Thermal and alkaline stability of meropenem: Degradation products and cytotoxicity

International Journal of Pharmaceutics

Volumn 350, Issue 1-2, 2008, Pages 95-102

  Mendez, Andreas ^a   Chagastelles, Pedro ^a   Palma, Eduardo ^a   Nardi, Nance ^a   Schapoval, Elfrides ^a  

^a FEDERAL UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

Author keywords

Cytotoxicity in vitro assay; Identification of degradation products; Meropenem; Thermal and alkaline degradation

Indexed keywords

BETA LACTAM; MEROPENEM;

ALKALINITY; AQUEOUS SOLUTION; ARTICLE; CELL VIABILITY; CONTROLLED STUDY; DRUG CYTOTOXICITY; DRUG DEGRADATION; DRUG STABILITY; DRUG STORAGE; ELECTROSPRAY MASS SPECTROMETRY; HUMAN; HUMAN CELL; IN VITRO STUDY; MONONUCLEAR CELL; NUCLEAR MAGNETIC RESONANCE; PRIORITY JOURNAL; THERMOSTABILITY;

ANTI-BACTERIAL AGENTS; CELL SURVIVAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; HUMANS; MAGNETIC RESONANCE SPECTROSCOPY; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; THIENAMYCINS;

EID: 38549091079     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2007.08.023     Document Type: Article

References (18)

1. Blumer J.L. Meropenem: evaluation of a new generation carbapenem. Int. J. Antimicrob. Agents 8 (1997) 73-92
2. Cai S., and Hu C. Chromatographic determination of polymerized impurities in meropenem. J. Pharm. Biomed. Anal. 37 (2005) 585-589
3. Cornacchione P., Scaringi L., Capodicasa E., Fettucciari K., Rosati E., Sabatini R., Benedetti C., Marconi P., Rossi R., and Del Fávero A. In vitro effects of meropenem and imipenem/cilastatin on some functions of human natural effector cells. Chemotherapy 46 (2000) 135-142
4. Dalhoff A., Janjic N., and Echols R. Redefining penems. Biochem. Pharm. 71 (2006) 85-1095
5. ICH, 1995. Guidance on specific aspects of regulatory genotoxicity tests for pharmaceuticals. In: Proceedings of International Conference on Harmonization.
6. ICH, 2000. Stability testing of new drug substances and products. In: Proceedings of International Conference on Harmonization, IFPMA, Geneva.
7. ICH, 2006. Impurities in new drug products. In: Proceedings of International Conference on Harmonization.
8. Labro M. Antibacterial agents-phagocytes: new concepts for old in immunomodulation. Int. J. Antimicrob. Agents 10 (1998) 11-21
9. Mendez A.S.L., Steppe M., and Schapoval E.E.S. Validation of HPLC and UV spectrophotometric methods for the determination of meropenem in pharmaceutical dosage form. J. Pharm. Biomed. Anal. 33 5 (2003) 947-954
10. Mendez A.S.L., Weisheimer V., Oppe T.P., Steppe M., and Schapoval E.E.S. Microbiological assay for the determination of meropenem in pharmaceutical dosage form. J. Pharm. Biomed. Anal. 37 (2005) 649-653
11. Mendez A.S.L., Dalomo J., Steppe M., and Schapoval E.E.S. Stability and degradation kinetics of meropenem in powder for injection and reconstituted solution. J. Pharm. Biomed. Anal. 41 (2006) 1363-1366
12. Novelli A., Fallani S., Cassetta M., Conti S., and Mazzei T. Postantibiotic leukocyte enhancement of meropenem against Gram-positive and Gram-negative strains. Antimicrob. Agents Chemother. (2000) 3174-3176
13. Pfaller M.A., and Jones R.N. A review of in vitro activity of meropenem and comparative antimicrobial agents tested against 30245 aerobic and anaerobic pathogens isolated world wide. Diagn. Microbiol. Infect. Dis. 28 (1997) 157-163
14. Rovatti L., Garzotti M., Casazza A., and Hamdan M. Investigation of potential degradation products of a newly synthesised β-lactam antibiotic by multi-stage liquid chromatography-electrospray mass spectrometry. J. Chromatogr. A 819 (1998) 133-142
15. Sajonz P., Natishan T., Wu Y., Williams J.M., Pipik B., Dimichele L., Novak T., Pitzenberger S., Dubost D., and Almarsson O. Preparation, isolation, and characterization of dimeric degradation products of the 1β-methylcarbapenem antibiotic, ertapenem. J. Liq. Chromatogr. Relat. Technol. 24 (2001) 2999-3015
16. Takeuchi Y., Sunagawa M., Isobe Y., Hamazume Y., and Noguchi T. Stability of a 1β-methylcarbapenem antibiotic meropenem (SM-7338) in aqueous solution. Chem. Pharm. Bull. 43 (1995) 689-692
17. Wiseman L.R., Wagstaff A.J., Brogden R.N., and Bryson H.M. Meropenem: a review of its antibacterial activity, pharmacokinetic, properties and clinical efficacy. Drugs 50 (1995) 73-101
18. Zajac M., Cielecka-Piontek J., and Jelinska A. Stability of ertapenem in aqueous solution. J. Pharm. Biomed. Anal. 43 (2007) 445-449