Peer-reviewed veterinary case report
How long buprenorphine buccal solution stays stable for cats
By Kirk, Loren Madden & Brown, Stacy D·Published in Journal of feline medicine and surgery·2015·Bill Gatton College of Pharmacy at East Tennessee State University, United States·View original on PubMed →
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Original publication title: Beyond-use date determination of buprenorphine buccal solution using a stability-indicating high-performance liquid chromatographic assay.
- Species:
- cat
Plain-English summary
A study looked at a buprenorphine buccal solution, which is used to manage pain in cats, to see how long it stays effective. The researchers found that the solution remained stable and effective for up to 90 days when stored at room temperature and in the refrigerator. While some white particles appeared in the room temperature samples after 21 days, the medication still met safety and potency standards. This means that veterinarians can confidently use this formulation for pain management in cats for up to three months after it’s made.
People also search for: cat pain management buprenorphine · how long does buprenorphine last for cats · cat medication storage guidelines
Abstract
OBJECTIVES: The objectives of this study included developing and validating a stability-indicating high-performance liquid chromatographic (HPLC) method with ultraviolet (UV) detection for the determination of buprenorphine in a buccal solution for veterinary use, and applying that method to determine the stability of a 3 mg/ml buprenorphine preparation in room temperature and refrigerated storage conditions. This preparation, intended for buccal administration in feline patients, plays an important role in pain management in cats. METHODS: A stability-indicating HPLC method was developed and validated for system suitability, accuracy, repeatability, intermediate precision, specificity, linearity and robustness based on US Pharmacopeia (USP) General Chapter <1225>. The method was then applied to the study of potency changes over 90 days in a buccal buprenorphine solution stored at two temperatures. RESULTS: All HPLC-UV method data met acceptable criteria for the quantification of buprenorphine in a buccal solution formulation. The buprenorphine concentrations found in each stability sample remained within the 90-110% of label claim throughout the 90 days of study. All stability test bottles of the buprenorphine buccal solution retained their original appearance. For the room temperature bottles, some white particulate matter was noted in the threads of the container bottles starting at day 21. The pH of the preparations during the course of the study was in the range of 3.57-4.06 and 4.01-4.16 for the room temperature and refrigerated samples, respectively. CONCLUSIONS AND RELEVANCE: Pharmacists have compounded a concentrated 3 mg/ml buccal solution to use easily in the home care or outpatient setting for treatment of feline pain. Prior to this investigation, pharmacists empirically assigned beyond-use dates to this formulation based on standards in USP General Chapter <795> Pharmaceutical Compounding - Nonsterile Preparations. This study of a 3 mg/ml buprenorphine buccal solution indicates stability through 90 days.
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Search related cases →Original publication on PubMed: https://pubmed.ncbi.nlm.nih.gov/25680734/