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Details for Patent: 5,202,125

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Details for Patent: 5,202,125

Title: Method and systems for administering nitroglycerin transdermally at enhanced transdermal fluxes
Abstract:Transdermal delivery systems for delivery of nitroglycerin are disclosed which deliver the drug at enhanced transdermal fluxes. The systems include, in addition to nitroglycerin, a permeation enhancer which is either a sorbitan ester, a C.sub.8 -C.sub.22 aliphatic alcohol, or a mixture thereof. Methods for administering nitroglycerin using such permeation enhancers are also disclosed.
Inventor(s): Ebert; Charles D. (Salt Lake City, UT), Patel; Dinesh (Murray, UT), Heiber; Sonja (Salt Lake City, UT)
Assignee: TheraTech, Inc. (Salt Lake City, UT)
Filing Date:Dec 10, 1990
Application Number:07/625,906
Claims:1. A method for providing nitroglycerin therapy to an individual in need of such therapy, wherein the method comprises administering transdermally through a predetermined area of skin a therapeutically effective amount of nitroglycerin and a permeation enhancing amount of an enhancer consisting essentially of

(a) a sorbitan ester having the structural formula ##STR3## wherein R.sub.1 has the formula --O(CO)R', R' is selected from the group consisting of saturated, mono-unsaturated, di-unsaturated, and tri-unsaturated aliphatic hydrocarbon substituents of 7 to 21 carbon atoms optionally containing 1 to 3 hydroxyl groups, and R.sub.2 and R.sub.3 are independently selected from the group consisting of hydroxyl and --O(CO)R'; and

(b) an alcohol R--OH, wherein R is a saturated, mono-unsaturated, di-unsaturated or tri-unsaturated aliphatic hydrocarbon substituent of 8-22 carbon atoms and may be either unsubstituted or substituted with 1-3 additional hydroxyl groups.

2. The method of claim 1 wherein the nitroglycerin and the enhancer are present in a single pharmaceutical composition.

3. The method of claim 1 wherein the pharmaceutical composition is delivered so that nitroglycerin permeates through the skin at a flux at least 50% higher than that obtained in the absence of said enhancer.

4. The method of claim 1 wherein the predetermined area of skin is in the range of about 1.0 to about 100 cm.sup.2.

5. The method of claim 1 wherein the predetermined area of skin is less than about 25 cm.sup.2.

6. The method of claim 1 wherein the predetermined area of skin is less than about 10 cm.sup.2.

7. The method of claim 1 wherein the R.sub.2 and R.sub.3 are both hydroxyl.

8. The method of claim 7 wherein the enhancer is sorbitan monooleate or sorbitan monolaurate.

9. The method of claim 8 wherein the enhancer is sorbitan monooleate.

10. The method of claim 1 wherein the enhancer is oleyl alcohol.

11. The method of claim 1 wherein the enhancer is lauryl alcohol.

12. The method of claim 1 wherein the nitroglycerin and the enhancer are administered using a transdermal delivery system for delivering the nitroglycerin over an administration period of about 12 to about 24 hours.

13. A method for providing nitroglycerin therapy to an individual in need of such therapy, wherein the method comprises administering transdermally through a predetermined area of skin a composition comprising a therapeutically effective amount of nitroglycerin and a permeation enhancing amount of an enhancer selected from the group consisting of sorbitan monooleate, sorbitan monolaurate, oleyl alcohol, and mixtures thereof, such that nitroglycerin permeates through the skin at a flux at least about 50% higher than that obtained in the absence of said enhancer.
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