Solid preparation

C - Chemistry – Metallurgy – 07 – D

Patent

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Details

C07D 209/16 (2006.01) A61K 31/404 (2006.01) A61P 3/04 (2006.01)

Patent

CA 2391646

The present invention provides a solid preparation comprising a crystal of [3- [(2R)-[[(2R)-(3-chlorophenyl)-2-hydroxyethyl]amino]propyl]-1H-indol-7- yloxy]acetic acid (Compound A), especially a crystal of Compound A having a particle size of not larger than 100 µm at the cumulative weight distribution value of 50 %, and not larger than 200 µm at the cumulative weight distribution value of 95 %, preferably a solid preparation having the excellent stability and the content uniformity of Compound A, which is prepared by preparing granules of the crystal of Compound A with fillers, disintegrants and binders, and then followed by mixing said granules with external excipients.

La présente invention concerne une préparation solide contenant un cristal d'acide acétique [3-[(2R)-[[(2R)-(3-chlorophényl)-2-hydroxyéthyl]amino]propyl]-1H-indol-7-yloxy] (Composé A), particulièrement un cristal de composé A dont la taille de particule est de 100 mu m maximum à la valeur cumulative de répartition du poids de 50 %, et de 200 mu m maximum à la valeur cumulative de répartition du poids de 95 %, de préférence une préparation solide caractérisé par l'excellente stabilité et l'uniformité de teneur du composé A, obtenue en préparant d'abord les granules de cristal du composé A avec des charges, des désintégrant et des liants, puis en mélangeant lesdits granules avec des excipients externes.

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