Dibenzo azepine compounds and their use in the treatment of otic diseases and disorders
AssigneePipeline Therapeutics, Inc.
InventorsThomas Jon Seiders, Catherine Yuling Lee, Yiwei Li
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Abstract
The present disclosure provides crystalline Compound I and crystalline Compound II, pharmaceutical compositions comprising one of said crystalline compounds suitable for intratympanic administration, and methods for treating otic disorders using the crystalline compounds and the pharmaceutical compositions.
Claims24
Crystalline Compound I having the formula:
- characterized by an x-ray powder diffraction pattern with peaks at 8.2, 13.8, 14.0, 18.4, and 20.9±0.15 degrees two-theta;
- and characterized as having a differential scanning calorimetry endotherm onset at about 238.5° C.
Crystalline Compound II having the formula:
- characterized by an x-ray powder diffraction pattern with peaks at 8.4, 15.2, 16.0, 20.6, and 22.6±0.15 degrees two-theta;
- and characterized as having a differential scanning calorimetry endotherm onset at about 173° C.
An aqueous pharmaceutical composition comprising:
- (1) an active agent selected from:
- a crystalline Compound I having the formula:
- characterized by an x-ray powder diffraction pattern with peaks at 8.2, 13.8, 14.0, 18.4, and 20.9±0.15 degrees two-theta;
- or
- a crystalline Compound II having the formula:
- characterized by an x-ray powder diffraction pattern with peaks at 8.4, 15.2, 16.0, 20.6, and 22.6±0.15 degrees two-theta;
- and
- (2) a pharmaceutically acceptable aqueous solution.
A method for the treatment of otic disorders which comprises intratympanic administration of a therapeutically effective amount of an active agent selected from:
- a crystalline Compound I having the formula:
- characterized by an x-ray powder diffraction pattern with peaks at 8.2, 13.8, 14.0, 18.4, and 20.9±0.15 degrees two-theta;
- or
- a crystalline Compound II having the formula:
- characterized by an x-ray powder diffraction pattern with peaks at 8.4, 15.2, 16.0, 20.6, and 22.6±0.15 degrees two-theta, to a patient in need thereof.
Dependencies are inferred from the claim text.