Risk assessment and physicochemical characterization of a metastable dihydrate API phase for intravenous formulation development

Journal of Pharmaceutical Sciences

Volumn 99, Issue 12, 2010, Pages 4973-4981

  Mortko, Christopher J ^a   Sheth, Agam R ^a   Variankaval, Narayan ^a   Li, Li ^a   Farrer, Brian T ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Crystal engineering; Formulation; Hydrate; Injectables; Particle size; Physical stability; Physicochemical properties; Preformulation; Pseudopolymorphism; Solubility

Indexed keywords

2 [(AZEPAN 4 YLAMINO)CARBONYL] 7 OXO 2,6 DIAZABICYCLO[3.2.0]HEPTANE 6 SULFONIC ACID; BETA LACTAMASE INHIBITOR; UNCLASSIFIED DRUG;

ARTICLE; CRYSTAL STRUCTURE; DRUG SOLUBILITY; DRUG STABILITY; INFRARED SPECTROSCOPY; PHYSICAL CHEMISTRY; PREFORMULATION; RISK ASSESSMENT; SOLID STATE; WATER CONTENT; X RAY POWDER DIFFRACTION;

EID: 78049494631     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22225     Document Type: Article

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