Polymorphs of Ivacaftor, process for its preparation and pharmaceutical composition thereof
AssigneeLaurus Labs Limited
InventorsRam Thaimattam, Venkata Srinivasa Rao Dama, Venkata Sunil Kumar Indukuri, Seeta Rama Anjaneyulu Gorantla, Satyanarayana Chava
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Abstract
The present invention relates to novel polymorphic forms of ivacaftor, process for its preparation and pharmaceutical compositions comprising the same.
Claims52
An ivacaftor Form-L2 polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 5.6, 7.0, 13.1, 13.4, 14.1, 15.2, 16.8, 20, 20.4, 24.4 and 28.5±0.2° 2θ.
An ivacaftor Form-L1 polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 5.48, 5.74, 6.46, 8.12, 8.56, 9.82, 10.28, 1 1.00, 1 1.70, 13.40, 13.90, 14.38, 15.22, 15.64, 16.38, 16.64, 17.30, 17.80, 18.24, 18.96, 19.22, 20.62, 20.86, 21.12, 21.74, 21.98, 23.06, 23.96, 24.82, 25.30, 25.94, 26.82, 28.08, 28.48 and 30.34±0.2° 2θ.
An ivacaftor Form-L3 polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 5.70, 7.96, 10.36, 1 1.22, 12.88, 14.10, 15.60, 17.34, 18.14, 18.80, 19.84, 20.90, 22.48, 23.68, 24.64, 25.62 and 28.00±0.2° 2θ.
An ivacaftor Form-L4 polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 5.74, 8.26, 10.68, 11.56, 13.30, 14.60, 15.76, 17.88, 21.02, 22.90, 23.78, 25.14, 25.94, 28.20 and 29.98±0.2° 2θ.
An ivacaftor Form-L5 polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 5.78, 6.42, 8.08, 10.18, 11.24, 12.90, 14.02, 14.34, 15.52, 17.40, 18.38, 19.28, 20.90, 22.60, 23.84, 24.76, 25.82, 27.16, 28.00 and 29.86±0.2° 2θ.
An ivacaftor Form-L6 polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 6.38, 7.32, 8.10, 9.94, 11.12, 12.84, 14.64, 15.56, 17.44, 19.28, 20.66, 21.46, 25.46 and 29.62±0.2° 2θ.
An ivacaftor Form-L7 polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 5.0, 7.32, 8.46, 10.08, 12.38, 13.66, 15.62, 16.54, 18.58, 20.18, 21.88, 22.36, 23.00, 24.30, 24.80, 25.12, 25.64, 26.30, 26.54, 27.60, 28.06 and 29.30±0.2° 2θ.
An ivacaftor Form-L8 polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 4.86, 7.84, 8.24, 9.70, 11.56, 13.98, 15.26, 15.62, 16.34, 16.70, 17.40, 18.10, 19.60, 20.72, 21.16, 22.40, 23.66, 24.96, 26.30, 28.72, 30.14 and 31.76±0.2° 2θ.
An ivacaftor Form-L9 characterized by a powder X-Ray diffraction pattern having one or more peaks at about 5.86, 6.84, 8.50, 10.18, 11.48, 11.96, 13.82, 14.84, 15.66, 16.74, 17.12, 18.28, 18.66, 19.50, 21.02, 21.30, 22.06, 22.42, 23.20, 25.16, 25.50, 27.02, 28.44, 30.74 and 32.84±0.2° 2θ.
An ivacaftor Form-L10 polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 5.98, 8.26, 9.94, 10.92, 12.10, 12.54, 13.24, 13.98, 14.74, 15.36, 17.42, 17.96, 18.24, 18.66, 19.38, 19.80, 20.24, 22.38, 23.54, 24.46, 25.98, 26.86, 27.76, 29.30, 30.74, 32.02, 35.30 and 38.22±0.2° 2θ.
An ivacaftor Form-L11 polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 4.66, 8.08, 8.46, 9.46, 11.30, 13.70, 14.98, 15.36, 16.26, 17.50, 17.90, 19.24, 20.44, 20.86, 22.16, 23.38, 24.64, 25.94, 29.04 and 31.60±0.2° 2θ.
An ivacaftor Form-L12A polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 4.18, 8.56, 11.32, 12.96, 15.04, 15.18, 17.62, 18.76, 20.28, 21.06, 23.00 and 26.22±0.2° 2θ.
An ivacaftor Form-L12B polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 4.46, 6.96, 7.88, 8.78, 10.88, 11.52, 11.80, 14.16, 15.84, 16.72, 17.50, 18.30, 18.88, 19.64, 20.52, 21.32, 23.46, 24.88, 27.52 and 28.64±0.2° 2θ.
An ivacaftor Form-L13 polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 4.72, 8.16, 9.50, 11.38, 13.78, 15.10, 15.46, 16.36, 17.70, 17.94, 19.36, 20.52, 22.32, 23.46, 24.72, 26.10, 29.16 and 31.64±0.2° 2θ.
An ivacaftor Form-L14 polymorph characterized by a powder X-Ray diffraction pattern having one or more peaks at about 4.98, 8.04, 8.50, 9.82, 11.84, 14.18, 15.38, 16.64, 17.74, 18.42, 19.72, 21.00, 22.82, 23.84, 25.14, 26.38, 28.88, 32.04±0.2° 2θ.
A pharmaceutical composition comprising a therapeutically effective amount of one of ivacaftor Form-L1, Form-L2, Form-L3, Form-L4, Form-L5, Form-L6, Form-L7, Form-L8, Form-L9, Form-L10, Form-L11, Form-L12A, Form-L12B, Form-L13, and Form-L14, and at least one pharmaceutically acceptable carrier or excipient.
Dependencies are inferred from the claim text.