Bioerodible silicon-based compositions for delivery of therapeutic agents
The invention comprises a composition comprising a bioerodible porous silicon-based carrier material wherein the carrier material carries at least one large molecule therapeutic agent and at least one amorphous sugar, optionally further comprising a crystallization inhibitor. The composition may be used in vitro or in vivo to deliver the therapeutic agent, preferably in a controlled fashion over an intended period of time such as over multiple days, weeks or months. The composition may be used for treating or preventing conditions of a patient such as chronic diseases.
1. A method of treating or preventing a condition in a patient comprising administering to the patient a composition comprising a bioerodible porous silicon-based carrier material, wherein at least one large-molecule therapeutic agent and an amorphous sugar are disposed in pores of the carrier material.
2. The method of claim 1 , wherein the composition is administered to the surface or the skin or eye of a patient.
3. The method of claim 1 , wherein the composition is administered intravitreally, subcutaneously, subconjunctivally, intraperitoneally, intramuscularly or subretinally.
4. The method of claim 1 , wherein the composition is administered into the eye.
5. The method of claim 4 , wherein the composition is administered within the aqueous of the eye.
6. The method of claim 4 , wherein the composition is administered within the vitreous of the eye.
7. The method of claim 1 , wherein the condition is selected from conditions of the eye.
8. The method of claim 7 , wherein the condition is selected from glaucoma, macular degeneration, diabetic macular edema, geographic atrophy and age-related macular degeneration.
9. The method of claim 1 , wherein the composition releases the therapeutic agent into the eye over the course of 1 day to 6 months.
10. The method of claim 9 , wherein the composition releases the therapeutic agent over the course of 1 week to 3 months.
11. The method of claim 1 , wherein the porous silicon-based carrier material is contacted with a solution comprising the therapeutic agent.
12. The method of claim 1 , wherein the carrier material is resorbable.
13. The method of claim 1 , wherein the therapeutic agent is selected from proteins, peptides, antibodies, carbohydrates, polymers and polynucleotides.
14. The method of claim 13 , wherein the therapeutic agent is an antibody.
15. The method of claim 1 , wherein the amorphous sugar is selected from trehalose, trehalose dihydrate, sucrose, mannitol, sorbitol, xylitol and glycerol, or a combination thereof.
16. The method of claim 1 , wherein the carrier material has a porosity in the range of about 40% to about 80%.
17. The method of claim 1 , wherein the average pore size is in the range 2-50 nm.
18. The method of claim 1 , wherein the average width of the walls in the carrier material which separate the pores is less than 5 nm.
19. The method of claim 1 , wherein a length of the carrier material measured at its longest point is between 1 and 500 microns.
20. The method of claim 1 , wherein the load level of the carrier material is less than 80% by weight based on the combined weight of the carrier material and therapeutic agent.