Stable injectable oil-in-water docetaxel nanoemulsion

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/107 (2006.01) A61K 9/19 (2006.01) A61K 31/337 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2731353

The present invention describes Stable injectable oil-in-water Docetaxel nanoemulsion composition having Doc-etaxel concentrations as high as 20 mg/ml, devoid of hypersensitivity reaction and fluid retention,. It employs Synthetic triglyc-erides, and DSPE PEG-2000, Natural phosphatides, Polyhydric alcohol and Water for injection. In another embodiment lyophilised products with added Cryoprotectants have been described which on reconstitution gives nanoemulsion suitable for parenteral administration.

L'invention concerne une composition de nanoémulsion huile dans l'eau injectable stable de docétaxel possédant une concentration en docétaxel d'au moins 20 mg/ml, ne provoquant pas de réaction d'hypersensibilité ni de rétention d'eau. L'invention fait appel à des triglycérides synthétiques, à du DSPE PEG-2000, à des phosphatides naturels, à de l'alcool polyhydrique et à de l'eau pour l'injection. Dans un autre mode de réalisation, l'invention concerne des produits lyophilisés auxquels ont été ajoutés des agents cryoprotecteurs et qui, lors de leur reconstitution, permettent d'obtenir une nanoémulsion apte à être administrée par voie parentérale..

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