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Transdermal drug delivery device

a technology of drug delivery and transdermal injection, which is applied in the direction of prosthesis, bandages, dressings, etc., can solve the problems of unsuitable, delayed onset of therapeutic effect, and inability to possess the capability of diffusional delivery devices known to the art, and achieve the effect of delayed onset of drug administration

Inactive Publication Date: 2007-04-24
ALZA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0009]An object of this invention is to provide a diffusional drug delivery device which provides for delayed onset of drug administration.
[0010]A further object of this invention is to provide a diffusional drug delivery device which does not deliver an initial burst of drug and hence is less likely to cause irritation.
[0012]A further object of this invention is to provide a diffusional delivery device where the adhesive and other components are protected from degradation by using a drug which in a first form is suitable for storage, said form being more compatible with the system components upon prolonged exposure.
[0013]A further object of this invention is to provide for the maintenance of drug potency and device efficacy during prolonged storage periods, whereby the device is inactive while stored, and active when applied to the skin.

Problems solved by technology

Such devices perform well in the administration of many agents but are not suitable for the administration of an agent whose dosage regime requires that the onset of therapeutic effect be delayed for a significant period of time after application of the device at the site of delivery.
Diffusional delivery devices known to the art however, do not possess this capability.
It is not possible, using concurrent application and removal of diffusional delivery devices known in the art, to substantially delay the onset of transdermal drug delivery from the time of application, such as bedtime, until shortly prior to arousal.
Additionally, a common problem encountered with state of the art systems is how to deal with unstable active agents, especially those that tend to degrade the adhesive and other system components.

Method used

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Examples

Experimental program
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Effect test

example i

[0064]A test sample was designed to deliver nicotine according to this invention. Nicotine which is transdermally administered to facilitate breaking the tobacco habit, is especially suited to illustrate this invention. Nicotine in its active form tends to degrade adhesives, especially those which are silicone based. Also, nicotine delivered in a sudden burst may irritate the skin. Therefore, use of this invention to deliver nicotine provides a system with an improved shelf-life by storing the nicotine in its salt form, and further provides elimination of the initial burst of drug by storing nicotine in a form which is not readily absorbed through mucous membrane and intact skin.

[0065]The drug reservoir was a polymeric matrix comprised of 60% nicotine tartrate and 40% EVA 40 carrier, and was about 6.5 mils thick. The activating layer was about 3.5 mils thick and was a polymeric matrix comprised of 60% Na2CO3 and 40% EVA 40 carrier. Sodium carbonate provides an aqueous solution which...

example ii

[0070]A system was designed according to this invention and is illustrated in FIG. 76. The backing was standard Medpar® and the system had the storage suitable form of the drug and the activating agent (base) mixed in the same reservoir. The drug reservoir was comprised of 42% nicotine tartrate, 18% Na2CO3 and 40% EVA 40 carrier. The system had a PVA rate controlling membrane about 1.5 mils thick and had a silicone adhesive layer.

[0071]The release rate of nicotine from this system at 35° C. in a release medium of water, is presented in the following table:

[0072]

TABLE 1Average Release Rate,Time, hrsμg / cm2 / hr272.64429.55665.84852.6013112.51

[0073]As is evidenced from the data presented, this system provides the desired delayed onset where the drug release rate during the first 8 hours is minimal and gradually increases to a significant level at 13 hours.

example iii

[0074]A test sample was designed to deliver nicotine. The drug reservoir was a polymeric matrix comprised of 40% nicotine tartrate, 50% EVA 40 carrier and 10% NaCl, and was about 8 mils thick. The activating layer was about 3.5 mils thick and was a polymeric matrix comprised of 60% Na2CO3 and 40% EVA 40 carrier.

[0075]The release rate was measured using a 1.5 mil Hytrel® membrane and is graphically illustrated in FIG. 11.

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Abstract

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.

Description

FIELD OF THE INVENTION[0001]This invention relates to the transdermal delivery of drugs or other biologically active agents and particularly to novel methods and compositions for providing stable systems under storage conditions. Still more particularly, this invention relates to novel methods and compositions for delaying the onset of drug delivery for transdermal systems.RELATED PATENT APPLICATIONS[0002]This application is related to the copending, coassigned patent application Ser. No. 07 / 022,301, filed Mar. 5, 1987 entitled “Moisture Activation of Transdermal Drug Delivery System”, which in turn is a continuation of patent application Ser. No. 06 / 874,263, filed June 13, 1986, of the same title; and to the copending coassigned patent application, Attorney Docket No. 1543 entitled “Improved Transdermal Drug Delivery Device”.BACKGROUND OF THE INVENTION[0003]The transdermal route of parenteral delivery of drugs provides many advantages and transdermal systems for delivering a wide v...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): A61F3/00A61K9/70A61M35/00A61M37/00
CPCA61K9/7084
Inventor LEE, EUN SOOYUM, SU IL
Owner ALZA CORP
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