This disclosure provides a chewing gum composition comprising an herbal extract comprising isoflavones and a gum base. The disclosure also provides methods of treating symptoms associated with menopause comprising administering to a subject in need thereof, a gum-based composition for chewing, the composition comprising an herbal extract comprising isoflavones and a gum base.

This disclosure provides a chewing gum composition comprising an herbal extract comprising isoflavones and a gum base. The disclosure also provides methods of treating symptoms associated with menopause comprising administering to a subject in need thereof, a gum-based composition for chewing, the composition comprising an herbal extract comprising isoflavones and a gum base.

The present invention defines a process for forming a chewable oral dosage form, such as a gum having a pleasant flavor and texture. In particular, the invention includes a process of forming an oral dosage form, comprising: a first step of hydrating a gelling agent of agar-agar and locust bean gum; a second step of mixing in components of the agar matrix; a third step of mixing in an active ingredient; a fourth step of cooking the mixture; a fifth step of flavoring; a sixth step of moulding and gelling; and a seventh step of demoulding, degreasing and drying. The oral dosage form according to the invention also comprises an agar-agar matrix combined with gums, such as locust bean gum, and/or sugar; glycerol; inulin; flavoring agents; citric acid; a coating; and water, to complete the composition, which includes active ingredients.

A tableted chewing gum composition for oral administration of cannabinoids includes a plurality of particles, including a first population of particles having water-insoluble gum base and a second population of particles having water-soluble chewing gum ingredients. The composition constitutes at least two layers, where a first layer of the composition has water-insoluble gum base and a second layer of the composition, which is cohered to and adjacent to the first layer, has water-soluble chewing gum ingredients. The second layer is free of water-insoluble gum base, and the composition includes one or more cannabinoids.

A tableted chewing gum composition for oral administration of cannabinoids includes a plurality of particles, including a first population of particles having water-insoluble gum base and a second population of particles having water-soluble chewing gum ingredients. The composition constitutes at least two layers, where a first layer of the composition has water-insoluble gum base and a second layer of the composition, which is cohered to and adjacent to the first layer, has water-soluble chewing gum ingredients. The second layer is free of water-insoluble gum base, and the composition includes one or more cannabinoids.

An improved method for manufacture of chewing gums containing active ingredient(s) that preserves the efficacy of the active ingredient(s) by avoiding exposure to high heat and extreme cold during milling that can otherwise degrade the active's efficacy. A chewing gum base is used, along with one or more therapeutically-active ingredients, one or more sweeteners (alcohol-based and/or natural), and one or more flavorings and optional flavor modifiers. The method generally comprises heating the gum base in ovens to melt the gum base. Separately, the active ingredient(s), sweeteners and flavorings are combined in a mixer. The melted gum base is added to the mixer and cools to produce a particulate mixture. As mixing continues the mass cools to room temperature and forms granular pieces. The granular pieces are ground into a powder at room temperature, mixed at room temperature with tableting excipients, and tableted. Several variations on the foregoing are also described.

An improved method for manufacture of chewing gums containing active ingredient(s) that preserves the efficacy of the active ingredient(s) by avoiding exposure to high heat and extreme cold during milling that can otherwise degrade the active's efficacy. A chewing gum base is used, along with one or more therapeutically-active ingredients, one or more sweeteners (alcohol-based and/or natural), and one or more flavorings and optional flavor modifiers. The method generally comprises heating the gum base in ovens to melt the gum base. Separately, the active ingredient(s), sweeteners and flavorings are combined in a mixer. The melted gum base is added to the mixer and cools to produce a particulate mixture. As mixing continues the mass cools to room temperature and forms granular pieces. The granular pieces are ground into a powder at room temperature, mixed at room temperature with tableting excipients, and tableted. Several variations on the foregoing are also described.

The present invention relates to a chewing gum for mucosal delivery of cannabinoids, the chewing gum being formulated as an extruded chewing gum including water-soluble chewing gum ingredients mixed into water-insoluble gum base, wherein the gum base has one or more natural resins in an amount of 10-40% by weight of the gum base, one or more elastomers in an amount of 3-30% by weight of the gum base, and one or more elastomer plasticizers in an amount of 8-50% by weight of the gum base, and wherein the one or more elastomer plasticizers includes one or more polyvinyl acetate elastomer plasticizers in an amount of 8-50% by weight of the gum base, and wherein the chewing gum has one or more cannabinoids.

The present invention relates to a chewing gum for mucosal delivery of cannabinoids, the chewing gum being formulated as an extruded chewing gum including water-soluble chewing gum ingredients mixed into water-insoluble gum base, wherein the gum base has one or more natural resins in an amount of 10-40% by weight of the gum base, one or more elastomers in an amount of 3-30% by weight of the gum base, and one or more elastomer plasticizers in an amount of 8-50% by weight of the gum base, and wherein the one or more elastomer plasticizers includes one or more polyvinyl acetate elastomer plasticizers in an amount of 8-50% by weight of the gum base, and wherein the chewing gum has one or more cannabinoids.

A pharmaceutical tablet for use in administering one or more pharmaceutically active ingredients, comprising a polymer system, the one or more pharmaceutically active ingredients, a flavor, and a sweetener, wherein at least 20% by weight of the pharmaceutical tablet comprises substantially non-elastomeric polymer and less than 5% by weight of the pharmaceutical tablet comprises one or a combination of elastomeric polymers, and wherein the pharmaceutical tablet comprises at least 70% by weight of said polymer system comprising polyvinyl acetate (PVA) and less than 10% by weight of said polymer system comprising polymer having a molecular weight (Mw) greater than 50,000 g/mol.