Method of delivering gonadotropin releasing hormone or an analogue thereof 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 - 20 . (canceled) 
     
     
         21 . A solid therapeutic preparation comprising GnRH or GnRH analogue, the preparation shaped as, or contained in, a solid tissue penetrating member, the preparation configured to be contained in a swallowable capsule to penetrate and be inserted into a gastro-intestinal (GI) wall after oral ingestion of the capsule, the preparation being adapted to be operably coupled to a delivery means in the capsule, the delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the GI wall in the second configuration. 
     
     
         22 . The preparation of  claim 21 , wherein the tissue penetrating member comprises a cavity, and wherein the preparation is contained in the tissue penetrating member disposed in the cavity. 
     
     
         23 . The preparation of  claim 22 , wherein the preparation is shaped as a pellet, a slug, or a cylinder. 
     
     
         24 . The preparation of  claim 21 , wherein the preparation comprises at least one pharmaceutical excipient, and wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. 
     
     
         25 . The preparation of  claim 21 , wherein the tissue penetrating member comprises a biodegradable material which degrades within the GI wall to release GnRH or GnRH analogue into the blood stream. 
     
     
         26 . The preparation of  claim 21 , wherein a weight percent of GnRH or GnRH analogue in the preparation is between about 2 to 15%. 
     
     
         27 . The preparation of  claim 21 , wherein a dose of GnRH or GnRH analogue in the preparation is in a range from about 0.3 to 1.5 mg. 
     
     
         28 . The preparation of  claim 21 , wherein the tissue penetrating member has sufficient stiffness to be advanced completely into the GI wall by an application of a force to the tissue penetrating member by the delivery means. 
     
     
         29 . The preparation of  claim 21 , wherein the preparation is configured to produce a long-term release of GnRH or GnRH analogue to produce a selectable t 1/2 . 
     
     
         30 . The preparation of  claim 21 , wherein the GnRH analogue is leuprorelin. 
     
     
         31 . A drug delivery device for delivering a gonadotropin releasing hormone (GnRH) or a GnRH analogue dosage to a gastro-intestinal (GI) wall of a patient, the device comprising:
 a swallowable capsule;   an actuator having a first configuration and a second configuration; and   a solid GnRH or GnRH analogue preparation shaped as, or contained in, a tissue penetrating member,   wherein the preparation is adapted to be operably coupled to the actuator, the actuator having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the GI wall in the second configuration.   
     
     
         32 . The drug delivery device of  claim 31 , wherein the tissue penetrating member comprises a cavity, and wherein the preparation is contained in the tissue penetrating member disposed in the cavity. 
     
     
         33 . The drug delivery device of  claim 31 , wherein the capsule is configured to align a longitudinal axis of the capsule with a longitudinal axis of a small intestine of the patient. 
     
     
         34 . The drug delivery device of  claim 31 , wherein the capsule comprises a capsule wall that is degradable by contact with liquid in a gastro-intestinal tract of the patient. 
     
     
         35 . The drug delivery device of  claim 31 , wherein the capsule comprises an outer coating or layer which only degrades in a pH found in a small intestine of the patient. 
     
     
         36 . The drug delivery device of  claim 31 , wherein the actuator comprises a release element or coating on the capsule which is degraded by a selected pH in a small intestine of the patient. 
     
     
         37 . The drug delivery device of  claim 36 , wherein the actuator is configured to move from the first configuration to the second configuration in response to the release element or coating being degraded, thereby advancing the preparation out of the capsule and into an intestinal wall. 
     
     
         38 . A method of delivering a gonadotropin releasing hormone (GnRH) or a GnRH analogue dosage to a patient in need thereof, the method comprising:
 providing the drug delivery device of  claim 31 ; and   providing instructions for the drug delivery device to be swallowed by a patient.   
     
     
         39 . A method of delivering a gonadotropin releasing hormone (GnRH) or a GnRH analogue dosage to a patient in need thereof, the method comprising:
 providing the drug delivery device of  claim 31 ; and   providing the drug delivery device to be swallowed by a patient.   
     
     
         40 . A method of delivering a gonadotropin releasing hormone (GnRH) or a GnRH analogue dosage to a patient in need thereof, the method comprising:
 ingesting a drug delivery device comprising a capsule, an actuator having a first configuration and a second configuration, and a solid therapeutic preparation operably coupled to the actuator, the preparation comprising a therapeutically effective dose of GnRH or GnRH analogue, the preparation being shaped as, or contained in, a solid tissue penetrating member, the preparation being contained within the capsule in the first configuration and advanced into a wall of a gastro-intestinal tract of the patient in the second configuration.