Micronised beclomethasone dipropionate monohydrate compositions and methods of use

• US 4,866,051 A
• Filed: 01/30/1985
• Issued: 09/12/1989
• Est. Priority Date: 10/19/1981
• Status: Expired due to Term

• Current Assignee: Glaxo Group Limited (Glaxosmithkline Holdings Ltd.)
• Original Assignee: Glaxo Group Limited (Glaxosmithkline Holdings Ltd.)
• Inventors: Padfield, John M., Hunt, John H.
• Primary Examiner(s): Robinson, Douglas W.
• Assistant Examiner(s): Lipovsky, Joseph A.
• Application Number:
  US06/696,427
• Time in Patent Office: 1,686 Days
• Field of Search: 260/397.45, 424/243, 514/180
• US Class Current: 514/180
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61K 9/145 with organic compounds
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: C07J 5/0076 by an alkyl group

Abstract

Beclomethasone dipropionate in the form of its micronised monohydrate substantially free from water other than water of crystallisation. Pharmaceutical compositions containing the compound are also described. The compositions may be in the form of powder inhalation cartridges especially suitable for the treatment and/or prophylaxis of asthma.

Claims

1. A pharmaceutical dry powder composition comprising micronised beclomethasone dipropionate monohydrate in association with at least one pharmaceutically acceptable dry powder carrier or excipient.

2. A composition according to claim 1 wherein at least 90% by weight of the micronised beclomethasone dipropionate monohydrate has an effective particle size below 10 μ

m.

3. A composition according to claim 2 wherein at least 90% by weight of the micronised beclomethasone dipropionate monohydrate has an effective particle size between 2 to 5 μ

m.

4. A composition according to claim 1 in the form of a dosage unit comprising a powder inhalation cartridge containing beclomethasone diproprionate monohydrate equivalent to from 10 to 1000 μ

g of beclomethasone dipropionate.

5. A composition according to claim 4 wherein the dosage unit contains beclomethasone dipropionate monohydrate equivalent to from 50 to 500 μ

g of beclomethasone dipropionate.

6. A composition according to claim 1 additionally containing at least one compound selected from the group consisting of salbutamol and sodium cromoglycate.

7. A pharamaceutical composition as claimed in claim 1 in association with a powder inhalation device.

8. A powder inhalation device containing a pharmaceutical composition as defined in claim 1.

9. A method of treating bronchial conditions in a subject which comprises administering to said subject by inhalation techniques an effective amount of micronised beclomethasone dipropionate monohydrate in a pharmaceutical dry powder composition.