Injectable drug delivery systems with cyclodextrin-polymer based hydrogels

1. A cyclodextrin polymer-based injectable composition comprising cyclodextrin, a polymer and a pharmacologically effective amount of at least one drug; wherein the polymer comprises ethylene glycol units and has a molecular weight of 5,000 to 50,000, which forms a hydrogel with the cyclodextrin, wherein the cyclodextrin and the polymer self-assemble to form a hydrogel by spontaneous association and are present in the composition in respective amounts effective to make the hydrogel thixotropic and injectable into the body of a person through a needle, and wherein the hydrogel forms a matrix and entraps the drug such that, when the composition is injected into the body of the person, the drug is released from the hydrogel in a sustained manner.

2. The composition of claim 1 , wherein the polymer is selected from the group consisting of star-shaped poly(ethylene glycol) and comb-like poly(ethylene glycol) structures, pegylated polysaccharides, pegylated poly(amino acid)s, pegylated proteins, pegylated poly(ethylene imine), pegylated polylysine, a poly(ethylene glycol) block copolymer with polypropylene oxide), pluronic polymer, poly(ethylene oxide) -poly(propylene oxide)-poly(ethylene oxide), poly(propylene oxide)-poly(ethylene oxide) -poly(propylene oxide) and poly(ethylene oxide)-poly(propylene oxide).

3. The composition of claim 1 wherein the polymer is a copolymer of poly(ethylene glycol) and a polymer selected from the group consisting of polyesters, polyurethanes, polyamides, polyethers, polysaccharides, poly(amino acid)s, polypeptides, and proteins.

4. The composition of claim 1 further comprising a secondary polymer which complexes with the drug, conjugates the drug, or both.

5. The composition of claim 4 wherein the secondary polymer is a di- or mono-functional polymer or polyionic polymer with poly(ethylene glycol) segments.

6. The composition of claim 1 wherein the drug is in a macromolecular form.

7. The composition of claim 1 , wherein the drug is selected from the group consisting of analgesics, anesthetics, antiarthritics, antiasthmas, anticoagulants, anticonvulsants, antidepressants, antidiabetics, antineplastics, antipsychotics, antihypertensives, antibiotics, antihistamines, decongestants, anti inflammatories, muscle relaxants, peptides: antiparasitics, antivirals, genes and vaccines.

8. The composition of claim 1 , wherein the hydrogel is injectable through a needle of up to 27 gauge.

9. The composition of claim 1 , wherein the polymer has a molecular weight of 50,000.

10. The composition of claim 1 , wherein the polymer has a molecular weight of between 5,000 and 35,000.

11. The composition of claim 1 , wherein the composition comprises an aqueous solution containing the polymer at a level of from about 1% to about 80%.

12. The composition of claim 1 , wherein the composition comprises an aqueous solution containing the polymer at a level of from about 10% to 40%.

13. The composition of claim 1 , wherein the polymer is selected from the group consisting of pegylated polysaccharides, pegylated poly (amino acids)s, pegylated proteins, pegylated poly(ethylene imine)s and pegylated polylysines.

14. The composition of claim 1 , wherein the polymer comprises a poly(ethylene glycol) block or triblock copolymer with poly(propylene oxide).

15. The composition of claim 1 , wherein the polymer comprises poly(ethylene oxide).

16. The composition of claim 1 , wherein the hydrogel in the composition is thermosensitive and transitions between a gel and a sol at a temperature above room temperature.

17. The composition of claim 1 further comprising DNA nanospheres.

18. The composition as claimed in claim 1 , wherein the composition consists essentially of the hydrogel and the drug.

19. A combination comprising:

(a) the composition of claim 1 ; and

(b) needle means for injecting the composition, with the cyclodextrin and the polymer forming the hydrogel, into the body of a patient.

20. The combination of claim 19 , wherein the needle means comprises a needle having a gauge of up to 27 G.

21. A method for administering a drug to a person in need thereof so that it is sustainably released in the body of the person, the method comprising the steps of:

(a) providing the composition of claim 1 ; and

(b) injecting the composition with the cyclodextrin and the polymer forming the hydrogel through a needle into the body of the person.

22. A method as claimed in claim 21 , wherein the method consists essentially of steps (a) and (b).

23. A cyclodextrin polymer-based injectable composition comprising cyclodextrin, a polymer and a pharmacologically effective amount of at least one drug; wherein the polymer is PEG and has a molecular weight of 8,000 to 100,000, which forms a hydrogel with the cyclodextrin, wherein the cyclodextrin and the polymer self-assemble to form a hydrogel by spontaneous association and are present in the composition in respective amounts effective to make the hydrogel thixotropic and injectable into the body of a person through a needle, and wherein the hydrogel forms a matrix and entraps the drug such that, when the composition is injected into the body of the person, the drug is released from the hydrogel in a sustained manner.

24. The composition of claim 23 , further comprising a secondary polymer which complexes with the drug, conjugates the drug, or both.

25. The composition of claim 24 , wherein the secondary polymer is a di- or mono-functional polymer or polyionic polymer with poly(ethylene glycol) segments.

26. The composition of claim 23 , wherein the drug is in a macromolecular form.

27. The composition of claim 23 , wherein the drug is selected from the group consisting of analgesics, anesthetics, antiarthritics, antiasthmas, anticoagulants, anticonvulsants, antidepressants, antidiabetics, antineplastics, antipsychotics, antihypertensives, antibiotics, antihistamines, decongestants, anti inflammatories, muscle relaxants, peptides: antiparasitics, antivirals, genes and vaccines.

28. The composition of claim 23 , wherein the hydrogel is injectable through a needle of up to 27 gauge.

29. The composition of claim 23 , wherein the polymer has a molecular weight is a member selected from the group consisting of 8000, 10,000, 20,000, 35,000, and 100,000.

30. The composition of claim 23 , wherein the polymer has a molecular weight of 35,000.

31. The composition of claim 23 , wherein the composition comprises an aqueous solution containing the polymer at a level of from about 1% to about 80%.

32. The composition of claim 23 , wherein the composition comprises an aqueous solution containing the polymer at a level of from about 10% to 40%.

33. The composition of claim 23 , wherein the hydrogel in the composition is thermosensitive and transitions between a gel and a sol at a temperature above room temperature.

34. The composition of claim 23 , further comprising DNA nanospheres.

35. The composition as claimed in claim 23 , wherein the composition consists essentially of the hydrogel and the drug.

36. A combination comprising:

(a) the composition of claim 23 ; and

(b) needle means for injecting the composition, with the cyclodextrin and the polymer forming the hydrogel, into the body of a patient.

37. The combination of claim 36 , wherein the needle means comprises a needle having a gauge of up to 27 G.

38. A method for administering a drug to a person in need thereof so that it is sustainably released in the body of the person, the method comprising the steps of:

(a) providing the composition of claim 23 ; and

(b) injecting the composition with the cyclodextrin and the polymer forming the hydrogel through a needle into the body of the person.

39. The method of claim 38 , wherein the method consists essentially of steps (a) and (b).