Formulations for delivering insulin

Abstract

Oral insulin formulations and processes for preparing oral insulin formulations are provided.

1 - 91 . (canceled) 
     
     
         92 . A tablet comprising (a) a delivery agent selected from N-(8-[2-hydroxybenzoyl]amino) caprylic acid and pharmaceutically acceptable salts thereof, (b) gelatin, (c) insulin, (d) dibasic calcium phosphate, and (e) magnesium stearate, wherein the delivery agent and insulin is in the form of a gel prior to being tableted or filled in a capsule. 
     
     
         93 . The tablet of  claim 92 , wherein the delivery agent is sodium N-(8-[2-hydroxybenzoyl]-amino caprylate. 
     
     
         94 . The tablet of  claim 92 , wherein the weight ratio of delivery agent to insulin is about 45:1. 
     
     
         95 . The tablet of  claim 92 , wherein the tablet consists of (a) the delivery agent sodium N-(8-[2-hydroxybenzoyl]amino) caprylate, (b) gelatin, (c) insulin, (d) dibasic calcium phosphate, and (e) magnesium stearate, wherein the delivery agent and insulin is in the form of a gel prior to being tableted or filled in a capsule, and the weight ratio of delivery agent to insulin is about 45:1. 
     
     
         96 . The tablet of  claim 96 , wherein the tablet consists of 240 mg sodium N-(8-[2-hydroxybenzoyl]amino) caprylate, 12 mg gelatin, 5.45 mg insulin, 113.8 mg dibasic calcium phosphate, and 3.75 mg magnesium stearate. 
     
     
         97 . The tablet of  claim 92 , prepared by a process comprising
 (a) mixing the delivery agent and the gelatin;   (b) granulating the product of step (a) with insulin; and   (c) blending the granules of step (b) with dibasic calcium phosphate and magnesium stearate.   
     
     
         98 . A method of treating diabetes in a patient in need thereof comprising administering to the patient a tablet of  claim 92 . 
     
     
         99 . The method of  claim 98 , wherein the diabetes is Type II diabetes. 
     
     
         100 . The method of  claim 98 , wherein the patient does not exhibit any statistically significant increase in weight, risk of hypoglycemia or risk of hyperinsulinemia over the treatment period. 
     
     
         101 . A method of improving glucose tolerance and/or glycemic control in a patient in need thereof comprising administering to the patient a tablet of  claim 92 . 
     
     
         102 . The method of  claim 101 , wherein the patient does not exhibit any statistically significant increase in weight, risk of hypoglycemia or risk of hyperinsulinemia over the treatment period. 
     
     
         103 . A solid dosage form comprising a delivery agent selected from N-(8-[2-hydroxybenzoyl]amino) caprylic acid and pharmaceutically acceptable salts thereof and insulin or insulin analog, wherein (i) the solid dosage form is a tablet or capsule and (ii) (a) the delivery agent and insulin are in the form of a gel or (ii) the delivery agent and insulin or insulin analog are in the form of a gel prior to being tableted or filled in a capsule.