Solid state forms of a pharmaceutical

Details Solid state forms of a pharmaceutical Solid state forms of a pharmaceutical

C - Chemistry, Metallurgy

07

J

C07J 1/00 (2006.01) A61K 31/569 (2006.01) A61P 3/00 (2006.01) A61P 29/00 (2006.01) C07J 5/00 (2006.01)

Patent

CA 2728889

The invention provides and describes solid state 17.alpha.-ethynyl-androst- 5- ene-3.beta.,7.beta.,17.beta.-triol including amorphous and crystalline forms and specific polymorphic forms thereof. Anhydrates and solvates of 17.alpha.-ethynyl-androst-5- ene-3.beta.,7.beta.,17.beta.-triol include Form I anhydrate and Form IV and Form V solvates. The invention further relates to solid and suspension formulations containing 17.alpha.-ethynyl-androst-5-ene-3.beta.,7.beta.,17.beta.-triol in a described solid state form and use of the formulations to treat hyperglycemic conditions, such as type 2 diabetes and metabolic syndrome, and autoimmune conditions, such as rheumatoid arthritis, ulcerative colitis and type 1 diabetes, among other inflammation related conditions in subjects or human patients. The invention also relates to methods to make liquid formulations from solid state forms of 17.alpha.-ethynyl-androst-5-ene-3.beta.,7.beta.,17.beta.-triol and uses of such formulations in treating the described conditions.

La présente invention concerne et décrit un 17a-éthynyl-androst-5-ène-3ß,7ß,17ß-triol à l'état solide, comprenant ses formes amorphes et cristallines ainsi que ses formes polymorphes spécifiques. Les anhydrates et les solvates de 17a-éthynyl-androst-5-ène-3ß,7ß,17ß-triol comprennent lanhydrate de forme I et les solvates de forme IV et de forme V. Linvention concerne en outre des formulations solides et de suspension contenant du 17a-éthynyl-androst-5-ène-3ß,7ß,17ß-triol dans une forme à létat solide décrite et lutilisation des formulations pour traiter les conditions hyperglycémiques, telles que le diabète de type 2 et le syndrome métabolique, et des maladies auto-immunes, telles que l'arthrite rhumatoïde, la rectocolite hémorragique et le diabète de type 1, entre autres conditions liées à une inflammation chez des sujets ou des patients humains. La présente invention concerne également des procédés de fabrication de formulations liquides à partir de formes solides de 17a-éthynyl-androst-5-ène-3ß,7ß,17ß-triol et les utilisations de ces formulations dans le traitement des conditions décrites.

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