Compositions Useful for the Treatment of Diabetes and Other Chronic Disorder

Abstract

The present invention provides a supramolecular protein assembly useful as a protein therapeutics for the treatment of metabolic disorders particularly diabetes. The supramolecular protein assembly disclosed in the present invention consists of insoluble and aggregated oligomers the protein. The invention also provides pharmaceutical compositions comprising supramolecular protein assembly. The composition disclosed in the present invention particularly comprises supramolecular insulin assembly.

1 - 15 . (canceled) 
     
     
         16 . A supramolecular calcitonin assembly (SCA) useful as protein therapeutics for the treatment of osteoporosis, wherein said assembly comprises insoluble and aggregated oligomeric form of calcitonin. 
     
     
         17 - 36 . (canceled) 
     
     
         37 . A pharmaceutical composition for the treatment of osteoporosis, said composition comprising supramolecular calcitonin assembly (SCA) as claimed in  claim 16 . 
     
     
         38 . (canceled) 
     
     
         39 . The pharmaceutical composition as claimed in  claim 37 , wherein said composition upon administration releases calcitonin for about 55 to 60 days, wherein concentration of calcitonin released is in the range of 15-20 pg/ml. 
     
     
         40 - 44 . (canceled) 
     
     
         45 . The pharmaceutical composition as claimed in  claim 16  optionally comprises pharmaceutically acceptable carriers, additives or diluents. 
     
     
         46 . The pharmaceutical composition as claimed in  claim 16  is administered intramuscularly, orally or subcutaneously, and/or wherein the pharmaceutical composition is administered through a device capable of releasing said composition, wherein said device is selected from a group consisting of pumps, catheters and implants. 
     
     
         47 - 51 . (canceled) 
     
     
         52 . A process of preparation of supramolecular calcitonin assembly (SCA) as claimed in  claim 16 , said process comprising;
 a. dissolving calcitonin at a temperature of about 25 to 60° C., preferably 37° C., in a solution having pH in the range of about 4.0 to 8.0, preferably 6.8 to 7.4, most preferably 7.2; and   b. incubating the above for a period of 6 to 48 hours preferably 8 to 12 hours, most preferably 8 hours with constant stirring to obtain Supramolecular Calcitonin Assembly (SCA), wherein SCA comprises insoluble and aggregated oligomeric form of calcitonin.   
     
     
         53 . The process as claimed in  claim 52 , wherein said process further comprises
 c. washing said SCA with PBS; and   d. re-suspending said SCA in water or 2% mannitol.   
     
     
         54 - 73 . (canceled) 
     
     
         74 . The pharmaceutical composition as claimed in  claim 37  optionally comprises pharmaceutically acceptable carriers, additives or diluents. 
     
     
         75 . The pharmaceutical composition as claimed in  claim 37  is administered intramuscularly, orally or subcutaneously, and/or wherein the pharmaceutical composition is administered through a device capable of releasing said composition, wherein said device is selected from a group consisting of pumps, catheters and implants. 
     
     
         76 . The pharmaceutical composition as claimed in  claim 39  is administered intramuscularly, orally or subcutaneously, and/or wherein the pharmaceutical composition is administered through a device capable of releasing said composition, wherein said device is selected from a group consisting of pumps, catheters and implants. 
     
     
         77 . The pharmaceutical composition as claimed in  claim 45  is administered intramuscularly, orally or subcutaneously, and/or wherein the pharmaceutical composition is administered through a device capable of releasing said composition, wherein said device is selected from a group consisting of pumps, catheters and implants.