Preparation comprising exanatide for delivery into a lumen of the intestinal tract

Abstract

Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

1 - 30 . (canceled) 
     
     
         31 . A swallowable device for delivering exenatide into a gastro-intestinal (GI) lumen wall of a patient, the device comprising:
 a swallowable enclosure having an interior;   a delivery means disposed in the interior; and   an exenatide preparation coupled to the delivery means, the exenatide preparation being supplied in the swallowable enclosure in a shaped form and comprising a therapeutically effective dose of exenatide;   wherein the delivery means is configured to advance the exenatide preparation out of the interior away from the delivery means and into the GI lumen wall to release the therapeutically effective dose of exenatide into the patient's blood stream.   
     
     
         32 . The device of  claim 31 , wherein the GI lumen wall is a wall of the small intestine. 
     
     
         33 . The device of  claim 31 , wherein the GI lumen wall is a wall of the stomach. 
     
     
         34 . The device of  claim 31 , wherein the delivery means is configured to advance the exenatide preparation out of the interior in response to a condition in the GI lumen. 
     
     
         35 . The device of  claim 34 , wherein the condition is a selected pH. 
     
     
         36 . The device of  claim 35 , wherein the selected pH is above about 7.1. 
     
     
         37 . The device of  claim 31 , wherein the exenatide preparation is formed into the shape of a tissue penetrating member configured to penetrate the GI lumen wall. 
     
     
         38 . The device of  claim 31 , wherein the exenatide preparation is disposed in a lumen of a tissue penetrating member, and wherein the tissue penetrating member comprises a biodegradable material which degrades to release exenatide into the blood stream. 
     
     
         39 . The device of  claim 31 , wherein the delivery means comprises at least one expandable balloon having an expanded state and a non-expanded state, wherein the first configuration is the non-expanded state and the second configuration is the expanded state. 
     
     
         40 . The device of  claim 31 , wherein the delivery means comprises a spring. 
     
     
         41 . The device of  claim 31 , wherein the exenatide preparation further comprises a biodegradable material which degrades to release exenatide into the blood stream. 
     
     
         42 . The device of  claim 41 , wherein the biodegradable material comprises poly (lactic-co-glycolic acid) (PLGA), a sugar, or maltose. 
     
     
         43 . The device of  claim 31 , wherein the exenatide preparation further comprises at least one pharmaceutical excipient. 
     
     
         44 . The device of  claim 31 , wherein the therapeutically effective dose of exenatide in the exenatide preparation is in a range of about 1 to 20 μg. 
     
     
         45 . The device of  claim 31 , wherein the therapeutically effective dose of exenatide in the exenatide preparation is in a range of about 1 to 10 μg. 
     
     
         46 . The device of  claim 31 , wherein the therapeutically effective dose of exenatide in the exenatide preparation is in a range of about 4 to 8 μg. 
     
     
         47 . The device of  claim 31 , wherein the exenatide preparation is configured to produce a long-term release of exenatide. 
     
     
         48 . The device of  claim 47 , wherein the long-term release of exenatide has a t½ in a range of about 6 to 24 hours. 
     
     
         49 . The device of  claim 31 , wherein the exenatide preparation further comprises a therapeutically effective dose of another therapeutic agent for the treatment of diabetes or another glucose regulation disorder. 
     
     
         50 . The device of  claim 49 , wherein the other therapeutic agent comprises insulin. 
     
     
         51 . The device of  claim 50 , wherein the therapeutically effective dose of insulin in the exenatide preparation is in a range selected from about 1 to 50 units of insulin and about 4 to 9 units of insulin. 
     
     
         52 . The device of  claim 49 , wherein the other therapeutic agent comprises metformin. 
     
     
         53 . The device of  claim 52 , wherein the therapeutically effective dose of exenatide and the therapeutically effective dose of metformin in the preparation are matched to control a blood glucose level of a patient without extravascularly injecting incretin into the patient.