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 swallowable device for delivering growth hormone 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   a growth hormone preparation coupled to the delivery means, the growth hormone preparation being supplied in the swallowable enclosure in a shaped form and comprising a therapeutically effective dose of growth hormone;   wherein the delivery means is configured to advance the growth hormone preparation out of the interior away from the delivery means and into the GI lumen wall to release the therapeutically effective dose of growth hormone into the patient's blood stream.   
     
     
         3 . The device of  claim 2 , wherein the GI lumen is the small intestine. 
     
     
         4 . The device of  claim 2  wherein the GI lumen is the stomach. 
     
     
         5 . The device of  claim 2 , wherein the delivery means is configured to advance the growth hormone preparation out of the interior in response to a condition in the GI lumen. 
     
     
         6 . The device of  claim 5 , wherein the condition is a selected pH. 
     
     
         7 . The device of  claim 6 , wherein the pH is above about 7.1. 
     
     
         8 . The device of  claim 2 , wherein a percentage by weight of growth hormone in the growth hormone preparation is between about 2% to about 10%. 
     
     
         9 . The device of  claim 2 , wherein the therapeutically effective dose of growth hormone is in a range from about 0.1 mg to about 4 mg. 
     
     
         10 . The device of  claim 9 , wherein the therapeutically effective dose of growth hormone is in a range from about 0.2 mg to about 1 mg. 
     
     
         11 . The device of  claim 2 , wherein the growth hormone is somatropin. 
     
     
         12 . The device of  claim 2 , wherein the growth hormone preparation further comprises at least one pharmaceutical excipient. 
     
     
         13 . The device of  claim 12 , wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative, or a disintegrant. 
     
     
         14 . The device of  claim 2 , wherein the growth hormone preparation further comprises a feature for retaining the growth hormone preparation within the GI lumen wall. 
     
     
         15 . The device of  claim 2 , further comprising a tissue penetrating member, wherein the tissue penetrating member comprises the growth hormone preparation, and wherein the delivery means is configured to apply a force to a surface of the tissue penetrating member to advance the growth hormone preparation into the GI lumen wall. 
     
     
         16 . The device of  claim 15 , wherein the tissue penetrating member is formed from the growth hormone preparation. 
     
     
         17 . The device of  claim 15 , wherein the tissue penetrating member further comprises a lumen, and wherein the growth hormone preparation is disposed in the lumen. 
     
     
         18 . The device of  claim 2 , wherein the delivery means comprises an expandable balloon. 
     
     
         19 . The device of  claim 2 , wherein the delivery means comprises a spring. 
     
     
         20 . A swallowable device for delivering growth hormone into a gastro-intestinal (GI) lumen wall of a patient, the device comprising:
 a swallowable capsule having an interior;   a delivery mechanism disposed in the interior; and   a growth hormone preparation operably coupled to the delivery mechanism, the growth hormone preparation being supplied in the swallowable capsule in a solid form and comprising a therapeutically effective dose of growth hormone;   wherein the delivery mechanism has a first configuration and a second configuration, the growth hormone preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the GI lumen wall in the second configuration to release the therapeutically effective dose of growth hormone into the patient's blood stream.   
     
     
         21 . The device of  claim 20 , wherein the delivery mechanism comprises at least one of an expandable member, an expandable balloon, a valve, a tissue penetrating member, a valve coupled to an expandable balloon, or a tissue penetrating member coupled to an expandable balloon.