Phospholipid Gel Compositions for Drug Delivery and Methods of Treating Conditions Using Same

A method of treating an otic infection in an animal comprising topically administering to the ear of the animal a pharmaceutical composition comprising:

• (i) a mixture of propylene carbonate and glycerol formal in a ratio ranging from about 90:10 to 10:90 containing hydroxypropylmethylcellulose dissolved therein, wherein the hydroxypropylmethylcellulose is present in an amount ranging from about 0.1 to 10% by weight of the composition;
• (ii) a phospholipid in an amount ranging from about 0.1 to 10 percent by weight of the composition, and
• (iii) an antifungal agent, an antibacterial agent, and an anti-inflammatory agent,
• wherein the combination of (i), (ii), and (iii) form a gel and the pharmaceutical composition is substantially free of water.

A method of treating an otic infection in an animal comprising topically administering to the ear of the animal a pharmaceutical composition comprising:

• (i) a mixture of propylene carbonate and glycerol formal containing hydroxypropylmethylcellulose dissolved therein,
• (ii) a phospholipid, and
• (iii) terbinafine or a pharmaceutically acceptable salt thereof, florfenicol or a pharmaceutically acceptable ester thereof, and betamethasone or a pharmaceutically acceptable ester thereof;
• wherein the combination of (i), (ii), and (iii) form a gel and the pharmaceutical composition is substantially free of water.

A method of treating an otic infection in an animal comprising topically administering to the ear of the animal a pharmaceutical composition comprising:

• (i) a mixture of propylene carbonate and glycerol formal in a ratio ranging from about 60:40 to 40:60 containing hydroxypropylmethylcellulose dissolved therein;
• (ii) a phospholipid having the structure:
• wherein R1 is —O− and R2 and R3 are each independently stearoyl groups or palmitoyl groups wherein the ratio of stearoyl groups to palmitoyl groups is about 85:15;
• (iii) terbinafine or a pharmaceutically acceptable salt thereof;
• (iv) florfenicol or a pharmaceutically acceptable ester thereof;
• and
• (v) betamethasone or a pharmaceutically acceptable ester thereof,
• wherein:
• the phospholipid is present in an amount ranging from about 1% to 4% by weight of the composition;
• the hydroxypropylmethylcellulose is present in an amount ranging from about 2% to 4% by weight of the composition;
• the terbinafine or a pharmaceutically acceptable salt thereof is present in an amount ranging from about 1% to 3% by weight of the composition;
• the florfenicol or a pharmaceutically acceptable ester thereof is present in an amount ranging from about 1% to 3% by weight of the composition;
• the betamethasone or a pharmaceutically acceptable ester thereof is present in an amount ranging from about 0.05% to 0.3% by weight of the composition;
• and
• wherein the combination of (i), (ii), (iii), (iv), and (v) form a gel and the pharmaceutical composition is substantially free of water.

A method of treating an otic infection in an animal comprising topically administering to the ear of the animal a pharmaceutical composition comprising:

• (i) a mixture of propylene carbonate and glycerol formal in a ratio ranging from about 90:10 to 10:90 containing hydroxypropylmethylcellulose dissolved therein, wherein the hydroxypropylmethylcellulose is present in an amount ranging from about 0.1 to 10% by weight of the composition;
• (ii) a phospholipid in an amount ranging from about 0.1 to 10 percent by weight of the composition, and
• (iii) an antifungal agent, an antibacterial agent, and an anti-inflammatory agent,
• wherein (i), (ii), and (iii) are combined together at a temperature of about 40° C. to provide a solution and then cooled to room temperature provide a gel, and
• wherein the pharmaceutical composition is substantially free of water.

A method of treating an otic infection in an animal comprising topically administering to the ear of the animal a pharmaceutical composition comprising:

• (i) a mixture of propylene carbonate and glycerol formal in a ratio ranging from about 60:40 to 40:60 containing hydroxypropylmethylcellulose dissolved therein;
• (ii) a phospholipid having the structure:
• wherein R1 is —O− and R2 and R3 are each independently stearoyl groups or palmitoyl groups wherein the ratio of stearoyl groups to palmitoyl groups is about 85:15;
• (iii) terbinafine or a pharmaceutically acceptable salt thereof;
• (iv) florfenicol or a pharmaceutically acceptable ester thereof;
• and
• (v) betamethasone or a pharmaceutically acceptable ester thereof,
• wherein:
• the phospholipid is present in an amount ranging from about 1% to 4% by weight of the composition;
• the hydroxypropylmethylcellulose is present in an amount ranging from about 2% to 4% by weight of the composition;
• the terbinafine or a pharmaceutically acceptable salt thereof is present in an amount ranging from about 1% to 3% by weight of the composition;
• the florfenicol or a pharmaceutically acceptable ester thereof is present in an amount ranging from about 1% to 3% by weight of the composition;
• the betamethasone or a pharmaceutically acceptable ester thereof is present in an amount ranging from about 0.05% to 0.3% by weight of the composition;
• and
• wherein (i), (ii), (iii), (iv), and (v) are combined together at a temperature of about 40° C. to provide a solution and then cooled to room temperature provide a gel, and
• wherein the pharmaceutical composition is substantially free of water.