Multi-phase delivery compositions and products incorporating such compositions

• US 10,532,046 B2
• Filed: 12/03/2015
• Issued: 01/14/2020
• Est. Priority Date: 12/03/2015
• Status: Active Grant

• Current Assignee: Modoral Brands, Inc. (British American Tobacco PLC)
• Original Assignee: Niconovum USA, Inc. (British American Tobacco PLC)
• Inventors: Rogers, James William, Davis, Michael F., Phillips, Percy D., Taluskie, Karen V., Sears, Stephen Benson, Garcia, Ercilia Hernandez
• Primary Examiner(s): Palenik, Jeffrey T.
• Application Number:
  US14/958,555
• Publication Number:
  US 20170157106A1
• Time in Patent Office: 1,503 Days
• Field of Search: None
• CPC Class Codes: A23L 27/79 in the form of films
• CPC Class Codes: A24B 13/00 Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff reconstituted tobacco products A24B3/14
• CPC Class Codes: A24B 15/10 Chemical features of tobacco products or tobacco substitutes
• CPC Class Codes: A24B 15/16 of tobacco substitutes
• CPC Class Codes: A24B 15/186 by coating with a coating composition, encapsulation of tobacco particles encapsulation of additives other than tobacco : A24B15/283
• CPC Class Codes: A24B 15/282 by indirect addition of the chemical substances, e.g. in the wrapper, in the case
• CPC Class Codes: A24B 15/283 by encapsulation of the chemical substances
• CPC Class Codes: A24B 15/301 by aromatic compounds
• CPC Class Codes: A24D 1/002 with additives, e.g. for flavouring preparing tobacco, e.g. flavouring, A24B
• CPC Class Codes: A24D 1/025 the covers having material applied to defined areas, e.g. bands for reducing the ignition propensity
• CPC Class Codes: A24D 3/048 containing additives
• CPC Class Codes: A24D 3/061 containing additives entrapped within capsules, sponge-like material or the like, for further release upon smoking constructional aspects of the filter A24D3/048
• CPC Class Codes: A24F 15/00 Receptacles or boxes specially adapted for cigars, cigarettes, simulated smoking devices or cigarettes therefor adaptations for use in vehicles B60N3/12; packages specially adapted for cigarettes B65D85/10
• CPC Class Codes: A24F 23/00 Cases for tobacco, snuff, or chewing tobacco
• CPC Class Codes: A24F 40/00 Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
• CPC Class Codes: A24F 40/10 Devices using liquid inhalable precursors
• CPC Class Codes: A24F 42/10 Devices with chemical heating means
• CPC Class Codes: A61K 31/465 Nicotine; Derivatives thereof
• CPC Class Codes: A61K 36/00 Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines antigens from pollen A61K39/36
• CPC Class Codes: A61K 47/44 Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14
• CPC Class Codes: A61K 9/0053 : Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• 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 9/10 : Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61K 9/7007 : Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61P 25/34 : Tobacco-abuse
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: B65D 2203/12 : Audible, olfactory or visual signalling means B65D51/248, B65D55/028, B65D79/02 and B65D81/24 take precedence
• CPC Class Codes: B65D 85/10 : for cigarettes
• CPC Class Codes: B65D 85/1081 : Inserts or accessories added or joined to the container, e.g. coins, pens, cards, spacers B65D85/1009 takes precedence

Abstract

The present disclosure relates to compositions that are useful in the delivery of various materials. In particular, the compositions comprise a suspension wherein an internal phase material is surrounded by an external phase material. The internal phase specifically can be a hydrophilic material, and the external phase specifically can be a hydrophobic material. The materials are combined so that the internal phase is substantially encapsulated by the external phase such that release can be controlled in relation to osmotic pressure differentials. The suspension can be combined with a carrier, and various systems and products can be formed with the suspension and optional carrier, such as oral strips, spray delivery systems, smokeless tobacco products, aerosol delivery devices, cigarettes, and packaging.

Claims

1. A delivery composition comprising:

(a) a carrier; and

(b) an aggregate of microcapsules each formed of an external phase surrounding an internal phase as a hydraulic encapsulation such that there is a pressure differential between the internal phase and an external environment at a site of delivery;

wherein the internal phase is hydrophilic and comprises a material selected from the group consisting of nicotine, flavorants, humectants, tobacco extracts, water, and combinations thereof; and

wherein the external phase is hydrophobic, comprises a lipid, and forms a substantially wall-like structure that is pseudoplastic and is non-collapsible.

2. The composition of claim 1, wherein the internal phase material is a liquid.

3. The composition of claim 1, wherein the aggregate of microcapsules is bioadhesive.

4. The composition of claim 1, wherein the carrier is a solid.

5. The composition of claim 4, wherein the solid carrier is dissolvable under mouth conditions.

6. The composition of claim 4, wherein the solid carrier is a gum or a lozenge.

7. The composition of claim 4, wherein the solid carrier is an oral thin film.

8. The composition of claim 7, wherein the composition is a layered construct comprising a first thin film, a second thin film, and the aggregate of microcapsules positioned between the first thin and the second thin film.

9. The composition of claim 8, wherein one of the first thin film and the second thin film is dissolvable under mouth conditions and the other is substantially non-dissolvable under mouth conditions.

10. The composition of claim 8, wherein both of the first thin film and the second thin film are dissolvable under mouth conditions and wherein under the same mouth conditions, one of the first thin film and the second thin film dissolves at a rate that is faster than the other by a rate of about 10% or greater.

11. The composition of claim 7, wherein the aggregate of microcapsules is dispersed in the oral thin film.

12. The composition of claim 1, wherein the hydraulic encapsulation is configured for controlled release of the internal phase from the external phase based upon the pressure differential between the internal phase and the external environment at the site of delivery.

13. The composition of claim 12, wherein the pressure differential is between the internal phase and saliva in the mouth of the user.

14. The composition of claim 1, wherein each microcapsule in the aggregate of microcapsules comprises about 50% to about 98% by weight of the internal phase material based on the total weight of the hydraulic encapsulation.

15. An oral strip comprising:

at least a first thin film; and

an aggregate of microcapsules each formed of an internal phase surrounded by an external phase in the form of a hydraulic encapsulation such that there is a pressure differential between the internal phase and an external environment at a site of delivery;

wherein the internal phase is hydrophilic and comprises material selected from the group consisting of nicotine, flavorants, humectants, tobacco extracts, and combinations thereof; and

wherein the external phase is hydrophobic, comprises a lipid, and forms a substantially wall-like structure that is pseudoplastic and is non-collapsible.

16. The oral strip of claim 15, wherein the aggregate of microcapsules is dispersed in the at least one first thin film.

17. The oral strip of claim 15, comprising a first thin film and second thin film, wherein the aggregate of microcapsules is positioned between the first thin and the second thin film.

18. The composition of claim 15, wherein each microcapsule in the aggregate of microcapsules comprises about 50% to about 98% by weight of the internal phase material based on the total weight of the hydraulic encapsulation.