# US 10,869,867 B2 · Intravenous infusion dosage form

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- Number: US 10,869,867 B2
- Document ID: US10869867B2
- Status: Granted
- Kind: B2
- Application number: 15/550,638
- Filed: 2016-02-12
- Published: 2018-02-08
- Granted: 2020-12-22
- Earliest claimed: 2015-02-13
- Assignees: Sun Pharmaceutical Industries Limited
- Applicants: Sun Pharmaceutical Industries Ltd.
- Inventors: Samarth Kumar; Prashant Kane; Subhas Balaram Bhowmick; Kirti Ganorkar; Nisarg Bipinchandra Mistry; Ramaji Karshanbhai Varu
- Web page: https://patentgrep.com/patent/US10869867B2

## CPC

- A61J 1/10: Bag-type containers
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 41/10: Inactivation or decontamination of a medicinal preparation prior to administration to an animal or a person
- A61K 47/02: Inorganic compounds
- A61P 35/00: Antineoplastic agents
- B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like}
- B65B 7/02: Closing containers or receptacles deformed by, or taking-up shape, of, contents, e.g. bags, sacks
- B65B 55/06: by heat
- A61M 5/14: Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The present invention relates to an intravenous infusion dosage form of pemetrexed or its pharmaceutically acceptable salt, having long term stability.

## Claims

### Claim 1

An intravenous infusion dosage form comprising
a) a composition consisting essentially of pemetrexed or its pharmaceutically acceptable salt present at a concentration ranging from about 0.7 mg/ml to about 21 mg/ml, an osmogent and an inert gas in solution in a parenteral aqueous vehicle, the solution having a volume ranging from about 50 ml to 1000 ml,
b) a flexible infusion container containing the composition of (a) and an inert gas in a headspace of the infusion container,
c) a second container surrounding the flexible infusion container with an inert gas or vacuum in the space between the flexible infusion container and the second container,
wherein the total impurities are less than 2.0% by weight.

### Claim 2 (depends on 1)

The intravenous infusion dosage form of claim 1, wherein the dosage form is subjected to moist heat sterilization.

### Claim 3 (depends on 1)

The intravenous infusion dosage form of claim 1, wherein the second container is made up of aluminum.

### Claim 4 (depends on 1)

The intravenous infusion dosage form of claim 1, wherein the inert gas is selected from nitrogen, argon or helium.

### Claim 5 (depends on 1)

The intravenous infusion dosage form of claim 1, wherein the dosage form is prepared by a method comprising the steps of
a) dissolving pemetrexed or its pharmaceutically acceptable salt and an osmogent in a parenteral aqueous vehicle,
b) filling the solution of step (a) into a flexible infusion container,
c) sealing the filled flexible infusion container,
d) surrounding the flexible infusion container by a second container and sealing the second container,
e) subjecting the container of step (d) to moist heat sterilization,
wherein in each of the above steps, low oxygen conditions are maintained in the solution and/or in the head space of the flexible infusion container and in the space between the flexible infusion container and the second container.

### Claim 6 (depends on 5)

The intravenous infusion dosage form of claim 5, wherein the method further comprises maintaining the dosage form of step (d) for at least 12 hours prior to step (e).

### Claim 7 (depends on 5)

The intravenous infusion dosage form of claim 5, wherein the increase in total impurities of Pemetrexed during moist heat sterilization is less than 0.2%.

### Claim 8

An intravenous infusion dosage form comprising:
a) a composition consisting essentially of pemetrexed or its pharmaceutically acceptable salt present at a concentration ranging from about 0.7 mg/ml to about 21 mg/ml, an osmogent and an inert gas in solution in a parenteral aqueous vehicle, the solution having a volume ranging from about 50 ml to 1000 ml,
b) a rigid infusion container containing the composition of (a) and an inert gas in a headspace of the infusion container,
wherein the dosage form is subjected to moist heat sterilization and wherein the total impurities are less than 2.0% by weight.

### Claim 9 (depends on 8)

The intravenous infusion dosage form of claim 8 wherein the infusion container is surrounded by a second container, with an inert gas or vacuum in the space between the infusion container and the second container.