Novel IGF-1 composition and its use

Abstract

A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided. The precipitated IGF-I syrup, IGF-I reconstituted from the IGF-I syrup, pharmaceutical compositions, and kits are useful in IGF-I therapy directed to IGF-I-responsive conditions.

1 . A method of therapy for an IGF-I responsive condition in a mammal, wherein said method comprises administering to said mammal a pharmaceutical composition comprising a highly concentrated form of biologically active IGF-I or variant thereof, wherein said IGF-I or variant thereof is present in a concentration of at least about 250 mg/ml. 
     
     
         2 . The method of claim  21 , wherein said highly concentrated form of biologically active IGF-I or variant thereof is a low salt-containing syrup comprising IGF-I in a concentration of about 250 mg/ml to about 500 mg/ml. 
     
     
         3 . The method of claim  21 , wherein said pharmaceutical composition is administered as a sustained-release formulation. 
     
     
         4 . The method of claim  21 , wherein said pharmaceutical composition is administered as a gel formulation. 
     
     
         5 . The method of claim  21 , wherein said pharmaceutical composition is administered as an implant. 
     
     
         6 . The method of claim  21 , wherein said pharmaceutical composition is administered in a miniature pump for prolonged delivery at a therapeutic site undergoing therapy for said IGF-I-responsive condition. 
     
     
         7 . The method of claim  26 , wherein said pump is osmotically driven.