Composition and Method for Improving Sensorineural Hearing

Abstract

The present invention is directed to compositions and methods for improving hearing parameters in a human (including hearing volume, hearing range and word recognition) by reversing or inhibiting damage to cochlear cells caused by toxic byproducts of oxygen metabolism. In a preferred embodiment, a pharmaceutically acceptable composition containing insulin-like growth factor one (IGF-1) and human growth hormone (HGH), or their derivatives in a 5:2 ratio by weight, is topically administered every three days in a dosage of 0.1 to 2 mcg per kilogram of body weight. The composition directly penetrates the inner ear and cochlea to provide greater regulation of sodium and potassium levels in the delicate sound-detecting hair cells. In accordance with the present invention, mean word recognition was improved by nearly 39 percent, hearing volume was improved by up to 40 dB, and the hearing range was improved above 6,000 Hz.

What is claimed is: 
     
         1 . A composition for improving hearing parameters in a human by intratympanically administering a dosage, within the range of 0.1 mcg per kilogram of body weight to 2 mcg per kilogram of body weight, of a pharmaceutically acceptable composition comprising a compound or mixture of compounds containing insulin-like growth factor 1 (IGF-1) and human growth hormone (HGH), wherein the hearing parameters include hearing volume, hearing range and word recognition. 
     
     
         2 . The composition according to  claim 1  wherein the composition is administered orally in liquid or solid dosage form within a pharmaceutically acceptable carrier, adjuvant, or vehicle. 
     
     
         3 . The composition according to  claim 1  wherein the composition is administered by a means selected from the group consisting of intravenously, subcutaneously, intranasally, intramuscularly, and intracutaneously. 
     
     
         4 . The composition according to  claim 1  wherein the composition further comprises one or more metabolites of IGF-1 and human growth hormone. 
     
     
         5 . The composition of  claim 1  wherein the composition is administered topically in the form of a cream, lotion, or serum. 
     
     
         6 . The composition of  claim 1  wherein the composition contains relative amounts of IGF-1 and human growth hormone in a ratio of 5:2 by weight. 
     
     
         7 . The composition of  claim 1  wherein the composition contains from 0.1% to 20% by weight of IGF-1 and HGH. 
     
     
         8 . The composition of  claim 1  wherein the IGF-1 comprises a single chain polypeptide that includes the compound somatotropin. 
     
     
         9 . A pharmaceutical composition for topical administration to the skin of a human to improve hearing parameters consisting essentially of a compound or mixture of compounds containing IGF-1 or its derivatives and human growth hormone as the active ingredients. 
     
     
         10 . The composition of  claim 9  that contains relative amounts of IGF-1 and HGH in a ratio of 5:2 by weight. 
     
     
         11 . The composition of  claim 9  that contains from 0.1% to 20% by weight of IGF-1 and HGH. 
     
     
         12 . The composition of  claim 9  that is administered to a human in a dosage selected from the group consisting of 50 mcg, 75 mcg, 100 mcg and 200 mcg of IGF-1 and HGH, and wherein the dosage is delivered within a pharmaceutically acceptable carrier, adjuvant, or vehicle. 
     
     
         13 . The composition of  claim 9  further comprising one or more metabolites of IGF-1 and HGH. 
     
     
         14 . The composition of  claim 9  wherein the IGF-1 or its derivatives comprises a single chain polypeptide of 70 amino acids having an approximate molecular weight of 7,649 Daltons. 
     
     
         15 . The composition of  claim 9  wherein HGH or its derivatives comprises a single chain polypeptide of 191 amino acids having an approximate molecular weight of 22,124 Daltons. 
     
     
         16 . The composition of  claim 14  wherein the single chain polypeptide includes the compounds somatomedin C, mecasermin, and Increlex. 
     
     
         17 . The composition of  claim 14  wherein the single chain polypeptide has three disulfide bridges and the following atomic composition: C 331 , H 512 , N 84 , O 101 , and S 7 . 
     
     
         18 . The composition of  claim 15  wherein the single chain polypeptide has two disulfide bridges and the following atomic composition: C 39 , H 60 , N 8 , and O 13 .