Get our Free Patent Expiration Newsletter

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Covington
Cipla
Mallinckrodt
Argus Health
Harvard Business School

Generated: August 26, 2019

DrugPatentWatch Database Preview

Claims for Patent: 9,956,178

  Try a free trial


See Plans and Pricing

« Back to Dashboard

Summary for Patent: 9,956,178
Title:Methods for delivering insulin preparations 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.
Inventor(s): Imran; Mir (Los Altos Hills, CA)
Assignee: Rani Therapeutics, LLC (San Jose, CA)
Application Number:15/252,193
Patent Claims:1. A method for delivering insulin to a patient, said method comprising: providing an oral solid insulin dosage shaped as a tissue penetrating member having a pointed tip, the tissue penetrating member configured to be carried by a swallowable capsule and penetrate and be inserted into an intestinal wall, wherein upon ingestion the capsule advances to the small intestine of the patient; and delivering the solid insulin dosage into the wall of the small intestine by an application of mechanical force upon a surface of the tissue penetrating member from an actuator operably coupled to the tissue penetrating member wherein upon insertion into the intestinal wall, the tissue penetrating member remains to release insulin into the blood stream from the intestinal wall by degradation of the of the tissue penetrating member.

2. A method as in claim 1, wherein actuator comprises an expandable member or an expandable balloon.

3. A method as in claim 1, wherein the insulin reaches a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of insulin.

4. A method as in claim 3, wherein a tmax for the insulin released from the therapeutic preparation is less than about 50% of a tmax for the extravascularly injected dose of insulin.

5. A method as in claim 3, wherein a tmax for the insulin released from the therapeutic preparation is less than about 30% of a tmax for the extravascularly injected dose of insulin.

6. A method as in claim 3, wherein a tmax for the insulin released from the preparation is less than about 10% of a tmax for the extravascularly injected dose of insulin.

7. A method as in claim 1, wherein the solid dosage insulin comprises a biodegradable material which degrades within the intestinal wall to release insulin into the blood stream.

8. A method as in claim 7, wherein the biodegradable material comprises PGLA, a sugar or maltose.

9. A method as in claim 7, wherein the solid dosage insulin comprises at least one pharmaceutical excipient.

10. A method as in claim 9, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant.

11. A method as in claim 10, wherein the binder comprises PEG.

12. A method as in claim 1, wherein a weight per cent of insulin in the solid dosage insulin comprises between about 2 to 15%.

13. A method as in claim 1, further comprising retaining the solid dosage within the intestinal wall after insertion.

14. A method as in claim 1, wherein the solid dosage insulin produces a long-term release of insulin.

15. A method as in claim 14, wherein the solid dosage insulin produces a long-term release of insulin to produce a selectable t1/2.

16. A method as in claim 15, wherein the t1/2 is about 12 hours.

17. A method as in claim 1, wherein the solid dosage insulin carries about 1 to 50 units of insulin.

18. A method as in claim 17, wherein the solid dosage insulin carries about 4 to 9 units of insulin.

19. A method as in claim 1, wherein the solid dosage insulin further comprises a therapeutically effective dose of an incretin for the treatment of diabetes or a glucose regulation disorder.

20. A method as in claim 19, wherein the incretin comprises a glucagon-like peptide-1 (GLP-1), a GLP-1 analogue, exenatide, liraglutide, albiglutide, taspoglutide or a gastric inhibitory polypeptide (GIP).

21. A method as in claim 20, wherein the incretin comprises exenatide and the dose is in a range from about 1 to 10 .mu.g.

22. A method as in claim 20, wherein the incretin comprises liraglutide and the dose is in a range from about 0.1 to 1 mg.

Details for Patent 9,956,178

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Glaxosmithkline Llc TANZEUM albiglutide INJECTABLE;INJECTION 125431 001 2014-04-15 ➤ Sign Up 2038-10-17 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

Subscribe to access the full database, or try a Free Trial

International Patent Family for US Patent 9,956,178

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Moodys
Daiichi Sankyo
AstraZeneca
US Department of Justice
US Army

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.