IP Library Granted Patent US 10,022,460
Granted Patent B2
US 10,022,460 · App. 15/602,534 · Granted Jul 17, 2018

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 10,022,460
App. No.
15/602,534
Granted
Jul 17, 2018
Kind
B2
Abstract

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

Claims (28)

1. A composition of an ultrasound contrast agent comprising

a non-aqueous mixture comprising DPPA, DPPC and MPEG5000-DPPE in propylene glycol and/or glycerol, and

a perfluorocarbon gas,

wherein the non-aqueous mixture comprises less than 5% w/w (weight/weight) water,

and wherein DPPA, DPPC and MPEG5000-DPPE are present in a ratio of about 10:82:8 (mole %).

2. The composition of claim 1 , wherein the composition comprises less than 10% impurities relative to total lipid content when stored at room temperature for about 3 months.

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

4. The composition of claim 1 , wherein the composition comprises less than 2% impurities relative to total lipid content when stored at room temperature for about 3 months.

5. The composition of claim 2 , wherein the impurities are measured using HPLC.

6. The composition of claim 1 , wherein the non-aqueous mixture comprises DPPA, DPPC and MPEG5000-DPPE in propylene glycol.

7. The composition of claim 6 , wherein the weight ratio of DPPA, DPPC and MPEG5000-DPPE combined to propylene glycol is in a range of about 1:100 to about 1:600.

8. The composition of claim 1 , wherein the non-aqueous mixture comprises DPPA, DPPC and MPEG5000-DPPE in propylene glycol and glycerol.

9. The composition of claim 8 , wherein the weight ratio of DPPA, DPPC and MPEG5000-DPPE combined to propylene glycol to glycerol is in a range of about 1:100:100 to about 1:600:700.

10. The composition of claim 1 , wherein the non-aqueous mixture comprises DPPA, DPPC and MPEG5000-DPPE in glycerol.

11. The composition of claim 10 , wherein the weight ratio of DPPA, DPPC and MPEG5000-DPPE combined to glycerol is about 1:100 to about 1:700.

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

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

14. The composition of claim 1 , wherein DPPA, DPPC and MPEG5000-DPPE combined are present in a concentration of about 0.1 to about 10 mg per ml of non-aqueous mixture.

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

16. The composition of claim 1 , wherein the composition consists essentially of DPPA, DPPC, MPEG5000-DPPE, propylene glycol, and perfluorocarbon gas.

17. The composition of claim 1 , wherein the composition is provided in a vial.

18. The composition of claim 1 , wherein the composition is provided in a vial with a V-bottom.

19. The composition of claim 1 , wherein the composition is provided in a vial with a flat-bottom.

20. The composition of claim 1 , wherein the composition is provided in a vial with a rounded-bottom.

21. The composition of claim 1 , wherein the composition is provided in a single chamber container.

22. The composition of claim 1 , wherein the composition is provided in a multiple chamber container.

23. A container comprising the composition of claim 1 in a first chamber and an aqueous diluent in a second chamber.

24. The container of claim 23 , wherein the aqueous diluent is an aqueous buffered saline solution.

Assignments (6)
RELEASE OF SECURITY INTEREST Recorded Dec 2, 2022
From: WELLS FARGO BANK, N.A.
To: LANTHEUS MEDICAL IMAGING, INC.
Reel/Frame 062047/0925 →
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 →
SECURITY AGREEMENT Recorded Jun 28, 2019
From: LANTHEUS MEDICAL IMAGING, INC.
To: WELLS FARGO BANK, N.A.
Reel/Frame 049628/0001 →
RELEASE OF SECURITY INTEREST Recorded Jun 27, 2019
From: JPMORGAN CHASE BANK, N.A.
To: LANTHEUS MEDICAL IMAGING, INC.
Reel/Frame 049623/0123 →
PATENT SECURITY AGREEMENT Recorded Apr 12, 2018
From: LANTHEUS MEDICAL IMAGING, INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 045929/0908 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 3, 2017
From: ROBINSON, SIMON P.; SIEGLER, ROBERT W.; ONTHANK, DAVID C.; NGUYEN, NHUNG TUYET
To: LANTHEUS MEDICAL IMAGING, INC.
Reel/Frame 043761/0657 →
Continuity (4)
Continuation 15203725 · Jul 6, 2016
Continuation PCTUS2015067615 · Dec 28, 2015
Provisional Application 62098453 · Dec 31, 2014
Related Publication 20170258946A1 · Sep 14, 2017
Cited By (1)
US 12,296,029