Claims for Patent: 8,357,657

Summary for Patent: 8,357,657

Title:	Therapeutic combination comprising a pulmonary surfactant and a steroid
Abstract:	Administration of a modified natural surfactant in combination with a corticosteroid is effective for the prevention of bronchopulmonary dysplasia (BPD) and lowers the markers of pulmonary oxidative stress.
Inventor(s):	Giossi; Massimo (Parma, IT), Razzetti; Roberta (Parma, IT), Chiesi; Paolo (Parma, IT)
Assignee:	Chiesi Farmaceutici S.p.A. (Parma, IT)
Application Number:	12/786,845
Patent Claims:	1. A composition, comprising poractant alfa and beclometasone dipropionate, wherein said poractant alfa and beclometasone dipropionate are present in relative amounts suitable for administering said poractant alfa at a dose of about 100 to about 200 mg/kg and said beclometasone dipropionate at a dose of about 0.6 to about 0.8 mg/kg. 2. A composition according to claim 1, wherein said poractant alfa and said beclometasone dipropionate are present in relative amounts suitable for administering said poractant alfa in a dose of about 100 to about 200 mg/kg and said beclometasone dipropionate in a dose of about 0.8 mq/kg. 3. A composition according to claim 1, wherein said poractant alfa and said beclometasone dipropionate are present in relative amounts suitable for administering said poractant alfa at a dose of about 200 mg/kg and said beclometasone dipropionate in a dose of about 0.8 mg/kg. 4. A composition according to claim 1, which is in a form suitable for inhalation or intratracheal administration. 5. A composition according to claim 1, which is in a form of a sterile suspension in a buffered physiological saline aqueous solution. 6. A method for prevention of bronchopulmonary dysplasia, comprising administering poractant alfa at a dose of about 100 to about 200 mg/kg and beclometasone dipropionate at a dose of about 0.6 to about 0.8 mq/kg to a subject in need thereof. 7. A method according to claim 6, wherein said poractant alfa is administered in a dose of about 200 mg/kg. 8. A method according to claim 6, wherein said beclometasone dipropionate is administered in a dose of about 0.6 mg/kg. 9. A method according to claim 6, wherein said beclometasone dipropionate is administered in a dose of about 0.8 mg/kg. 10. A method according to claim 6, wherein said poractant alfa is administered in a dose of about 200 mg/kg and said beclometasone dipropionate is administered in a dose of about 0.6 mg/kg. 11. A method according to claim 6, wherein said poractant alfa is administered in a dose of about 200 mg/kg and said beclometasone dipropionate is administered in a dose of about 0.8 mg/kg. 12. A method for lowering a marker of pulmonary oxidative stress, comprising administering poractant alfa at a dose of about 100 to about 200 mg/kg and beclometasone dipropionate at a dose of about 0.6 to about 0.8 mg/kg to a subject in need thereof. 13. A method according to claim 12, wherein said poractant alfa is administered in a dose of about 200 mg/kg. 14. A method according to claim 12, wherein said beclometasone dipropionate is administered in a dose of about 0.6 mg/kg. 15. A method according to claim 12, wherein said beclometasone dipropionate is administered in a dose of about0.8 mg/kg. 16. A method according to claim 12, wherein said poractant alfa is administered in a dose of about 200 mg/kg and said beclometasone dipropionate is administered in a dose of about 0.6 mg/kg. 17. A method according to claim 13, wherein said poractant alfa is administered in a dose of about 200 mg/kg and said beclometasone dipropionate is administered in a dose of about 0.8 mg/kg. 18. A kit, comprising: (a) poractant alfa at a dose of about 100 and about 200 mg/kg and a pharmaceutically acceptable carrier or diluent in a first unit dosage form; (b) beclometasone dipropionate at a dose of about 0.6 to about 0.8 mg/kg and a pharmaceutically acceptable carrier or diluent in a second unit dosage form; and (c) a container which contains said first and second dosage forms. 19. A kit according to claim 18, wherein the dose of poractant alfa is about 200 mg/kg. 20. A kit according to claim 18, wherein said first unit dosage form is a single-use vial filled with about 2.5 ml of a sterile formulation of about 80 mg/ml poractant alfa suspended in a buffered physiological saline aqueous solution, while the second unit dosage form is a single-use vial filled with about 2 ml of a sterile formulation of micronised beclometasone dipropionate suspended in an aqueous solution comprising polysorbate (Tween) 20, sorbitan monolaurate, and sodium chloride.

Details for Patent 8,357,657

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Chiesi Usa, Inc.	CUROSURF	poractant alfa	Suspension	020744	11/18/1999		2029-05-25