Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

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 . (canceled) 
     
     
         2 . A device for delivering interferon into a lumen wall of a gastro-intestinal (GI) lumen of a patient, the device comprising:
 an enclosure having an interior;   an actuating mechanism disposed within the interior; and   a therapeutic preparation coupled to the actuating mechanism, the therapeutic preparation being supplied in the enclosure in a shaped form and comprising a therapeutically effective dose of interferon;   wherein the actuating mechanism has a first configuration and a second configuration, the therapeutic preparation being contained within the interior in the first configuration and advanced out of the interior and into the lumen wall by application of force on the therapeutic preparation in the second configuration, to deliver the therapeutic preparation into the lumen wall; and   wherein the actuating mechanism is triggered in response to a condition in the GI lumen to deliver the therapeutic preparation from the enclosure into the lumen wall.   
     
     
         3 . The device of  claim 2 , wherein the actuating mechanism comprises at least one expandable member having an expanded state and a non-expanded state, and wherein the first configuration is the non-expanded state and the second configuration is the expanded state. 
     
     
         4 . The device of  claim 3 , wherein the at least one expandable member comprises an expandable balloon. 
     
     
         5 . The device of  claim 2 , wherein the actuating mechanism comprises a spring. 
     
     
         6 . The device of  claim 2 , wherein the actuating mechanism comprises an electro-mechanical device. 
     
     
         7 . The device of  claim 6 , wherein the electro-mechanical device comprises a solenoid or a piezoelectric device. 
     
     
         8 . The device of  claim 2 , wherein the GI lumen is the patient's stomach and the therapeutic preparation degrades within a wall of the stomach to release the therapeutically effective dose of interferon into the patient's blood stream. 
     
     
         9 . The device of  claim 2 , wherein the GI lumen is the patient's small intestine and the therapeutic preparation degrades within a wall of the small intestine to release the therapeutically effective dose of interferon into the patient's blood stream. 
     
     
         10 . The device of  claim 2 , wherein the condition in the GI lumen is a presence of a GI fluid. 
     
     
         11 . The device of  claim 2 , wherein the therapeutic preparation is shaped as a solid tissue penetrating member. 
     
     
         12 . The device of  claim 2 , wherein a weight percentage of interferon in the therapeutic preparation is in a range of about 0.1% to about 3%. 
     
     
         13 . The device of  claim 2 , wherein the therapeutically effective dose of interferon is in a range of about 0.03 mg to about 25 mg of Interferon. 
     
     
         14 . The device of  claim 2 , wherein the enclosure comprises a swallowable capsule. 
     
     
         15 . A device for delivering interferon into a lumen wall of a GI lumen of a patient, the device comprising:
 an enclosure defining an interior;   an actuating mechanism disposed within the interior; and   a therapeutic preparation coupled to the actuating mechanism, the therapeutic preparation being supplied in the enclosure in a shaped form and comprising a therapeutically effective dose of interferon;   wherein the actuating mechanism is configured to advance the therapeutic preparation from the interior into the lumen wall by applying force on a surface of the therapeutic preparation in response to a condition in the GI lumen.   
     
     
         16 . The device of  claim 15 , wherein the actuating mechanism comprises at least one expandable member. 
     
     
         17 . The device of  claim 15 , wherein the actuating mechanism comprises a spring. 
     
     
         18 . The device of  claim 15 , wherein the actuating mechanism comprises an electro-mechanical device. 
     
     
         19 . The device of  claim 15 , wherein the therapeutic preparation is shaped as a solid tissue penetrating member. 
     
     
         20 . A device for delivering interferon into a lumen wall of a GI lumen of a patient, the device comprising:
 an enclosure defining an interior;   an actuator disposed within the interior; and   a therapeutic preparation coupled to the actuator, the therapeutic preparation being supplied in the enclosure in a solid form and comprising a therapeutically effective dose of interferon;   wherein the actuator is configured to advance the therapeutic preparation from the interior into the lumen wall by pushing on the therapeutic preparation in response to a condition in the GI lumen.   
     
     
         21 . The device of  claim 20 , wherein the therapeutic preparation is shaped as a solid tissue penetrating member.