Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Cantor Fitzgerald
Federal Trade Commission
US Department of Justice
AstraZeneca
Harvard Business School

Generated: August 21, 2019

DrugPatentWatch Database Preview

Claims for Patent: 9,844,655

  Try a free trial


See Plans and Pricing

« Back to Dashboard

Summary for Patent: 9,844,655
Title: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.
Inventor(s): Imran; Mir (Los Altos Hills, CA)
Assignee: Rani Therapeutics, LLC (San Jose, CA)
Application Number:15/043,052
Patent Claims:1. A method for delivering a natalizumab dosage to a patient, the method comprising: providing a solid natalizumab dosage shaped as a tissue penetrating member; and penetrating the tissue penetrating member into an intestinal wall after oral ingestion, wherein the natalizumab is released into the blood stream from the solid dosage natalizumab in the intestinal wall.

2. The method of claim 1, wherein the natalizumab released into the blood stream from the solid dosage natalizumab reaches a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of natalizumab.

3. The method of claim 2, wherein a tmax for the natalizumab released from the solid dosage natalizumab is less than about 80% of a tmax for the extravascularly injected dose of natalizumab.

4. The method of claim 2, wherein a tmax for the natalizumab released from the solid dosage natalizumab is less than about 50% of a tmax for the extravascularly injected dose of natalizumab.

5. The method of claim 2, wherein a tmax for the natalizumab released from the solid dosage natalizumab is less than about 30% of a tmax for the extravascularly injected dose of natalizumab.

6. The method of claim 2, wherein a tmax for the natalizumab released from the solid dosage natalizumab is less than about 10% of a tmax for the extravascularly injected dose of natalizumab.

7. The method of claim 1, wherein the tissue penetrating member is inserted into a wall of the small intestine.

8. The method of claim 1, wherein the solid natalizumab dosage is orally delivered in a swallowable capsule.

9. The method of claim 8, wherein penetrating the tissue penetrating member into the intestinal wall comprises operably coupling the tissue penetrating member to a delivery means having a first configuration wherein the tissue penetrating member is within the capsule, and a second configuration wherein the tissue penetrating member is advanced out of the capsule and into the intestinal wall.

10. The method of claim 9, wherein penetrating the tissue penetrating member into the intestinal wall comprises expanding at least one expandable balloon from the first to the second configuration.

11. The method of claim 1, wherein the solid dosage natalizumab comprises a biodegradable material which degrades within the intestinal wall to release natalizumab into the blood stream.

12. The method of claim 11, wherein the biodegradable material comprises PGLA, a sugar or maltose.

13. The method of claim 11, wherein the solid dosage natalizumab comprises at least one pharmaceutical excipient.

14. The method of claim 13, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant.

15. The method of claim 14, wherein the binder comprises PEG.

16. The method of claim 1, wherein a weight percent of natalizumab in the solid dosage natalizumab comprises between about 8 to 12%.

17. The method of claim 1, wherein a dose of natalizumab in the solid dosage natalizumab is in a range from about 1 to 5 mg.

18. The method of claim 17, wherein the dose of natalizumab in the solid dosage natalizumab is about 3 mg.

19. The method of claim 1, further comprising retaining the solid dosage natalizumab within the intestinal wall after insertion.

20. The method of claim 19, wherein retaining comprises anchoring at least one of a barb or an inverse taper shape of the solid dosage natalizumab in the intestinal tissue.

21. The method of claim 1, wherein penetrating the tissue penetrating member comprises applying a force to the tissue penetrating member, wherein the tissue penetrating member has sufficient stiffness to be advanced completely into the intestinal wall by such application of force.

22. The method of claim 1, wherein the solid dosage natalizumab produces a long-term release of natalizumab.

23. The method of claim 22, wherein the long-term release of natalizumab is up to about 40 days.

24. The method of claim 1, wherein the Cmax achieved by delivering the solid dosage natalizumab into the intestinal wall is at least about 10 times greater than the Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall.

Details for Patent 9,844,655

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Biogen Idec TYSABRI natalizumab VIAL; SINGLE-USE 125104 001 2004-11-23   Try a Free Trial Rani Therapeutics, LLC (San Jose, CA) 2030-12-23 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

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

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Fish and Richardson
Cantor Fitzgerald
Chubb
Citi
Boehringer Ingelheim

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.