# US 9,517,216 B2 · Compositions comprising salbutamol sulphate

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- Number: US 9,517,216 B2
- Document ID: US9517216B2
- Status: Granted
- Kind: B2
- Application number: 14/351,075
- Filed: 2012-10-12
- Published: 2014-08-21
- Granted: 2016-12-13
- Earliest claimed: 2011-10-12
- Assignees: Mexichem Amanco Holding S.A. de C.V.
- Applicants: Mexichem Amanco Holding S.A. De C.V.
- Inventors: Stuart Corr; Timothy James Noakes
- Web page: https://patentgrep.com/patent/US9517216B2

## CPC

- A61K 47/06: Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K 9/008: {comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]}
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)}
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like}
- B65B 31/003: {Adding propellants in fluid form to aerosol containers (in solid form B65B31/10)}
- 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)
- 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)}
- 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)

## Abstract

A pharmaceutical composition is described that is suitable for delivery from a pressurized container. The composition is free of polar excipients and comprises: (a) a propellant component that consists essentially of 1,1-difluoroethane (R-152a); (b) a surfactant component that comprises oleic acid; and (c) a drug component that consists of salbutamol sulphate. The pharmaceutical composition can be delivered using a metered dose inhaler (MDI).

## Claims

### Claim 1

A pharmaceutical composition consisting of at least 95 weight % of:
(a) 1,1-difluoroethane (R-152a),
(b) a surfactant component consisting of oleic acid; and
(c) salbutamol sulphate.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein the composition is free of polar excipients.

### Claim 3 (depends on 1, 2)

The pharmaceutical composition of claim 1 or 2, wherein at least 99 weight % of the pharmaceutical composition consists of components (a), (b) and (c).

### Claim 4 (depends on 1, 2)

The pharmaceutical composition of claim 1 or 2 which consists entirely of components (a), (b) and (c).

### Claim 5 (depends on 4)

The pharmaceutical composition of claim 4 which comprises from 0.01 to 1.0 weight % of salbutamol sulphate, from 96.5 to 99.94 weight % of 1,1-difluoroethane and from 0.05 to 2.5 weight % of oleic acid.

### Claim 6 (depends on 1, 2)

The pharmaceutical composition of claim 1 or 2, wherein the oleic acid comprises (9Z)-octadec-9-enoic acid.

### Claim 7 (depends on 1)

A sealed container that contains a pharmaceutical composition as claimed in claim 1.

### Claim 8 (depends on 7)

The sealed container of claim 7 which is a pressurized container for use with a metered dose inhaler (MDI).

### Claim 9 (depends on 8)

A metered dose inhaler (MDI) fitted with a pressurized container as claimed in claim 8.

### Claim 10 (depends on 1)

A method for treating a patient suffering or likely to suffer from a respiratory disorder which comprises administering to the patient a therapeutically or prophylactically effective amount of a pharmaceutical composition as claimed in claim 1.

### Claim 11 (depends on 10)

The method of claim 10, wherein the respiratory disorder is asthma.

### Claim 12 (depends on 10, 11)

The method of claim 10 or claim 11, wherein the pharmaceutical composition is delivered to the patient using a metered dose inhaler (MDI).

### Claim 13 (depends on 1)

A method for manufacturing a pharmaceutical composition as claimed in claim 1, said method comprising the steps of:
introducing a weighed amount of the salbutamol sulphate into an open container from which the salbutamol sulphate will ultimately be released as an aerosol spray using a medication delivery device;
fitting a valve device onto the container;
introducing the 1,1-difluoroethane, in liquid form, through the valve into the container under pressure; and
introducing the oleic acid through the valve into the container under pressure.

### Claim 14 (depends on 13)

The method of claim 13, wherein the liquid 1,1-difluoroethane is mixed together with the oleic acid and the resulting liquid mixture introduced into the container under pressure via the valve.