IP Library Granted Patent US 12,178,852
Granted Patent B2
US 12,178,852 · App. 17/487,601 · Granted Dec 31, 2024

Insulin formulations and uses in infusion devices

Inventors: Massi Joe E. Kiani (Laguna Niguel, CA); Kevin Hughes Pauley (Lake Forest, CA); Venkatramanan Krishnamani (Irvine, CA)
Assignee: Willow Laboratories, Inc.
A61K38/28A61K9/0019A61K45/06A61K47/42
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Quick Facts
Patent No.
US 12,178,852
App. No.
17/487,601
Granted
Dec 31, 2024
Kind
B2
Abstract

Embodiments of the present disclosure provide insulin formulations having a near neutral pH and improved pharmacokinetic/pharmacodynamic properties, and uses in insulin infusion devices that may provide extended infusion period up to 7-14 days. Also provided are systems for administering insulin, the system may include a first reservoir, a second reservoir, an insulin pump configured to administer contents of the first reservoir or the second reservoir, and one or more hardware processors in communication with the insulin pump.

Claims (23)

1. A system for administering insulin, the system comprising:

a sensor configured to detect blood glucose concentration of a subject;

a device for administering insulin, the device comprising

a first reservoir comprising an effective amount of insulin, wherein the insulin has a pH between about 6.8 and about 7.4; and

a second reservoir comprising one or more insulin adjunctive excipients, wherein the insulin adjunctive excipients comprise at least one hyaluronidase;

an insulin pump configured to administer contents from the device to the subject;

one or more hardware processors in communication with the insulin pump, the one or more hardware processors configured to:

receive a signal from the sensor indicative of a blood glucose concentration;

determine, based at least in part on the blood glucose concentration, a desired insulin response speed;

determine, based on the desired insulin response speed, a first infusion amount of insulin and a second infusion amount of insulin adjunctive excipients; and

administer, using the insulin pump, the first infusion amount of insulin and the second infusion amount of insulin adjunctive excipients, wherein the volumetric ratio of the first infusion amount and second infusion amount is tunable to achieve a particular pharmacokinetic/pharmacodynamic response from the subject.

2. The system of claim 1 , wherein the insulin adjunctive excipients comprise hyaluronidases, insulin dissolution agents, anti-platelet agents, anti-thrombosis agents, cell self markers, glucagon, glucagon activating agents, insulin inhibiting agents, or combination thereof.

3. The system of claim 1 , wherein one or both the first or the second reservoir further comprises one or more insulin dissolution agents.

4. The system of claim 3 , wherein the insulin dissolution agents comprise citric acid, a salt, or a substituted derivative thereof; oligosaccharides; or combinations thereof.

5. The system of claim 1 , wherein the insulin is a slow-acting insulin, a fast-acting insulin, or is in the form of a hexamer, and wherein the insulin in the first reservoir has a concentration of at least 100 U/mL, at least 150 U/mL, or at least 200 U/mL.

6. The system of claim 1 , wherein one or both of the first reservoir and the second reservoir further comprises one or more anti-platelet agents, one or more anti-thrombosis agents, or one or more cell self markers, or combination thereof.

7. The system of claim 1 , further comprising an administration mechanism configured to deliver the insulin from the first reservoir to a subject.

8. The system of claim 7 , wherein the administration mechanism comprises a cannula or a syringe.

9. The system of claim 7 , wherein the administration mechanism is coated with one or more anti-platelet agents, one or more anti-thrombosis agents, or one or more cell self markers, or combination thereof.

10. The system of claim 7 , wherein the administration mechanism further comprises one or more hyaluronidases.

11. The system of claim 10 , wherein the one or more hyaluronidase in the administration mechanism are configured to be delivered to the subject prior to the administration of the insulin.

12. The system of claim 1 , wherein the second reservoir further comprises glucagon or a glucagon activating agent.

13. The system of claim 1 , wherein the content in each of the first reservoir and the second reservoir are administrable independently or simultaneously.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2024
From: KIANI, MASSI JOE E.; KRISHNAMANI, VENKATRAMANAN
To: CERCACOR LABORATORIES, INC.
Reel/Frame 067477/0467 →
PROPRIETARY INFORMATION AND INVENTOR’S AGREEMENT Recorded May 21, 2024
From: PAULEY, KEVIN
To: MASIMO LABORATORIES
Reel/Frame 067477/0700 →
CHANGE OF NAME Recorded May 21, 2024
From: MASIMO LABORATORIES, INC.
To: CERCACOR LABORATORIES, INC.
Reel/Frame 067484/0454 →
CHANGE OF NAME Recorded Mar 21, 2024
From: CERCACOR LABORATORIES, INC.
To: WILLOW LABORATORIES, INC.
Reel/Frame 066867/0264 →
Continuity (3)
Provisional Application 63085344 · Sep 30, 2020
Provisional Application 63136053 · Jan 11, 2021
Related Publication 20220096603A1 · Mar 31, 2022
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