VERFAHREN ZUR HERSTELLUNG VON CARBAPENEM- ANTIBIOTIKA ZUBEREITUNGEN

A novel process for preparing a stabilized, lyophilized carbapenem, antibiotic formulation suitable for intravenous administration to patients in need thereof, wherein the active ingredient is of formula (II). The process entails compounding an unstable, monosodium salt carbapenem with a sodium bica...

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Hauptverfasser: AL-DEHNEH, ANTHONY, ILLIG, KATHLEEN, J, TSINONTIDES, STELIOS, C, HUNKE, WILLIAM, A, KANIKE, ANAND, PATEL, HIREN, REYNOLDS, SCOTT, D
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Sprache:ger
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Zusammenfassung:A novel process for preparing a stabilized, lyophilized carbapenem, antibiotic formulation suitable for intravenous administration to patients in need thereof, wherein the active ingredient is of formula (II). The process entails compounding an unstable, monosodium salt carbapenem with a sodium bicarbonate solution at a temperature range of from about 0 DEG to about 5 DEG C while maintaining a pH between about 7.0 and about 8.0, filtering the resultant solution, bottling under sterile conditions, and lyophilizing to produce the formulation.