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Stability of daptomycin reconstituted vials and infusion solutions
  1. Javier Sánchez-Rubio Ferrández1,2,
  2. Rocío Vázquez Sánchez2,
  3. Damián Córdoba Díaz3,
  4. Manuel Córdoba Díaz3,
  5. María Carmen Lozano Estevan1,
  6. Teresa Molina García2
  1. 1Alfonso X El Sabio University, Villanueva de la Cañada, Madrid, Spain
  2. 2Pharmacy Department, Getafe University Hospital, Getafe, Madrid, Spain
  3. 3Department of Pharmacy and Pharmaceutical Technology, Complutense University, Madrid, Spain
  1. Correspondence to Dr Javier Sánchez-Rubio Ferrández, Pharmacy Department, Hospital Universitario de Getafe, Crta Toledo km 12,5, Getafe Madrid 28905, Spain; javier.sanchez{at}salud.madrid.org

Abstract

Objectives Daptomycin is a cyclic lipopeptide with selective action against drug-resistant Gram-positive bacteria. The stability of daptomycin solutions in different containers while stored at different temperatures was assessed.

Methods Daptomycin vials were reconstituted with NaCl (50 mg/mL). Daptomycin infusion solutions (5.6 and 14.0 mg/mL) were prepared in polypropylene infusion bags. All test solutions were stored either under refrigeration or at room temperature over 7 days. Samples were withdrawn on days 0, 2, 4 and 7 and assayed in triplicate using a stability-indicating high-performance liquid chromatography (HPLC) method.

Results The HPLC analysis revealed no significant loss in daptomycin concentration in vials or bags when stored at 2–8°C. All samples remained clear and colourless and there were no significant changes in pH throughout the study period.

Conclusions Reconstituted daptomycin vials (50 mg/mL) and infusion bags (5.6 and 14 mg/mL) were found to be physicochemically stable over a period of 1 week when stored at 2–8°C.

  • daptomycin
  • Drug stability < DRUG MANUFACTURING / PREPARATION / COMPOUNDING
  • HPLC
  • IV administration < DRUG MANUFACTURING / PREPARATION / COMPOUNDING

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