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 Samples were withdrawn on days 0, 2, 4 and 7 and assayed in triplicate using a stability-indicating high-performance liquid chromatography (HPLC) method.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.
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 Samples were withdrawn on days 0, 2, 4 and 7 and assayed in triplicate using a stability-indicating high-performance liquid chromatography (HPLC) method.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.
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Keywords:
Drug stability < DRUG MANUFACTURING / PREPARATION / COMPOUNDING; HPLC; IV administration < DRUG MANUFACTURING / PREPARATION / COMPOUNDING; daptomycin
Authors: C Bardin; A Astier; A Vulto; G Sewell; J Vigneron; R Trittler; M Daouphars; M Paul; M Trojniak; F Pinguet Journal: Ann Pharm Fr Date: 2011-08-03
Authors: Vance G Fowler; Helen W Boucher; G Ralph Corey; Elias Abrutyn; Adolf W Karchmer; Mark E Rupp; Donald P Levine; Henry F Chambers; Francis P Tally; Gloria A Vigliani; Christopher H Cabell; Arthur Stanley Link; Ignace DeMeyer; Scott G Filler; Marcus Zervos; Paul Cook; Jeffrey Parsonnet; Jack M Bernstein; Connie Savor Price; Graeme N Forrest; Gerd Fätkenheuer; Marcelo Gareca; Susan J Rehm; Hans Reinhardt Brodt; Alan Tice; Sara E Cosgrove Journal: N Engl J Med Date: 2006-08-17 Impact factor: 91.245