A method and apparatus for producing liposomal parenteral...

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A61K 9/127 (2006.01) A61K 31/4422 (2006.01) A61K 31/4709 (2006.01) B01F 5/08 (2006.01) B01F 13/06 (2006.01)

Patent

CA 2237554

In the procedure for the production of a formulation of parenterally administrable pharmaceutical preparations, a liposome dispersion is used as a carrier for a pharmaceutical active compound. For the preparation of the liposome dispersion, an aqueous predispersion of one or more amphiphilic substances is fed to a high- pressure homogenizer in which the predispersion is pumped under a pressure from 600 bar to 900 bar through a homogenizer nozzle (2) having a diameter of 0.1 to 0.5 mm. The homogenizer nozzle has an inlet channel (14, 16) and an outlet channel (15, 18) and consists of a hard ceramic plate (11), in which the bore (13) is present, pressed into a steel body (12, 19). The inlet channel (14, 16) and the outlet channel (15, 18) are likewise incorporated into the steel body (12, 19).

L'invention concerne un procédé destiné à produire une formulation de préparations médicamenteuses administrée par voie parentérale, selon lequel on utilise une dispersion de liposomes comme substrat pour une substance active pharmaceutique. Pour produire cette dispersion de liposomes, une prédispersion aqueuse d'au moins un agent amphiphile est acheminée vers un homogénéisateur haute pression dans lequel la prédispersion est pompée à une pression comprise entre 600 et 900 bars par une buse d'homogénéisation dont le diamètre est compris entre 0,1 et 0,5 mm. La buse d'homogénéisation présente un canal d'alimentation et un canal d'évacuation et est constituée d'une plaque en céramique dure enfoncée dans un corps d'acier, ladite plaque présentant un orifice. Le canal d'alimentation et le canal d'évacuation sont également intégrés dans le corps d'acier.

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