Method and apparatus for reducing the incidence of tobacco use

• US 7,455,654 B2
• Filed: 10/21/2004
• Issued: 11/25/2008
• Est. Priority Date: 10/28/2003
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Cormier, Michel J. N., Scott, Andrew G., Gale, Robert M.
• Primary Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US10/971,224
• Publication Number:
  US 20050089553A1
• Time in Patent Office: 1,496 Days
• Field of Search: 604/22, 604/117, 604/173, 604/239, 604/46, 604/500, 424/448
• US Class Current: 604/46
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61P 25/34 Tobacco-abuse

Abstract

An apparatus for transdermally delivering a nicotine-based agent to a tobacco or nicotine user comprising a microprojection member having a plurality of microprojections that are adapted to pierce the stratum corneum of the tobacco user, the microprojection member having a biocompatible coating disposed thereon that includes a nicotine-based agent.

Claims

1. An apparatus for transdermally delivering nicotine-based agents to a nicotine user, comprising a microprojection member having a plurality of microprojections that are adapted to pierce said nicotine user'"'"'s stratum corneum for bolus delivery of at least one nicotine-based agent, said microprojection member including a biocompatible coating having at least one nicotine-based agent;

wherein a total amount of the nicotine-based agent coated on the microprojections is sufficient to effectively deliver in the range of approximately 0.02-2.0 mg of the agent to the nicotine user, and wherein the composition of the coating is selected to deliver at least 50% of the total amount of the nicotine-based agent coated on the microprojection into the skin of the user one hour or less following application of the microprojection member to the user'"'"'s skin.

2. The apparatus of claim 1, wherein said nicotine-based agent is selected from the group consisting of nicotine base, nicotine salts and simple derivatives of nicotine.

3. The apparatus of claim 1, wherein each of said microprojections has a length less than approximately 1000 microns.

4. The apparatus of claim 3, wherein each of said microprojections has a length less than approximately 500 microns.

5. The apparatus of claim 4, wherein each of said microprojections has a length less than approximately 250 microns.

6. The apparatus of claim 1, wherein said biocompatible coating further includes at least one wetting agent.

7. The apparatus of claim 1, wherein said biocompatible coating further includes a hydrophilic polymer.

8. The apparatus of claim 1, wherein said biocompatible coating further includes a surfactant.

9. The apparatus of claim 1, wherein said bio compatible coating further includes an amphiphilic polymer.

10. The apparatus of claim 1, where said biocompatible coating further includes a vasoconstrictor.

11. The apparatus of claim 1, wherein said biocompatible coating further includes a biocompatible carrier.

12. The apparatus of claim 1, wherein said biocompatible coating has a thickness less than approximately 50 microns.

13. The apparatus of claim 1, wherein said biocompatible coating has a thickness less than approximately 25 microns.

14. The apparatus of claim 1, further including an applicator having a contacting surface, wherein said microprojection member is releasably mounted on said applicator by a retainer and wherein said applicator, once activated, brings said contacting surface into contact with said microprojection member in such a manner that said microprojection member strikes the stratum corneum of the nicotine user with a power of at least 0.05 joules per cm.sup.2 of the microprojection member in 10 milliseconds or less.

15. A method for transdermally delivering a nicotine-based agent to a nicotine user, comprising the steps of:

providing a microprojection member having a plurality of microprojections that are adapted to pierce said nicotine user'"'"'s stratum corneum for bolus delivery of at least one nicotine-based agent, said microprojections including a biocompatible coating having at least one nicotine-based agent;

wherein a total amount of the nicotine-based agent coated on the microprojections is sufficient to effectively deliver in the range of approximately 0.02-2.0 mg of the agent to the nicotine user; and

applying said microprojection member to said nicotine user'"'"'s skin, whereby said microprojection members pierce said stratum corneum and deliver said nicotine-based agent, and wherein the composition of the coating is selected to deliver at least 50% of the total amount of the nicotine-based agent coated on the microprojection into the skin of the user one hour or less following application of the microprojection member to the user'"'"'s skin.

16. The method of claim 15, wherein said biocompatible coating is applied to said microprojection member by immersing said microprojections in a coating formulation.

17. The method of claim 15, wherein said biocompatible coating is applied to said microprojection member by spraying a coating formulation onto said microprojections.

18. The method of claim 15, further comprising the steps of:

providing an applicator having a contacting surface, wherein said microprojection member is releasably mounted on said applicator by a retainer; and

activating said applicator to bring said contacting surface into contact with said microprojection member in such a manner that said microprojection member strikes the stratum corneum of a nicotine user.