Controlled agglomeration

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/16 (2006.01) A61K 9/20 (2006.01) B01J 2/00 (2006.01) B01J 2/02 (2006.01) B01J 2/16 (2006.01)

Patent

CA 2452330

A process for the preparation of a particulate material by a controlled agglomeration method, i.e. a method that enables a controlled growth in particle size. The method is especially suitable for use in the preparation of pharmaceutical compositions containing a therapeutically and/or prophylactically active substance which has a relatively low aqueous solubility and/or which is subject to chemical decomposition. The process comprising i) spraying a first composition comprising a carrier, which has a melting point of about 5~C or more which is present in the first composition in liquid form, on a second composition comprising a material in solid form, the second composition having a temperature of at the most a temperature corresponding to the melting point of the carrier and/or the carrier composition and ii) mixing or others means of mechanical working the second composition onto which the first composition is sprayed to obtain the particulate material.

L'invention se rapporte à un procédé de préparation d'un matériau particulaire au moyen d'un procédé d'agglomération contrôlé, c'est-à-dire un procédé qui permet une croissance granulométrique contrôlée. Ce procédé convient tout particulièrement à la préparation de compositions pharmaceutiques contenant une substance active d'un point de vue thérapeutique et/ou prophylactique qui présente une faible solubilité aqueuse et/ou est soumise à une décomposition chimique. Ce processus consiste i) à vaporiser une première composition contenant un support dont le point de fusion est d'environ 5· ou plus et est présent dans la première composition sous forme liquide, sur une seconde composition contenant un matériau sous forme solide, cette seconde composition présentant une température qui, au maximum, correspond au point de fusion du support et/ou de la composition comprenant un support, et ii) à mélanger ou à travailler au moyen d'autres procédés mécaniques, la seconde composition sur laquelle la première composition est vaporisée afin d'obtenir le matériau particulaire.

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