Claims for Patent: 9,724,303

Summary for Patent: 9,724,303

Title:	Liposomes useful for drug delivery
Abstract:	The present invention provides liposome compositions containing substituted ammonium and/or polyanion, and optionally with a desired therapeutic or imaging entity. The present invention also provide methods of making the liposome compositions provided by the present invention.
Inventor(s):	Hong; Keelung (San Francisco, CA), Drummond; Daryl C. (Lincoln, MA), Kirpotin; Dmitri (Revere, MA)
Assignee:	IPSEN BIOPHARM LTD. (Wrexham, GB)
Application Number:	14/965,140
Patent Claims:	1. An irinotecan liposome composition comprising irinotecan sucrose octasulfate encapsulated in lipid vesicles comprising one or more phospholipids, encapsulating a total of 150-550 mg irinotecan base per mmol total vesicle phospholipids. 2. The irinotecan liposome composition of claim 1, containing a total of 500 mg irinotecan base per mmol total vesicle phospholipids. 3. The irinotecan liposome composition of claim 1, wherein the lipid vesicles consist of a lecithin, cholesterol, and an amphipathic polymer. 4. The irinotecan liposome composition of claim 3, wherein the lecithin is a diacylphosphatidylcholine. 5. The irinotecan liposome composition of claim 3, wherein the amphipathic polymer is a polyethylene glycol-lipid derivative. 6. The irinotecan liposome composition of claim 3, wherein the amphipathic polymer comprises a polyethylene glycol-lipid derivative having a poly(ethylene glycol) portion with a molecular weight from about 250 to about 20,000. 7. The irinotecan liposome composition of claim 3, wherein the amphipathic polymer is selected from the group consisting of a polyethylene glycol phosphatidylethanolamine, a polyethylene glycol-diacylglycerol, and a polyethyleneglycol-ceramide derivative. 8. The irinotecan liposome composition of claim 3, wherein a. the lecithin is DSPC and b. the amphipathic polymer is a polyethylene glycol-lipid derivative having a poly(ethylene glycol) portion with a molecular weight from about 250 to about 20,000. 9. The irinotecan liposome composition of claim 1, wherein the lipid vesicles comprise an uncharged lipid component and a neutral phospholipid. 10. The irinotecan liposome composition of claim 9, wherein the lipid vesicles comprise one or more uncharged lipid component(s) selected from the group consisting of: cholesterol, ceramide, diacylglycerol, an acyl(poly ether) and an alkylpoly(ether). 11. The irinotecan liposome composition of claim 9, wherein the lipid vesicles comprise a neutral phospholipid selected from the group consisting of: a diacylphosphatidylcholine, a sphingomyelin, and a diacylphosphatidylethanolamine. 12. The irinotecan liposome composition of claim 11, wherein the lipid vesicles comprise a neutral phospholipid selected from the group consisting of: a diacylphosphatidylcholine, a sphingomyelin, and a diacylphosphatidylethanolamine. 13. An irinotecan liposome dispersion comprising irinotecan liposomes encapsulating irinotecan sucrose octasulfate in unilamellar lipid bilayer vesicles having a size of about 110 nm and comprising one or more phospholipids, the irinotecan liposomes encapsulating a total of 150-500 mg irinotecan free base per mmol total vesicle phospholipids. 14. The irinotecan liposome dispersion of claim 13, wherein the vesicles comprise a lecithin, cholesterol and a polyethylene glycol-lipid derivative. 15. The irinotecan liposome dispersion of claim 14, wherein the vesicles consist of a lecithin, cholesterol and a polyethylene glycol-lipid derivative. 16. The irinotecan liposome dispersion of claim 14, wherein the vesicles consist of DSPC, cholesterol and a polyethylene glycol-lipid derivative. 17. The irinotecan liposome dispersion of claim 14, wherein the vesicles consist of DSPC, cholesterol and N-(methoxy-poly(ethylene glycol)-oxycarbonyl)-distearoylphosphatidylethanolamine (PEG-DSPE). 18. The irinotecan liposome dispersion of claim 14, wherein the irinotecan liposomes encapsulate a total of 500 mg irinotecan free base as irinotecan sucrose octasulfate. 19. The irinotecan liposome dispersion of claim 18, having a total irinotecan free base concentration of 3.44 to 4.62 mg/mL of the irinotecan liposome dispersion. 20. An irinotecan liposome dispersion comprising irinotecan liposomes encapsulating irinotecan sucrose octasulfate in unilamellar lipid bilayer vesicles having a size of about 110 nm and consisting of DSPC, cholesterol and a polyethylene glycol-lipid derivative, the irinotecan liposomes encapsulating a total of 150-500 mg irinotecan free base as irinotecan octasulfate per mmol total vesicle phospholipids, and up to 5 mg irinotecan free base per mL of the liposome dispersion.