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Pharmaceutical formulations comprising crystalline forms of (R) -7-chloro-N- (quinuclidin-3-yl) benzo (b) thiophene-2-carboxamide hydrochloride monohydrate
专利权人:
Forum Pharmaceuticals Inc.
发明人:
OLIVER-SHAFFER, Patricia,SHAPIRO, Gideon,CHESWORTH, Richard,KISHIDA, Muneki,ISHIGE, Takayuki
申请号:
ES15202184
公开号:
ES2649539T3
申请日:
2011.05.17
申请国别(地区):
ES
年份:
2018
代理人:
摘要:
A pharmaceutical formulation, comprising a therapeutically effective amount of a crystalline form I of (R) -7-chloro-N- (quinuclidin-3-yl) benzo [b] thiophene-2-carboxamide monohydrate hydrochloride, in which the Pharmaceutical formulation is a tablet or capsule, in which the crystalline form I of (R) -7-chloro-N- (quinuclidin-3-yl) benzo [b] thiophene-2-carboxamide monohydrate hydrochloride is characterized by a X-ray powder diffraction pattern that has peaks expressed as 2θ in one or both of 17.48 and 20.58 ± 0.20 degrees when measured against an internal silicon pattern and characterized by a powder diffraction pattern X-ray which also has at least four peaks, six peaks, eight peaks or all peaks expressed as 2θ to 4.50, 9.04, 14.60, 15.14, 15.80, 16.60, 18, 16, 18.44, 19.48, 21.74 and 25.46 ± 0.20 degrees when measured against an internal silicon pattern.Una formulación farmacéutica, que comprende una cantidad terapéuticamente eficaz de una forma cristalina I de clorhidrato de (R)-7-cloro-N-(quinuclidin-3-il)benzo[b]tiofeno-2-carboxamida monohidratado, en la que la formulación farmacéutica es un comprimido o una cápsula, en la que la forma cristalina I de clorhidrato de (R)-7-cloro-N- (quinuclidin-3-il)benzo[b]tiofeno-2-carboxamida monohidratado se caracteriza por un patrón de difracción de polvo de rayos X que tiene picos expresados como 2θ en uno o ambos de 17,48 y 20,58 ± 0,20 grados cuando se mide frente a un patrón de silicio interno y caracterizada por un patrón de difracción de polvo de rayos X que tiene además al menos cuatro picos, seis picos, ocho picos o todos los picos expresados como 2θ a 4,50, 9,04, 14,60, 15,14, 15,80, 16,60, 18,16, 18,44, 19,48, 21,74 y 25,46 ± 0,20 grados cuando se mide frente a un patrón de silicio interno.
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