A case study of nondelamination glass dissolution resulting in visible particles: Implications for neutral pH formulations

Journal of Pharmaceutical Sciences

Volumn 103, Issue 4, 2014, Pages 1104-1114

  Ratnaswamy, Gayathri ^a,b   Hair, Alison ^a   Li, Gary ^a   Thirumangalathu, Renuka ^a   Nashed Samuel, Yasser ^a   Brych, Lejla ^a   Dharmavaram, Vasumathi ^a   Wen, Zai Qing ^a   Fujimori, Kiyoshi ^a   Jing, Wendy ^a   Sethuraman, Ananth ^a   Swift, Rob ^a   Ricci, Margaret Speed ^a   Piedmonte, Deirdre Murphy ^a  

^a AMGEN INC   (United States)

^b Agensys Inc   (United States)

Author keywords

excipients; formulation; glass; glass dissolution; interaction; leachable; neutral pH; silicic acid; solubility; surface interactions

Indexed keywords

EXCIPIENT; GLASS; PLACEBO; POLYSORBATE 20; SILICATE;

ARTICLE; DEGRADATION; DRUG FORMULATION; DRUG INCOMPATIBILITY; FREEZE THAWING; LIQUID; PH; STORAGE TEMPERATURE;

EXCIPIENTS; FORMULATION; GLASS; GLASS DISSOLUTION; INTERACTION; LEACHABLE; NEUTRAL PH; SILICIC ACID; SOLUBILITY; SURFACE INTERACTIONS;

DRUG PACKAGING; EXCIPIENTS; FREEZING; GLASS; HYDROGEN-ION CONCENTRATION; PARTICLE SIZE; POLYSORBATES; SILICA GEL; SOLUBILITY; TEMPERATURE;

EID: 84896402686     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23871     Document Type: Article

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