Claims for Patent: 10,022,460

Summary for Patent: 10,022,460

Title:	Lipid-encapsulated gas microsphere compositions and related methods
Abstract:	The invention provides, inter alia, improved lipid formulations used to generate lipid-encapsulated gas microspheres, and methods of their use.
Inventor(s):	Simon P. Robinson, Robert W. Siegler, David C. Onthank, Nhung Tuyet Nguyen
Assignee:	Lantheus Medical Imaging Inc
Application Number:	US15/602,534
Patent Claims:	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.