Local delivery method and composition
View Patent ↗This invention provides a rapidly degrading composition for local delivery of a medicament, such as, an antibiotic. Additionally, this invention provides a method that can be used on the battlefield to deliver antibiotics as a preliminary treatment through the use of a rapidly degrading composition.
1. A local delivery composition comprising:
a paste comprising calcium sulfate dihydrate, a medicament, a mixing solution and a binding agent, wherein said paste is treated to form a pellet, said pellet formulated to dissolve within 24 hours of implantation in a release environment wherein said release environment is selected from the group consisting of an open wound, tissue of a burn patient and a musculoskeletal injury.
2. A local delivery composition comprising:
a paste comprising calcium sulfate dihydrate, a medicament, a mixing solution and carboxymethylcellulose, wherein said paste is treated to form a pellet and said medicament is retained in said pellet wherein said pellet substantially dissolves in a release environment within 24 hours of implantation in said release environment.
3. A method to make a local delivery composition comprising:
a) mixing calcium sulfate dihydrate, a binding agent and
a medicament in a mixing solution to form a paste; and
b) evaporating said solution to form a pellet.
4. The method of claim 3 wherein said pellet is sterilized by gamma radiation.
5. A method to release a medicament within twenty-four hours of implantation comprising placing the composition of claim 1 into a release environment and releasing said medicament to the environment within twenty-four hours.
6. A method to release a medicament within twenty-four hours of implantation comprising placing the composition of claim 2 into a release environment and releasing said medicament to the environment within twenty-four hours.
7. The composition of claim 1 wherein said calcium sulfate dihydrate comprises 92.6%, said medicament 3.7% and said binding agent 3.7% of said local delivery composition.
8. The composition of claim 7 wherein said binding agent is carboxymethylcellulose.
9. The composition of claim 1 wherein said medicament is an antibiotic and said antibiotic comprises about 4 percent by weight of said local delivery composition.
10. The composition of claim 2 wherein said medicament is an antibiotic and said antibiotic comprises about 4 percent by weight of said local delivery composition.
11. A local delivery composition comprising:
a calcium sulfate dihydrate and a binder formulated to dissolve within 24 hours of implantation in a release environment and a medicament wherein said local delivery agent is in the form of a pellet, and made by the process comprising:
mixing calcium sulfate dihydrate, a binding agent and
a medicament in a mixing solution to form a paste; and evaporating said solution to form a pellet.
12. The composition of claim 11 wherein the binding agent is carboxymethylcellulose.
13. The composition of claim 12 wherein said calcium sulfate dihydrate comprises 92.6%, said medicament 3.7% and said carboxymethylcellulose 3.7% of said local delivery composition.
14. The method of claims 5 wherein the release environment is an open wound.
15. The method of claims 5 wherein the release environment is the tissue of a burn patient.
16. The method of claims 5 wherein the release environment is a musculoskeletal injury.
17. The method of claim 3 wherein the binding agent is carboxymethylcellulose.
18. The method of claim 3 wherein the mixing solution is selected form the group consisting of: sterile water, saline, phosphate buffered saline, potassium chloride, potassium sulfate, EDTA, ammonium sulfate, ammonium acetate and sodium acetate.
19. The method of claim 3 wherein the binding agent is select form the group consisting of methylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, ethylcellulose, hydroxyethycellulose and cellulose acetate butyrate.
20. The composition of claim 2 wherein in said release environment is selected from the group consisting of an open wound, tissue of a burn patient and a musculoskeletal injury.
21. The composition of claim 1 wherein said medicament is Vancomycin and the minimum inhibitory concentration is sustained for at least twelve hours from implantation in a release environment.
22. The composition of claim 2 wherein said medicament is Vancomycin and the minimum inhibitory concentration is sustained for at least twelve hours from implantation in a release environment.
23. The composition of claim 1 wherein said medicament is selected from the group consisting of Amikacin and Gentamicin and the minimum inhibitory concentration is sustained for at least four hours from implantation in a release environment.
24. The composition of claim 2 wherein said medicament is selected from the group consisting of Amikacin and Gentamicin and the minimum inhibitory concentration is sustained for at least four hours from implantation in a release environment.