Reivindicaciones

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.