Method and composition for enhanced parenteral nutrition

Abstract

A composition and method for improved parenteral administration of nutrients is provided, comprising administration of an insulinotropic peptide, or its derivatives, analogs, and fragments. GLP-1 is a preferred insulinotropic hormone. Patients who are especially suited for treatment include patients with activated counterregulatory hormones, such as would occur after trauma, accidents, and surgery.

We claim:  
     
         1 . A method for non-alimentary nutrition comprising administering to a patient in need of nutrition a pharmaceutical composition comprising a source of nutrients and one or more insulinotropic peptides.  
     
     
         2 . A method according to  claim 1  wherein the source of nutrients is a source of carbohydrates.  
     
     
         3 . A method according to  claim 2  wherein the source of carbohydrate is a hexose, pentose, hexose alcohol, pentose alcohol, or any combination thereof.  
     
     
         4 . A method according to  claim 3  wherein the source of carbohydrate is glucose, fructose, galactose, zylitol, mannitol, sorbitol, or any combination thereof.  
     
     
         5 . A method according to  claim 1  wherein the source of nutrients is one or more assimilable amino acids, lipids, free fatty acids, mono- or diglycerides or glycerol.  
     
     
         6 . A method according to  claim 2  wherein the administration of the source of carbohydrate to the patient produces a blood glucose level in the patient of no more than from about 80 to 180 mg glucose per deciliter of blood and the rate of administration of the source of carbohydrate is calculated to deliver up to about 1000 g of glucose or its equivalent per patient per day.  
     
     
         7 . A method according to  claim 1  wherein the administration of the insulinotropic peptide or peptides produces a blood level of the peptide or peptides in the range of 1 pmol per L to 1 mmol per L of blood plasma.  
     
     
         8 . A method according to  claim 1  wherein the insulinotropic peptide is GLP-1, GIP, GLP-1 (7-34), GLP-1 (7-35), GLP-1 (7-36), GLP-1 (7-37), the deletion sequences thereof, the natural and non-natural amino acid residue substitutes thereof, the C-terminus carboxamides thereof, the C-terminus esters thereof, the C-terminus ketone modifications thereof, the N-terminus modifications thereof or any mixture thereof.  
     
     
         9 . A method according to  claim 2  wherein the pharmaceutical composition comprises the source of carbohydrate in a first aqueous medium and one or more insulinotropic peptides in a second aqueous medium or in a pharmaceutically acceptable solid or gel tab or sustained release matrix.  
     
     
         10 . A pharmaceutical composition comprising a source of nutrients and one or more insulinotropic peptides in combined or separate form.  
     
     
         11 . A pharmaceutical composition according to  claim 10  wherein the source of nutrients is a source of carbohydrates.  
     
     
         12 . A pharmaceutical composition according to  claim 11  wherein the source of carbohydrate is present at a concentration of about a 2% to about a 50% by weight of glucose or its equivalent per L.  
     
     
         13 . A composition according to  claim 10  wherein the insulinotropic peptide or peptides are present at a concentration of about 1 nmol per L to about 1 mmol per L.  
     
     
         14 . A pharmaceutical composition comprising a kit containing a first aqueous mixture of a source of nutrients contained in a form for parenteral administration and a second aqueous mixture or solid or gel tab or sustained release matrix of one or more insulinotropic peptides contained in a form for parenteral administration.  
     
     
         15 . Use of a pharmaceutical composition according to  claim 10  for nutrition of a patient.  
     
     
         16 . Manufacture of a pharmaceutical composition for use in nutrition of a patient comprising preparation of a pharmaceutically acceptable formulation of a source of nutrients and preparation of a pharmaceutically acceptable formulation of one or more insulinotropic peptides.