Self-gelling tunable drug delivery system

• US 20080102123A1
• Filed: 10/27/2006
• Published: 05/01/2008
• Est. Priority Date: 10/27/2006
• Status: Abandoned Application

• Current Assignee: Endo-Surgery, Inc.
• Original Assignee: Endo-Surgery, Inc.
• Inventors: Zhou, Yue, Schachter, Deborah M.
• Application Number:
  US11/588,612
• Publication Number:
  US 20080102123A1
• Time in Patent Office: Days
• US Class Current: 424/486
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/1658 Proteins, e.g. albumin, gelatin
• CPC Class Codes: A61P 23/02 Local anaesthetics

Abstract

A self-gelling tunable drug delivery system is disclosed. The self-gelling tunable drug delivery system is comprised of a hydrophilic matrix and a hydrophobic matrix.

Claims

1. A self-gelling, tunable drug delivery system, comprising:

a hydrophilic matrix, which is comprised of a hydrophilic polymer and a first drug; and

,

a hydrophobic matrix, which is comprised of a hydrophobic polymer and a second drug.

2. The system of claim 1, wherein the hydrophilic polymer is selected from the group consisting of hydroxyethylcellulose, hydroxypropylmethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, hyaluronic acids, salts of hyaluronic acid, sodium hyaluronate, alginates, polyvinylpyrrolidone, polyethylene oxide, polysccarrides, chitins, chitosan, gelatin, polyacrylic acid, derivatives of polyacrylic acid, gums, and polymers derived from starch.

3. The system of claim 1, wherein the hydrophilic polymer comprises high molecular weight sodium hyaluronate.

4. The system of claim 1, wherein the hydrophobic polymer comprises an aliphatic polyester selected from the group consisting of lactide, glycolide, epsilon-caprolactone, p-dioxanone, and trimethylene carbonate and copolymers and terpolymers thereof.

5. The system of claim 4, wherein the aliphatic polyester has a melt processing temperature less than 100°

C.

6. The system of claim 4, wherein the aliphatic polyester comprises 50/50 mol/mol percent poly(lactic acid-co-glycolic acid).

7. The system of claim 1, wherein the first drug and the second drug are selected from the group consisting of anti-infectives, analgesics, anesthetics, immunosupressives, steroids, statins, alpha-2-agonists, VR1-agonists, proton pump inhibitors, collagen peptides, parathyroid hormone, bone morphogenic proteins, p38 kinase inhibitors and combinations thereof.

8. The system of claim 1, wherein the first drug and the second drug are selected from the group consisting of ibuprofen, oxycodone, morphine, fentanyl, hydrocodone, naproxyphene, codeine, acetaminophen with codeine, acetaminophen, benzocaine, lidocaine, procaine, bupivacaine, ropivacaine, mepivacaine, chloroprocaine, tetracaine, cocaine, etidocaine, prilocaine, procaine, clonidine, xylazine, medetomidine, dexmedetomidine, VR1 antagonists and combinations thereof.

9. The system of claim 1 wherein the first drug and the second drug are bupivacaine or lidocaine.

10. The system of claim 1 wherein the first drug and the second drug are the same.

11. The system of claim 1, wherein the first drug is different than the second drug.

25. The system of claim 1, wherein the hydrophilic matrix swells upon contact with a hydrating agent, thereby creating a hydrogel.

27. The system of claim 1, additionally comprising a hydrating agent.

12. A method for treating pain comprising the steps of:

providing a self-gelling tunable drug delivery system comprising;

a hydrophilic matrix comprising a hydrophilic polymer and a first drug; and

,

a hydrophobic matrix comprising a hydrophobic polymer and a second drug; and

,

applying the drug delivery system locally to an affected area.

13. The method of claim 12, additionally comprising the step of hydrating the drug delivery system prior to applying the drug delivery system.

14. The method of claim 12, wherein the hydrophilic polymer is selected from the group consisting of hydroxyethylcellulose, hydroxypropylmethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, hyaluronic acids, salts of hyaluronic acid, sodium hyaluronate, alginates, polyvinylpyrrolidone, polyethylene oxide, polysccarrides, chitins, chitosan, gelatin, polyacrylic acid, derivatives of polyacrylic acid, gums, and polymers derived from starch.

15. The method of claim 12, wherein the hydrophilic polymer comprises high molecular weight sodium hyaluronate.

16. The method of claim 12, wherein the hydrophilic polymer comprises high molecular weight sodium hyaluronate.

17. The method of claim 12, wherein the hydrophobic polymer comprises an aliphatic polyester selected from the group consisting of lactide, glycolide, epsilon-caprolactone, p-dioxanone, and trimethylene carbonate and copolymers and terpolymers thereof.

18. The method of claim 17, wherein the aliphatic polyester has a melt processing temperature less than 100°

C.

19. The method of claim 17, wherein the aliphatic polyester comprises 50/50 mol/mol percent poly(lactic acid-co-glycolic acid).

20. The method of claim 12, wherein the first drug and the second drug are selected from the group consisting of anti-infectives, analgesics, anesthetics, immunosupressives, steroids, statins, alpha-2-agonists, VR1-agonists, proton pump inhibitors, collagen peptides, parathyroid hormone, bone morphogenic proteins, p38 kinase inhibitors and combinations thereof.

21. The method of claim 12, wherein the first drug and the second drug are selected from the group consisting of ibuprofen, oxycodone, morphine, fentanyl, hydrocodone, naproxyphene, codeine, acetaminophen with codeine, acetaminophen, benzocaine, lidocaine, procaine, bupivacaine, ropivacaine, mepivacaine, chloroprocaine, tetracaine, cocaine, etidocaine, prilocaine, procaine, clonidine, xylazine, medetomidine, dexmedetomidine, VR1 antagonists and combinations thereof.

22. The method of claim 12, wherein the first drug and the second drug are bupivacaine or lidocaine.

23. The method of claim 12, wherein the first drug and the second drug are the same.

24. The method of claim 12, wherein the first drug is different than the second drug.

26. The method of claim 12, wherein the hydrophilic matrix swells upon contact with a hydrating agent, thereby creating a hydrogel.

28. The method of claim 12, wherein the system additionally comprises a hydrating agent.