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Last Updated: November 22, 2024

Claims for Patent: 11,053,214

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Summary for Patent: 11,053,214

Title:	Compositions and methods related to pyridinoylpiperidine 5-HT.sub.1F agonists
Abstract:	The present invention provides new pseudo-polymorphs of the hemisuccinate salt of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-y- l]-benzamide which are useful in pharmaceutical compositions, for example, for the treatment and prevention of migraine headache.
Inventor(s):	Allieri; Brigida (Verona, IT), Fagan; Paul (Cambridge, MA), Sharp; Emma (London, GB), Skwierczynski; Raymond D. (Cambridge, MA)
Assignee:	CoLucid Pharmaceuticals, Inc. (Indianapolis, IN)
Application Number:	16/467,208
Patent Claims:	1. A crystalline Form D di-hydrate of the hemisuccinate salt of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benza- mide characterized by an X-ray diffraction pattern when measured using Cu-K.sub..alpha. radiation having at least peaks at about 18.7+/-0.2 degrees 2.theta., 26.5+/-0.2 degrees 2.theta., 27.0+/-0.2 degrees 2.theta., 27.5+/-0.2 degrees 2.theta. and 27.8+/-0.2 degrees 2.theta.. 2. The crystalline di-hydrate of claim 1, wherein the X-ray diffraction pattern includes at least one or more additional peaks selected from the group consisting of the following peaks at about degrees 2.theta., +/-0.2 degrees 2.theta., using Cu-K.sub..alpha. radiation: TABLE-US-00011 8.5 9.7 11.9 13.8 14.0 15.4 15.5 15.8 17.0 17.3 17.7 18.0 18.7 18.9 19.3 19.8 20.0 20.8 21.4 21.6 21.9 22.4 22.7 23.0 24.1 24.3 24.7 25.6 25.9 26.1 26.4 27.0 27.5 27.8 28.4 29.1 29.6 29.8, and 31.9. 3. The di-hydrate of claim 1, produced by a method comprising wet granulation of amorphous Compound I. 4. A pharmaceutical composition comprising the di-hydrate of claim 1 and a pharmaceutically acceptable carrier. 5. The pharmaceutical composition of claim 4, wherein said di-hydrate is substantially free from impurities. 6. The pharmaceutical composition of claim 5, wherein said di-hydrate has a chemical purity greater than 98.0% as determined by HPLC. 7. A method of treating migraine in a human in need thereof comprising administering to a mammal in need of such treatment an effective amount of the di-hydrate of claim 1.

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