Ophthalmic pharmaceutical compositions of roflumilast

An ophthalmic pharmaceutical composition comprising:

• a therapeutically effective amount of roflumilast at about 0.3% w/v to about 1.0% w/v;
• a viscosity agent comprising polyvinylpyrrolidone at about 0.1% w/v to about 5.0% w/v;
• a surfactant at about 0.05% w/v to about 3.0% w/v;
• and
• a buffer at about 0.3% w/v to about 7.5% w/v,
• wherein the composition has a pH between 6.0 and 6.7, and
• wherein the composition has less than 0.25% of any roflumilast-related impurity as measured by high-performance liquid chromatography (HPLC).

An ophthalmic pharmaceutical composition comprising:

• a therapeutically effective amount of roflumilast at about 0.3% w/v to about 1.0% w/v;
• a viscosity agent comprising carboxymethyl cellulose at about 0.1% w/v to about 5% w/v;
• a surfactant at about 0.05% w/v to about 3.0% w/v;
• and
• a buffer at about 0.3% w/v to about 7.5% w/v,
• wherein the composition has a pH between 6.0 and 6.7, and
• wherein the composition has less than 0.25% of any roflumilast-related impurity as measured by high-performance liquid chromatography (HPLC).

A method of manufacturing a stable, ophthalmic pharmaceutical composition of roflumilast comprising:

• (a) mixing about 0.3% to 1.0% w/v of roflumilast and at least one inactive ingredient to obtain a pharmaceutical composition having a pH of between 6.0 and 6.7;
• (b) packaging the pharmaceutical composition;
• and
• (c) terminally sterilizing the pharmaceutical composition in the packaging by using gamma radiation.