Claims for Patent: 8,753,665

Summary for Patent: 8,753,665

Title:	Controlled delivery system
Abstract:	The present invention relates to novel anesthetic compositions containing a non-polymeric carrier material and an anesthetic, where the compositions are suitable for providing a sustained local anesthesia without an initial burst and having a duration for about 24 hours or longer. Certain compositions are also provided that include a first anesthetic and a second anesthetic. In such compositions, the second anesthetic is a solvent for the first anesthetic and provides an initial anesthetic effect upon administration to a subject. The non-polymeric carrier may optionally be a high viscosity liquid carrier material such as a suitable sugar ester. The compositions can further include one or more additional ingredients including active and inactive materials. Methods of using the compositions of the invention to produce a sustained anesthetic effect at a site in a subject are also provided. Preferably the composition contains bupivacaine and a sugar ester such as saib.
Inventor(s):	Verity; A. Neil (Sunnyvale, CA)
Assignee:	Durect Corporation (Cupertino, CA)
Application Number:	11/663,125
Patent Claims:	1. A composition comprising: 20% to 10% by weight bupivacaine free base relative to the total weight of the composition; about 75% to about 25% by weight sucrose acetate isobutyrate (SAIB) relative to the total weight of the composition; and about 55% to about 10% by weight benzyl alcohol relative to the total weight of the composition; wherein upon administration to a subject, bupivacaine is released from the composition in an amount sufficient to provide a local anesthetic effect at a site of administration for at least 24 hours after administration. 2. A method for providing sustained local anesthesia to a subject, said method comprising administering to the subject the composition of claim 1. 3. The method of claim 2, wherein said administering is by topical application. 4. The method of claim 2, wherein said administering is by injection. 5. The method of claim 2, wherein said administering comprises administering as an implant. 6. The method of claim 2, wherein the site is a surgical wound. 7. The method of claim 2, wherein the composition is administered in or adjacent a surgical wound. 8. The composition of claim 1, wherein said composition is suitable for topical, systemic, or parenteral administration. 9. The composition of claim 1, wherein said composition is suitable for administration via injection, pouring, spraying, dipping, aerosolizing, or via a coating applicator. 10. The method of claim 2, wherein said composition is administered by pouring. 11. The method of claim 2, wherein said subject is a human patient undergoing surgical inguinal hernia repair or an appendectomy. 12. The method of claim 2, wherein said composition is used to treat post-operative pain. 13. The method of claim 2, wherein less than about 20% of the bupivacaine present in the composition is released within 24 hours after administration. 14. The composition of claim 1, wherein the SAIB and the benzyl alcohol form a low viscosity liquid carrier material having a viscosity ranging from 200 cP to 6000 cP. 15. The composition of claim 1, wherein the composition does not comprise a polymer. 16. The method of claim 2, wherein the administering does not comprise injection. 17. The composition of claim 1, wherein the composition provides the local anesthetic effect up to 4 days after administration. 18. A composition comprising: 20% to 10% by weight bupivacaine free base relative to the total weight of the composition; sucrose acetate isobutyrate (SAIB) present in an amount of from about 75% to about 25% by weight relative to the total weight of the composition; and benzyl alcohol present in an amount of from about 50% to about 15% by weight relative to the total weight of the composition, wherein upon administration to a subject, bupivacaine is released from the composition in an amount sufficient to provide a local anesthetic effect at a site of administration for at least 24 hours after administration. 19. The composition of claim 18, wherein the composition provides the local anesthetic effect for at least 36 hours after administration. 20. The composition of claim 19, wherein the composition provides the local anesthetic effect for at least 48 hours after administration. 21. The composition of claim 18, wherein said composition is suitable for topical, systemic, or parenteral administration. 22. The composition of claim 18, wherein said composition is suitable for administration via injection, pouring, spraying, dipping, aerosolizing, or via a coating applicator. 23. The composition of claim 18, wherein the SAIB and the benzyl alcohol form a low viscosity liquid carrier material having a viscosity ranging from 200 cP to 6000 cP. 24. The composition of claim 18, wherein the composition does not comprise a polymer. 25. The composition of claim 18, wherein the composition provides the local anesthetic effect up to 4 days after administration. 26. A method for providing sustained local anesthesia to a subject, said method comprising administering to the subject the composition of claim 18. 27. The method of claim 26, wherein said administering is by topical application. 28. The method of claim 26, wherein said administering is by injection. 29. The method of claim 26, wherein said administering comprises administering as an implant. 30. The method of claim 26, comprising administering to a surgical wound. 31. The method of claim 26, wherein the composition is administered in or adjacent a surgical wound. 32. The method of claim 26, wherein said composition is administered by pouring. 33. The method of claim 26, wherein said subject is a human patient undergoing surgical inguinal hernia repair or an appendectomy. 34. The method of claim 26, wherein said composition is used to treat post-operative pain. 35. The method of claim 26, wherein less than about 20% of the bupivacaine present in the composition is released within 24 hours after administration. 36. The method of claim 26, wherein the administering does not comprise injection.