Physicochemical stability of binary admixtures of paracetamol and dexketoprofen-trometamol for patient-controlled analgesia use

• Published in: European journal of hospital pharmacy. Science and practice Vol. 26; no. 6; pp. 308 - 313
• Main Authors: López Navarro, Alfonso Ángel, Martínez Gómez, María Amparo, Gras Colomer, Elena, Campillos, Pilar, Climente Martí, Mónica
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01-11-2019; BMJ Publishing Group
• Subjects: Analgesics; Chromatography; Clinical medicine; Drug dosages; Hospitals; Low density polyethylenes; Methods; Narcotics; Original; Pain; Patient safety; Pharmaceuticals; Pharmacy; Polyethylene; United Kingdom > UK; United States > US; Germany; Spain; Storage Conditions; Stability And Incompatibility; Validation Analytical Procedure; Drug Stability; Pain Management
• ISSN: 2047-9956; 2047-9964
• DOI: 10.1136/ejhpharm-2018-001535

BackgroundIntravenous admixtures of dexketoprofen-trometamol and paracetamol are frequently used in clinical practice due to synergism obtained administering both drugs concomitantly. Physicochemical stability of binary admixture containing both drugs is currently unknown.ObjectiveTo determine physicochemical stability of binary admixture containing dexketoprofen-trometamol 50 mg and paracetamol 1000 mg in a low-density polyethylene bottle at different storage conditions of light and temperature for advanced preparation.MethodsEight mixtures containing dexketoprofen-trometamol (Enantyum ampule 2 mL) 50 mg and paracetamol (Paracetamol B. Braun bottle 100 mL) 1000 mg were prepared and stored at: room temperature and exposed to light; room temperature and protected from light; refrigerated and exposed to light; and refrigerated and protected from light. From each mixture, aliquots were extracted at different times for 15 days. For physical compatibility, pH measure, gravimetric analysis and visual inspection were carried out. For chemical stability, concentrations of dexketoprofen-trometamol and paracetamol were simultaneously measured by high performance liquid chromatography.ResultsOnly refrigerated mixtures showed incompatibility since white precipitation appeared at day 6, possibly due to paracetamol instability. Remaining drugs concentrations were in all cases≥90% after 15 days.ConclusionBinary mixture containing paracetamol (100 mL) 1000 mg and dexketoprofen-trometamol (2 mL) 50 mg in a low-density polyethylene bottle is physicochemically stable for 5 days under refrigeration and 15 days at room temperature. By considering also microbial contamination, this mixture can be prepared in advance, 5 days stored refrigerated and 2 days stored at room temperature, being unnecessary protection from light.