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EP-4740755-A1 - SMOKELESS ARTICLE

EP4740755A1EP 4740755 A1EP4740755 A1EP 4740755A1EP-4740755-A1

Abstract

The present invention relates to a smokeless article for oral delivery comprising a pouch enclosing an oral nicotine delivery (OND) formulation, the OND formulation comprising at least two pH regulators selected from the list of sodium carbonate, sodium hydroxide, calcium lactate, sodium phosphate dibasic, sodium citrate, meglumine, ammonia, ammonium carbonate, and calcium carbonate. A method of manufacturing the article and kits comprising the article are also described.

Inventors

  • DAVIES, Zak Paul
  • HALL, STEVEN

Assignees

  • Imperial Tobacco Limited

Dates

Publication Date
20260513
Application Date
20241111

Claims (15)

  1. A smokeless article for oral delivery comprising a pouch enclosing a content, the content comprising at least two pH regulators selected from the list consisting of sodium carbonate, sodium hydroxide, calcium lactate, sodium phosphate dibasic, sodium citrate, meglumine, ammonia, ammonium carbonate, and calcium carbonate.
  2. A smokeless article according to claim 1, wherein the content comprises sodium carbonate and at least one further pH regulator selected from the list consisting of sodium hydroxide, calcium lactate, sodium phosphate dibasic, sodium citrate, meglumine, ammonia, ammonium carbonate, and calcium carbonate.
  3. A smokeless article according to claim 1 or 2, wherein the content comprises between 0.01 and 1 wt.% sodium carbonate.
  4. A smokeless article according to any one of claims 1 to 3, wherein any pH regulator selected from the list consisting of sodium hydroxide, calcium lactate, sodium phosphate dibasic, sodium citrate, meglumine, ammonia, ammonium carbonate, and calcium carbonate is independently present in the content in an amount between 0.01 and 10 wt.%, based on the total weight of the content, such that the content has a pH of between 8 and 9.
  5. A smokeless article according to any one of the preceding claims, wherein the content comprises sodium carbonate and calcium lactate.
  6. A smokeless article according to any one of claims 1 to 4, wherein the content comprises sodium carbonate and sodium phosphate dibasic.
  7. A smokeless article according to any one of claims 1 to 4, wherein the content comprises sodium carbonate and sodium hydroxide.
  8. A smokeless article according to any one of claims 1 to 4, wherein the content comprises sodium carbonate and sodium citrate.
  9. A smokeless article according to any one of claims 1 to 4, wherein the content comprises sodium carbonate and meglumine.
  10. The smokeless article according to any one of the preceding claims, wherein the smokeless article comprises less than 5 wt.% tobacco.
  11. The smokeless article according to claim 10, which is free of tobacco.
  12. The smokeless article according to any one of the preceding claims, wherein the content comprises an active agent which comprises or consists of a nicotinic compound.
  13. The use of sodium carbonate and at least one further pH regulator selected from the list consisting of sodium hydroxide, calcium lactate, sodium phosphate dibasic, sodium citrate, meglumine, ammonia, ammonium carbonate, and calcium carbonate, in a smokeless article for oral delivery to improve nicotine absorption through the oral mucosa, and/or improve pH stability, and/or improve shelf life; optionally wherein the smokeless article is according to any one of claims 1 to 12.
  14. A method of manufacturing a smokeless article according to any one of claims 1 to 12 comprising the steps of: (i) forming one or more sheets of pouch material around the contents; and, (ii) thermally or chemically sealing the pouch material to enclose the contents.
  15. A kit comprising a plurality of smokeless articles according to any one of claims 1 to 12 and a container.

Description

FIELD The present disclosure relates to a smokeless article. In particular, the disclosure relates to a smokeless article for oral delivery comprising a pouch enclosing a content which comprises nicotine for oral delivery. This disclosure also relates to methods of manufacturing the smokeless article. BACKGROUND Smokeless articles are placed in the mouth where saliva extracts the soluble element from the content contained within. Typically, the smokeless article is placed in the oral cavity, sublingually or in the oral vestibule (between the teeth and lips/cheeks). The user may assist extraction by oral manipulation, such as by chewing and/or sucking or pressing on the outside of the mouth to squeeze the pouch. There is a need for improved design of smokeless articles to enhance the user experience and improve the function of its constituent components. The present disclosure has been devised in the light of the above considerations. SUMMARY At its most general, the present disclosure relates to a smokeless article e.g. an oral nicotine delivery (OND) article, for oral use. The present disclosure provides, in a first aspect, a smokeless article for oral delivery comprising a pouch enclosing a content, e.g., an oral nicotine delivery (OND) formulation. The content comprises at least two pH regulators selected from the list of sodium carbonate, sodium hydroxide, calcium lactate, sodium phosphate dibasic, sodium citrate, meglumine, ammonia, ammonium carbonate, and calcium carbonate. A smokeless article comprising a content comprising at least two pH regulators selected from the list of sodium carbonate, sodium hydroxide, calcium lactate, sodium phosphate dibasic, sodium citrate, meglumine, ammonia, ammonium carbonate, and calcium carbonate leads to improved properties of the content and the article itself. Without being bound by any theory, the pH of an OND formulation is thought to affect nicotine absorption through the oral mucosa. It is important for smokeless articles to provide good nicotine absorption for a good user experience. In addition, it is preferred that the pH does not vary significantly over time before use, as this can reduce the shelf-life of a smokeless article. For the user to extract the nicotine and, for example, get good absorption of nicotine through the oral mucosa, the pH of the content is preferably within a range allowing it to easily cross the mucous membranes. For instance, under acidic conditions, nicotine is protonated and does not readily cross mucous membranes. The resultant content as described herein has a pH value that is well controlled and more stable over time due to the combination of the pH regulators in the content. Comparatively, smokeless articles that only contain one pH regulator may experience a drop in pH over time prior to use. The improved stability of the pH of the content is advantageous because it ensures that the content maintains the correct pH for good nicotine absorption through the oral mucosa over time. This improves the shelf-life of the content. If the pH drops over time, then when the article is used the nicotine absorption is worse, so the shelf-life of the products is shortened. In addition, the nicotine absorption through the oral mucosa may be improved by using the combination of at least two pH regulators selected from the list of sodium carbonate, sodium hydroxide, calcium lactate, sodium phosphate dibasic, sodium citrate, meglumine, ammonia, ammonium carbonate, and calcium carbonate in the content as it gives better pH control to enable optimum bioavailability and uptake of the active compound. Therefore, the user's perception of the active ingredient is improved, e.g. an improved, stronger, nicotine perception. The term "sodium carbonate" may be used to refer to sodium bicarbonate, sodium carbonate, and mixtures thereof. As used herein, the terms "pH regulator", "buffer", "pH stabiliser", "pH modifier", and "pH adjuster" interchangeably refer to components of the content used to control the pH. Within these definitions, the terms "pH regulator", "buffer" and "pH stabiliser" refer to compounds that have the capacity to resist pH change to some level so providing some ability to maintain pH in a specific buffer range as compared to just altering the pH. In preferred embodiments herein, buffering activity is provided so "pH regulators", "buffers" and "pH stabilisers" are preferred. In general, pH regulators, buffers, pH stabilisers, pH modifiers, and pH adjusters are provided to adjust the user experience and/or modify the bioavailability of a pharmacologically active compound. The overall pH of the smokeless article is preferably pH 7 to pH 10, such as pH 7.5 to pH 9.5, pH 7.75 to pH 9.25, pH 8 to pH 9, or pH 7.5 to pH 8.5. Preferred pH ranges provide good nicotine absorption conditions without causing detriment to the user experience, e.g., without the content causing irritation due to its alkalinity. The overall pH of a smokeless article ma