Inhalation formulations of treprostinil

• US 20090124697A1
• Filed: 09/19/2008
• Published: 05/14/2009
• Est. Priority Date: 12/16/2003
• Status: Abandoned Application

• Current Assignee: United Therapeutics Corporation
• Original Assignee: United Therapeutics Corporation
• Inventors: Crow, James, Cloutier, Gilles, Loyd, James E., Parker, Richard E., Wade, Michael
• Application Number:
  US12/232,611
• Publication Number:
  US 20090124697A1
• Time in Patent Office: Days
• US Class Current: 514/569
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/191 having two or more hydroxy groups, e.g. gluconic acid
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/201 having one or two double bonds, e.g. oleic, linoleic acids
• CPC Class Codes: A61K 31/557 Eicosanoids, e.g. leukotrienes or prostaglandins
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone

Abstract

The present invention describes novel methods for using Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof, for the treatment and/or prevention of ischemic lesions, such as digital ulcers, in subjects with scleroderma (including systemic sclerosis), Buerger'"'"'s disease, Raynaud'"'"'s disease, Raynaud'"'"'s phenomenon and/or other conditions that cause such lesions. The invention also relates to kits for treatment and/or prevention of ischemic lesions, comprising an effective amount of Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof.

Claims

1. An inhalation formulation comprising a pharmaceutically effective amount of treprostinil sodium and a carrier suitable for administration with a nebulizer, wherein the formulation is in a solution form.

2. The inhalation formulation of claim 1, which is prepared by combining treprostinil sodium, sodium citrate, citric acid, hydrochloric acid, sodium hydroxide, sterile saline, and water for injection.

3. The inhalation formulation of claim 2, wherein the pH is about 7.3.

4. A method of treating pulmonary hypertension comprising administering by inhalation to a subject in need thereof an inhalation formulation as claimed in claim 1.

5. A method of treating an ischemic lesion, comprising administering by inhalation to a subject in need thereof an inhalation formulation as claimed in claim 1.