title: Do formulation differences between the reference listed drug and generic piperacillin-tazobactam impact reconstitution?
abstract: Pharmaceutical differences between the reference listed drug (RLD) and generic formulations of piperacillin-tazobactam may impact the reconstitution process for intravenous administration. This study evaluated the RLD against three generic formulations and measured their reconstitution times using a standardized process. The mean (standard deviation [SD]) reconstitution time for one generic formulation was 5.57 (1.49) min, which was 35% to 42% longer (P < 0.002) than that for the RLD and two other formulations. Observable microscopic differences in powder particle morphology may explain these findings.
authors.affiliation: Albany College of Pharmacy and Health Sciences, Albany, New York, USA haian.zheng@acphs.edu amit.pai@acphs.edu.
authors.forename: HaiAn
authors.initials: H
authors.lastname: Zheng
authors.affiliation: Albany College of Pharmacy and Health Sciences, Albany, New York, USA.
authors.forename: James
authors.initials: J
authors.lastname: Truong
authors.affiliation: Pfred Pharma Consulting, LLC, East Lyme, Connecticut, USA.
authors.forename: Fred
authors.initials: F
authors.lastname: Carroll
authors.affiliation: Albany College of Pharmacy and Health Sciences, Albany, New York, USA haian.zheng@acphs.edu amit.pai@acphs.edu.
authors.forename: Manjunath P
authors.initials: MP
authors.lastname: Pai
mesh_terms: D061605:Administration, Intravenous / Q000379:methods; D000900:Anti-Bacterial Agents / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical / Q000379:methods; D016568:Drugs, Generic / Q000737:chemistry*; D010397:Penicillanic Acid / Q000031:analogs & derivatives* / Q000737:chemistry; D010878:Piperacillin / Q000737:chemistry*; D000077725:Piperacillin, Tazobactam Drug Combination; D000078142:Tazobactam
chemical_list: D000900:Anti-Bacterial Agents; D016568:Drugs, Generic; D000077725:Piperacillin, Tazobactam Drug Combination; D010397:Penicillanic Acid; D000078142:Tazobactam; D010878:Piperacillin