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Claims for Patent: 4,436,741

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Claims for Patent: 4,436,741

Title: Method for administering scopolamine transdermally
Abstract:Method and therapeutic system in the form of a bandage that administer scopolamine base transdermally in an initial pulse of 10 to 200 .mu.g/cm.sup.2 of skin that quickly brings the concentration of scopolamine in the plasma to a level at which emesis and nausea are inhibited without intolerable side effects, followed by a substantially constant dosage in the range of 0.3 to 15 .mu.g/hr that holds said level. The bandage is a four-layer laminate of, from the top: a protective backing; a gelled, mineral oil-polyisobutene-scopolamine reservoir lamina that is the source of the constant dosage; a microporous membrane that controls the constant dosage rate; and a gelled, mineral oil-polyisobutene-scopolamine adhesive layer that is the source of the pulse dose and the means by which the bandage is attached to the skin.
Inventor(s): Urquhart; John (Palo Alto, CA), Chandrasekaran; Santosh K. (Palo Alto, CA), Shaw; Jane E. (Atherton, CA)
Assignee: ALZA Corporation (Palo Alto, CA)
Application Number:06/474,754
Patent Claims: 1. A method for administering scopolamine transdermally for a prolonged time period comprising administering scopolamine base to a predetermined area of unbroken skin in a skin saturating initial dose of about 10 to about 200 .mu.g/cm.sup.2 of skin and thereafter at a substantially constant rate in the range of about 0.3 to about 15 .mu.g/hr which rate is sufficient to maintain the urinary excretion of scopolamine in the range of from 0.05 to about 1.5 .mu.g/hr for said prolonged period of time.

2. A method for administering scopolamine transdermally for a prolonged period of time comprising:

(a) administering scopolamine base to a predetermined area of unbroken skin until sufficient scopolamine has been administered to occupy the scopolamine binding sites associated with said area of skin and;

(b) after said binding site have been occupied continuously administering scopolamine to said area of skin at a substantially constant rate in the range of about 0.3 to about 15 .mu.g/hr for said prolonged period of time.

3. The method of claim 2 wherein said area of skin is located at the mastoidal area.

4. The method of claim 2 wherein the scopolamine is administered to the skin of a subject suffering from a vestibular disturbance.

5. The method of claim 2 wherein the substantially constant rate is about 5 to 15 .mu.g/hr for adults and 3 to 10 .mu.g/hr for children.

6. The method of claim 3 wherein the substantially constant rate is about 5 to 15 .mu.g/hr for adults and 3-10 .mu.g/hr for children.

7. The method of claim 5 wherein said scopolamine binding sites are saturated by the administration of a dose of about 10 to about 200 .mu.g/cm.sup.2 of skin.

8. The method of claim 2 wherein the scopolamine is administered to the skin of a pregnant subject.

9. The method of claim 2 wherein the scopolamine is administered to the skin of a subject undergoing chemotherapy.

10. The method of claim 2 wherein the scopolamine is administered to the skin of a subject undergoing radiation therapy.

11. The method of claim 2 wherein the scopolamine is administered to the skin of a subject treated with an anesthetic.
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