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 - 23 . (canceled) 
     
     
         24 . A therapeutic preparation comprising natalizumab, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro-intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release natalizumab into the patient's blood stream. 
     
     
         25 . The preparation of  claim 24 , wherein the entire preparation is in solid form. 
     
     
         26 . The preparation of  claim 24 , wherein the preparation is adapted to be orally delivered in a swallowable capsule. 
     
     
         27 . The preparation of  claim 26 , wherein the expandable member has a first configuration and a second configuration, the preparation being configured to be contained within the capsule in the first configuration and advanced out of the capsule and into the GI wall in the second configuration. 
     
     
         28 . The preparation of  claim 27 , wherein the expandable member comprises an expandable balloon having an expanded and a non-expanded state, and wherein the first configuration is the non-expanded state and the second configuration is the expanded state. 
     
     
         29 . The preparation of  claim 27 , wherein the expandable member comprises a spring. 
     
     
         30 . The preparation of  claim 24 , wherein the GI wall is a wall of the stomach. 
     
     
         31 . The preparation of  claim 24 , wherein the GI wall is a wall of the intestine. 
     
     
         32 . The preparation of  claim 24 , wherein the preparation comprises a biodegradable material which degrades to release natalizumab into the blood stream. 
     
     
         33 . The preparation of  claim 32 , wherein the biodegradable material comprises at least one of PGLA or a sugar. 
     
     
         34 . The preparation of  claim 24 , wherein the preparation comprises at least one pharmaceutical excipient. 
     
     
         35 . The preparation of  claim 34 , wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative, or a disintegrant. 
     
     
         36 . The preparation of  claim 24 , wherein the solid tissue penetrating member comprises a biodegradable material which degrades to release natalizumab into the blood stream. 
     
     
         37 . The preparation of  claim 24 , wherein a weight percent of natalizumab in the tissue penetrating member comprises between about 8 to 12%. 
     
     
         38 . The preparation of  claim 24 , wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member in the GI wall. 
     
     
         39 . The preparation of  claim 24 , wherein the natalizumab is contained in the tissue penetrating member in a shaped section. 
     
     
         40 . The preparation of  claim 39 , wherein the shaped section has a cylinder or pellet shape. 
     
     
         41 . The preparation of  claim 24 , wherein a Cmax achieved by delivering the preparation by insertion into an intestinal wall is substantially greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. 
     
     
         42 . The preparation of  claim 24 , wherein the preparation is configured to produce a release of natalizumab over a time period of up to about 40 days. 
     
     
         43 . The preparation of  claim 24 , wherein a dose of natalizumab in the preparation is in a range from about 1 to 5 mg.