A process for the preparation of suspensions of drug...

A - Human Necessities – 61 – K

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A61K 31/573 (2006.01) A61K 9/12 (2006.01) A61K 9/14 (2006.01) A61K 9/72 (2006.01) A61P 11/00 (2006.01) A61L 2/08 (2006.01)

Patent

CA 2349268

The invention is directed to a process for the preparation of suspensions of drug particles for inhalation delivery, said process providing particles of optimised particle size and distribution homogeneously dispersed in the carrier. The process, which is also suitable for the preparation of sterile suspensions, includes the step of homogenising and micronising the formulation in a turboemulsifier provided with a high-potency turbine, optionally followed by a treatment in a high-pressure homogeniser. A further aspect of the invention is directed to a process for preparing micronised sterile beclomethasone dipropionate by gamma-irradiation.

L'invention concerne un procédé de préparation de suspensions de particules médicamenteuses destinées à être inhalées, ce procédé fournissant des particules dont les tailles de particules et la distribution de tailles de particules optimales leur permettent d'être réparties de manière homogène à l'intérieur de l'excipient. Ce procédé, qui peut également être utilisé pour préparer des suspensions stériles, consiste notamment à homogénéiser et à microniser la formulation dans un turboémulseur pourvu d'une turbine haute puissance, puis éventuellement à procéder à un traitement dans un homogénéiseur haute pression. Cette invention concerne enfin un procédé de préparation de dipropionate de béclométhasone stérile micronisé par irradiation gamma.

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