High concentration pharmaceutical compositions of roflumilast for ophthalmic delivery

A high concentration ophthalmic pharmaceutical composition comprising:

• about 2% to about 5% w/v of roflumilast;
• about 0.2% to about 0.8% w/v of sodium carboxymethyl cellulose;
• about 0.2% to about 0.8% w/v of sodium chloride;
• about 0.02% to about 0.25% w/v of polysorbate 20;
• about 0.005% to about 0.20% w/v of potassium chloride;
• about 0.005% to about 0.20% w/v of calcium chloride;
• about 0.005% to about 0.20% w/v of magnesium chloride;
• about 0.005% to about 0.20% w/v of sodium acetate;
• about 0.005% to about 0.20% w/v of sodium citrate;
• and
• water,
• wherein the pH of the composition is between 5.5 and 7.5, and
• wherein the ophthalmic pharmaceutical composition is suitable for intravitreal administration into the eye.

A method for treating an eye disorder in a patient comprising:

• injecting a high concentration ophthalmic pharmaceutical composition of roflumilast into the eye of the patient,
• wherein the pharmaceutical composition comprises about 2% to about 5% w/v of roflumilast;
• a viscosity agent;
• a tonicity agent;
• a buffer agent;
• a surfactant;
• and water;
• wherein the ophthalmic pharmaceutical composition is suitable for intravitreal administration.