The invention relates to novel, sustained-release IGF-I therapeutic compositions, a preparation and production method thereof and the use of same in the production of medicaments for the treatment and prevention of neurodegenerative diseases such as, among others, Alzheimer's disease or cerebellar ataxia. The inventive compositons take the form of microspheres having a size of less than 5 micrometres, among other characteristics, and subcutaneous implantation capsules. <IMAGE>
CLAIMS: 1. A therapeutic formulation comprising recombinant human IGF-I for slow release of intact and functionally active recombinant human IGF-I, wherein the recombinant human IGF-I is contained in microspheres of copolymers having an inherent viscosity of 0.5 dl/g to 1.5 dl/g, where the microspheres have a diameter of less than 5 micrometers. 2. A therapeutic formulation according to claim 1, wherein the inherent viscosity of the copolymers of the microspheres is 0.8 dl/g and the diameter of the microspheres is about 1.3 micrometers. 3. A process for preparation and production of a therapeutic formulation as defined in claim 1 or 2 comprising a triple emulsion technique and solvent extraction, wherein the process comprises homogenization at a high rate of homogenization of a solution comprising the recombinant human IGF-I and the copolymers as defined in claim 1 or 2, wherein the solution has a non-alkaline pH and excludes high-molecular-weight proteins. 4. A process according to claim 3, wherein the homogenization rate is 13,500 rpm. 5. A process according to claim 3 or 4, wherein the excluded high-molecular-weight proteins comprise albumin and gelatin. 6. A process according to any one of claims 3 to 5, wherein the copolymers comprise a 50:50 copolymer of lactic acid and glycolic acid which has an inherent viscosity in the range of 0.5 dl/g to 1.5dl/g. 7. A use of a therapeutic formulation as defined in claim 1 or 2 in preparation of a medicament for treatment or prevention of a neurodegenerative disease in a patient. 8. A use according to claim 7, wherein the neurodegenerative disease is Alzheimer's disease, cerebellar ataxia, ataxia-telangiectasia, vascular dementia, multiple sclerosis, stroke, peripheral neuropathy, cerebral trauma or spinal trauma. 9. A use of a therapeutic formulation as defined in claim 1 or 2 for treatment or prevention of a neurodegenerative disease in a patient. 10. A use according to claim 9, wherein the neurodegenerative disease is Alzheimer's disease, cerebellar ataxia, ataxia-telangiectasia, vascular dementia, multiple sclerosis, stroke, peripheral neuropathy, cerebral trauma or spinal trauma. 11. A therapeutic formulation as defined in claim 1 or 2 for treatment or prevention of a neurodegenerative disease in a patient. 12. A therapeutic formulation according to claim 11, wherein the neurodegenerative disease is Alzheimer's disease, cerebellar ataxia, ataxia-telangiectasia, vascular dementia, multiple sclerosis, stroke, peripheral neuropathy, cerebral trauma or spinal trauma. 13. A tablet for prolonged release of IGF-I prepared by a method comprising the following steps: a) dissolving the IGF-I in 0.01 mM acetic acid, b) adding cyclosporin to the resulting solution, wherein the cyclosporin is suspended in the solution, c) adding the cyclosporine suspended in the solution resulting from step b) to a lactic acid and glycolic acid copolymer, kneading gently and sieving the resulting product through a 2-mm mesh, d) drying the sieved product at room temperature for three hours and re-sieving the dried product through a 2-mm mesh, e) allowing the re-sieved product to dry at room temperature for a further 15 hours, f) compressing the product of step e) with a concave punch to form the tablet. 14. A tablet according to claim 13, wherein the lactic acid and glycolic acid copolymer is Resomer 503H, Boehringer Ingelheim. 15. A tablet according to claim 13 or 14, wherein the concave punch is 6mm in diameter. 16. A use of a tablet as defined in any one of claims 13 to 15 in preparation of a medicament for treatment or prevention of a neurodegenerative disease in a patient. 17. A use according to claim 16, wherein the neurodegenerative disease is Alzheimer's disease, cerebellar ataxia, ataxia-telangiectasia, vascular dementia, multiple sclerosis, stroke, peripheral neuropathy, cerebral trauma or spinal trauma. 18. A use of a tablet as defined in any one of claims 13 to 15 for treatment or prevention of a neurodegenerative disease in a patient. 19. A use according to claim 18, wherein the neurodegenerative disease is Alzheimer's disease, cerebellar ataxia, ataxia-telangiectasia, vascular dementia, multiple sclerosis, stroke, peripheral neuropathy, cerebral trauma or spinal trauma. 20. A tablet as defined in any one of claims 13 to 15 for treatment or prevention of a neurodegenerative disease in a patient. 21. A tablet according to claim 20, wherein the neurodegenerative disease is Alzheimer's disease, cerebellar ataxia, ataxia-telangiectasia, vascular dementia, multiple sclerosis, stroke, peripheral neuropathy, cerebral trauma or spinal trauma.