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    • 10. 发明公开
    • POLYMORPH PURITY, MONITORING AND ASSOCIATED COMPOSITIONS
    • POLYMORPH REINEN,ÜBERWACHUNGUNDZUGEHÖRIGEZUSAMMENSETZUNGEN
    • EP3140290A1
    • 2017-03-15
    • EP15724189.4
    • 2015-05-07
    • Remedica Ltd
    • PATTIHIS, CharalambosNORDMANN, Antje
    • C07D239/94G01N23/20A61K31/517A61P35/00
    • C07D239/94G01N23/20G01N2223/62
    • The present invention relates to erlotinib hydrochloride Form A that includes no detectable erlotinib hydrochloride Form B; as determined by X-ray powder diffraction analysis that includes a differentiation resolution and a 2-theta scan region that enables detection of the absence, or presence, of a characteristic 2-theta peak of eriotinib hydrochloride Form B in the region of 6.0 to 6.4 degrees 2-theta. There is also provided a pharmaceutical composition comprising the same. Furthermore, a composition according to the invention can be further characterized by a stability profile whereby on storage at (i) a temperature of at least about 23°C, (ii) a relative humidity of at least about 55%, and (iii) for a period of at least about 6 months, no erlotinib hydrochloride Form B is detectable by X-ray powder diffraction analysis.
    • 本发明涉及不含可检测的盐酸埃罗替尼形式B的盐酸埃洛替尼形式A; 如通过X射线粉末衍射分析确定的,其包括分化分辨率和2-θ扫描区域,其能够检测6.0至6.4范围内的盐酸埃替替韦形式B的特征2-θ峰的不存在或存在 度2-θ。 还提供了包含其的药物组合物。 此外,根据本发明的组合物的进一步特征还在于其稳定性,其特征在于:(i)至少约23℃的温度,(ii)至少约55%的相对湿度,和(iii) 至少约6个月的时间,通过X射线粉末衍射分析可以检测到盐酸埃罗替尼形式B。