# US 2014/0155835 A1 · Leuprolide injection

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- Number: US 2014/0155835 A1
- Document ID: US20140155835A1
- Status: Published application
- Kind: A1
- Application number: 14/172,384
- Filed: 2014-02-04
- Published: 2014-06-05
- Earliest claimed: 2012-04-30
- Assignees: Sun Pharmaceuticals, Inc.
- Applicants: Sun Pharmaceuticals Ltd.
- Inventors: Alex GEORGE; Prashant KANE; Subhas BHOWMICK
- Web page: https://patentgrep.com/patent/US20140155835A1

## CPC

- A61M 5/31593: {Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir}
- 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 38/09: Luteinising hormone-releasing hormone [LHRH] {, i.e. Gonadotropin-releasing hormone [GnRH]}; Related peptides
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- A61P 5/02: of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
- A61P 5/10: of the posterior pituitary hormones, e.g. oxytocin, ADH
- A61P 13/08: of the prostate
- A61P 35/00: Antineoplastic agents
- A61M 5/3146: {Priming, e.g. purging, reducing backlash or clearance}
- A61M 5/3155: {by rotational movement of dose setting member, e.g. during setting or filling of a syringe}
- A61M 2005/3126: {related to dosing}
- 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)}
- 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

## Abstract

The present invention provides a sterile solution comprising leuprolide acetate in a pharmaceutically acceptable vehicle, wherein solution is present as a reservoir in a multiple dose pen injection device, the device being adapted to subcutaneously inject a portion of the said reservoir in a single daily dose and further being adapted to provide multiple portions of solution said while the reservoir remains sterile.

## Claims

### Claim at position 1

1-5. (canceled)

### Claim 6

A multiple dose leuprolide actetate pen injection device comprising a cartridge holder holding a cartridge and a cap covering said cartridge holder, said cartridge having a reservoir of a sterile solution of leuprolide actetate in a pharmaceutically acceptable vehicle, wherein said reservoir contains multiple doses of said sterile solution; wherein the device is adapted to subcutaneously inject a single daily dose and further adapted to deliver multiple doses while the solution remains sterile.

### Claim 7 (depends on 6)

The multiple dose leuprolide actetate pen injection device as claimed in claim 6 wherein the sterile solution contains leuprolide acetate in a range from 5 mg to 20 mg/ml.

### Claim 8 (depends on 6)

The multiple dose leuprolide actetate pen injection device as claimed in claim 6 wherein the reservoir contains 28 doses of said sterile solution of leuprolide acetate.

### Claim 9 (depends on 6)

The multiple dose leuprolide actetate pen injection device as claimed in claim 6 wherein the sterile solution contains leuprolide acetate in an amount of 10 mg per milliliter.

### Claim 10 (depends on 6)

The multiple dose leuprolide acetate pen injection device as claimed in claim 6 further comprising a dose dialing facility having a dose dial with a range of markings visible through a dose window.

### Claim 11 (depends on 10)

The multiple dose leuprolide acetate pen injection device as claimed in claim 10 further comprising a dose set knob to select the desired dose.

### Claim 12 (depends on 11)

The multiple dose leuprolide acetate pen injection device as claimed in claim 11 wherein the dose dial has markings to indicate the volume of the sterile solution to be administered.

### Claim 13 (depends on 11)

The multiple dose leuprolide acetate pen injection device as claimed in claim 11 wherein the dose dial has markings to indicate the amount of the leuprolide acetate to be administered.