Interconnected Active Ingredient Containing Pouches

This application is a continuation of U.S. application Ser. No. 18/806,449, filed Aug. 15, 2024, which application is a continuation of U.S. application Ser. No. 17/250,423 filed on Jan. 19, 2021, which application is a U.S. National Phase Application to PCT/EP2019/069559, filed Jul. 19, 2019, which application claims priority to Denmark application PA 2018 70490 filed Jul. 19, 2018. The entire contents of which are hereby expressly incorporated by reference in their entirety including, without limitation, the specification, claims, and abstract, as well as any figures, tables, or drawings thereof.

The present invention relates to interconnected pouches comprising an active ingredient containing composition.

Buccal administration is a well-known technique for the administration of pharmacologically active ingredients, especially nicotine and nicotine-like stimulants. Nicotine replacement therapy (NRT) is a medically-approved way to take nicotine as a method to quit smoking. Known ways of administering NRT are for example by means of nicotine patches, nicotine lozenges, or nicotine pouches similar to snus pouches, adapted to be placed between the gum and the upper lip. Thereby, nicotine contained in said pouches may be absorbed by the user through the oral mucosa. The amount of nicotine in each NRT pouch is often relatively low compared with the nicotine content of tobacco products such as snus. A similar product is pouches/sachets containing snus, a way to consume tobacco without burning said tobacco. Snus is a traditional Swedish product being a moist mixture of tobacco that is mostly placed between the gum and the upper lip. Thereby, nicotine contained in said snus may be absorbed by the user through the oral mucosa. Thus, snus is a way to absorb nicotine without the inhalation of smoke. Another similar format is pouches/sachets containing nicotine without tobacco and without medical approval, sometimes named nicopods. The nicopods are mostly placed between the gum and the upper lip. Thereby, nicotine contained in said snus may be absorbed by the user through the oral mucosa. The term nicotine-containing product is used herein to collectively describe all different formats.

Those only wishing to consume a small quantity of nicotine can do that by using one nicotine-containing product while others preferring larger portions could consume two or more nicotine containing products at the same time to achieve the desired effect.

The same reasoning applies to a large range of other active ingredients suitable for buccal administration, e.g. medicinal products, and also nicotine-free tobacco substitutes that act by replacing the sensation of nicotine and tobacco through the addition of other components in a pouch format.

The problem of having two or more pouches in the mouth at the same time is that they can be difficult to keep in place. The consumer would be benefited by a stable placement of the pouches underneath the lip as this concentrates the composition to one place and prevents dilution and/or swallowing.

The object of the invention is to solve some of the above-mentioned problems. According to a broad aspect of the invention, an active ingredient-containing product suitable for the release of an active ingredient comprising an outer water-permeable pouch chamber containing an active ingredient-containing composition is disclosed. The product is characterised in that said pouch chamber is interconnected to another pouch chamber containing the same or another composition, thereby resulting in at least two interconnected pouch chambers each comprising a composition and wherein a separation section separates one pouch chamber from another.

It is to be understood that this invention is not limited to the particular configurations, process steps, and materials disclosed herein as such configurations, process steps, and materials may vary somewhat. It is also to be understood that the terminology employed herein is used for the purpose of describing particular embodiments only and is not intended to be limiting since the scope of the present invention will be limited only by the appended claims and equivalents thereof.

It must be noted that, as used in this specification and the claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates other-wise.

In this specification, unless otherwise stated, the term “about” modifying the quantity of an ingredient in the active ingredient-containing product or composition or package of the invention or employed in the methods of the invention refers to variation in the numerical quantity that can occur, for example, through typical measuring and liquid handling procedures used for making concentrates or use solutions in the real world; through inadvertent error in these procedures; through differences in the manufacture, source, or purity of the ingredients employed to make the active ingredient-containing products or compositions, or to carry out the methods; and the like. The term “about” also encompasses amounts that differ due to different equilibrium conditions for a composition resulting from a particular initial mixture. Whether or not modified by the term “about”, the claims include equivalents to the quantities.

The ranges provided herein provide preferred amounts of each of the components. Each of these ranges may be taken alone or combined with one or more other component ranges to provide a preferred aspect of the invention.

According to an aspect of the invention, there is provided an active ingredient-containing product suitable for the release of an active ingredient, said active ingredient-containing product comprising an outer water-permeable pouch chamber containing an active ingredient-containing composition; wherein said pouch chamber is interconnected to another pouch chamber containing the same or another composition, thereby resulting in at least two interconnected pouch chambers each comprising a composition and wherein a separation section separates one pouch chamber from another, wherein each pouch chamber has a length of from about 1 mm to about 40 mm and a width of no greater than about 10 mm.

By an active ingredient-containing product is meant a product containing one or more active ingredients. Active ingredients are characterised by having a pharmacological effect and may include nicotine, nicotine salts (e.g. nicotine ditartrate/nicotine bitartrate), nicotine-free tobacco substitutes, other alkaloids such as caffeine, medicinal products, or essential nutrients. Medicinal products may include painkillers, allergy alleviating substances, or substances to treat motion sickness. Essential nutrients may include vitamins and/or minerals. Common for these types of active ingredients are their ability to be absorbed through the oral mucosa/gums or their ability to be dissolved in a liquid, e.g. water or have a local effect or sensation, such as nicotine-free tobacco substitutes. The active ingredient is contained in an active ingredient-containing composition. Thus, said active ingredient-containing composition is embodied in the active ingredient-containing product. When using nicotine for the active ingredient, said nicotine may be contained as part of nicotine replacement therapy (NRT), tobacco snus, or tobacco free nicotine products without medical approval. In case of using nicotine being part of NRT, the product may be considered a nicotine-containing pharmaceutical product. Likewise, in general, the active ingredient-containing product may be considered a nicotine-containing product when used with nicotine. NRT is a medically-approved way to take nicotine by means other than tobacco. It is used to help with quitting smoking. Thus, the active ingredient-containing product according to the invention may be used with a NRT composition, with tobacco, nicotine-free tobacco substitutes and with tobacco free nicotine. Further, the active ingredient-containing product may be used for medicinal purposes when used with medicinal substances, e.g. painkillers.

In some embodiments, the active ingredient containing product comprises an active-ingredient containing composition that comprises nicotine or a nicotine-free tobacco substitute. The nicotine may be contained as part of nicotine replacement therapy (NRT), tobacco snus, or tobacco free nicotine products without medical approval. In case of using nicotine being part of NRT, the product may be considered a nicotine-containing pharmaceutical product. Likewise, in general, the active ingredient-containing product may be considered a nicotine-containing product when used with nicotine. NRT is a medically-approved way to take nicotine by means other than tobacco. It is used to help with quitting smoking. Thus, the active ingredient-containing product according to the invention may be used with a NRT composition, with tobacco, nicotine-free tobacco substitutes and with tobacco-free nicotine. The active ingredient-containing product may thus be a nicotine-containing product or a nicotine-free tobacco substitute product.

By a product being suitable for the release of active ingredients is meant a product allowing such active ingredients to be contained, yet free to be released through/across such accommodation. For example, the product may be suitable for buccal administration, i.e. the product is configured for insertion in the mouth of a user, i.e. a product having dimensions making it possible to insert and accommodate said product in the mouth, preferably between the gum and the upper lip. For example, each pouch chamber according to the invention may have dimensions on the order of 1-4 cm. For example, each pouch chamber may have a length of more than 3 cm, e.g. 3.5 cm or 4 cm.

Each pouch chamber may have a length of from about 1 mm to about 40 mm and a width of no greater than about 10 mm. In some embodiments, each pouch chamber may have a width of less than about 10 mm. In some embodiments, each pouch chamber may have a width of from about 1 mm to about 10 mm, such as a width of from about 3 mm to about 10 mm, such as a width of from about 3 mm to about 9.5 mm, such as a width of from about 3 mm to about 9 mm, such as a width of from about 5 mm to about 9 mm, such as a width of from about 5 mm to about 7 mm. In some embodiments, each pouch chamber may have a width of from about 7 mm to about 9 mm.

In some embodiments, each pouch chamber may have a length of from about 20 mm to about 40 mm and a width of no greater than about 10 mm. In some embodiments, each pouch chamber may have a length of from about 25 mm to about 40 mm and a width of no greater than about 10 mm.

In some embodiments, the ratio of length to width of each pouch chamber is from about 3 to about 6, such as from about 3 to about 5, such as from about 3.5 to about 4.5.

In some embodiments, the thickness of each pouch chamber may be from about 2 mm to about 8 mm, such as from about 3 mm to about 7 mm, such as from about 4 mm to about 6 mm. In some embodiments, the thickness of each pouch chamber may be from about 2 mm to about 3 mm. The thickness of each pouch chamber may also be referred to as the “height” of the chamber, and is the dimension in a direction perpendicular to the width of the pouch chamber. The thickness may be measured as the height of the pouch chamber (in a non-compressed state) at the centre of the length of the pouch chamber, i.e. at half the maximum length of the pouch chamber.

Likewise, the product may be suitable for immersion in liquid, whereby it is meant that the design and material choice of the product allow for such immersion, and where the active ingredient-containing composition is contained within the disclosed water-permeable pouch chamber. Hence, the active ingredient may be allowed to dissolve in or to be released into said liquid. The liquid may be water. Thus, the product may resemble a tea bag. Thus, the product allows for containing an active ingredient-containing composition, which may pass through the disclosed water-permeable pouch to be dissolved by liquid, e.g. saliva of the mouth in buccal administration or water in a glass during immersion. In other words, the product is suitable for containing an at least partly dissolvable composition, where components of said composition may pass through the water-permeable pouch chamber.

By a water-permeable pouch chamber is meant a pouch chamber comprising walls made of a water-permeable material, e.g. a textile or paper-like membrane. During use, due to the generation and presence of saliva (a fluid high in water) in the mouth, the pouch chamber is soaked over time, accelerating the release of components of the composition contained in said pouch chamber. Likewise, if immersing the product in a liquid, the release of components is likewise accelerated. During the manufacturing process, the active ingredient-containing composition is disposed within each pouch, whereupon said pouch is scaled, such that a chamber containing said active ingredient-containing composition is formed.

By the pouch chamber being interconnected to another pouch chamber is meant that at least two pouch chambers are connected. By means of the disclosed separation section, said pouch chambers are physically connected, but the content of the first pouch chamber is not in contact with the content of the second pouch chamber. Rather, the pouch chambers are connected by means of a section made of the water-permeable material, where said section may be made by means of welding said material together. In other words, the content of the first pouch chamber is not in communication with the content of the second pouch chamber.

In some embodiments, the pouch chambers may be connected by means of a section made of the water-permeable material. In some embodiment, the separation section may be made by means of welding said material together.

Preferably, more than two pouches chambers are interconnected. For example, 10, 15, or 20 pouch chambers may be interconnected by means of a separation section according to the invention. The pouch chamber is referred to as a pouch for the remaining part of this document. Due to the separation section, the product may attain an uneven thickness (thickness variation), which, in combination with its flexibility, improves the case of accommodation under the lip, as said lip adapts to the thickness variation, thereby holding the product in place better than what may be experienced in products not comprising such a separation section.

Thereby, the user may more easily dispense the amount of the active ingredient-containing composition. For example, each of the pouches may contain an amount of active ingredient-containing composition not fulfilling the needs of most users, but due to said pouches being interconnected, the user may choose to tear off/detach two or more of said pouches, such that said user reaches his/her desired amount. Such customisation is particularly relevant for use with nicotine-containing compositions, where the needs are highly individual for each user. Thus, each of said pouches may be relatively small, which would be unpleasant to store in the mouth due to the risk of loss, but due to the provision of interconnected pouches, the product is more easily handled in the mouth. For example, most users may dispense two or three pouches at a time in order to fulfil his/her needs, whereby the pouches become easier to control in the mouth, due to their interconnected nature. Likewise, for immersion in a liquid, prompting the release of the active ingredient into said liquid, the user may easily adjust the amount by tearing off the desired number of pouches, which are thereby still interconnected, casing the handling.

Therefore, in some embodiments, the separation section is made of the water-permeable material and each pouch chamber may have a length of from about 1 mm to about 40 mm and a width of no greater than about 10 mm, such as a length of from about 1 mm to about 40 mm and a width of from about 3 mm to about 10 mm.

Further, the storing of the product in a container is cased, which in turn provides an enhanced aesthetical/visual impression, due to said pouches being interconnected. Further, the product according to the invention allows for the use of smaller storing containers, since the packaging procedure may be optimised and due to the pouches behaving in a predictable manner during packaging due to their interconnected nature.

Further, the product may be less appealing to children, since the pouches are interconnected in a large row or array according to the invention, which does not readily express a product intended for oral use or individual use in general.

In an embodiment, the product may comprise at least three pouch chambers and wherein opposing sides of one pouch chamber are connected to two other pouch chambers on opposing sides.

By opposing sides, it is understood that said pouches may be polygonally shaped, e.g. rectangular. Thereby, the product may resemble a row or chain of interconnected pouches. Said row may comprise more than three pouches, e.g. 10, 15 or 20 pouches being interconnected. During a packaging process, using interconnected pouches allows for using length as a determining factor when determining the number of pouches to go into each package. Using length as the determining factor, e.g. instead of counting or mass, may be easier in certain configurations of the packaging machinery. For example, using length is easier than to integrate a scale for measuring the mass of the pouches in each package.

In an embodiment, the product may comprise at least three pouch chambers and wherein neighbouring sides of one pouch chamber are connected to two other pouch chambers on neighbouring sides.

In some embodiments, the product comprises at least three pouch chambers, wherein two neighbouring sides of one pouch chamber are each connected to distinct pouch chambers. In some embodiments, the product comprises at least four pouch chambers, wherein three neighbouring sides of on pouch chamber are connected to three other pouch chambers.

Thereby, the product may form an array of interconnected pouch chambers. Such array of pouch chambers may allow for certain advantages in the packaging procedure, including space optimisation and aesthetical features. The area or dimensions of the array may be used to determine the number of pouches, such that the packaging procedure may be optimised. The array may be considered a two-dimensional sheet of pouches being interconnected.

In an embodiment, the separation section may comprise a separation line. By a separation line is meant a line easing the detachment of one pouch chamber from another. Preferably, the separation line is of a strength such that one pouch chamber is not detached from another during use. One should bear in mind that the strength may decrease once the water-permeable material used to form the pouch, and thereby the separation section, is soaked with liquid/saliva.

In an embodiment, the separation line may comprise a row of perforations or holes enabling detachment of the one pouch chamber form the other pouch chamber by ripping. In an embodiment, the separation line may comprise a row of perforations or holes enabling detachment of the one pouch chamber form the other pouch chamber by ripping, tearing or cutting.

Thereby, a convenient and easy-to-use separation line may be employed.

In an embodiment, the separation section may be made by welding opposite pouch surfaces together, whereby the separation section is a welding section between neighbouring pouch chambers.

The pouches may be made from a long tube of the desired water-permeable material, where sidewalls of said tube are welded together, in a way such that no active ingredient-containing composition is arranged within the formed welding section. Instead, the welding section ensures that said active ingredient-containing composition is contained within the individual pouch chambers defined by said welding section and the sidewalls.

In an embodiment, the welding section may be shaped ensuring an efficient separation and minimizing the area of the separation section.

For example, the welding section may be curved, which may ease the process of detaching the interconnected pouches from each other. Alternatively, the welding section may have a width being smaller than a width of each pouch, such that the user does not need to tear a great distance. Such shape reduces the amount of material used.

In an embodiment, the at least two interconnected pouch chambers may comprise a first and a second composition, respectively, wherein said first composition is different from said second composition. In some embodiments, at least one of the first and second compositions comprises nicotine or a nicotine-free tobacco substitute.

In other words, the first pouch may comprise a first composition, whereas the second pouch may comprise a second composition being different from the first composition.

Thereby, the user is capable of mixing the pouches he/she inserts into the mouth/immerses in liquid, while keeping said pouches interconnected, such that they are more easily accommodated in said mouth/liquid. A division of the content within each of said the pouches may be beneficial in case said content is not suitable for mixing prior to use, or if the user wants to control what combinations he/she wants.

In some embodiments, at least one of the active ingredient-containing compositions comprises a flavouring agent. For example, the flavouring agent may be included in the same active ingredient-containing composition as the nicotine and/or tobacco substitute.

Alternatively, the first active ingredient-containing composition may comprise nicotine and/or tobacco substitute, and the second active ingredient-containing composition may comprise the flavouring agent.

In an embodiment, the first composition may be a flavour composition. As used herein, the terms “flavour” and “flavourant” refer to materials which, where local regulations permit, may be used to create a desired taste or aroma in a product for adult consumers. They may include extracts (e.g., licorice, hydrangea, Japanese white bark magnolia leaf, chamomile, fenugreek, clove, menthol, Japanese mint, aniseed, cinnamon, herb, wintergreen, cherry, berry, peach, apple, Drambuie, bourbon, scotch, whiskey, spearmint, peppermint, lavender, cardamom, celery, cascarilla, nutmeg, sandalwood, bergamot, geranium, honey essence, rose oil, vanilla, lemon oil, orange oil, cassia, caraway, cognac, jasmine, ylang-ylang, sage, fennel, piment, ginger, anise, coriander, coffee, or a mint oil from any species of the genus Mentha), flavour enhancers, bitterness receptor site blockers, sensorial receptor site activators or stimulators, sugars and/or sugar substitutes (e.g., sucralose, acesulfame potassium, aspartame, saccharine, cyclamates, lactose, sucrose, glucose, fructose, sorbitol, or mannitol), and other additives such as charcoal, chlorophyll, minerals, botanicals, or breath freshening agents. They may be imitation, synthetic or natural ingredients or blends thereof. They may be in any suitable form, for example, oil, liquid, or powder.

Alternatively, the first composition may be a mixture of a flavour composition and an active ingredient-containing composition, such that said first composition provides a flavour, on the cost of a reduced amount of the active ingredient-containing composition. Said reduced amount may be compensated by a non-flavoured second composition comprising the pure active ingredient-containing composition. Since the user is capable of dispensing/inserting two interconnected pouches at a time, the case of use is enhanced.

Thereby, the first composition may be suitable for adding a flavour to the experience of the product.

In an embodiment, the product may comprise at least 10 interconnected pouch chambers comprising said first and second interconnected pouches.

Thereby, the product comprises multiple interconnected pouches, e.g. arranged in a row or in an array. Such multiple interconnected pouches may more easily be arranged in a package/container, such that the size of said package/container may be reduced. Likewise, the packaging procedure may be sped up due to the pouches being interconnected and as such behave predictably. Finally, length or area may be used instead of mass or counting when determining the number of pouches during the packaging process.