# US 2014/0197062 A1 · Packaging system for pharmaceutical compositions and kit for intravenous administration

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- Number: US 2014/0197062 A1
- Document ID: US20140197062A1
- Status: Published application
- Kind: A1
- Application number: 14/178,999
- Filed: 2014-02-12
- Published: 2014-07-17
- Earliest claimed: 2006-09-29
- Assignees: Infa S.A.
- Applicants: Infa S.A.
- Inventors: Paolo Magri'; Flavio Villani
- Web page: https://patentgrep.com/patent/US20140197062A1

## CPC

- A61J 1/05: for collecting, storing or administering blood, plasma or medical fluids {(multiple bags systems for separating or storing blood components A61M1/0209); Infusion or perfusion containers}
- A61J 1/2089: {Containers or vials which are to be joined to each other in order to mix their contents (combinations of vial and syringe for mixing their contents A61J1/2096)}
- A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents}
- 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)}
- A61P 35/00: Antineoplastic agents
- A61J 1/201: {having one piercing end}
- A61J 1/2013: {having two piercing ends}
- A61J 1/2055: {having gripping means}
- A61J 1/2086: {for fluid filtration}
- 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

## Abstract

The invention refers to a new system for packaging pharmaceutical compositions comprising active principles that may be administered intravenously, in particular it concerns a system for packaging in bottles which makes it possible to ensure the complete transfer of the content of the bottle into the liquid for intravenous infusion and at the same time prevent any accidental contact with the active principle by the health-care personnel preparing said intravenous infusion, and a complete kit for intravenous administration.

## Claims

### Claim 1

A packaging system comprising a pharmaceutical composition to be administered in a liquid for intravenous infusion, wherein said system is a bottle which comprises said pharmaceutical composition and an empty volume ranging from 80% to 99% of the total volume of the bottle and wherein said bottle has a capacity of more than 5 ml and said pharmaceutical composition comprises as active principle tacrolimus in a pharmaceutically acceptable oily vehicle.

### Claim 2 (depends on 1)

A packaging system according to claim 1, wherein said bottle comprises an empty volume ranging from 80% to 95% of the total volume of the bottle.

### Claim 3 (depends on 1)

A packaging system according to claim 1, wherein said bottle is made of glass.

### Claim 4 (depends on 1)

A packaging system according to claim 1, wherein said bottle has a capacity between 5 ml and 10 ml.

### Claim 5 (depends on 1)

A packaging system according to claim 1, wherein said bottle has a capacity between 6 and 9 ml.

### Claim 6 (depends on 1)

A packaging system according to claim 1, wherein said bottle has a capacity of 7 ml.

### Claim 7 (depends on 1)

A packaging system according to claim 1, wherein said pharmaceutical composition comprises 5 mg of tacrolimus dissolved in 1 ml of solvent composed of 200 mg of polyoxyethylenated hydrogenated castor oil (HCO-60) and ethanol q.s. to 1 ml.

### Claim 8 (depends on 7)

A packaging system according to claim 7, wherein said ethanol is absolute ethanol or anhydrous ethanol USP 80.0% v/v.

### Claim 9 (depends on 5)

A packaging system according to claim 5, wherein said pharmaceutical composition comprises 5 mg of tacrolimus dissolved in 1 ml of solvent composed of 200 mg of polyoxyethylenated hydrogenated castor oil (HCO-60) and ethanol q.s. to 1 ml.

### Claim 10 (depends on 9)

A packaging system according to claim 9, wherein said ethanol is absolute ethanol or anhydrous ethanol USP 80.0% v/v.

### Claim 11 (depends on 6)

A packaging system according to claim 6, wherein said pharmaceutical composition comprises 5 mg of tacrolimus dissolved in 1 ml of solvent composed of 200 mg of polyoxyethylenated hydrogenated castor oil (HCO-60) and ethanol q.s. to 1 ml.

### Claim 12 (depends on 11)

A packaging system according to claim 11, wherein said ethanol is absolute ethanol or anhydrous ethanol USP 80.0% v/v.

### Claim 13 (depends on 1)

A packaging system according to claim 1, wherein said bottle is a container for pharmaceutical compositions closed with a rubber cap, said cap being able to be pierced with needles or conventional piercing spikes.