Quality by design in formulation and process development for a freeze-dried, small molecule parenteral product: A case study

Pharmaceutical Development and Technology

Volumn 16, Issue 6, 2011, Pages 549-576

  Mockus, Linas N ^a   Paul, Timothy W ^b   Pease, Nathan A ^b   Harper, Nancy J ^c   Basu, Prabir K ^a   Oslos, Elizabeth A ^b   Sacha, Gregory A ^b   Kuu, Wei Y ^b   Hardwick, Lisa M ^b   Karty, Jacquelyn J ^b   Pikal, Michael J ^d   Hee, Eun ^a   Khan, Mansoor A ^e   Nail, Steven L ^b  

^a PURDUE UNIVERSITY   (United States)

^b Baxter Pharmaceutical Solutions LLC   (United States)

^c PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^d UNIVERSITY OF CONNECTICUT   (United States)

^e CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Design space; Formulation development; Lyophilization; Risk assessment; Sodium ethacrynate

Indexed keywords

ETACRYNIC ACID;

AQUEOUS SOLUTION; ARTICLE; CRYSTALLIZATION; DIELS ALDER REACTION; DRUG DEGRADATION; DRUG DESIGN; DRUG FORMULATION; DRUG HYDROLYSIS; DRUG QUALITY; DRUG SOLUBILITY; DRUG STABILITY; DRUG STORAGE; DRUG STRUCTURE; FREEZE DRYING; LOW TEMPERATURE; MELTING POINT; MICROSCOPY; MOLECULAR SIZE; PH; POLYMERIZATION; PRIORITY JOURNAL; PROCESS DEVELOPMENT; SOLID; STORAGE TEMPERATURE; THERMAL ANALYSIS;

BUFFERS; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; DRUG DESIGN; DRUG STABILITY; ETHACRYNIC ACID; FREEZE DRYING; HYDROGEN-ION CONCENTRATION; HYDROLYSIS; TRANSITION TEMPERATURE;

EID: 80755187577     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.3109/10837450.2011.611138     Document Type: Article

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