申请人:RK Pharma Solutions LLC
公开号:US20190233428A1
公开(公告)日:2019-08-01
Novel polymorphs of rucaparib camsylate include Form alpha having XRPD peaks at diffraction angles (2θ) of 6.14±0.2, 12.41±0.2, 15.34±0.2, 15.95±0.2, 16.36±0.2, 16.51±0.2 and 19.67±0.2, Form beta having XRPD peaks at diffraction angles (2θ) of 6.86±0.2, 9.58±0.2, 12.75±0.2, 14.56±0.2, 15.05±0.2, 20.76±0.2 and 22.45±0.2, and Form gamma having XRPD peaks at diffraction angles (2θ) of 9.5±0.2, 12.73±0.2, 14.77±0.2, 15.16±0.2, 20.62±0.2, 22.33±0.2, 22.63±0.2 and 27.29±0.2. Methods are disclosed for the preparation of such polymorphic forms and pharmaceutical compositions containing such polymorphic forms. A method is disclosed for preparing a highly pure Form B of rucaparib camsylate. Pharmaceutical compositions containing highly pure Form B prepared by the method are disclosed.
鲁卡帕尼坎西酸盐的新型多晶形包括α型,其XRPD峰位于衍射角度(2θ)为6.14±0.2、12.41±0.2、15.34±0.2、15.95±0.2、16.36±0.2、16.51±0.2和19.67±0.2;β型,其XRPD峰位于衍射角度(2θ)为6.86±0.2、9.58±0.2、12.75±0.2、14.56±0.2、15.05±0.2、20.76±0.2和22.45±0.2;和γ型,其XRPD峰位于衍射角度(2θ)为9.5±0.2、12.73±0.2、14.77±0.2、15.16±0.2、20.62±0.2、22.33±0.2、22.63±0.2和27.29±0.2。公开了制备这些多晶形式和含有这些多晶形式的药物组合物的方法。还公开了制备高纯度B型鲁卡帕尼坎西酸盐的方法。公开了含有通过该方法制备的高纯度B型的药物组合物。