Suspension of sparingly water-soluble acidic drug

Details Suspension of sparingly water-soluble acidic drug Suspension of sparingly water-soluble acidic drug

A - Human Necessities

61

K

A61K 47/34 (2006.01) A61K 9/00 (2006.01) A61K 9/107 (2006.01) A61K 31/19 (2006.01) A61K 47/10 (2006.01)

Patent

CA 2253260

A suspension of a sparingly water-soluble acidic drug especially, a nonsteroidal anti-inflammatory analgetic agent, which is stable for a prolonged period of time and is highly dissolvable; and a process for simply and easily producing the suspension. This suspension has a pH value of 2 to 5 and comprises a sparingly water-soluble acidic drug whose average particle size ranges from 1 to 15 µm, a polyglycerol fatty acid ester, a water- soluble polyhydric alcohol and water, optionally, together with an inorganic powder having an average particle size of 1 to 15 µm. This process is characterized by carrying out pulverization and dispersion of sparingly water- soluble acid drug, a polyglycerol fatty acid ester, a water-soluble polyhydric alcohol and water by means of a pulverizer comprising a main shaft adapted to rotate in a casing and a plurality of layshafts adapted to revolve in relationship interlocked with the rotation of the main shaft, each of the layshafts being fitted with a multiplicity of annular grinding media.

L'invention concerne une suspension d'un médicament acide difficilement soluble dans l'eau, notamment un analgésique anti-inflammatoire non stéroïdien, qui reste stable longtemps et qui est très facile à dissoudre, ainsi qu'un procédé permettant de produire simplement et facilement ladite suspension. Celle-ci a un pH compris entre 2 et 5, et comprend un médicament acide difficilement soluble dans l'eau, dont le diamètre particulaire moyen est compris entre 1 et 15 µm, un ester d'un polyglycérol d'acide gras, un alcool polyhydrique soluble dans l'eau et de l'eau, ainsi éventuellement qu'une poudre inorganique ayant un diamètre particulaire moyen compris entre 1 et 15 µm. Le procédé est caractérisé par la pulvérisation et la dispersion d'un médicament acide difficilement soluble dans l'eau, d'un ester d'un polyglycérol d'acide gras, d'un alcool polyhydrique et d'eau au moyen d'un pulvérisateur constitué d'un arbre principal conçu pour tourner dans un boîtier et d'une pluralité d'arbres secondaires conçus pour tourner en suivant la rotation de l'arbre principal, chaque arbre secondaire comportant une pluralité de dispositifs de broyage annulaires.

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