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Physicochemical stability of binary admixtures of paracetamol and dexketoprofen-trometamol for patient-controlled analgesia use
  1. Alfonso Ángel López Navarro1,
  2. María Amparo Martínez Gómez2,
  3. Elena Gras Colomer1,
  4. Pilar Campillos1,
  5. Mónica Climente Martí1
  1. 1 Servicio de Farmacia, Hospital Universitario Doctor Peset, Valencia, Spain
  2. 2 Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO), Valencia, Spain
  1. Correspondence to María Amparo Martínez Gómez, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO), Valencia 46017, Spain; martinez_margoma{at}gva.es

Abstract

Background Intravenous 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.

Objective To 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.

Methods Eight 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.

Results Only 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.

Conclusion Binary 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.

  • Drug Stability
  • Storage Conditions
  • Validation Analytical Procedure
  • Pain Management
  • Stability And Incompatibility

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