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 therapeutic preparation comprising a solid infliximab dosage, the preparation shaped as a solid tissue penetrating member, the preparation configured to be contained in a swallowable capsule and detachably coupled to an actuator to be released from the capsule to penetrate and be inserted into a lumen wall of a gastro-intestinal (GI) tract of a patient after oral ingestion of the capsule by an application of force from the actuator on the preparation, wherein upon insertion into the lumen wall, the preparation releases infliximab into the blood stream of the patient. 
     
     
         3 . The preparation of  claim 2 , wherein the lumen wall is a wall of the stomach. 
     
     
         4 . The preparation of  claim 2 , wherein the lumen wall is a wall of the intestine. 
     
     
         5 . The preparation of  claim 4 , wherein the infliximab released into the blood stream from the solid dosage reaches a C max  in a shorter time period than a time period to achieve a C max  for an extravascularly injected dose of infliximab. 
     
     
         6 . The preparation of  claim 5 , wherein a t max  for the infliximab released from the solid dosage is less than 80% of a t max  for the extravascularly injected dose of infliximab. 
     
     
         7 . The preparation of  claim 2 , wherein the actuator has a first configuration in which the solid dosage of infliximab is within the capsule and a second configuration in which the solid dosage of infliximab is advanced out of the capsule and into the lumen wall. 
     
     
         8 . The preparation of  claim 7 , wherein the actuator comprises a feature selected from a release element and a coating on the capsule which is degraded by a selected pH in a small intestine. 
     
     
         9 . The preparation of  claim 8 , wherein the actuator is configured to move from the first configuration to the second configuration in response to the release element or in response to the coating being degraded, respectively, to thereby advance the preparation out of the capsule. 
     
     
         10 . The preparation of  claim 2 , wherein the solid infliximab dosage comprises a biodegradable material which degrades in the lumen wall to release infliximab into the blood stream. 
     
     
         11 . The preparation of  claim 2 , wherein the solid infliximab dosage comprises at least one pharmaceutical excipient. 
     
     
         12 . The preparation of  claim 2 , wherein a weight percent of infliximab in the solid infliximab dosage is from about 8% to about 12%. 
     
     
         13 . The preparation of  claim 2 , wherein a dose of infliximab in the tissue penetrating member is in a range from about 1 mg to about 10 mg. 
     
     
         14 . A drug delivery device for delivering a solid infliximab dosage to a lumen wall of a gastro-intestinal (GI) tract of a patient, the device comprising:
 a swallowable capsule;   an actuator disposed in the capsule, the actuator having a first configuration and a second configuration; and   a therapeutic preparation detachably coupled to the actuator, the preparation comprising the solid infliximab dosage, the preparation shaped as a solid tissue penetrating member,   wherein the preparation is contained within the capsule in the first configuration and advanced out of the capsule and into the lumen wall in the second configuration upon an application of force from the actuator on the preparation.   
     
     
         15 . The drug delivery device of  claim 14 , wherein the lumen wall is a wall of the stomach. 
     
     
         16 . The drug delivery device of  claim 14 , wherein the lumen wall is a wall of the intestine. 
     
     
         17 . The drug delivery device of  claim 14 , wherein the capsule comprises a capsule wall that is degradable by contact with liquid in the GI tract of the patient. 
     
     
         18 . The drug delivery device of  claim 14 , wherein the actuator comprises an expandable balloon or a spring. 
     
     
         19 . The drug delivery device of  claim 14 , wherein the actuator comprises a feature selected from a release element and a coating on the capsule which is degraded by a selected pH in a small intestine. 
     
     
         20 . The drug delivery device of  claim 19 , wherein the actuator is configured to move from the first configuration to the second configuration in response to the release element or in response to coating being degraded, respectively, to thereby advance the preparation out of the capsule. 
     
     
         21 . A method of delivering a solid infliximab dosage to a patient in need thereof, the method comprising:
 providing a drug delivery device comprising a swallowable capsule, an actuator having a first configuration and a second configuration, and a solid infliximab preparation detachably coupled to the actuator, the solid infliximab preparation comprising a therapeutically effective dose of infliximab, the solid infliximab preparation being contained within the capsule in the first configuration and advanced out of the capsule into a lumen wall of a gastro-intestinal (GI) tract of the patient in the second configuration by an application of force on the preparation from the actuator, wherein the solid infliximab preparation has a shape configured for penetration of the lumen wall; and   providing instructions for the device to be swallowed by the patient.