PHARMACEUTICAL PARENTERAL FORMULATION CONTAINING CARGLUMIC ACID

The present invention relates to a pharmaceutical formulation suitable for parenteral administration containing carglumic acid and a buffering agent having a pK a from 5.5 to 9.0 at 25°C; according to an embodiment, the buffering agent may have a pK a from 7.5 to 8.5, preferably a pK a of about 8.07...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser:	MATTEI, ALBERTO, FARINA, PIERLUIGI, BERLATI, FABIO, PROVVEDINI, DIEGO, MENEGON, SERGIO, BARCHIELLI, MARCO
Format:	Patent
Sprache:	eng ; srp
Schlagworte:	HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
Online-Zugang:	Volltext bestellen
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Beschreibung
Zusammenfassung:	The present invention relates to a pharmaceutical formulation suitable for parenteral administration containing carglumic acid and a buffering agent having a pK a from 5.5 to 9.0 at 25°C; according to an embodiment, the buffering agent may have a pK a from 7.5 to 8.5, preferably a pK a of about 8.07, such as trometamol. The formulation may also contain at least one bulking agent, such as mannitol. The invention also includes a method for manufacturing a lyophilised sterile formulation by freeze-drying a water solution containing carglumic acid, a buffering agent having a pK a from 5.5 to 9.0 at 25°C, preferably from 7.5 to 8.5, and optionally a bulking agent to obtain a freeze-dried powder.