Silicon-containing biodegradable material for anti-inflammatory therapy

Abstract

The present invention relates to a silicon-containing, biodegradable material for preventing and/or treating diseases that are associated with increased interleukin-1β and/or interleukin-6 and/or interleukin-8 activity and/or that can be treated by lowering said cytokine activity.

1 . A silicon-containing, biodegradable material for preventing and/or treating a disease associated with increased interleukin-1β and/or interleukin-6 and/or interleukin-8 activity and/or disease in which a reduction in the activity of interleukin-1β and/or interleukin-6 and/or interleukin-8 is beneficial for the healing process, wherein the silicon-containing, biodegradable material is a polyhydroxysilicic acid ethyl ester compound, with the proviso that wound defects, comprising chronic diabetic-neuropathic ulcer, chronic leg ulcer, bedsores, secondary-healing infected wounds, non-irritating, primary-healing wounds, ablative lacerations and/or abrasions, are excluded from said disease that can be prevented and/or treated with said material. 
     
     
         2 . The silicon-containing, biodegradable material according to  claim 1 , wherein the material is in the form of a fibre, a fibre matrix, powder, liquid formulation, monolith and/or coating. 
     
     
         3 . The silicon-containing, biodegradable material according to  claim 2 , capable of being produced by:
 a) at least one hydrolysis-condensation reaction of tetraethoxysilane   b) evaporation for producing a single-phase solution optionally with simultaneous gentle mixing of reaction system;   c) cooling of the single-phase solution;   d) maturation for producing silica sol material; and   e) drawing of threads from said silica sol material to generate a fibre or a fibre matrix and/or
 drying, optionally spray drying or freeze-drying of said silica sol material to generate a powder and optionally dissolving said powder in a solvent to generate a liquid formulation and/or 
 coating said silica sol material on an object that is to be coated with said material, and/or
 casting said silica sol material in a mould to generate a monolith. 
 
   
     
     
         4 . The silicon-containing, biodegradable material produced according to  claim 3 , wherein the tetraethoxysilane is acid-catalysed in a) at an initial pH from 0 to ≦7, optionally in the presence of a water-soluble solvent, optionally ethanol, at a temperature from 0° C. to 80° C. and
 in b), a single-phase solution is evaporated to a viscosity in a range from 0.5 to 2 Pa·s at a shear rate of 10 s-1 at 4° C. 
 
     
     
         5 . The silicon-containing, biodegradable material according to  claim 4 , wherein the acid catalysis in a) is carried out with aqueous solution of nitric acid in a molar ratio to the silicon compound in a range 1:1.7 to 1:1.9, optionally in a range from 1:1.7 to 1:1.8. 
     
     
         6 . The silicon-containing, biodegradable material of  claim 1 , wherein said disease is selected from the group consisting of:
 autoimmune diseases, allergies, enteritis, colitis, gastritis, arthritis, myocarditis, dermatitis, otitis, pneumonitis, shock lung, blood clotting disorders, inflammatory bone and joint diseases, rheumatoid arthritis, sepsis, septic shock, post-transplantation sequelae, acute and chronic inflammations, inflammatory bowel disease, graft-versus-host disease, shock, stroke, acute respiratory syndrome (ARDS), psoriasis, restenosis, AIDS, cachexia, cerebrocranial trauma, allergy, parasitic infection, allergic rhinitis, allergic asthma, atopic dermatitis, multiple sclerosis, systemic lupus erythematosus, graft-versus-host disease, transplant rejection, asthma and chronic obstructive pulmonary disease, chronic gastritis, acute and chronic inflammations of the skin, psoriasis, skin allergies, parasitic skin infection, atopic dermatitis in particular neurodermatitis, dermatomyositis, pemphigus vulgaris and/or other local and systemic infections and/or acute and chronic inflammatory situations.   
     
     
         7 . The silicon-containing, biodegradable material according to  claim 6 , wherein said disease is selected from the group consisting of:
 acute and chronic inflammations of the skin, psoriasis, skin allergies, parasitic skin infection, atopic dermatitis in particular neurodermatitis, dermatomyositis and/or pemphigus vulgaris.   
     
     
         8 . A method for preventing and/or treating a disease associated with increased interleukin-1β and/or interleukin-6 and/or interleukin-8 activity and/or disease in which a reduction in the activity of interleukin-1β and/or interleukin-6 and/or interleukin-8 is beneficial for healing, said method comprising utilizing a silicon-containing, biodegradable material comprising a polyhydroxysilicic acid ethyl ester compound, with the proviso that wound defects comprising chronic diabetic-neuropathic ulcer, chronic leg ulcer, bedsores, secondary-healing infected wounds, non-irritating, primary-healing wounds, ablative lacerations and/or abrasions, are excluded from said disease that is prevented and/or treated with said material. 
     
     
         9 . A method of  claim 8 , wherein said disease is selected from the group consisting of autoimmune diseases, allergies, enteritis, colitis, gastritis, arthritis, myocarditis, dermatitis, otitis, pneumonitis, shock lung, blood clotting disorders, inflammatory bone and joint diseases, rheumatoid arthritis, sepsis, septic shock, post-transplantation sequelae, acute and chronic inflammations, inflammatory bowel disease, graft-versus-host disease, shock, stroke, acute respiratory syndrome (ARDS), psoriasis, restenosis, AIDS, cachexia, cerebrocranial trauma, allergy, parasitic infection, allergic rhinitis, allergic asthma, atopic dermatitis, multiple sclerosis, systemic lupus erythematosus, graft-versus-host disease, transplant rejection, asthma and chronic obstructive pulmonary disease, chronic gastritis, acute and chronic inflammations of the skin, psoriasis, skin allergies, parasitic skin infection, atopic dermatitis in particular neurodermatitis, dermatomyositis, pemphigus vulgaris and/or other local and systemic infections and/or acute and chronic inflammatory situations. 
     
     
         10 . A method of  claim 8 , wherein said disease is selected from the group consisting of acute and chronic inflammations of the skin, psoriasis, skin allergies, parasitic skin infection, atopic dermatitis in particular neurodermatitis, dermatomyositis and/or pemphigus vulgaris. 
     
     
         11 . Anti-inflammatory therary method comprising utilizing a silicon-containing, biodegradable material comprising a polyhydroxysilicic acid ethyl ester compound.