Claims for Patent: 9,241,948

Summary for Patent: 9,241,948

Title:	Ready to be infused gemcetabine solution
Abstract:	A large volume infusion dosage form of gemcitabine, comprising a stable large volume solution of gemcitabine or its pharmaceutically acceptable salt in an aqueous vehicle filled in a large volume infusion container, wherein the solution is ready-to-be-infused.
Inventor(s):	Kumar; Samarth (Vadodara, IN), Kane; Prashant (Vadodara, IN), Namdeo; Alok B. (Vadodara, IN), Bhowmick; Subhas B (Vadodara, IN), Ganorkar; Kirti (Mumbai, IN)
Assignee:	Sun Pharmaceutical Industries Ltd. (Mumbai, IN)
Application Number:	13/871,438
Patent Claims:	1. An infusion dosage form of gemcitabine comprising at least 100 ml of a stable solution of free gemcitabine or its pharmaceutically acceptable salt in an aqueous vehicle filled in an infusion container, wherein the solution is ready-to-be-infused, and wherein the injection dosage form is obtained by subjecting the solution of free gemcitabine or a pharmaceutically acceptable salt thereof in the filled infusion container to terminal sterilization in an autoclave. 2. The infusion dosage form as claimed in claim 1 wherein the infusion container is a polymeric single compartment container free of polyvinylchloride. 3. The infusion dosage form as claimed in claim 1 wherein the aqueous vehicle is free of co-solvents. 4. The infusion dosage form as claimed in claim 1 wherein the solution has a concentration of gemcitabine of 5 mg per ml to 20 mg per ml. 5. A kit comprising an infusion dosage form comprising at least 100 ml of a stable solution of free gemcitabine or its pharmaceutically acceptable salt in an aqueous vehicle filled in a polymeric infusion container covered with a secondary packaging system, wherein the solution is ready-to-be-infused, and wherein the injection dosage form is obtained by subjecting the solution of free gemcitabine or a pharmaceutically acceptable salt thereof in the filled infusion container to terminal sterilization in an autoclave. 6. The kit as claimed in claim 5, wherein the free gemcitabine or its pharmaceutically acceptable salt is present at a concentration of 10 mg per ml and is filled in volumes ranging from 100 ml to 300 ml. 7. The kit as claimed in claim 6, wherein the infusion container includes 160 ml of the stable solution of free gemcitabine or its pharmaceutically acceptable salt and provides a dose of 1600 mg of gemcitabine hydrochloride per container. 8. The kit as claimed in claim 6, wherein the infusion container includes 170 ml of the stable solution of free gemcitabine or its pharmaceutically acceptable salt and provides a dose of 1700 mg of gemcitabine hydrochloride per container. 9. The kit as claimed in claim 6, wherein the infusion container includes 180 ml of the stable solution of free gemcitabine or its pharmaceutically acceptable salt and provides a dose of 1800 mg of gemcitabine hydrochloride per container. 10. The kit as claimed in claim 6, wherein the infusion container includes 190 ml of the stable solution of free gemcitabine or its pharmaceutically acceptable salt and provides a dose of 1900 mg of gemcitabine hydrochloride per container.