Compatibility and Stability of Binary Mixtures of Ketorolac Tromethamine and Tramadol Hydrochloride Injection Concentrate and Diluted Infusion Solution
| Autor: | Yu-Chang Yeh, Wei-Zen Sun, Feng-Sheng Lin, Shou-Zen Fan, Chih-Peng Lin, Wei-Han Chou, Tzu-Fu Lin |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Sodium
Drug Compounding Analgesic chemistry.chemical_element Sodium Chloride Shelf life Ketorolac Tromethamine Ampoule Drug Stability Medicine Infusions Parenteral Chromatography High Pressure Liquid Tramadol Chromatography business.industry Anti-Inflammatory Agents Non-Steroidal General Medicine Ketorolac Analgesics Opioid Drug Combinations Anesthesiology and Pain Medicine chemistry Anesthesia Tramadol Hydrochloride business medicine.drug |
| Zdroj: | Acta Anaesthesiologica Taiwanica. 48(3):117-121 |
| ISSN: | 1875-4597 |
| DOI: | 10.1016/s1875-4597(10)60042-2 |
| Popis: | Objective Ketorolac added to tramadol as an injection mixture convenient for clinical use has been shown to be an effective balanced analgesic regimen in alleviating moderate-to-severe pain. However, analytical confirmation of the compatibility and stability of this combination is not available. This study examined the compatibility and stability of this combination. Methods Two different mixtures containing ketorolac tromethamine and tramadol hydrochloride were examined: ketorolac (10 mg/mL) and tramadol (33.3 mg/mL) prepared as injection concentrate in ampoule mingled together in the ratio of one ampoule to one ampoule; diluted ketorolac (2 mg/mL) and tramadol (20 mg/mL) prepared in saline infusion solution, with or without pH adjustment. The mixtures were visually inspected for precipitation and color change. Quantitative chemical analysis was performed on days 0, 1, 3 and 7 by high-performance liquid chromatography. Results When stored at room temperature under ambient light, the ketorolac (10 mg/mL)-tramadol (33.3 mg/mL) injection concentrate and ketorolac (2 mg/mL)-tramadol (20 mg/mL) solution, without pH adjustment and adjusted to pH 5–8, were physico-chemically stable, and neither visible precipitation nor loss of concentration was found. With the ketorolac (2 mg/mL)-tramadol (20 mg/mL) solution adjusted to pH 9, however, precipitation occurred immediately, resulting in a significant loss of tramadol. Conclusion This study suggests that a ready-to-use ketorolac-tramadol mixture, either undiluted or diluted in physiological saline solution, can be prepared, with a shelf life of at least 7 days when stored at room temperature under ambient light. |
| Databáze: | OpenAIRE |
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