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 method of treating hypoparathyroidism in a patient with a solid therapeutic composition comprising a therapeutically effective dose of parathyroid hormone (PTH) or PTH analogue, the method comprising:
 providing a swallowable drug delivery device to the patient for oral ingestion, the swallowable drug delivery device comprising a swallowable capsule having an interior, an actuator disposed in the interior, and a tissue penetrating member operably coupled to the actuator within the interior, wherein the tissue penetrating member is comprised of or contains the solid therapeutic composition;   wherein the actuator has a first configuration and a second configuration, wherein the tissue penetrating member is contained within the capsule in the first configuration and is advanced out of the capsule away from the actuator into a lumen wall of the gastrointestinal (GI) tract of the patient in the second configuration.   
     
     
         25 . The method of  claim 24 , wherein the lumen wall is a wall of the stomach. 
     
     
         26 . The method of  claim 24 , wherein the lumen wall is a wall of the intestine. 
     
     
         27 . The method of  claim 26 , wherein upon penetration, the tissue penetrating member releases the therapeutically effective dose of PTH or PTH analogue into the patient's blood stream to achieve a t½ that is greater than a t½ for an orally ingested dose of PTH or PTH analogue that is not inserted into the intestinal wall. 
     
     
         28 . The method of  claim 24 , wherein a weight percent of PTH or PTH analogue in the therapeutic composition is in a range from about 1 to 2%. 
     
     
         29 . The method of  claim 24 , wherein the therapeutically effective dose of PTH or PTH analogue in the therapeutic composition is in a range from 10 to 30 μg. 
     
     
         30 . The method of  claim 24 , wherein the tissue penetrating member comprises a lumen, and wherein the solid therapeutic composition is disposed in the lumen. 
     
     
         31 . The method of  claim 24 , wherein the tissue penetrating member further comprises at least one biodegradable material. 
     
     
         32 . The method of  claim 24 , wherein the actuator is configured to apply a force to a surface of the tissue penetrating member to advance the tissue penetrating member into the lumen wall. 
     
     
         33 . The method of  claim 32 , wherein the actuator comprises an expandable balloon. 
     
     
         34 . The method of  claim 32 , wherein the actuator comprises a spring. 
     
     
         35 . The method of  claim 24 , wherein the therapeutic composition produces a long-term release of the PTH or PTH analogue. 
     
     
         36 . A method of treating hypoparathyroidism in a patient, the method comprising:
 providing a swallowable drug delivery device comprising a swallowable capsule having an interior, a delivery mechanism disposed in the interior, and a tissue penetrating member operably coupled to the delivery mechanism within the interior, the tissue penetrating member comprised of or containing a solid therapeutic composition, the solid therapeutic composition comprising a therapeutically effective dose of PTH or PTH analogue for the treatment of hypoparathyroidism, the delivery mechanism having a first configuration and a second configuration, the tissue penetrating member being contained within the capsule in the first configuration and advanced out of the capsule away from the actuator into a lumen wall of the gastrointestinal (GI) tract of the patient in the second configuration; and   providing instructions to the patient for swallowing the device.   
     
     
         37 . The method of  claim 36 , wherein the lumen wall is a wall of the stomach. 
     
     
         38 . The method of  claim 36 , wherein the lumen wall is a wall of the intestine. 
     
     
         39 . The method of  claim 36 , wherein the tissue penetrating member comprises a lumen, and wherein the solid therapeutic composition is disposed in the lumen. 
     
     
         40 . The method of  claim 36 , wherein the delivery mechanism is configured to apply a force to a surface of the tissue penetrating member to advance the tissue penetrating member into the lumen wall. 
     
     
         41 . The method of  claim 40 , wherein the delivery mechanism comprises an expandable balloon. 
     
     
         42 . The method of  claim 40 , wherein the delivery mechanism comprises a spring. 
     
     
         43 . The method of  claim 36 , wherein the therapeutic composition produces a long-term release of the PTH or PTH analogue.