Methods for delivering etanercept preparations 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 comprising:
 a swallowable capsule;   a therapeutic preparation disposed in the swallowable capsule, the therapeutic preparation comprising a therapeutically effective dose of etanercept and configured to be inserted into a lumen wall of a gastrointestinal (GI) tract after oral ingestion of the swallowable capsule; and   a delivery mechanism operably coupled to the therapeutic preparation, the delivery mechanism having a first configuration and a second configuration, the therapeutic preparation being contained within the swallowable capsule in the first configuration and advanced out of the swallowable capsule and into the lumen wall in the second configuration;   wherein upon insertion into the lumen wall, the therapeutic preparation releases the therapeutically effective dose of etanercept into the blood stream.   
     
     
         3 . The swallowable device of  claim 1 , wherein the lumen wall is an intestinal wall, and wherein a t max  for the etanercept released from the therapeutic preparation into the blood stream from the intestinal wall is less than about 80% of a t max  for an extravascularly injected dose of etanercept. 
     
     
         4 . The swallowable device of  claim 1 , wherein the therapeutic preparation is in a solid form shaped as a tissue penetrating member configured to be advanced into the lumen wall. 
     
     
         5 . The swallowable device of  claim 1 , further comprising a tissue penetrating member operably coupled to the delivery mechanism, wherein the therapeutic preparation is disposed in the tissue penetrating member. 
     
     
         6 . The swallowable device of  claim 4 , wherein the tissue penetrating member comprises a biodegradable material which degrades within the lumen wall to release the therapeutically effective dose of etanercept into the blood stream. 
     
     
         7 . The swallowable device of  claim 1 , wherein a weight percent of etanercept in the therapeutic preparation comprises between about 70% to about 90%. 
     
     
         8 . The swallowable device of  claim 1 , wherein the therapeutically effective dose of etanercept is in a range from about 1 mg to about 5 mg. 
     
     
         9 . The swallowable device of  claim 1 , wherein the delivery mechanism comprises at least one of an expandable member, an expandable balloon, or a valve. 
     
     
         10 . The swallowable device of  claim 1 , wherein the therapeutic preparation is configured to detach from the delivery mechanism upon an application of a force on the therapeutic preparation by the delivery mechanism in the second configuration. 
     
     
         11 . A swallowable device comprising:
 a swallowable capsule;   a tissue penetrating member disposed in the swallowable capsule, the tissue penetrating member comprising a therapeutically effective dose of etanercept and configured to be inserted into a lumen wall of a gastrointestinal (GI) tract after oral ingestion of the swallowable capsule; and   a delivery mechanism operably coupled to the tissue penetrating member, the delivery mechanism having a first configuration and a second configuration, the tissue penetrating member being contained within the swallowable capsule in the first configuration and advanced out of the swallowable capsule and into the lumen wall in the second configuration;   wherein the tissue penetrating member is configured to detach from the delivery mechanism upon an application of a force on a surface of the tissue penetrating member by the delivery mechanism in the second configuration; and   wherein upon insertion into the lumen wall, the tissue penetrating member releases the therapeutically effective dose of etanercept into the blood stream.   
     
     
         12 . The swallowable device of  claim 10 , wherein the lumen wall is an intestinal wall, and wherein the tissue penetrating member releases etanercept into the blood stream from the intestinal wall to achieve a C max  in a shorter time period than a time period to achieve a C max  for an extravascularly injected dose of etanercept. 
     
     
         13 . The swallowable device of  claim 10 , wherein the tissue penetrating member comprises a biodegradable material which degrades within the lumen wall to release the therapeutically effective dose of etanercept into the blood stream. 
     
     
         14 . The swallowable device of  claim 10 , wherein a weight percent of etanercept in the tissue penetrating member comprises between about 8% to about 12%. 
     
     
         15 . The swallowable device of  claim 10 , wherein the therapeutically effective dose of etanercept is in a range from about 1 mg to about 5 mg. 
     
     
         16 . The swallowable device of  claim 10 , wherein the delivery mechanism comprises at least one of an expandable member, an expandable balloon, or a valve. 
     
     
         17 . A swallowable device comprising:
 a swallowable capsule;   a tissue penetrating member disposed in the swallowable capsule, the tissue penetrating member formed from, or containing, a solid therapeutic preparation comprising a therapeutically effective dose of etanercept, the tissue penetrating member being configured to be inserted into a lumen wall of a gastrointestinal (GI) tract after oral ingestion of the swallowable capsule; and   a mechanism operably coupled to the therapeutic preparation, the mechanism having a first configuration and a second configuration, the tissue penetrating member being contained within the swallowable capsule in the first configuration and advanced out of the swallowable capsule and into the lumen wall in the second configuration upon an application of a force by the mechanism on a surface of the tissue penetrating member;   wherein upon insertion into the lumen wall, the tissue penetrating member releases the therapeutically effective dose of etanercept into the blood stream.   
     
     
         18 . The swallowable device of  claim 16 , wherein a weight percent of etanercept in the tissue penetrating member comprises between about 8% to about 12%. 
     
     
         19 . The swallowable device of  claim 16 , wherein the therapeutically effective dose of etanercept is in a range from about 1 mg to about 5 mg. 
     
     
         20 . The swallowable device of  claim 16 , wherein the mechanism comprises at least one of an expandable member, an expandable balloon, or a valve. 
     
     
         21 . The swallowable device of  claim 16 , wherein the tissue penetrating member is configured to detach from the mechanism in the second configuration.