Claims for Patent: 12,115,164

Summary for Patent: 12,115,164

Title:	Pemetrexed formulations
Abstract:	The present invention is directed to pemetrexed formulations comprising a non-aqueous solvent that remains stable after dilution for at least about 48 hours when stored at 2° C. to 8° C. The present invention is also directed to pemetrexed formulations comprising a non-aqueous solvent that remains stable for at least about 24 months when stored at 2° C. to 8° C.
Inventor(s):	Feng-Jing Chen, Steven L. Krill
Assignee:	Eagle Pharmaceuticals Inc
Application Number:	US18/470,952
Patent Claims:	1. A method of treating pleural mesothelioma or non-squamous, non-small cell lung cancer in a patient in need thereof comprising providing a liquid pharmaceutical composition consisting of: 20 mg/mL to 30 mg/mL of pemetrexed diacid; 200 mg/mL to 300 mg/mL of propylene glycol; 12 mg/mL to 24 mg/mL of tromethamine; optionally HCl; and water, wherein the pH of the composition is from about 7.4 to 7.6, wherein the composition is suitable for multi-dose administration, and wherein the composition remains stable when stored for about 14 months at a temperature of 2° ° C. to 8° C. in a container having a head-space oxygen content of about 20% v/v, such that the composition comprises no more than 3% w/w of total impurities after said storage; diluting the liquid composition with normal saline, water for injection, 5% dextrose in water, Ringer's Injection, or Lactated Ringer's Injection to form a diluted liquid composition; and intravenously administering the diluted liquid composition to the patient. 2. The method of claim 1, wherein the liquid pharmaceutical composition consists of: 25 mg/mL of the pemetrexed diacid; 250 mg/mL to 300 mg/mL of the propylene glycol; 17 mg/mL to 21 mg/mL of the tromethamine; optionally HCl; and water, wherein the pH of the composition is from about 7.4 to 7.6. 3. The method of claim 1, wherein the liquid pharmaceutical composition consists of: 25 mg/mL of the pemetrexed diacid; 250 mg/mL to 300 mg/mL of the propylene glycol; 18 mg/mL to 20 mg/mL of the tromethamine; optionally HCl; and water, wherein the pH of the composition is from about 7.4 to 7.6. 4. The method of claim 1, wherein the liquid composition is in a vial. 5. The method of claim 4, wherein the vial is a multi-dose vial. 6. A method of treating pleural mesothelioma in a patient in need thereof comprising providing a liquid pharmaceutical composition consisting of: 20 mg/mL to 30 mg/mL of pemetrexed diacid; 200 mg/mL to 300 mg/mL of propylene glycol; 12 mg/mL to 24 mg/mL of tromethamine; optionally HCl; and water, wherein the pH of the composition is from about 7.4 to 7.6, wherein the composition is suitable for multi-dose administration, and wherein the composition remains stable when stored for about 14 months at a temperature of 2° C. to 8° C. in a container having a head-space oxygen content of about 20% v/v, such that the composition comprises no more than 3% w/w of total impurities after said storage; diluting the liquid composition with normal saline, water for injection, 5% dextrose in water, Ringer's Injection, or Lactated Ringer's Injection to form a diluted liquid composition; and intravenously administering the diluted liquid composition to the patient. 7. The method of claim 6, wherein the liquid pharmaceutical composition consists of: 25 mg/mL of the pemetrexed diacid; 250 mg/mL to 300 mg/mL of the propylene glycol; 17 mg/mL to 21 mg/mL of the tromethamine; optionally HCl; and water, wherein the pH of the composition is from about 7.4 to 7.6. 8. The method of claim 6, wherein the liquid pharmaceutical composition consists of: 25 mg/mL of the pemetrexed diacid; 250 mg/mL to 300 mg/mL of the propylene glycol; 18 mg/mL to 20 mg/mL of the tromethamine; optionally HCl; and water, wherein the pH of the composition is from about 7.4 to 7.6. 9. The method of claim 6, wherein the liquid composition is in a vial. 10. The method of claim 9, wherein the vial is a multi-dose vial. 11. A method of treating non-squamous, non-small cell lung cancer in a patient in need thereof comprising providing a liquid pharmaceutical composition consisting of: 20 mg/mL to 30 mg/mL of pemetrexed diacid; 200 mg/mL to 300 mg/mL of propylene glycol; 12 mg/mL to 24 mg/mL of tromethamine; optionally HCl; and water, wherein the pH of the composition is from about 7.4 to 7.6, wherein the composition is suitable for multi-dose administration, and wherein the composition remains stable when stored for about 14 months at a temperature of 2° ° C. to 8° C. in a container having a head-space oxygen content of about 20% v/v, such that the composition comprises no more than 3% w/w of total impurities after said storage; diluting the liquid composition with normal saline, water for injection, 5% dextrose in water, Ringer's Injection, or Lactated Ringer's Injection to form a diluted liquid composition; and intravenously administering the diluted liquid composition to the patient. 12. The method of claim 11, wherein the liquid pharmaceutical composition consists of: 25 mg/mL of the pemetrexed diacid; 250 mg/mL to 300 mg/mL of the propylene glycol; 17 mg/mL to 21 mg/mL of the tromethamine; optionally HCl; and water, wherein the pH of the composition is from about 7.4 to 7.6. 13. The method of claim 11, wherein the liquid pharmaceutical composition consists of: 25 mg/mL of the pemetrexed diacid; 250 mg/mL to 300 mg/mL of the propylene glycol; 18 mg/mL to 20 mg/mL of the tromethamine; optionally HCl; and water, wherein the pH of the composition is from about 7.4 to 7.6. 14. The method of claim 11, wherein the liquid composition is in a vial. 15. The method of claim 14, wherein the vial is a multi-dose vial.