Transdermal drug delivery device

Details

Inventors: Lee, Eun S.; Yum, Su I.;
Assignee: ALZA Corporation (Palo Alto, CA)
Primary Examiner: Page; Thurman K.
Assistant Examiner: Horne; L. R.
Attorney, Agent or Firm: Mandell; Edward L., Precivale; Shelley G., Stone; Steven F.

A diffusional drug delivery device is described which can provide for stability of the adhesive and system components, elimination of the initial burst of drug and hence irritation, and to provide for delayed onset of therapeutic effect along with delivery of a therapeutic agent at an optimum rate. The therapeutic agent in a first form which is suitable for storage, and the anhydrous activating means are inert when in an anhydrous environment. Moisture activates the system whereby the activating means provides an acidic or basic solution and the first form of the therapeutic agent is converted to a second form which is suitable for absorption through the skin or mucosa.

DETAILED DESCRIPTION What is claimed is: 1.
A controlled release medical device for delivery of at least one therapeutic agent in a pre-determined delivery rate pattern to a biological environment comprising, in combination: reservoir means containing a therapeutic agent which in a first form as a salt is suitable for storage and in a second form is a member selected from the group consisting of a free acid, a free base, an ester, is suitable for absorption through the skin or mucosa, and said reservoir means having a surface substantially impermeable to said therapeutic agent in said first form and permeable to said therapeutic agent in said second form and through which the second form of said therapeutic agent is released to the biological environment; and activating means containing an activating agent wherein said activating agent in a first state is anhydrous, and in a second state is hydrated and in solution wherein said means is in the only anhydrous form; whereby the therapeutic agent is changed from its first to its second form by the activating means in its second state and whereby the passage of therapeutic agent to the biological environment by diffusion is impeded until the therapeutic agent changes form.
2.
The device of claim 1 wherein the activating means is moistened by cutaneous liquids, whereby said activating agent is changed from said first to said second state.
3.
The device of claim 1 wherein said reservoir means is a matrix having a therapeutic agent dispersed throughout, said means being substantially free of activating agent.
4.
The device of claim 3 wherein said activating means is a matrix having an activating agent dispersed throughout, said means being substantially free of therapeutic agent.
5.
The device of claim 4 which further comprises: rate controlling means for controlling the rate at which said activating means becomes hydrated when placed at its environment of use.
6.
The device of claim 4 which further comprises: rate controlling means for controlling the rate at which said activating agent in its second state diffuses into said reservoir means

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