Claims for Patent: 9,144,561

Summary for Patent: 9,144,561

Title:	Pharmaceutical compositions having desirable bioavailability
Abstract:	The present invention is directed to the provision of pharmaceutical compositions. The compositions include a therapeutic agent and a relatively low amount of surfactant for providing higher bioavailability of the therapeutic agent. The compositions are particularly desirable as ophthalmic compositions in which the therapeutic agent is a prostaglandin such as travoprost and the surfactant is a vegetable oil such as castor oil.
Inventor(s):	Kabra; Bhagwati P. (Euless, TX)
Assignee:	Alcon Research, Ltd. (Fort Worth, TX)
Application Number:	14/267,668
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,144,561
Patent Claims:	1. An ophthalmic pharmaceutical composition, comprising: a pharmaceutical vehicle suitable for topical application to an eye of a human; at least 0.001 w/v % but less than 0.01 w/v % travoprost as a therapeutic agent for lowering intraocular pressure; greater than 0.0003 w/v % but less than 0.003 w/v % polymeric quaternary ammonium compound as a preservative; and an effectively low amount of surfactant sufficient for providing a high degree of bioavailability of the travoprost, wherein: i. the amount of surfactant is at least 0.01 w/v % but below 0.4 w/v % of the composition; ii. the surfactant is entirely ethoxylated and hydrogenated castor oil; iii. the composition is substantially free of benzalkonium chloride; and iv. the pharmaceutical vehicle includes water. 2. A composition as in claim 1 wherein the concentration of the surfactant is at least 0.03 w/v % but less than 0.3 w/v %. 3. A composition as in claim 1 wherein the composition has a pH of 6.4 to 7.5. 4. A composition as in claim 1 wherein the surfactant is non-ionic. 5. A composition as in claim 1 wherein the composition has a pH of 6.4 to 7.2. 6. A composition as in claim 1 wherein the composition satisfies Ph. Eur. A, Ph. Eur. B or both. 7. A composition as in claim 1 wherein the composition is disposed in an eye dropper. 8. A composition as in claim 1 wherein concentration of the surfactant in the composition is less than 0.15 w/v %. 9. A composition as in claim 1 wherein the surfactant is entirely Polyoxyl 40 Hydrogenated castor Oil. 10. A composition as in claim 1 wherein the travoprost is in the composition at a concentration of less than 0.006 w/v %. 11. A composition as in claim 1 wherein concentration of the polymeric quaternary ammonium compound in the composition is greater than 0.0007 w/v % but less than 0.0015 w/v % of the pharmaceutical composition. 12. A composition as in claim 1 wherein the polymeric quaternary ammonium compound is polyquaternium-1. 13. A composition as in claim 2 wherein the composition has a pH of 6.4 to 7.5. 14. A composition as in claim 13 wherein the travoprost is in the composition at a concentration of less than 0.006 w/v %. 15. A composition as in claim 14 wherein the surfactant is entirely Polyoxyl 40 Hydrogenated castor Oil. 16. A composition as in claim 15 wherein concentration of the polymeric quaternary ammonium compound in the composition is greater than 0.0007 w/v % but less than 0.0015 w/v % of the pharmaceutical composition. 17. A composition as in claim 16 wherein the composition is disposed in an eye dropper. 18. A composition as in claim 17 wherein concentration of the surfactant in the composition is less than 0.15 w/v %. 19. A composition as in claim 18 wherein the composition satisfies Ph. Eur. A, Ph. Eur. B or both. 20. A composition as in claim 19 wherein the composition has a pH of 6.4 to 7.2. 21. A composition as in claim 20 wherein the surfactant is non-ionic.