Unraveling the complexity of amorphous solid as direct ingredient for conventional oral solid dosage form: The story of Elagolix Sodium

[Display omitted] •Amorphous Elagolix Sodium, a first-in-class GnRH antagonist.•Lack of crystallization due to IMHB, repulsive API-API and solvent effects by MD.•Amorphous API, enabled by high surface area, functions as drug product binder.•Impinging jet mixer for precipitation; solvent removal step...

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Veröffentlicht in:	International journal of pharmaceutics 2024-11, Vol.665, p.124656, Article 124656
Hauptverfasser:	Ho, Raimundo, Hong, Richard S., Kalkowski, Joseph, Spence, Kevin C., Kruger, Albert W., Jayanth, Jayanthy, Nere, Nandkishor K., Mukherjee, Samrat, Sheikh, Ahmad Y., Bordawekar, Shailendra V.
Format:	Artikel
Sprache:	eng
Schlagworte:	Amorphous drug substance Glass transition Impinging jet precipitation Microstructure Multi-scale modeling Physical property control Scale-up
Online-Zugang:	Volltext
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