Dibenzo azepine compounds and their use in the treatment of otic diseases and disorders

An aqueous pharmaceutical composition for intratympanic administration 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 and 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 comprising:
• (A) approximately 15% to 25% by weight (w/w) of poloxamer 407;
• or
• (B) (i) approximately 15% to 25% by weight (w/w) of poloxamer 407 and
• (ii) approximately 0.5% to 4% by weight (w/w) of hydroxypropyl methylcellulose having a nominal viscosity of 40-60 cP or grade 80-120 cP;
• or
• (C) (i) approximately 10%-20% by weight (w/w) of poloxamer 407, and
• (ii) approximately 0.1%-0.3% by weight (w/w) of Carbopol® 974P;
• or
• (D) (i) approximately 0.5% to 8% by weight (w/w) of a hyaluronic acid;
• or
• (E) (i) approximately 0.5% to 4% by weight (w/w) of a hyaluronic acid, and
• (ii) approximately 5% to 20% by volume of polyethylene glycol 400;
• wherein said active agent is present in approximately 0.01% to about 20% w/v of said aqueous solution.