Formulations for delivering insulin

Abstract

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

1 - 64 . (canceled) 
     
     
         65 . A solid dosage form wherein a delivery agent is lyophilized with insulin or an insulin analog. 
     
     
         66 . A solid dosage form wherein a delivery agent is rotary evaporated with insulin or an insulin analog. 
     
     
         67 . (canceled) 
     
     
         68 . A solid dosage form wherein a delivery agent and insulin or an insulin analog is in the form of a gel prior to being tableted or filled in a capsule. 
     
     
         69 . The solid dosage form of  claim 68  comprising a gelatin. 
     
     
         70 . The compositions of any one of  claim 65  wherein the delivery agent is 4-CNAB. 
     
     
         71 - 73 . (canceled) 
     
     
         74 . A process for preparing a solid dosage form of  claim 65  comprising the steps of
 (a) preparing an insulin/delivery agent solution; 
 (b) freeze-drying the insulin/delivery agent solution; 
 (c) milling the insulin/delivery agent colyophilized powder obtained by freeze-drying the insulin/delivery agent solution; 
 (d) mixing the milled co-lyophilized powder with intragranular excipients; 
 (e) performing dry granulation, 
 (f) adding extragranular excipients; and 
 (g) forming a unit dosage form from the resulting composition. 
 
     
     
         75 . A process for preparing a solid dosage form of  claim 66  comprising the steps of
 (a) preparing an insulin/delivery agent solution; 
 (b) performing rotary evaporation on the insulin/delivery agent solution; and 
 (c) forming a unit dosage form from the rotary evaporated insulin/delivery agent solution. 
 
     
     
         76 . The process of  claim 75  further comprising at least one of the steps of (c) milling the insulin/delivery agent powder obtained by rotary evaporation of the insulin/delivery agent solution;
 (d) mixing the milled powder with intragranular excipients; 
 (e) granulating the milled powder and intragranular excipients; and 
 (f) adding extragranular excipients. 
 
     
     
         77 . A process for preparing a solid dosage form of  claim 68  comprising the step of mixing a gelling agent with (a) a delivery agent compound and (b) insulin or an insulin analog. 
     
     
         78 . The process of  claim 77  wherein the gelling agent is gelatin. 
     
     
         79 . The process of any one of  claim 77  wherein the delivery agent is 4-CNAB or a salt thereof. 
     
     
         80 . The process of  claim 79  wherein the delivery agent is sodium 4-CNAB. 
     
     
         81 - 91 . (canceled)