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Claims for Patent: 4,262,003

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Claims for Patent: 4,262,003

Title: Method and therapeutic system 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; Kumar (Palo Alto, CA), Shaw; Jane (Atherton, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Application Number:05/777,130
Patent Claims: 1. Method for inhibiting emesis and nausea for a prolonged time period comprising administering scopolamine base to unbroken skin in an initial pulse 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 for as long as therapy is required.

2. The method of claim 1 wherein the emesis and nausea arre induced by a vestibular disturbance and the administration begins at least about 3 hr before the disturbance requires therapy.

3. The method of claim 1 wherein the total quantity of scopolamine base administered is in the range of 0.1 to 2.5 mg.

4. The method of claim 1 wherein the skin is located at the mastoidal area.

5. The method of claim 1 wherein the skin is at a body site other than a mastoidal area and the skin is treated with an effective amount of a skin permeation enhancing agent.

6. The method of claim 5 wherein the skin permeation enhancing agent is selected from the group consisting of dimethyl lauramide, dimethyl sulfoxide, and dodecyl pyrrolidone.

7. The method of claim 1 wherein the initial pulse is about 50 to about 150 .mu.g/cm.sup.2 of skin and the substantially constant rate is about 5 to 15 .mu.g/hr for adults and 3 to 10 .mu.g/hr for children.

8. A method of claim 7 wherein the skin is located at a mastoidal area.
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