Preparation comprising exanatide for delivery into a lumen of the intestinal tract
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. A method for delivering exenatide into a wall of a gastrointestinal tract, comprising: providing a drug delivery device comprising a capsule, an actuator having a first
configuration and a second configuration, and a solid exenatide preparation operably coupled to the actuator, the solid exenatide preparation comprising a therapeutically effective dose of exenatide, the solid exenatide preparation being contained within the capsule in the first configuration and advanced into the wall of the gastrointestinal tract in the second configuration, wherein the solid exenatide preparation has a shape configured for penetration of the wall of the gastrointestinal tract; and
providing instructions for the ingestible device to be swallowed by a patient.
2. The method of claim 1 , wherein the dose of exenatide treats diabetes or another glucose regulation disorder.
3. The method of claim 1 , wherein a weight percent of exenatide in the preparation comprises between 0.1 to 11%.
4. The method of claim 1 , wherein the dose of exenatide in the preparation is in a range of 1 to 20 μg.
5. The method of claim 1 , wherein the exenatide preparation comprises at least one pharmaceutical excipient.
6. The method of claim 1 , wherein the solid exenatide preparation advanced into the wall of the gastrointestinal tract is retained within the wall of the gastrointestinal wall to release the dose of exenatide therein.
7. The method of claim 1 , wherein the exenatide is advanced into the wall of the gastrointestinal tract to release into the blood stream from the wall, and wherein the exenatide released reaches a C max in a shorter time period than a time period to achieve a C max for an extravascularly injected dose of exenatide.
8. The method of claim 1 , wherein the exenatide is advanced into the wall of the gastrointestinal tract to release into the blood stream from the wall, and wherein a t max for the exenatide released is about 80% of a t max for an extravascularly injected dose of exenatide.
9. The method of claim 1 , wherein the solid exenatide preparation further comprises a therapeutically effective dose of another therapeutic agent different from the exenatide.
10. The method of claim 1 , wherein the solid exenatide preparation is configured to be advanced into the wall of the wall of the gastrointestinal tract in the second configuration of the capsule in response to a selected pH in the gastrointestinal tract.
11. A method for delivering exenatide into a wall of a gastrointestinal tract, comprising: configuring a drug delivery device to comprise a capsule, an actuator having a first
configuration and a second configuration, and a solid exenatide preparation operably coupled to the actuator, the solid exenatide preparation comprising a therapeutically effective dose of exenatide, the solid adalimumab preparation being contained within the capsule in the first configuration and advanced into the wall of the gastrointestinal tract in the second configuration, wherein the solid exenatide preparation has a shape configured for penetration of the wall of the gastrointestinal tract; and
providing the ingestible device to be swallowed by a patient.
12. The method of claim 11 , wherein the dose of exenatide treats diabetes or another glucose regulation disorder.
13. The method of claim 11 , wherein a weight percent of exenatide in the preparation comprises between 0.1 to 11%.
14. The method of claim 11 , wherein the dose of exenatide in the preparation is in a range of 1 to 20 μg.
15. The method of claim 11 , wherein the exenatide preparation comprises at least one pharmaceutical excipient.
16. The method of claim 11 , wherein the solid exenatide preparation advanced into the wall of the gastrointestinal tract is retained within the wall of the gastrointestinal wall to release the dose of exenatide therein.
17. The method of claim 11 , wherein the exenatide is advanced into the wall of the gastrointestinal tract to release into the blood stream from the wall, and wherein the exenatide released reaches a C max in a shorter time period than a time period to achieve a C max for an extravascularly injected dose of exenatide.
18. The method of claim 11 , wherein the exenatide is advanced into the wall of the gastrointestinal tract to release into the blood stream from the wall, and wherein a t max for the exenatide released is about 80% of a t max for an extravascularly injected dose of exenatide.
19. The method of claim 11 , wherein the solid exenatide preparation further comprises a therapeutically effective dose of another therapeutic agent different from the exenatide.
20. The method of claim 11 , wherein the solid exenatide preparation is configured to be advanced into the wall of the wall of the gastrointestinal tract in the second configuration of the capsule in response to a selected pH in the gastrointestinal tract.
21. A method, comprising:
providing a capsule, an actuator having a first configuration and a second configuration, and a solid exenatide preparation that (i) comprises a therapeutically effective dose of exenatide, (ii) is operably coupled to the actuator, and (iii) is contained within the capsule in the first configuration and is advanced into a wall of the gastrointestinal tract in the second configuration; and
providing the capsule to be swallowed.
22. The method of claim 21 , wherein the dose of exenatide treats diabetes or another glucose regulation disorder.
23. The method of claim 21 , wherein a weight percent of exenatide in the preparation comprises between 0.1 to 11%.
24. The method of claim 21 , wherein the dose of exenatide in the preparation is in a range of 1 to 20 μg.
25. The method of claim 21 , wherein the exenatide preparation comprises at least one pharmaceutical excipient.
26. The method of claim 21 , wherein the solid exenatide preparation advanced into the wall of the gastrointestinal tract is retained within the wall of the gastrointestinal wall to release the dose of exenatide therein.
27. The method of claim 21 , wherein the exenatide is advanced into the wall of the gastrointestinal tract to release into the blood stream from the wall, and wherein the exenatide released reaches a C max in a shorter time period than a time period to achieve a C max for an extravascularly injected dose of exenatide.
28. The method of claim 21 , wherein the exenatide is advanced into the wall of the gastrointestinal tract to release into the blood stream from the wall, and wherein a t max for the exenatide released is about 80% of a t max for an extravascularly injected dose of exenatide.
29. The method of claim 21 , wherein the solid exenatide preparation further comprises a therapeutically effective dose of another therapeutic agent different from the exenatide.
30. The method of claim 21 , wherein the solid exenatide preparation is configured to be advanced into the wall of the wall of the gastrointestinal tract in the second configuration of the capsule in response to a selected pH in the gastrointestinal tract.