Claims for Patent: 9,730,891

Summary for Patent: 9,730,891

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:	14/879,302
Patent Claims:	1. A method of treatment comprising the parenteral administration of a therapeutically effective amount of a liposomal irinotecan pharmaceutical composition comprising irinotecan liposomes to a patient, the irinotecan liposomes comprising irinotecan sucrose octasulfate and one or more phospholipids with a total of 150-500 mg irinotecan base per mmol total liposome phospholipids to a patient. 2. The method of claim 1, wherein the pharmaceutical composition is intravenously administered. 3. The method of claim 1, wherein the irinotecan liposomes comprise one or more lipids and the molar ratio of the irinotecan to the one or more lipids in totality is about 0.02-5. 4. The method of claim 1, wherein the irinotecan liposomes comprise one or more lipids and has a total of about 0.5 mg irinotecan per mg of total lipid in the liposome. 5. The method of claim 1, wherein the irinotecan liposomes comprise one or more lipids and has a total of about 0.15 to 1.5 moles of irinotecan per mole of total lipid in the liposome. 6. The method of claim 1, wherein the irinotecan liposomes comprise one or more lipids and has a ratio of about 0.8 mmol irinotecan per 1 g of total lipid in the liposome. 7. The method of claim 1, wherein the irinotecan liposomes comprise one or more phospholipids and has a total of about 500 mg irinotecan per mmol of total phospholipid in the liposome. 8. The method of claim 1, wherein the irinotecan liposomes comprise DSPC and cholesterol. 9. The method of claim 1, wherein the irinotecan liposomes comprise DSPC, cholesterol and PEG-DSPE in a molar ratio of 3:2:0.015. 10. The method of claim 1, wherein the irinotecan liposomes have a volume-averaged mean of the liposome size of about 110-120 nm determined by quasi-elastic light scattering (QELS) using Gaussian model. 11. The method of claim 1, having at least one additional characteristic selected from the group consisting of: a. the pharmaceutical composition is intravenously administered; b. the liposome comprises one or more lipids and the molar ratio of the irinotecan to the one or more lipids in totality is about 0.2; c. the irinotecan liposomes comprise one or more lipids and has a total of about 0.5 mg irinotecan per mg of total lipid in the liposome; d. the irinotecan liposomes comprise one or more lipids and has a total of about 0.15 to 1.5 moles of irinotecan per mole of total lipid in the liposome; e. the irinotecan liposomes comprise one or more lipids and has a ratio of about 0.8 mmol irinotecan per 1 g of total lipid in the liposome; f. the irinotecan liposomes comprise one or more phospholipids and has a total of about 500 mg irinotecan per mmol of total phospholipid in the liposome; g. the irinotecan liposomes comprise DSPC and cholesterol; h. the irinotecan liposomes comprise DSPC, cholesterol and PEG-DSPE in a molar ratio of 3:2:0.015; i. the liposome is about 110-120 nm; j. the irinotecan liposomes comprise about 1.25-2.42 mol irinotecan per g of lipid; and k. at least 90% of the irinotecan in the pharmaceutical composition is encapsulated in the irinotecan liposomes. 12. A method of treatment comprising the parenteral administration of a therapeutically effective amount of an irinotecan liposome pharmaceutical composition to a patient, the irinotecan liposome pharmaceutical composition comprising irinotecan sucrose octasulfate encapsulated in a liposome comprising DSPC, cholesterol and PEG2000-DSPE in a molar ratio of 3:2:0.015, with about 0.15 to 1.5 moles of irinotecan per mole of total lipid in the liposome. 13. The method of claim 12, wherein the liposome has a volume-averaged mean of the liposome size of about 110-120 nm determined by quasi-elastic light scattering (QELS) using Gaussian model. 14. The method of claim 12, wherein the liposome has a total of about 500 mg irinotecan per mmol total phospholipid in the liposome. 15. The method of claim 12, wherein at least 90% of the irinotecan in the pharmaceutical composition is encapsulated in the liposomes. 16. The method of claim 12, wherein the liposome has a total of about 0.5 moles of irinotecan per mole of total lipid in the liposome. 17. The method of claim 12, having at least one additional characteristic selected from the group consisting of: a. the pharmaceutical composition is intravenously administered; b. the molar ratio of the irinotecan to the one or more lipids in totality is about 0.02- 5; c. the liposome comprises one or more lipids and has a total of about 0.5 mg irinotecan per mg of total lipid in the liposome; d. the liposome comprises one or more lipids and has a total of about 0.15 to 1.5 moles of irinotecan per mole of total lipid in the liposome; e. the liposome comprises one or more lipids and has a ratio of about 0.8 mmol irinotecan per 1 g of total lipid in the liposome; f. the liposome comprises one or more phospholipids and has a total of about 500 mg irinotecan per mmol of total phospholipid in the liposome; g. the liposome is about 110-120 nm; and h. the liposome comprises about 1.25-2.42 mol irinotecan per g of lipid. 18. A method of treatment comprising the intravenous administration of a therapeutically effective amount of an irinotecan liposome pharmaceutical composition to a patient, the irinotecan liposome pharmaceutical composition comprising irinotecan and sucrose octasulfate encapsulated in a liposome comprising DSPC, cholesterol and PEG2000-DSPE in a molar ratio of 3:2:0.015, with a total of about 0.5 moles irinotecan per mole of total lipid in the liposome, and a total of about 500 mg irinotecan per mmol total phospholipid in the liposome. 19. The method of claim 18, wherein at least 90% of the irinotecan in the pharmaceutical composition is encapsulated in the liposomes. 20. The method of claim 19, wherein the liposome has a volume-averaged mean of the liposome size of about 110-120 nm determined by quasi-elastic light scattering (QELS) using Gaussian model.