength testing, compounded torsemide suspension (5 mg/mL) for oral administration was prepared using torsemide tablets suspended in OraPlus:OraSweet 1:1, buffered to a pH of 8.3 and stored at refrigeration (2–8°C) and room temperature (20–25°C) in 2 oz amber plastic bottles. Samples were analyzed by reverse phase high‐performance liquid chromatography (RP‐HPLC) on days 0, 14, 30, 60, and 90. RESULTS: Prescriptions for torsemide increased from 2008 to 2015. Analysis of the torsemide 5 mg/mL suspension for oral administration at each time point met United States Pharmacopeia (USP) requirements for torsemide content of 90–110% of label claim. The average strength at 90 days decreased to 92 ± 3% at 2–8°C and 95 ± 2% at 20–25°C. Stability testing did not detect unknown impurities. CONCLUSIONS: Increasing torsemide use warrants availability of a validated and stable compounded formulation. Our results support the assignment of a 90‐day BUD for torsemide 5 mg/mL suspension for oral administration compounded in OraPlus:Sweet 1:1 buffered to a pH of 8.3. John Wiley and Sons Inc. 2017-09-15 2017 /pmc/articles/PMC5697182/ /pubmed/28913839 http://dx.doi.org/10.1111/jvim.14819 Text en Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | SMALL ANIMAL Adin, D. Johnson, P.R. Kim, C.H. Nguyenba, T. Rosen, S. Long‐term Stability of a Compounded Suspension of Torsemide (5 mg/mL) for Oral Administration |
title | Long‐term Stability of a Compounded Suspension of Torsemide (5 mg/mL) for Oral Administration |
title_full | Long‐term Stability of a Compounded Suspension of Torsemide (5 mg/mL) for Oral Administration |
title_fullStr | Long‐term Stability of a Compounded Suspension of Torsemide (5 mg/mL) for Oral Administration |
title_full_unstemmed | Long‐term Stability of a Compounded Suspension of Torsemide (5 mg/mL) for Oral Administration |
title_short | Long‐term Stability of a Compounded Suspension of Torsemide (5 mg/mL) for Oral Administration |
title_sort | long‐term stability of a compounded suspension of torsemide (5 mg/ml) for oral administration |
topic | SMALL ANIMAL |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5697182/ https://www.ncbi.nlm.nih.gov/pubmed/28913839 http://dx.doi.org/10.1111/jvim.14819 |
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