CRYSTALLINE FORM OF y-AMINOBUTYRIC ACID ANALOG
A crystalline form of a γ-aminobutyric acid analog, and methods of preparing same, are provided.
1 . Unsolvated crystalline 1-{[(α-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane acetic acid.
2 . The crystal of claim 1 corresponding to the representative X-ray powder diffraction pattern of FIG. 1 in an X-ray powder diffractogram using Cu Kα radiation.
3 . The crystal of claim 1 having an X-ray powder diffraction pattern comprising peaks at 7.0, 16.4 and 17.9±0.3 degrees 2θ in an X-ray powder diffractogram using Cu Kα radiation.
4 . The crystal of claim 3 further comprising peaks at 8.2, 10.5, 18.9, 20.9 and 23.3±0.3 degrees 2θ in an X-ray powder diffractogram using Cu Kα radiation.
5 . The crystal of claim 1 corresponding to the representative thermogravimetric analysis thermogram of FIG. 2 .
6 . The crystal of claim 1 having a differential scanning calorimetry thermogram comprising an exotherm with a maximum at 63±2° C., as determined by a differential scanning calorimetry at a scan rate of 5° C./minute.
7 . A method of treating restless legs syndrome comprising administering unsolvated crystalline 1-{[(α-isobutanoyloxyethoxy)carbonyl] aminomethyl}-1-cyclohexane acetic acid.
8 . A method of treating post herpetic neuralgia comprising administering unsolvated crystalline 1-{[(α-isobutanoyloxyethoxy)carbonyl] aminomethyl}-1-cyclohexane acetic acid.
9 . A pharmaceutical composition comprising the unsolvated crystalline 1-{[(α-isobutanoyloxyethoxy)carbonyl] aminomethyl}-1-cyclohexane acetic acid.