Claims for Patent: 8,905,979

Summary for Patent: 8,905,979

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:	13/252,532
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 tubes, nasogastric tubes, and catheters having a outer diameter of 5 Fr into the trachea of said infant; c) administering a formulation of a pulmonary surfactant suspended in a vehicle consisting of a buffered physiological aqueous saline solution through said tube by a syringe over a period of from 1 to 5 minutes and d) removing said tube wherein the surfactant is administered at a dose of 100-200 mg per kg body weight and the suspension thereof has a viscosity between 5 and 15 mPas; and wherein the tube has a marked scale to allow the correct length of introduction into the trachea. 2. The method of claim 1, wherein the viscosity is comprised between 6 and 10 mPas. 3. The method of claim 1, wherein the concentration of the surfactant suspension is comprised between 40 and 80 mg/ml. 4. The method of claim 1, wherein the surfactant is a modified natural surfactant or a reconstituted surfactant. 5. The method of claim 4, wherein said surfactant is selected from the group consisting of poractant alfa, beractant, bovactant and calfactant. 6. The method of claim 1, wherein nCPAP is applied with a nasal mask. 7. The method of claim 1, wherein the pressure is from 2 to 8 cm water. 8. The method of claim 1, wherein the surfactant is suspended in a volume of not more than 3 ml. 9. The method of claim 8, wherein the volume is not more than 2.5 ml. 10. The method of claim 1, wherein the respiratory distress syndrome is infant Respiratory Distress Syndrome (RDS). 11. The method of claim 1, wherein the respiratory distress syndrome is due to meconium aspiration or pulmonary infection.

Details for Patent 8,905,979

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	SURVANTA	beractant	Suspension	020032	07/01/1991		2027-06-08
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521	07/01/1998		2027-06-08
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521	12/12/2002		2027-06-08