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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Hauptverfasser: GUIMARAES ENEIDA, MACHADO ANTONIO, SANTINI MARCO ANTONIO, SANTIAGO JUNIOR MARCIO, SILVA MARIA, MARANDUBA AURELIO
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creator GUIMARAES ENEIDA
MACHADO ANTONIO
SANTINI MARCO ANTONIO
SANTIAGO JUNIOR MARCIO
SILVA MARIA
MARANDUBA AURELIO
description 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).
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subjects CHEMISTRY
HETEROCYCLIC COMPOUNDS
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
METALLURGY
ORGANIC CHEMISTRY
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
title Process for the preparation of concentrated, sterile injectable solutions containing docetaxel
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