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Enhanced suspension Formulation in the form of a corticosteroid that can be administered by inhalation
专利权人:
CHIESI FARMACEUTICI S.P.A.
发明人:
CANTARELLI ANNA MARIA,MINARI STEFANO,BASSI BARBARA
申请号:
ARP120101550
公开号:
AR086248A1
申请日:
2012.05.02
申请国别(地区):
AR
年份:
2013
代理人:
摘要:
2. Aqueous suspension containing drug particles, especially corticosteroids; It can be managed by atomization and has the best distribution of particle size, It is characterized as including particles in crystalline cortical cholesterol suspended from the solution, wherein (I) no more than 10% of the suspended particles are less than 0.6 mm according to the volume diameter [D (V, 0.1)],ii) no more than 50% of the particles have a diameter based on the volume [d (v, 0.5)] of between 1.5 mm and 1.9 mm; and iii) at least 90% of the particles [d (v, 0.9)] have a diameter based on volume equal to or less than 4.7 mm, and where the particles have a size range, defined as [d (v, 0.9) - d (v, 0.1)] / d (v, 0.5),From 1.2 to 2.2 Claim 6: in accordance with the expression of claim 5, the corioide is a diode of beclomethasone. Claim 13: in accordance with the expression of claim 12, which is characterized by the addition of salbutamol sulfate as the active ingredient. Claim 14: a container characterized in that its filling conforms to the wording of any claims 1 to 13. 115. Claim 15: a set of characteristics is (a) expressed in a single dose container in accordance with any of the requirements of 1 to 13; and (b) aerosol.Formulación en forma de suspensión acuosa que comprende partículas de drogas, particularmente de corticosteroides, que puede administrarse por nebulización y que presenta una distribución óptima del tamaño de las partículas.Reivindicación 1: Una formulación farmacéutica estéril libre de propelentes que puede administrarse por nebulización, caracterizada porque comprende partículas micronizadas de un corticosteroide cristalino suspendidas en una solución acuosa, donde i) no más de 10% de las partículas suspendidas tienen un diámetro basado en el volumen [d(v,0,1)] inferior a 0,6 mm, ii) no más de 50% de las partículas tienen un diámetro basado en el volumen [d(v,0,5)] de entre 1,5 mm y 1,9 mm; y iii) al menos 90% de las partículas [d(v,0,9)] tienen un diámetro b
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