Lyophilized Drug Product Cake Appearance: What Is Acceptable?

Cake appearance is an important attribute of freeze-dried products, which may or may not be critical with respect to product quality (i.e., safety and efficacy). Striving for “uniform and elegant” cake appearance may continue to remain an important goal during the design and development of a lyophil...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2017-07, Vol.106 (7), p.1706-1721
Hauptverfasser:	Patel, Sajal Manubhai, Nail, Steven L., Pikal, Michael J., Geidobler, Raimund, Winter, Gerhard, Hawe, Andrea, Davagnino, Juan, Rambhatla Gupta, Shailaja
Format:	Artikel
Sprache:	eng
Schlagworte:	amorphous Drug Compounding - methods Drug Stability drying formulation freeze drying Freeze Drying - methods glass transition lyophilization Pharmaceutical Preparations - chemistry Phase Transition processing protein formulation Quality Control stability
Online-Zugang:	Volltext
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