Claims for Patent: 11,147,817

Summary for Patent: 11,147,817

Title:	Pharmaceutical composition of pemetrexed
Abstract:	The present invention relates to pharmaceutical composition comprising pemetrexed, a ready to use injection comprising pemetrexed. Liquid composition of pemetrexed comprises head space oxygen less than 5%, dissolved oxygen less than 2 ppm and individual impurity level less than 0.2%.
Inventor(s):	Mandal Jayanta Kumar, Mehta Sandip Pareshbhai
Assignee:	FTF PHARMA PRIVATE LIMITED
Application Number:	US17127278
Patent Claims:	2. The liquid composition of claim 1 , wherein the pharmaceutically acceptable excipient is selected from the group consisting of an osmolarity adjusting agent claim 1 , a stabilizing agent claim 1 , a pH adjusting agent claim 1 , a vehicle claim 1 , and combinations thereof.3. The liquid composition of claim 1 , wherein the chelating agent is selected from the group consisting of ethylene diamine tetraacetic acid or a salt thereof claim 1 , diethylene triamine pentaacetic acid or a salt thereof claim 1 , calteridol or a salt thereof claim 1 , and combinations thereof.4. The liquid composition of claim 3 , wherein the composition is prepared using a process of terminal sterilization.5. The liquid composition of claim 4 , wherein said terminal sterilization is steam sterilization with an Fvalue of from 1 minute to 30 minutes.6. The liquid composition of claim 1 , wherein the composition comprises less than 0.5% w/w total impurities.8. The liquid composition of claim 7 , wherein the pharmaceutically acceptable excipient is selected from the group consisting of an osmolarity adjusting agent claim 7 , a stabilizing agent claim 7 , a pH adjusting agent claim 7 , a vehicle claim 7 , and combinations thereof.9. The liquid composition of claim 7 , wherein said chelating agent is selected from the group consisting of ethylene diamine tetraacetic acid or a salt thereof claim 7 , diethylene triamine pentaacetic acid or a salt thereof claim 7 , calteridol or a salt thereof claim 7 , and combinations thereof.10. The liquid composition of claim 7 , wherein the composition comprises less than 0.5% w/w total impurities.11. A process for preparing the liquid composition of claim 1 , comprising: (i) 5 mg/mL to 100 mg/mL of pemetrexed or its pharmaceutically acceptable salts,', '(ii) L-cysteine or salt thereof;', '(iii) a pharmaceutically acceptable excipient; and', '(iv) less than 1% w/w total impurities,', 'under conditions to maintain dissolved oxygen level of 2 parts per million (ppm) or less; and, '(a) preparing a solution mixture comprising(b) filtering and filling a vial with the solution of step (a) and maintaining head space oxygen of less than 5% v/v to produce the liquid composition.12. The process of claim 11 , further comprising the step of sterilizing the filtered solution by steam sterilization with an Fvalue of from 1 minute to 30 minutes.13. The process of claim 11 , wherein the solution mixture comprises less than 0.5% w/w total impurities.14. The liquid composition of claim 1 , wherein the pH of the composition is between 6 and 8.15. The liquid composition of claim 14 , wherein the pH of the composition is about 7.4.16. The liquid composition of claim 7 , wherein the pH of the composition is between 6 and 8.