IP Library Granted Patent US 9,943,466
Granted Patent B1
US 9,943,466 · App. 15/622,238 · Granted Apr 17, 2018

Biocompatible dental putty formulations for controlled release of bupivacaine

Inventors: Leah Marie Johnson (Durham, NC); Ginger Denison Rothrock (Cary, NC); Sarah Dorothy Shepherd (Raleigh, NC); Sandra Cordel O'Buckley (Durham, NC); Andrea Gail Neely (Durham, NC)
Assignees: Research Triangle Institute; The University of North Carolina at Chapel Hill
A61K6/0067A61K6/0002A61K9/0002A61K9/1647A61K47/42A61K2300/00
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Quick Facts
Patent No.
US 9,943,466
App. No.
15/622,238
Granted
Apr 17, 2018
Kind
B1
Abstract

The disclosure provides biocompatible dental material that is moldable and biodegradable and provides sustained and/or controlled delivery of one or more local anesthetics within a dental cavity or space. Such dental material is customizable for the size and shape needed for a particular patient or particular application. The dental material may also provide customizable sustained and/or controlled delivery of one or more local anesthetics.

Claims (38)

1. A biocompatible dental putty comprising a biodegradable hemostatic matrix having biodegradable microparticles dispersed therein, said biodegradable microparticles encapsulating a local anesthetic agent, wherein the biodegradable microparticles upon biodegradation thereof release the local anesthetic agent into the biodegradable hemostatic matrix and wherein the biodegradable hemostatic matrix is permeable to diffusion therethrough of the released local anesthetic agent.

2. The biocompatible dental putty of claim 1 , wherein the biodegradable hemostatic matrix comprises an absorbable gelatin material.

3. The biocompatible dental putty of claim 1 , wherein the biodegradable hemostatic matrix comprises an absorbable porcine gelatin material.

4. The biocompatible dental putty of claim 1 , wherein the biodegradable microparticles comprise a polymeric material capable of providing controlled release of the local anesthetic agent encapsulated therein.

5. The biocompatible dental putty of claim 3 , wherein the biodegradable microparticles comprise (poly)lactic-co-glycolic acid).

6. The biocompatible dental putty of claim 5 , wherein the local anesthetic agent comprises bupivacaine.

7. A pain management system configured to be positioned in a dental extraction cavity in a patient after dental surgery comprising a biocompatible dental putty comprising a biodegradable hemostatic matrix having biodegradable microparticles dispersed therein, said biodegradable microparticles encapsulating a local anesthetic agent, wherein the biodegradable microparticles upon biodegradation thereof release the local anesthetic agent into the biodegradable hemostatic matrix and wherein the biodegradable hemostatic matrix is permeable to diffusion therethrough of the released local anesthetic agent.

8. The pain management system of claim 7 , wherein the biodegradable hemostatic matrix comprises an absorbable porcine gelatin material, the biodegradable microparticles comprise (poly)lactic-co-glycolic acid), and the local anesthetic agent comprises bupivacaine.

9. A dental kit comprising one or more units of the pain management system of claim 7 .

10. A method of providing controlled release of a local anesthetic at a tooth extraction site in a patient in need of said local anesthetic, comprising:

molding into a desired shape and size a biocompatible dental putty comprising a biodegradable hemostatic matrix having biodegradable microparticles dispersed therein, said biodegradable microparticles encapsulating a local anesthetic agent, wherein the biodegradable microparticles upon biodegradation thereof release the local anesthetic agent into the biodegradable hemostatic matrix and wherein the biodegradable hemostatic matrix is permeable to diffusion therethrough of the released local anesthetic agent; and

applying the biocompatible dental putty to the tooth extraction site in the patient.

11. The method of claim 10 , wherein the biodegradable hemostatic matrix comprises an absorbable gelatin material.

12. The method of claim 10 , wherein the biodegradable hemostatic matrix comprises an absorbable porcine gelatin material.

13. The method of claim 10 , wherein the biodegradable microparticles comprise a polymeric material capable of providing controlled release of the local anesthetic agent encapsulated therein.

14. The method of claim 12 , wherein the biodegradable microparticles comprise (poly)lactic-co-glycolic acid).

15. The method of claim 14 , wherein the local anesthetic agent comprises bupivacaine.

16. The method of claim 14 , wherein the biocompatible dental putty degrades in less than 7 days.

17. A method of controlling pain in a patient after a tooth extraction comprising:

molding into a desired shape and size a biocompatible dental putty comprising a biodegradable hemostatic matrix having biodegradable microparticles dispersed therein, said biodegradable microparticles encapsulating a local anesthetic agent, wherein the biodegradable microparticles upon biodegradation thereof release the local anesthetic agent into the biodegradable hemostatic matrix and wherein the biodegradable hemostatic matrix is permeable to diffusion therethrough of the released local anesthetic agent; and

applying the biocompatible dental putty to the tooth extraction site in the patient.

18. The method of claim 17 , wherein the biodegradable hemostatic matrix comprises an absorbable porcine gelatin material, the biodegradable microparticles comprise (poly)lactic-co-glycolic acid), and the local anesthetic agent comprises bupivacaine.

19. The method of claim 18 , wherein the biocompatible dental putty degrades in less than 7 days.

20. The biocompatible dental putty of claim 1 , wherein the biodegradable microparticles contain the local anesthetic agent at a loading of from about 5% to about 25% by weight of the biodegradable microparticle.

21. The biocompatible dental putty of claim 1 , wherein the biodegradable microparticles comprise (poly)lactic-co-glycolic acid having a molecular weight in a range of from 7 to 17 kDa.

22. The biocompatible dental putty of claim 21 , wherein the (poly)lactic-co-glycolic acid is ester-terminated.

23. The biocompatible dental putty of claim 1 , wherein the biodegradable microparticles contain the local anesthetic agent in a base form.

24. The biocompatible dental putty of claim 1 , wherein the biocompatible dental putty provides a biphasic release of the local anesthetic agent.

25. The biocompatible dental putty of claim 1 , wherein:

the biodegradable microparticles contain the local anesthetic agent at a loading of from about 5% to about 25% by weight of the biodegradable microparticle;

the biodegradable microparticles comprise ester-terminated (poly)lactic-co-glycolic acid having a molecular weight in a range of from 7 to 17 kDa;

the biodegradable microparticles contain the local anesthetic agent in a base form; and

the biocompatible dental putty provides a biphasic release of the local anesthetic agent.

26. The method of claim 10 , wherein the biodegradable microparticles contain the local anesthetic agent at a loading of from about 5% to about 25% by weight of the biodegradable microparticle.

27. The method of claim 10 , wherein the biodegradable microparticles comprise (poly)lactic-co-glycolic acid having a molecular weight in a range of from 7 to 17 kDa.

28. The method of claim 27 , wherein the (poly)lactic-co-glycolic acid is ester-terminated.

29. The method of claim 10 , wherein the biodegradable microparticles contain the local anesthetic agent in a base form.

30. The method of claim 10 , wherein the biocompatible dental putty provides a biphasic release of the local anesthetic agent.

Assignments (3)
CONFIRMATORY LICENSE Recorded Sep 7, 2017
From: UNIV OF NORTH CAROLINA CHAPEL HILL
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 043775/0147 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 14, 2017
From: O'BUCKLEY, SANDRA CORDEL; NEELY, ANDREA GAIL
To: THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL
Reel/Frame 042703/0116 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 14, 2017
From: JOHNSON, LEAH MARIE; ROTHROCK, GINGER DENISON; SHEPHERD, SARAH DOROTHY
To: RESEARCH TRIANGLE INSTITUTE
Reel/Frame 042807/0079 →
Continuity (1)
Provisional Application 62503683 · May 9, 2017