MANUFACTURE OF DEGARELIX

The present invention provides methods for producing a lyophilized degarelix product which, upon reconstitution with water for injection in an amount of 20 mg/ml, shows a viscosity of up to 15 mPas.The present invention also provides a lyophilized degarelix drug substance which shows, upon dissoluti...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: SCHWACH, GRÉGOIRE, RASMUSSEN, JON HOLBECH, ANNBY, ULF, NILSSON, ANDERS, GOTTSCHALK BOEVING, TINE ELISABETH, FOMSGAARD, JENS, MÖRNSTAM, BIRGITTA, TSIRK, ANDERS
Format: Patent
Sprache:eng ; pol
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Zusammenfassung:The present invention provides methods for producing a lyophilized degarelix product which, upon reconstitution with water for injection in an amount of 20 mg/ml, shows a viscosity of up to 15 mPas.The present invention also provides a lyophilized degarelix drug substance which shows, upon dissolution in water in an amount of 20 mg/ml, a viscosity of up to 3.2 mPas, and processes for providing this lyophilized degarelix drug substance.