Majalah Farmasi Airlangga (Airlangga Journal of Pharmacy)
ISSN 0852-1050
Vol. 7 / No. 2 / Published : 2009-10
Order : 6, and page :31 - 35
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Original Article :
Perbandingan stabilitas injeksi kering meropenem repacking dengan pengendalian terhadap kelembaban, suhu dan udara antara produk inovator dan paten “x” selama penyimpanan
Author :
- Tri Widiandani*1
- Dosen Fakultas Farmasi
Abstract :
Meropenem is a parenteral carbapenem antibiotic with a very broad spectrum of antibiotics activity against the majority of gram-positive and gram-negative patogens. Like all β-lactam antibiotics, aqueous solution of meropenem is unstable and subject to hydrolitic degradation after 12 hours at room temperature. In a solid state formulation meropenem was found to be stable at room temperature for 4 years. Considering the extensive degradation of meropenem in aqueous solution and the possibility to repacking the meropenem in powder for injection in to many vials in small dose for noenatus and pediatric pasient, the aim of the present work was to studied the stability of meropenem repacking in powder or injection with control from humidity, temperature and oxygen in order to investigate the kinetics of this drug. Samples from inovator and me too product were store at 0, 2, 4, 8, 16 and 32 days in climate chamber with temperature 300C after repacking with control from humidity, temperature and oxygen. The analyses of the samples were performed by high performance liquid chromatographic (HPLC). The result showed that the decomposition reaction of meropenem repacking in powder for injection could be described by first-order kinetics. The stability of meropenem repacking showed that their were stable at least 13 days for innovator product and 10 days for me too product “X”. The above result showed that there are significant different for shelf life (t90) from meropenem repacking in powder for injection from innovator versus me too product “X”.
Keyword :
meropenem, powder for injection, high performance liquid chromatographic, stability, repacking,
References :
Cai, S., Hu, C.,(2005) Agents. 8: pp.73-92 Cai, S., Hu, C., 2005, Cromatograpic Determination of Polymerized Impurities in Meropenem 37, pp. 585-589 : Journal of Pharmaceutical and Biomedical Analysis
Dalhoff, A., Janjic, N., Echols, R,(2006) Redefining penem. 71, pp. 85-1095 : Biochemical. Pharm.
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Volume : 7 / No. : 2 / Pub. : 2009-10 |
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