Erodible polymers for injection
A composition for administration of a beneficial agent, contains a solvent mixture including a hydrophobic solvent and a hydrophilic solvent; a bioerodible polymer; and a beneficial agent. The polymer and the beneficial agent are dissolved. The composition has a low viscosity, allowing for easy injection through standard hypodermic needles.
1. A method of administering a beneficial agent, comprising injecting a composition comprising:
a solvent mixture comprising one or more hydrophobic solvents and one or more hydrophilic solvents, wherein the one or more hydrophobic solvents have a solubility in water of less than 1 wt % and wherein at least 55 wt % of the solvent mixture is the one or more hydrophobic solvents;
a bioerodible polymer; and
a beneficial agent,
wherein the composition is a solution or suspension; and
wherein the viscosity of the composition is less than 900 centipoise;
into an organism through a needle, wherein the needle is a 25-gauge needle.
2. A method of administering a beneficial agent, comprising injecting a composition comprising:
a solvent mixture comprising one or more hydrophobic solvents and one or more hydrophilic solvents, wherein the one or more hydrophobic solvents have a solubility in water of less than 1 wt % and wherein at least 55 wt % of the solvent mixture is the one or more hydrophobic solvents;
a bioerodible polymer; and
a beneficial agent,
wherein the composition is a solution or suspension; and
wherein the viscosity of the composition is less than 900 centipoise;
into an organism through a needle, wherein the needle is a 28-gauge needle.
3. A method of administering a beneficial agent, comprising injecting a composition comprising:
a solvent mixture comprising one or more hydrophobic solvents and one or more hydrophilic solvents, wherein the one or more hydrophobic solvents have a solubility in water of less than 1 wt % and wherein at least 55 wt % of the solvent mixture is the one or more hydrophobic solvents;
a bioerodible polymer; and
a beneficial agent,
wherein the composition is a solution or suspension; and
wherein the viscosity of the composition is less than 900 centipoise;
into an organism through a needle, wherein the needle is a 30-gauge needle.
4. A method of administering a beneficial agent, comprising injecting a composition comprising:
a solvent mixture, comprising a hydrophobic solvent and a hydrophilic solvent, wherein said hydrophobic solvent has a solubility in water of less than 1 wt %;
a bioerodible polymer; and
a beneficial agent,
wherein the composition is a solution or suspension; and
wherein the viscosity of the composition is less than 900 centipoise;
into an organism through a needle, wherein the needle is a 25-gauge needle.
5. A method of administering a beneficial agent, comprising injecting a composition comprising:
a solvent mixture, comprising a hydrophobic solvent and a hydrophilic solvent, wherein said hydrophobic solvent has a solubility in water of less than 1 wt %;
a bioerodible polymer; and
a beneficial agent,
wherein the composition is a solution or suspension; and
wherein the viscosity of the composition is less than 900 centipoise;
into an organism through a needle, wherein the needle is a 28-gauge needle.
6. A method of administering a beneficial agent, comprising injecting a composition comprising:
a solvent mixture, comprising a hydrophobic solvent and a hydrophilic solvent, wherein said hydrophobic solvent has a solubility in water of less than 1 wt %;
a bioerodible polymer; and
a beneficial agent,
wherein the composition is a solution or suspension; and
wherein the viscosity of the composition is less than 900 centipoise;
into an organism through a needle, wherein the needle is a 30-gauge needle.
7. The method of claim 1 , wherein at least 90 wt % of the solvent mixture in said composition is the one or more hydrophobic solvents.
8. The method of claim 1 , wherein the one or more hydrophobic solvents in said composition have a solubility in water of less than 0.1 wt %.
9. The method of claim 1 , wherein the beneficial agent in said composition has a concentration from 0.1 mg/ml to 500 mg/ml.
10. The method of claim 1 , wherein the beneficial agent in said composition has a concentration from 10 mg/ml to 100 mg/ml.
11. The method of claim 1 , wherein less than 25% of the beneficial agent in said composition is released in 24 hours following administration in vivo.
12. The method of claim 1 , wherein the one or more hydrophilic solvents, the one or more hydrophobic solvents, the bioerodible polymer, and the beneficial agent in said composition form a suspension.
13. The method of claim 1 , wherein the one or more hydrophilic solvents, the one or more hydrophobic solvents, the bioerodible polymer, and the beneficial agent in said composition form a solution.
14. The method of claim 4 , wherein at least 55 wt % of the solvent mixture in said composition is the hydrophobic solvent.
15. The method of claim 4 , wherein at least 90 wt % of the solvent mixture in said composition is the hydrophobic solvent.
16. The method of claim 4 , wherein the hydrophobic solvent of said composition has a solubility in water of less than 0.1 wt %.
17. The method of claim 4 , wherein the viscosity of said composition is less than 200 centipoise.
18. The method of claim 4 , wherein the hydrophobic solvent is benzyl benzoate, the hydrophilic solvent is benzyl alcohol, the bioerodible polymer is polylactide, and the beneficial agent is a peptide or protein.
19. The method of claim 4 , wherein the hydrophilic solvent, the hydrophobic solvent, the bioerodible polymer, and the beneficial agent form a solution.
20. The method of claim 4 , wherein the hydrophilic solvent, the hydrophobic solvent, the bioerodible polymer, and the beneficial agent form a suspension.
21. The method of claim 1 , wherein the viscosity of said composition is less than 300 centipoise.
22. The method of claim 4 , wherein the viscosity of said composition is less than 300 centipoise.
23. The method of claim 2 , wherein at least 90 wt % of the solvent mixture in said composition is the one or more hydrophobic solvents.
24. The method of claim 2 , wherein the one or more hydrophobic solvents in said composition have a solubility in water of less than 0.1 wt %.
25. The method of claim 2 , wherein the beneficial agent in said composition has a concentration from 0.1 mg/ml to 500 mg/ml.
26. The method of claim 2 , wherein the beneficial agent in said composition has a concentration from 10 mg/ml to 100 mg/ml.
27. The method of claim 2 , wherein less than 25% of the beneficial agent in said composition is released in 24 hours following administration in vivo.
28. The method of claim 2 , wherein the one or more hydrophilic solvents, the one or more hydrophobic solvents, the bioerodible polymer, and the beneficial agent in said composition form a suspension.
29. The method of claim 2 , wherein the one or more hydrophilic solvents, the one or more hydrophobic solvents, the bioerodible polymer, and the beneficial agent in said composition form a solution.
30. The method of claim 2 , wherein the viscosity of said composition is less than 300 centipoise.
31. The method of claim 3 , wherein at least 90 wt % of the solvent mixture in said composition is the one or more hydrophobic solvents.
32. The method of claim 3 , wherein the one or more hydrophobic solvents in said composition have a solubility in water of less than 0.1 wt %.
33. The method of claim 3 , wherein the beneficial agent in said composition has a concentration from 0.1 mg/ml to 500 mg/ml.
34. The method of claim 3 , wherein the beneficial agent in said composition has a concentration from 10 mg/ml to 100 mg/ml.
35. The method of claim 3 , wherein less than 25% of the beneficial agent in said composition is released in 24 hours following administration in vivo.
36. The method of claim 3 , wherein the one or more hydrophilic solvents, the one or more hydrophobic solvents, the bioerodible polymer, and the beneficial agent in said composition form a suspension.
37. The method of claim 3 , wherein the one or more hydrophilic solvents, the one or more hydrophobic solvents, the bioerodible polymer, and the beneficial agent in said composition form a solution.
38. The method of claim 3 , wherein the viscosity of said composition is less than 300 centipoise.
39. The method of claim 5 , wherein at least 55 wt % of the solvent mixture in said composition is the hydrophobic solvent.
40. The method of claim 5 , wherein at least 90 wt % of the solvent mixture in said composition is the hydrophobic solvent.
41. The method of claim 5 , wherein the hydrophobic solvent of said composition has a solubility in water of less than 0.1 wt %.
42. The method of claim 5 , wherein the viscosity of said composition is less than 200 centipoise.
43. The method of claim 5 , wherein the hydrophobic solvent is benzyl benzoate, the hydrophilic solvent is benzyl alcohol, the bioerodible polymer is polylactide, and the beneficial agent is a peptide or protein.
44. The method of claim 5 , wherein the hydrophilic solvent, the hydrophobic solvent, the bioerodible polymer, and the beneficial agent form a solution.
45. The method of claim 5 , wherein the hydrophilic solvent, the hydrophobic solvent, the bioerodible polymer, and the beneficial agent form a suspension.
46. The method of claim 5 , wherein the viscosity of said composition is less than 300 centipoise.
47. The method of claim 6 , wherein at least 55 wt % of the solvent mixture in said composition is the hydrophobic solvent.
48. The method of claim 6 , wherein at least 90 wt % of the solvent mixture in said composition is the hydrophobic solvent.
49. The method of claim 6 , wherein the hydrophobic solvent of said composition has a solubility in water of less than 0.1 wt %.
50. The method of claim 6 , wherein the viscosity of said composition is less than 200 centipoise.
51. The method of claim 6 , wherein the hydrophobic solvent is benzyl benzoate, the hydrophilic solvent is benzyl alcohol, the bioerodible polymer is polylactide, and the beneficial agent is a peptide or protein.
52. The method of claim 6 , wherein the hydrophilic solvent the hydrophobic solvent, the bioerodible polymer, and the beneficial agent form a solution.
53. The method of claim 6 , wherein the hydrophilic solvent the hydrophobic solvent, the bioerodible polymer, and the beneficial agent form a suspension.
54. The method of claim 6 , wherein the viscosity of said composition is less than 300 centipoise.