Claims for Patent: 4,994,278

Summary for Patent: 4,994,278

Title:	Breathable backing
Abstract:	A composition comprising a flexible backing for a transdermal drug preparation with a water vapor transmission rate about equal to or in excess of that of ethylene vinyl alcohol copolymer, namely equal to or in excess of, at one mil thickness, of about 2 to 4 grams and more preferably in excess of 6 grams per 24 hours per 100 square inches at 40.degree. C. and 90% relative humidity and an oxygen transmission rate equal to or less than ethylene vinyl alcohol copolymer, namely at one mil thickness equal to or less than about 0.01 to 0.1 cubic centimeters per 100 square inches measured over 24 hours at 1 atmospheric pressure, 20.degree. C. and 65% relative humidity.
Inventor(s):	Sablotsky; Steven (Miami, FL), Gentile; Cheryl M. (Plantation, FL)
Assignee:	Noven Pharmaceuticals, Inc. (Miami, FL)
Application Number:	07/295,788
Patent Claims:	1. A composition, which comprises: a pharmacologically active agent in a transdermal carrier having two surfaces, one surface being adapted for application to the skin and a second surface opposed thereto; and a backing of at least a first layer of a plastic film for said second surface of the carrier, having a thickness from about 0.2 to 3 mils, and having a water vapor transmission rate at 1 mil thickness in excess of about 2 grams per 100 square inches per 24 hours, at 40.degree. C. and 90% relative humidity and an oxygen transmission rate at 1 mil thickness equal to or less than 0.1 cubic centimeters per 100 square inches measured over 24 hours at 1 atmosphere of pressure, at 20.degree. C. and 65% relative humidity, said backing having a first side facing the second surface of the transdermal carrier and a second side opposite thereto. 2. The composition of claim 1, in which the backing has a water vapor transmission rate in excess of 2 to 4 grams per 24 hours per 100 square inches at 40.degree.C. and 90% relative humidity. 3. The composition of claim 2, in which said backing has a second layer in contact with said first second side of said backing having a water vapor transmission rate in excess of about 6 grams per 100 square inches per 24 hours at 40.degree. C. and 90% relative humidity. 4. The composition of claim 3, in which the second layer of the backing has a water vapor transmission rate equal to or in excess of about 6 grams per 24 hours per 100 square inches, at 40.degree. C. and at 90% relative humidity. 5. The composition of claim 3, having a third layer in said backing adjacent the second layer said backing having a water vapor transmission rate in excess of about 6 grams per 100 inches square for 24 hours at 40.degree. C. and 90% relative humidity. 6. The composition of claim 5, in which said second and third layers have water vapor transmission rates in excess of 9 grams per 24 hours per 100 square inches at 40.degree. C. and 90% relative humidity. 7. The composition of claim 2, in which the backing is ethylene vinyl alcohol copolymer having a water vapor transmission rate in excess of about 6 grams per 24 hours per 100 inches at 40.degree. C. and 90% relative humidity and an oxygen transmission rate below about 0.1 cubic centimeters per 100 square inches per 24 hours at 1 atmosphere pressure, 20.degree. C., and 65% relative humidity and a second layer of a polyurethane, having a water vapor transmission rate in excess of 6 grams under said conditions. 8. The composition of claim 7, having a third layer of polyurethane having a water vapor transmission rate in excess of 9 grams per 24 hours per inch at 40.degree. C. and 90% relative humidity.