High pressure compaction for pharmaceutical formulations

Details High pressure compaction for pharmaceutical formulations High pressure compaction for pharmaceutical formulations

A - Human Necessities

61

K

A61K 9/14 (2006.01) A61K 9/16 (2006.01)

Patent

CA 2510319

Methods for producing a pharmaceutical preparation of pressure-fused particles including an active pharmaceutical ingredient are disclosed. The methods include the application of a pressure of between 0.1 GPa and 10 GPa to produce a compacted sample. The pressure-fused particles of the invention are useful for parenteral administration, and particularly sustained-release formulations, due to dissolution kinetics which are superior to conventional crystalline or amorphous packed powder preparations of active pharmaceutical ingredients. Pharmaceutical preparations including such pressure-fused microparticles are also disclosed.

L'invention concerne des procédés pour fabriquer une préparation pharmaceutique de particules fusionnées sous pression comprenant un ingrédient pharmaceutique actif. Les procédés comprennent l'application d'une pression entre 0,1 GPa et 10 GPa pour produire un échantillon compacté. Les particules fusionnées sous pression de l'invention sont conçues pour l'administration parentérale, notamment dans les formulations à libération prolongée grâce à une cinétique de dissolution supérieure à celle des préparations pulvérulentes sous forme cristalline ou amorphe d'ingrédients pharmaceutiques actifs. L'invention concerne également des préparations pharmaceutiques comprenant ces microparticules fusionnées sous pression.

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