Claims for Patent: 8,846,072

Summary for Patent: 8,846,072

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.
Inventor(s):	Verity; A. Neil (Sunnyvale, CA)
Assignee:	Durect Corporation (Cupertino, CA)
Application Number:	13/789,416
Patent Claims:	1. A composition comprising: about 5% to about 20% by weight bupivacaine free base relative to the total weight of the composition; about 25% to about 75% by weight sucrose acetate isobutyrate (SAIB) relative to the total weight of the composition; and about 10% to about 55% 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 composition is administered to a surgical wound. 7. The method of claim 6, wherein the composition is administered in or adjacent the 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 benzyl alcohol is present in an amount of from about 50% to about 15% by weight relative to the total weight of the composition. 18. The composition of claim 1, wherein the composition provides the local anesthetic effect up to 4 days after administration.