Therapeutic agent preparations into a lumen of the intestinal tract using a swallowable drug delivery device
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 within the wall to release the drug to produce a therapeutic effect. The preparation can be coupled to an actuator 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. An apparatus for delivering a therapeutic agent into a lumen of a gastrointestinal (GI) tract, the lumen having a lumen wall, the apparatus comprising:
a tissue penetrating member formed from a therapeutically effective dose of at least one therapeutic agent;
an actuator operably coupled to the tissue penetrating member;
a swallowable capsule comprising a capsule wall that defines an interior, wherein the capsule wall encapsulates the tissue penetrating member to protect the therapeutically effective dose from degradation by digestive fluids within the GI tract while the swallowable capsule travels along at least a portion of the GI tract to a target treatment location of the GI tract;
wherein the swallowable capsule is shaped to self-align with a wall of the GI tract at the target treatment location; and
wherein the actuator comprises a first configuration and a second configuration, the tissue penetrating member being contained within the interior in the first configuration and expelled out of the interior in the second configuration so as to penetrate the lumen wall of the GI tract to deliver the therapeutic agent into the lumen wall at the target treatment location.
2. The apparatus of claim 1 , further comprising:
a release element operatively coupled to the actuator;
wherein the release element is responsive to a condition of the GI tract so as to trigger actuation of the actuator from the first configuration to the second configuration in response to said condition.
3. The apparatus of claim 2 , wherein the release element is configured to degrade in response to action of digestive fluids within the GI tract; and
wherein actuation from the first configuration to the second configuration is triggered upon degradation of at least a portion of the release element.
4. The apparatus of claim 3 , wherein the release element is configured to degrade so as to release at a location within the GI tract corresponding to the target treatment location.
5. The apparatus of claim 3 , wherein the release element is configured to degrade so as to release within a specified time period corresponding to the target treatment location and travel of the swallowable capsule within the GI tract after consumption of the swallowable capsule.
6. The apparatus of claim 2 , wherein the condition of the GI tract to trigger actuation of the actuator is a selected pH.
7. The apparatus of claim 6 , wherein the selected pH is above about 7.1.
8. The apparatus of claim 2 , wherein the condition of the GI tract to trigger actuation of the actuator is a presence of GI fluid.
9. The apparatus of claim 1 , wherein the capsule is sized and shaped such that at least a portion of the capsule wall contacts the lumen wall at the target treatment location such that after ingestion of the swallowable capsule and actuation of the actuator in the second configuration, the tissue penetrating member releases from the capsule, embeds in the lumen wall, and is retained in the lumen wall to deliver the at least one therapeutic agent into the lumen wall.
10. The apparatus of claim 9 , wherein the actuator comprises a biasing element configured to provide linear articulation of the tissue penetrating member within the capsule between the first configuration and the second configuration.
11. The apparatus of claim 10 , wherein the biasing element comprises a spring.
12. The apparatus of claim 10 , wherein the biasing element comprises an expandable member.
13. The apparatus of claim 12 , wherein the expandable member comprises a balloon.
14. The apparatus of claim 10 :
wherein the capsule wall comprises an aperture, and wherein the tissue penetrating member is expelled out from the interior through the aperture.
15. The apparatus of claim 14 , wherein the aperture is orthogonally oriented with respect to an external surface of the capsule such that the linear articulation of the tissue penetrating member is orthogonally oriented with respect to the lumen wall.
16. The apparatus of claim 14 , wherein the aperture is radially oriented with respect to a longitudinal axis of the apparatus.
17. The apparatus of claim 1 , wherein the lumen is a stomach and the tissue penetrating member is configured to degrade within a wall of the stomach.
18. The apparatus of claim 1 , wherein the lumen is a small intestine, wherein the lumen wall comprises a wall of the small intestine, and wherein the tissue penetrating member is configured to degrade within the wall of the small intestine.
19. The apparatus of claim 1 , wherein the at least one therapeutic agent comprises at least one pharmaceutical excipient.
20. The apparatus of claim 1 , wherein the tissue penetrating member comprises a pointed tip.
21. The apparatus of claim 1 , wherein the tissue penetrating member comprises barbs.
22. The apparatus of claim 1 , wherein the tissue penetrating member is configured to have a selectable surface area to volume ratio to achieve a selectable rate of release of the at least one therapeutic agent in the lumen wall.
23. The apparatus of claim 1 , wherein the capsule is oval shaped.
24. The apparatus of claim 1 , wherein an amount of the at least one therapeutic agent within the tissue penetrating member to produce a desired therapeutic effect is less than an amount to produce said desired therapeutic effect if the agent was orally delivered without enclosure in the swallowable capsule.
25. The apparatus of claim 1 , wherein the at least one therapeutic agent is for treatment of diabetes or a glucose regulation disorder.
26. The apparatus of claim 1 , wherein the at least one therapeutic agent comprises a combination of a first therapeutic agent and a second therapeutic agent different from the first therapeutic agent.
27. The apparatus of claim 1 , wherein the at least one therapeutic agent comprises one or more of an antibiotic, an anti-migraine agent, an anti-seizure agent, an antiviral compound, a biguanide, a chemotherapeutic agent, a growth hormone, an immune suppressive agent, an incretin, insulin, or a parathyroid hormone.