IP Library Granted Patent US 11,395,856
Granted Patent B2
US 11,395,856 · App. 16/779,872 · Granted Jul 26, 2022

Lipid-encapsulated gas microsphere compositions and related methods

Inventors: Simon P. Robinson (Stow, MA); Robert W. Siegler (Chelmsford, MA); David C. Onthank (Groton, MA); Nhung Tuyet Nguyen (Westford, MA)
Assignee: Lantheus Medical Imaging, Inc.
A61K49/223A61K9/5089A61K47/10A61K47/24
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Quick Facts
Patent No.
US 11,395,856
App. No.
16/779,872
Granted
Jul 26, 2022
Kind
B2
Abstract

The invention provides, inter alia, improved lipid formulations used to generate lipid-encapsulated gas microspheres, and methods of their use.

Claims (20)

1. A composition comprising

a non-aqueous mixture comprising one or more phospholipids selected from DPPA, DPPC and PEG5000-DPPE, in propylene glycol and/or glycerol, and

a perfluorocarbon gas,

wherein the non-aqueous mixture comprises equal to or less than 5% w/w (weight/weight) of water.

2. The composition of claim 1 , wherein the non-aqueous mixture comprises less than 5% w/w (weight/weight) of water.

3. The composition of claim 1 , wherein the composition further comprises a buffer.

4. The composition of claim 1 , wherein the composition further comprises a non-phosphate buffer.

5. The composition of claim 1 , wherein the one or more phospholipids are present in a concentration of about 0.9 to about 7.5 mg per ml of non-aqueous mixture.

6. The composition of claim 1 , wherein the one or more phospholipids are present in a concentration of about 3.75 mg per ml of non-aqueous mixture.

7. The composition of claim 1 , wherein the composition comprises less than 5% impurities when stored at room temperature for about 3 months.

8. The composition of claim 1 , wherein the perfluorocarbon gas is perfluoropropane gas.

9. The composition of claim 1 , wherein PEG5000-DPPE is MPEG5000-DPPE.

10. A method of forming an ultrasound contrast agent formulation comprising

adding glycerol and/or propylene glycol and/or an aqueous diluent to the composition of claim 1 to form an ultrasound contrast agent formulation.

11. The method of claim 10 , further comprising then activating the ultrasound contrast agent formulation to form lipid-encapsulated perfluorocarbon gas microspheres.

12. A method of using lipid-encapsulated perfluorocarbon gas microspheres comprising

( 1 ) forming lipid-encapsulated perfluorocarbon gas microspheres by

(a) adding an aqueous diluent to the composition of claim 1 to form a mixture, and

(b) activating the mixture to form lipid-encapsulated perfluorocarbon gas microspheres, and

( 2 ) administering the lipid-encapsulated perfluorocarbon gas microspheres to a subject.

Assignments (2)
SECURITY INTEREST Recorded Dec 2, 2022
From: LANTHEUS MEDICAL IMAGING, INC.; MOLECULAR INSIGHT PHARMACEUTICALS, INC.; PSMA DEVELOPMENT COMPANY, LLC; PROGENICS PHARMACEUTICALS, INC.
To: CITIZENS BANK, N.A.
Reel/Frame 062047/0960 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 7, 2020
From: ROBINSON, SIMON P.; ONTHANK, DAVID C.; NGUYEN, NHUNG TUYET; SIEGLER, ROBERT W.
To: LANTHEUS MEDICAL IMAGING, INC.
Reel/Frame 052327/0360 →