Claims for Patent: 11,534,395

Summary for Patent: 11,534,395

Title:	Ophthalmic suspension composition
Abstract:	A suspension includes an ophthalmic active ingredient suspended in a formulation vehicle including a suspending agent and a non-ionic cellulose derivative. The ophthalmic active agent is present as particles having Dv90<5 μm and Dv50<1 μm. The suspension may be administered to a patient for treating an ophthalmic inflammatory condition.
Inventor(s):	Mohannad Shawer, Eric Phillips, Martin J. Coffey
Assignee:	Bausch and Lomb Ireland Ltd
Application Number:	US16/826,366
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,534,395
Patent Claims:	1. An ophthalmic suspension comprising an ophthalmic active ingredient suspended in a formulation vehicle, wherein the ophthalmic active ingredient is present as milled particles that have Dv90<5 μm and Dv50<1 μm, and the formulation vehicle comprises a suspending agent comprising a cross-linked carboxyl-containing polymer and a particle size stabilizing agent comprising a non-ionic cellulose derivative, wherein the non-ionic cellulose derivative is hydroxypropylmethylcellulose present at a concentration effective to provide at least moderate particle size protection, the ophthalmic active ingredient is loteprednol etabonate, the cross-linked carboxyl-containing polymer is polycarbophil, and the suspension comprises loteprednol etabonate at 3.80 mg/mL, polycarbophil at 3.75 mg/mL, hydroxypropylmethyl cellulose E4M at 2.5 mg/mL, benzalkonium chloride at 0.03 mg/mL, edetate disodium dihydrate at 0.55 mg/mL, sodium chloride at 0.5 mg/mL, poloxamer 407 at 2.0 mg/mL, glycerin at 8.8 mg/mL, propylene glycol at 4.4 mg/mL, and boric acid at 5.0 mg/mL. 2. The suspension of claim 1, which is storage stable for at least one year. 3. The suspension of claim 1, which is storage stable for at least two years. 4. The suspension of claim 1, wherein the ophthalmic active ingredient is present as particles having Dv90<3 μm and Dv50<1 μm. 5. The suspension of claim 1, wherein the ophthalmic active ingredient is present as particles having Dv90<3 μm and D50<0.6 μm. 6. A method of treating an ophthalmic inflammatory condition comprising administering to an eye of a patient in need of said treating a suspension comprising an ophthalmic anti-inflammatory active ingredient suspended in a formulation vehicle, wherein the ophthalmic anti-inflammatory active ingredient is present as milled particles that have Dv90<5 μm and Dv50<1 μm, and the formulation vehicle comprises a suspending agent comprising a cross-linked carboxyl-containing polymer and a particle size stabilizing agent comprising a non-ionic cellulose derivative, wherein the non-ionic cellulose derivative is hydroxypropylmethylcellulose present at a concentration effective to provide at least moderate particle size protection, the ophthalmic active ingredient is loteprednol etabonate, the cross-linked carboxyl-containing polymer is polycarbophil, and the suspension comprises loteprednol etabonate at 3.80 mg/mL, polycarbophil at 3.75 mg/mL, hydroxypropylmethyl cellulose E4M at 2.5 mg/mL, benzalkonium chloride at 0.03 mg/mL, edetate disodium dihydrate at 0.55 mg/mL, sodium chloride at 0.5 mg/mL, poloxamer 407 at 2.0 mg/mL, glycerin at 8.8 mg/mL, propylene glycol at 4.4 mg/mL, and boric acid at 5.0 mg/mL. 7. The method of claim 6, wherein the suspension is administered at a frequency of one or two times per day. 8. The method of claim 6, wherein the ophthalmic inflammatory condition is inflammation resulting from post-ocular surgery or from uveitis.