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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Hauptverfasser: Santini, Marco Antônio, Machado, Antônio, Maranduba, Aurélio, Guimarães, Eneida, Santiago Junior, Marcio, Silva, Maria
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creator Santini, Marco Antônio
Machado, Antônio
Maranduba, Aurélio
Guimarães, Eneida
Santiago Junior, Marcio
Silva, Maria
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-5β-20-epoxy-1,7-β-10-β-tri-hydroxy-9-oxo-tax-11-en-13α-il 3-tert-butoxy carbonylamino-2-hydroxy-3-phenylpropionate (I); 4-acetoxy-2-α-benzoyloxy-5-β-20-epoxy-1,7β-10-β-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-5β-20-epoxy-1, 7-β-10-β-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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title Process for the preparation of concentrated, sterile injectable solutions containing docetaxel
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