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US 6,720,453 B2Granted
Formoterol tartrate polymorph
AssigneeSepracor Inc.
InventorsGerald J. Tanoury, Chris H. Senanayake, Donald W Kessler
Life of this patent
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Abstract
A method of preparation of a highly pure salt of R,R-formoterol L-tartrate is disclosed. The process provides the most thermodynamically stable polymorph by recrystallization of a novel polymorph.
Claims15
A crystalline solid consisting of greater than 99.5% by weight of (R,R)-formoterol L-tartrate and less than 0.5% by weight of chemical impurities other than formoterol L-tartrate;
- said chemical impurities including less than 0.2% by weight (based on total crystalline solid) of a compound of formula 7
- said (R,R)-formoterol L-tartrate being at least 95% in the polymorphic form of a thermodynamically stable third polymorph (A) having peaks at the diffraction degrees with the intensity shown below in an x-ray powder diffraction pattern:
- peak number 2-Theta Intensity 1 8.8 33.1 2 9.3 33.4 3 12.1 58.1 4 12.4 60.6 5 14.2 30.9 6 15.2 87.4 7 15.5 82.8 8 16.8 69.8 9 18.9 39.6 10 19.7 41.1 11 20.8 40.6 12 22.5 38.8 13 23.0 59.9 14 23.7 100.0 15 25.6 55.9 16 26.8 37.2 17 28.6 25.6 18 30.9 37.2 19 36.1 28.0 20 38.1 25.0 21 39.1 22.7 22 41.5 21.3 23 43.3 20.9.
A crystalline solid consisting of greater than 99.5% by weight of (R,R)-formoterol L-tartrate and less than 0.5% by weight of chemical impurities other than formoterol L-tartrate;
- said chemical impurities including less than 0.1% by weight (based on total crystalline solid) of a compound of formula 8
- said (R,R)-formoterol L-tartrate being at least 95% in the polymorphic form of a thermodynamically stable third polymorph (A) having peaks at the diffraction degrees with the intensity shown below in an X-ray powder diffraction pattern:
- peak number 2-Theta Intensity 1 8.8 33.1 2 9.3 33.4 3 12.1 58.1 4 12.4 60.6 5 14.2 30.9 6 15.2 87.4 7 15.5 82.8 8 16.8 69.8 9 18.9 39.6 10 19.7 41.1 11 20.8 40.6 12 22.5 38.8 13 23.0 59.9 14 23.7 100.0 15 25.6 55.9 16 26.8 37.2 17 28.6 25.6 18 30.9 37.2 19 36.1 28.0 20 38.1 25.0 21 39.1 22.7 22 41.5 21.3 23 43.3 20.9.
Dependencies are inferred from the claim text.