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Tomasello C, Leggieri A, Cavalli R, et al. In Vitro Stabilifighty Evaluation of Different Pharmaceutical Products Containing Meropenem. Hosp Pharm. 2015;50(4):296-303doi: 10.1310/hpj5004-296.
Tomasello, C., Leggieri, A., Cavalli, R., Di Perri, G., & D'Avolio, A. (2015). In Vitro Stabilifighty Evaluation of Different Pharmaceutical Products Containing Meropenem. Hospital pharmacy, 50(4), 296-303. https://doi.org/10.1310/hpj5004-296
Tomasello, Cristina, et al. "In Vitro Stabilifighty Evaluation of Different Pharmaceutical Products Containing Meropenem." Hospital pharmacy vol. 50,4 (2015): 296-303. doi: https://doi.org/10.1310/hpj5004-296
Tomasello C, Leggieri A, Cavalli R, Di Perri G, D'Avolio A. In Vitro Stabilifighty Evaluation of Different Pharmaceutical Products Containing Meropenem. Hosp Pharm. 2015 Apr;50(4):296-303. doi: 10.1310/hpj5004-296. Epub 2015 Apr 08. PMID: 26448659; PMCID: PMC4589882.
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Hosp Pharm. 2015 Apr;50(4):296-303. doi: 10.1310/hpj5004-296. Epub 2015 Apr 08.

In Vitro Stabilifighty Evaluation of Different Pharmaceutical Products Containing Meropenem.

Hospital pharmacy

Cristina Tomasello, Anna Leggieri, Roberta Cavalli, Giovanni Di Perri, Antonio D'Avolio

Affiliations

  1. Hospital Pharmacy, Maria Vittoria, S.G. Bosco, and Amedeo di Savoia Hospitals, ASL TO2 , Turin, Italy.
  2. Department of Medicine Science and Technology, University of Turin , Italy.
  3. Departmental Director, Unit of Infectious Diseases, University of Turin , Turin, Italy ; Department of Medical Sciences, Amedeo di Savoia Hospital , Turin, Italy.
  4. Department of Medical Sciences, Amedeo di Savoia Hospital , Turin, Italy.

PMID: 26448659 PMCID: PMC4589882 DOI: 10.1310/hpj5004-296

Abstract

BACKGROUND: Meropenem is a beta-lactam antibiotic for treating multidrug-resistant gram-negative bacilli infections. The expiry of the drug's patent (Merrem) allowed the production of generics to be commercialized by a few companies, including Hospira and Hikma. The stability of these medicines after reconstitution as reported on a data sheet report is 6 hours for Merrem and 1 hour for generics.

OBJECTIVES: The aim of this work was to evaluate the stability profile of 3 products in 0.9% sodium chloride until 6 hours.

METHODS: Six polyolefin bags (2 for each drug, stored in the light and in the dark) were prepared for every test run (n =10) at concentrations of 4 and 10 mg/mL. All solutions were stored at controlled room temperature (25°C ± 3°C) and sampled immediately after preparation and at every hour until 6 hours had passed. The concentrations, pH changes, and the visual clarity were used as stability and compatibility indicators.

RESULTS: All 3 drugs retained over 95% of the initial concentration at 3 to 4 hours. At the sixth hour, all the concentrations decayed 8% to 10%. No statistical differences were observed in the percentage deviation values of the stability profile between generics and the branded drug.

CONCLUSION: The stability profile of the products in polyolefin bags, at 4 and 10 mg/mL, was superimposable during the period of analysis and seems to show small values of deviation (1%-2%). These data do not affect the pharmacokinetics because these variations could be attributed to the intra- and interindividual variability between patients. The products showed the same stability, and consequently they could be used interchangeably in hospital pharmacy.

Keywords: UPLC-PDA; hospital pharmacy; meropenem; pharmacokinetic; stability

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