Methods and formulations for increasing intestinal function

Abstract

A method for increasing intestinal function is provided. The method comprising orally and/or enterally administering to a subject in need thereof a therapeutically effective amount of insulin, thereby increasing intestinal function.

1 . A method of treating a disease or condition associated with intestinal malfunction in a subject in need thereof the method comprising, orally and/or enterally administering to the subject a therapeutically effective amount of insulin thereby treating the disease or condition associated with intestinal function, wherein the disease or condition is selected from the group consisting of: (i) intestinal developmental or structural abnormalities including short bowel syndrome, intestinal failure, midgut volvulus, intestinal atresia, age associated weight loss, postgastrectomy syndrome, dumping syndrome, postvagotomy diarrhea, bariatric surgery-associated diarrhea, chronic diarrhea associated with maldigestion and malabsorption, chronic diarrhea in idiopathis primary gastrointestinal motility disorders, cystic fibrosis, cancer, gastrointestinal peptide tumors, endocrine tumors and chronic diarrhea in gastrinoma; (ii) intestinal inflammation including inflammation due to infection, inflammation of the bowel, necrotizing enterocolitis, severe acute gastroenteritis, chronic gastroenteritis, cholera, chronic infections of the bowel, AIDS, infectious diarrhea, diarrhea due to bacterial overgrowth, irritable bowel syndrome, chronic diarrhea associated with collagenous colitis, ischemia reperfusion and sepsis; (iii) intestinal developmental abnormalities or inflammation including secretory diarrhea, acute diarrhea and chronic diarrhea; (iv) autoimmune disease, including Crohn's Disease, chronic ulcerative colitis, immunologic disorders affecting the small intestine; and (v) radiotherapy-associated intestinal malfunction, tube-feeding related diarrhea, parenteral feeding dependency, diarrhea associated with thyroid disorders, antibiotic-associated diarrhea, nutritional deficiency, anemia, and an eating disorder. 
     
     
         2 . The method of  claim 1 , wherein the disease or disorder is selected from the group consisting of secretory diarrhea, acute diarrhea and chronic diarrhea. 
     
     
         3 . The method of  claim 1 , wherein the subject is a human subject. 
     
     
         4 . The method of  claim 1 , wherein the subject is a non-human mammal. 
     
     
         5 . The method of  claim 3 , wherein the subject is a full-term infant. 
     
     
         6 . The method of  claim 1 , wherein the orally administering is effected by an oral dosage unit. 
     
     
         7 . The method of  claim 6  wherein the oral dosage unit comprises from about 1 mu to about 10,000 units of said insulin. 
     
     
         8 . The method of  claim 6 , wherein the oral dosage unit is solid. 
     
     
         9 . The method of  claim 6 , wherein the oral dosage unit is selected from the group consisting of a pill, a dragee, a tablet and a capsule. 
     
     
         10 . The method of  claim 1 , wherein the insulin is administered in an amount ranging from about 1 mu/Kg body weight/day to about 100 u/Kg/day. 
     
     
         11 . An oral dosage unit form comprising from about 1 mu to about 10,000 units of insulin. 
     
     
         12 . The oral dosage unit form of  claim 11 , said dosage unit is solid. 
     
     
         13 . The oral dosage unit of  claim 12 , selected from the group consisting of a pill, a dragee, a tablet and a capsule. 
     
     
         14 . The oral dosage unit of  claim 12 , further comprising a pharmacological agent. 
     
     
         15 . A method of increasing intestinal absorption of a pharmacological agent, the method comprising orally and/or rectal-enterally administering to a subject in need thereof a therapeutically effective amount of insulin prior to, concomitant with or following administration of the pharmacological agent, thereby increasing intestinal absorption of the pharmacological agent. 
     
     
         16 . The method of  claim 15 , wherein each of the insulin and the pharmacological agent is formulated in a dosage unit. 
     
     
         17 . The method of  claim 15 , wherein the insulin and the pharmacological agent are formulated in a dosage unit. 
     
     
         18 . The method of  claim 16  or  17 , wherein the dosage unit is for oral administration.