Development of a control strategy for benzene impurity in hpmcas-stabilized spray-dried dispersion drug products using a science-based and risk-based approach

Pharmaceutical Research

Volumn 32, Issue 8, 2015, Pages 2636-2648

  Yue, Hongfei ^a   Nicholson, Sarah J ^a   Young, Joel D ^a   Hsieh, Daniel ^a   Ketner, Rodney J ^a   Hall, Robert G ^b   Sackett, Jeremy ^b   Banks, Elizabeth C ^a   Castoro, John A ^a   Randazzo, Michael E ^a  

^a BRISTOL MYERS SQUIBB   (United States)

^b Bend Research   (United States)

Author keywords

Benzene; Control; Impurity; Solvent; Spray dried dispersion (SDD)

Indexed keywords

ACETONE; BENZENE; HYDROXYPROPYLMETHYLCELLULOSE ACETATE SUCCINATE; METHANOL; EXCIPIENT; METHYLCELLULOSE; SOLVENT;

ARTICLE; CONTROL STRATEGY; CONTROLLED STUDY; DIFFUSION; DIFFUSION COEFFICIENT; DISPERSION; DRUG IMPURITY; DRUG STABILITY; MATHEMATICAL MODEL; MOLECULAR WEIGHT; PRIORITY JOURNAL; PROCESS CONTROL; RISK ASSESSMENT; SPRAY DRYING; ANALOGS AND DERIVATIVES; CHEMISTRY; DESICCATION; DRUG CONTAMINATION; DRUG FORMULATION; GAS CHROMATOGRAPHY; PREVENTION AND CONTROL; REPRODUCIBILITY; STATISTICAL MODEL;

ACETONE; BENZENE; CHROMATOGRAPHY, GAS; DESICCATION; DIFFUSION; DRUG COMPOUNDING; DRUG CONTAMINATION; EXCIPIENTS; METHANOL; METHYLCELLULOSE; MODELS, STATISTICAL; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; SOLVENTS;

EID: 84964638206     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-015-1649-7     Document Type: Article

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