Compositions comprising salbutamol sulphate

Patent metadata

Field	Value
Publication number	US-9517216-B2
Application number	US-201214351075-A
Country	US
Kind code	B2
Filing date	Oct 12, 2012
Priority date	Oct 12, 2011
Publication date	Dec 13, 2016
Grant date	Dec 13, 2016

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).

First claim

What is claimed is:

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.

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

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

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

5. 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.

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

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

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

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

10. 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 .

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

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

13. 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.

14. 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.

Assignees

• Mexichem Amanco Holding Sa

Inventors

• Corr Stuart
• Noakes Timothy James

Classifications

• A61P11/00

  Drugs for disorders of the respiratory system · CPC title

• A61K9/008 Primary

  comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI] · CPC title

• A61K47/06 Primary

  Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite · CPC title

• B65B3/003

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title

• B65B31/003

  Adding propellants in fluid form to aerosol containers (in solid form B65B31/10) · CPC title