Process for the preparation of concentrated, sterile injectable solutions containing docetaxel

Process for the preparation of concentrated, sterile injectable solutions containing docetaxel

This invention describes a process for the production of ANHYDROUS active pharmaceutical ingredients (APIs); a process for the preparation of HYDRATED active pharmaceutical ingredients, a process for the preparation of sterile and stable injectable solutions, and their use, more specifically, APIs w...

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Bibliographische Detailangaben
Hauptverfasser: GUIMARAES ENEIDA, MACHADO ANTONIO, SANTINI MARCO ANTONIO, SANTIAGO JUNIOR MARCIO, SILVA MARIA, MARANDUBA AURELIO
Format: Patent
Sprache:eng
Schlagworte:
CHEMISTRY
HETEROCYCLIC COMPOUNDS
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
METALLURGY
ORGANIC CHEMISTRY
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Beschreibung
Zusammenfassung:This invention describes a process for the production of ANHYDROUS active pharmaceutical ingredients (APIs); a process for the preparation of HYDRATED active pharmaceutical ingredients, a process for the preparation of sterile and stable injectable solutions, and their use, more specifically, APIs which are taxane derivatives, especially (2R,3S) 4-acetoxy-2-α-benzoyloxy-5 -20-epoxy-1,7- -10- -tri-hydroxy-9-oxo-tax-11-en-13α-il 3-tert-butoxy carbonylamino-2-hydroxy-3-phenylpropionate (I); 4-acetoxy-2-α-benzoyloxy-5- -20-epoxy-1,7 -10- -tri-hidroxy-9-oxo-tax-11-en-13α-il (2R,3S) 3-benzoylamino-2-hydroxy-3-phenylpropionate (II), and particularly 4-acetoxy-2-α-benzoyloxy-5 -20-epoxy-1, 7- -10- -tri-hidroxy-9-oxo-tax-11-en-13α-il (2R,3S) 3-tert-butoxycarbonylamino-2-hydroxy-3-phenylpropionate tri-hydrate (III).