Method and therapeutic system for smoking cessation

• US 5,135,753 A
• Filed: 03/12/1991
• Issued: 08/04/1992
• Est. Priority Date: 03/12/1991
• Status: Expired due to Term

• Current Assignee: McNeil AB (Johnson & Johnson)
• Original Assignee: Pharmetrix Corporation
• Inventors: Baker, R. W., Vintilla-Friedman, S., Santus, Gian C.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): AZPURU, CARLOS A
• Application Number:
  US07/669,116
• Time in Patent Office: 511 Days
• Field of Search: 424/434, 424/435, 424/443, 424/447, 424/448, 424/449, 514/343, 514/813
• US Class Current: 424/435
• CPC Class Codes: A61K 31/465 Nicotine; Derivatives thereof
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/7069 obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches

Abstract

A method for smoking cessation therapy is described that utilizes transdermal nicotine delivery for obtaining base-line coupled with buccal administration of nicotine to satisfy transient craving.

Claims

1. A method of smoking cessation therapy comprising the concurrent transdermal and buccal administration of nicotine wherein said buccally administered nicotine provides transient blood levels of nicotine about 5 ng/ml above that provided by the transdermal administration of nicotine.

2. A method of smoking cessation therapy as described in claim 1, wherein said transdermal administration of nicotine from said transdermal system results in nicotine blood levels of between 5 to 30 ng/mL for at least 12 hours.

3. A method of smoking cessation therapy as described in claim 1, wherein said buccal nicotine administration results in maximum nicotine blood levels that are at least 5 ng/mL above the maximum nicotine blood level provided by said transdermal administration of nicotine.

4. A method of smoking cessation therapy as described in claim 1, wherein said buccal nicotine administration results in maximum nicotine blood levels from 2 to 30 minutes after said buccal nicotine administration.

5. A method of smoking cessation therapy as described in claim 1, wherein said buccal nicotine administration results in maximum nicotine blood levels from 2 to 10 minutes after said buccal nicotine administration.

6. A method of smoking cessation therapy as described in claim 1, wherein said buccal nicotine administration obtained by allowing a nicotine lozenge to completely dissolve in the mouth results in maximum nicotine blood levels from 2 to 10 minutes after said buccal nicotine administration.

7. A method of smoking cessation therapy as described in claim 1, wherein said buccal nicotine administration comprises nicotine lozenges formulated to a pH of between 7 and 11.

8. A method of smoking cessation therapy as described in claim 1, wherein said buccal nicotine administration comprises nicotine tablets formulated to a pH of between 7 and 11.

9. A method of smoking cessation therapy as described in claim 1, wherein said buccal nicotine administration comprises nicotine capsules formulated to a pH of between 7 and 11.

10. The method of smoking cessation therapy as described in claim 1, wherein said transdermal system comprises:

(a) A nicotine depot layer, having a skin-facing side and a skin-distal side, said depot layer containing a sufficient quantity of nicotine to maintain a useful flux of nicotine from said patch for a total time period of 12 hours or more;

(b) an occlusive backing layer in contact with and covering said depot layer on said skin-distal side; and

(c) rate-controlling means for controlling diffusion of nicotine from said skin-facing side at a first flux of greater than zero but less than 2 mg/cm² in any hour for a first time period of greater than zero but less than 5 hours, then at a second flux between 20 and 800 μ

g/cm².h for a second time period of 7 hours or more.

11. A method of smoking cessation therapy as described in claim 9, wherein said transdermal administration of nicotine from a transdermal system or systems results in nicotine blood levels of between 5 to 30 ng/mL for at least 12 hours.

12. A method of smoking cessation therapy as described in claim 9, wherein said buccally administered nicotine result in maximum nicotine blood levels that are at least 5 ng/mL more than the maximum nicotine blood level provided by said transdermal administration of nicotine.

13. A method of smoking cessation therapy as described in claim 9, wherein said buccally administered nicotine in maximum nicotine blood levels from 2 to 30 minutes after said buccal nicotine administration.

14. A method of smoking cessation therapy as described in claim 9, wherein said nicotine lozenges, tablets, or capsules results in maximum nicotine blood levels from 2 to 10 minutes after said buccally administered nicotine.

15. A method of smoking cessation therapy as described in claim 9, wherein said nicotine lozenges, are formulated at a pH of between 7 and 11.

16. A method of smoking cessation therapy as described in claim 9, wherein said nicotine capsules are formulated at a pH of between 7 and 11.

17. A method of smoking cessation therapy as described in claim 9, wherein said nicotine tablets are formulated at a pH of between 7 and 11.