Claims for Patent: 8,048,043

Summary for Patent: 8,048,043

Title:	Method of administration of a pulmonary surfactant
Abstract:	The present invention concerns a method for treating a respiratory distress in a infant in need of such treatment, the method comprising intratracheal administration of a pulmonary surfactant by a thin tube. The invention also concerns a kit for performing said method.
Inventor(s):	Herting; Egbert (Parma, IT), Gopel; Wolfgang (Parma, IT), Chiesi; Paolo (Parma, IT)
Assignee:	Chiesi Farmaceutici S. P. A. (Parma, IT)
Application Number:	11/811,351
Patent Claims:	1. A method for treating a respiratory distress syndrome in a spontaneously breathing pre-term infant in need of such treatment, said method comprising the steps of: a) applying nasal Continuous Positive Airway Pressure (nCPAP) with a nasal device to said infant at a pressure of from 1 to 12 cm water; b) introducing a tube selected from the group consisting of gastric tube, nasogastric tube, arterial or suction catheter and having an outer diameter of 5 Fr into the trachea of said infant; c) administering poractant alfa pulmonary surfactant suspended in a pharmaceutically acceptable aqueous medium through said tube and d) removing said tube wherein the surfactant suspension is applied at a concentration of from 40 mg/ml to 80 mg/ml and has a viscosity of between 5 and 15 mPas. 2. The method of claim 1 wherein the viscosity is comprised between 6 and 10 mPas. 3. The method of claim 1 wherein the surfactant is a modified natural surfactant or a reconstituted surfactant. 4. The method of claim 1 wherein nCPAP is applied with a nasal mask. 5. The method of claim 1 wherein the pressure is from 2 to 8 cm water. 6. The method of claim 1 wherein the surfactant is suspended in a buffered physiological saline aqueous solution. 7. The method of claim 6 wherein the surfactant is suspended in a volume of not more than 3 ml. 8. The method of claim 7 wherein the volume is not more than 2.5 ml. 9. The method of claim 1 wherein the respiratory distress syndrome is infant Respiratory Distress Syndrome (RDS). 10. The method of claim 1 wherein the respiratory distress syndrome is due to meconium aspiration or pulmonary infection. 11. A kit comprising: a) a sterile pharmaceutical composition having a viscosity of between 5 and 15 mPas comprising a poractant alfa pulmonary surfactant suspended in a pharmaceutically acceptable aqueous medium at a concentration of from 40 mg/ml to 80 mg/ml; b) a tube having an outer diameter of 5 Fr; c) a device for administering the surfactant at a controlled rate; d) container means for containing the pharmaceutical composition, the tube and the device. 12. The kit of claim 11 wherein the sterile pharmaceutical composition is supplied in a single-use glass vial. 13. The kit of claim 11 wherein the sterile pharmaceutical composition is supplied directly in the device used for administering the surfactant at a controlled rate.

Details for Patent 8,048,043

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Chiesi Usa, Inc.	CUROSURF	poractant alfa	Suspension	020744	11/18/1999		2040-03-31