Claims for Patent: 10,596,107

Summary for Patent: 10,596,107

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 D.sub.v90<5 .mu.m and D.sub.v50<1 .mu.m. The suspension may be administered to a patient for treating an ophthalmic inflammatory condition.
Inventor(s):	Shawer; Mohannad (Lexington, MA), Phillips; Eric (Ontario, NY), Coffey; Martin J. (Buffalo Grove, IL)
Assignee:	Bausch & Lomb Incorporated (Rochester, NY)
Application Number:	15/006,525
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,596,107
Patent Claims:	1. An ophthalmic suspension comprising an ophthalmic active ingredient suspended in a formulation vehicle, wherein the ophthalmic active ingredient is present as particles that have Dv90<5 .mu.m and Dv50<1 .mu.m, and the formulation vehicle comprises a suspending agent and a non-ionic cellulose derivative, wherein the suspending agent comprises a carboxyvinyl polymer. 2. The suspension of claim 1, which is storage stable for at least two years. 3. The suspension of claim 1, wherein the carboxyvinyl polymer is polycarbophil. 4. The suspension of claim 3, wherein the non-ionic cellulose derivative is hydroxypropylmethyl cellulose. 5. The suspension of claim 4, wherein the non-ionic cellulose derivative is hydroxypropylmethyl cellulose E4M. 6. The suspension of claim 1, wherein the formulation vehicle further comprises a surfactant. 7. The suspension of claim 6, wherein the surfactant comprises poloxamer 407. 8. The suspension of claim 1, wherein the formulation vehicle comprises polycarbophil, hydroxypropylmethyl cellulose, a poloxamer surfactant, glycerin, propylene glycol, and a borate buffer agent. 9. The suspension of claim 1, comprising loteprednol at 0.1 wt % to 0.4 wt %. 10. The suspension of claim 9, comprising loteprednol etabonate at 0.38 wt %. 11. The suspension of claim 1, wherein the ophthalmic active ingredient is present as particles having Dv90<3 .mu.m and Dv50<1 .mu.m. 12. The suspension of claim 1, wherein the ophthalmic active ingredient is present as particles having Dv90<3 .mu.m and Dv50<0.6 .mu.m. 13. The suspension of claim 1, wherein the ophthalmic active ingredient is loteprednol at 0.1 wt % to 0.4 wt %, the suspending agent is polycarbophil at 0.1 wt % to 0.5 wt %, and the non-ionic cellulose derivative is hydroxypropylmethyl cellulose at 0.1 wt % to 0.5 wt %. 14. A method of treating an ophthalmic inflammatory condition comprising administering to an eye of a patient in need of said treating an ophthalmic suspension according to claim 1. 15. The method of claim 14, wherein the suspension is administered at a frequency of one or two times per day. 16. The method of claim 14, wherein the ophthalmic inflammatory condition is inflammation resulting from post-ocular surgery or from uveitis. 17. The method of claim 14, wherein the formulation vehicle comprises polycarbophil, hydroxypropylmethyl cellulose, benzalkonium chloride, a non-ionic surfactant, glycerin, propylene glycol, and a borate buffer agent.