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Claims for Patent: 8,178,582

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Claims for Patent: 8,178,582

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:12/403,529
Patent Claims: 1. An ophthalmic pharmaceutical composition, comprising: a pharmaceutical vehicle suitable for topical application to an eye of a human; an amount of a prostaglandin suitable for treating glaucoma; a polymeric quaternary ammonium compound for preserving the composition; and a surfactant wherein the surfactant is ethoxylated and/or hydrogenated vegetable oil at a concentration in the composition of at least 0.01 w/v % but less than 0.4 w/v %, wherein: i. the ethoxylated and/or hydrogenated vegetable oil surfactant is entirely or substantially entirely the only surfactant in the composition; ii. the pharmaceutical vehicle includes water; and iii. the composition is free of any benzalkonium chloride.

2. A composition as in claim 1 wherein the prostaglandin is the only therapeutic agent.

3. A composition as in claim 1 wherein the prostaglandin, the surfactant or both are non-ionic.

4. A composition as in claim 2 wherein the prostaglandin is travoprost.

5. A composition as in claim 1 wherein the ethoxylated and/or hydrogenated vegetable oil surfactant is entirely castor oil.

6. A composition as in claim 1 wherein the ethoxylated and/or hydrogenated vegetable oil surfactant is entirely Polyoxyl 40 Hydrogenated castor Oil.

7. A composition as in claim 1 wherein the surfactant is between 0.001 and 0.3 w/v % of the composition.

8. A composition as in claim 1 wherein the composition satisfies Ph. Eur. A, Ph. Eur. B or both.

9. A composition as in claim 1 wherein the composition is substantially free of any other chlorine containing preservation agents.

10. A composition as in claim 1 wherein the prostaglandin is less than 0.01 w/v % of the composition.

11. A composition as in claim 1 wherein the prostaglandin is less than 0.006 w/v % of the composition.

12. A composition as in claim 1 wherein the prostaglandin is non-ionic and/or relatively insoluble in aqueous solution.

13. A composition as in claim 1 wherein the surfactant and the prostaglandin are non-ionic.

14. An ophthalmic pharmaceutical composition, comprising: a pharmaceutical vehicle suitable for topical application to an eye of a human; an amount of therapeutic agent suitable for treating glaucoma wherein the therapeutic agent is a prostaglandin; a polymeric quaternary ammonium compound for preserving the composition; and a surfactant, the surfactant being ethoxylated and/or hydrogenated vegetable oil at a concentration in the composition of at least 0.01 w/v % but less than 0.3 w/v %, wherein: i. the ethoxylated and/or hydrogenated vegetable oil surfactant is entirely or substantially entirely the only surfactant in the composition; ii. the prostaglandin is travoprost; iii. the pharmaceutical vehicle includes water; and iv. the composition is free of any benzalkonium chloride.

15. A composition as in claim 14 wherein the composition is disposed within an eye dropper.

16. A composition as in claim 6 wherein the concentration of the surfactant is between 0.001 and 0.15 w/v %.

17. A composition as in claim 14 wherein the concentration of the surfactant is between 0.001 and 0.15 w/v %.

18. A composition as in claim 1 wherein the prostaglandin is travoprost.

19. A composition as in claim 18 wherein the ethoxylated and/or hydrogenated vegetable oil surfactant is entirely Polyoxyl 40 Hydrogenated castor Oil.

20. A composition as in claim 1 wherein the polymeric quaternary ammonium compound is polyquaternium 1.
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