Compositions for treating IRDS and ARDS with a combination of a Glucocorticosteroid and a lung surfactant, and their use

• US 5,891,844 A
• Filed: 06/19/1997
• Issued: 04/06/1999
• Est. Priority Date: 09/28/1994
• Status: Expired due to Term

• Current Assignee: Takeda GmbH (Takeda Pharmaceutical Company Limited)
• Original Assignee: BYK Gulden Lomberg Chemische Fabrik GMBH (Takeda Pharmaceutical Company Limited)
• Inventors: Hafner, Dietrich
• Primary Examiner(s): Cook, Rebecca
• Application Number:
  US08/809,687
• Time in Patent Office: 656 Days
• Field of Search: 514/7, 514/12, 514/171
• US Class Current: 514/1.5
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• 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 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 35/42 Respiratory system, e.g. lungs, bronchi or lung cells
• CPC Class Codes: A61K 38/1709 from mammals
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/16 Central respiratory analeptics
• CPC Class Codes: A61P 5/44 Glucocorticosteroids; Drugs increasing or potentiating the activity of glucocorticosteroids

Abstract

Novel compositions for the treatment of IRDS and ARDS contain at least one glucocorticosteroid and a pulmonary surfactant. The duration of treatment with these compositions and the mortality associated with these syndromes can be significantly reduced with the administration of these compositions.

Claims

1. A composition for treating IRDS (Infant Respiratory Distress Syndrome) and ARDS (Acute Respiratory Distress Syndrome) comprising a synergistic combination of a glucocorticosteroid and a lung surfactant.

2. A composition according to claim 1, wherein the glucocorticosteroid is betamethasone, methylprednisolone, dexamethasone or ciclesonide.

3. A composition to claim 1, wherein the lung surfactant is a mixture of phospholipids.

4. A composition according to claim 3, wherein each phospholipid is one which is present in a natural lung surfactant.

5. A composition according to claim 3, which further comprises a lung surfactant protein.

6. A composition according to claim 5, which further comprises SP-B and/or SP-C and/or one or more modified derivatives thereof.

7. A composition according to claim 4, which further comprises a surfactant obtained by lung lavage.

9. A method of treating IRDS or ARDS which comprises administering an effective amount of a composition of claim 1 to a subject afflicted with one of these syndromes.

8. A composition having an active component for treating IRDS and ARDS, the active component consisting essentially of glucocorticosteroid and lung surfactant.

10. In a composition which is useful for treating IRDS (Infant Respiratory Distress Syndrome) or ARDS (Acute Respiratory Distress Syndrome) and which has an active component for that purpose, the improvement wherein the active component is a synergistic combination of pharmaceutically-active ingredients comprising a glucocorticosteroid and a lung surfactant.