Nicotine formulations and use thereof

• US 20050053665A1
• Filed: 09/07/2004
• Published: 03/10/2005
• Est. Priority Date: 09/08/2003
• Status: Abandoned Application

• Current Assignee: McNeil AB (Johnson & Johnson)
• Original Assignee: McNeil AB (Johnson & Johnson)
• Inventors: Mihranyan, Albert, Lindberg, Nils-Olof, Bosson, Bengt, Ek, Ragnar, Andersson, Sven-Borje
• Application Number:
  US10/935,658
• Publication Number:
  US 20050053665A1
• Time in Patent Office: Days
• US Class Current: 424/488
• CPC Class Codes: A61K 31/4439 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole nicotine A61K31/465
• 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 9/0058 Chewing gums non-medicinal aspects, preparing chewing gum A23G4/00; chewing gum for care of the teeth or oral cavity, e.g. with breath freshener A61Q11/00
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61K 9/146 with organic macromolecular compounds
• CPC Class Codes: A61K 9/7053 obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
• 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
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Abstract

Nicotine-containing pharmaceutical compositions wherein nicotine is absorbed into and/or adsorbed onto cellulose of non-seed organism origin, especially cellulose from algae, bacteria and/or fungi.

Claims

1. A nicotine-containing pharmaceutical composition comprising nicotine and cellulose of non-seed organism origin.

2. The nicotine-containing pharmaceutical composition according to claim 1 wherein said cellulose has a surface area of more than 5 m²/g.

3. The nicotine-containing pharmaceutical composition according to claim 1 wherein said cellulose comprises particles having a pore volume above about 0.01 cm³/g.

4. The nicotine-containing pharmaceutical composition according to claim 1 wherein said cellulose is obtained from algae, bacteria, fungi or mixtures thereof.

5. The nicotine-containing pharmaceutical composition according to claim 4 wherein said cellulose is obtained from algae selected from the group consisting of blue-green algae (Cyanophyta), green algae (Chlorophyta), gold algae (Chrysophyta), dinoflagellates (Pyrrophyta), brown algae (Phaeophyta), red algae (Rhodophyta), and mixtures thereof.

6. The nicotine-containing pharmaceutical composition according to claim 5 wherein said cellulose is green algae comprising Cladophora species.

7. The nicotine-containing pharmaceutical composition according to claim 4 wherein said cellulose is obtained from bacteria selected from the group consisting of Acetobacter;

Achromobacter;

Aerobacter;

Agrobacterium;

Alcaligenes;

Polyspondium pallidum;

Pseudomonas;

Rhizobium;

Sarcina;

Sphaerofilus natans;

Xanthomonas campestris;

Zoogloega and mixtures thereof.

8. The nicotine-containing pharmaceutical composition according to claim 4 wherein said cellulose is obtained from fungi selected from the group consisting of Achlya bisexualis;

Saprolegnia;

Dictyostelium;

Phytophtora;

Microdochium nivale;

Ophiostoma ulmi;

Colletotrichum lindemuthianum;

Pythium and mixtures thereof.

9. The nicotine-containing pharmaceutical composition according to claim 1 wherein said nicotine is selected from the group consisting of a nicotine salt, the free base form of nicotine, a nicotine derivative, nicotine in any non-covalent binding form, and mixtures thereof.

10. The nicotine-containing pharmaceutical composition according to claim 1 wherein said nicotine is a nicotine salt selected from the group consisting of salts formed as tartrate, hydrogen tartrate, hydrochloride, acetate, salicylate salts and mixtures thereof.

11. The nicotine-containing pharmaceutical composition according to claim 1 wherein the pH of said composition is controlled by the use of a buffering agent selected from the group consisting of a carbonate, glycinate, phosphate, glycerolphosphate, acetate, gluconate, alkali metal citrate or mixtures thereof.

12. The nicotine-containing pharmaceutical composition according to claim 1 wherein the pH of said composition is controlled by the use of an agent selected from the group consisting of sodium hydroxide, potassium hydroxide, calcium hydroxide, calcium oxide or mixtures thereof.

13. The nicotine-containing pharmaceutical composition according to claim 1 comprising a delivery form selected from the group consisting of an inhaling device, a transdermal patch, a nasal spray or an oral dosage form.

14. The nicotine-containing pharmaceutical composition according to claim 13 wherein said oral dosage form is selected from the group consisting of chewing gum, mouth spray, buccal sachet, lozenge, tablet or powder.

15. The nicotine-containing pharmaceutical composition according to claim 1 wherein said nicotine is adsorbed onto said cellulose.

16. The nicotine-containing pharmaceutical composition according to claim 15 wherein said cellulose has a surface area of more than 5 m²/g.

17. The nicotine-containing pharmaceutical composition according to claim 15 wherein said cellulose comprises particles having a pore volume above about 0.01 cm³/g.

18. The nicotine-containing pharmaceutical composition according to claim 1 wherein said nicotine is reversibly absorbed into said cellulose.

19. The nicotine-containing pharmaceutical composition according to claim 18 wherein said cellulose has a surface area of more than 5 m²/g.

20. The nicotine-containing pharmaceutical composition according to claim 18 wherein said cellulose comprises particles having a pore volume above about 0.01 cm³/g.

21. A method for obtaining reduction of the urge to smoke or otherwise use tobacco containing material and/or for providing a sense of smoking satisfaction without smoking, comprising administering to a subject a nicotine-containing pharmaceutical composition according to claim 1.