Edible, chewable matrix for the oral administration of biologically active substances

Abstract

An edible, chewable dosage form with a coherent, structurally stable matrix body, characterized in that the matrix body is formed from plant-based base components which, as a result of targeted processing, form a dense, elastic network structure, wherein the matrix body exhibits a two-phase rheological behavior during chewing, such that in a first chewing phase, water-soluble substances located near the surface are released by the saliva produced, and in a second chewing phase, an elastic, coherent chewing mass remains, thereby enabling a prolonged chewing duration, a sustained stimulation of physiological saliva secretion, and oral absorption of the substances without simultaneous liquid intake.

Description

Technical field

[0001] The invention relates to an edible, chewable dosage form for the oral administration of biologically active, water-soluble substances. It comprises a cohesive matrix body that retains its structural coherence in the mouth during chewing and does not disintegrate due to saliva. The water-soluble substances are arranged such that they are released by the saliva produced during chewing.

[0002] The prolonged chewing time stimulates sustained physiological saliva secretion, with the saliva acting as a natural solvent and transport medium for the released substances, enabling their swallowing without simultaneous liquid intake. The matrix body serves both as an edible carrier for the substances and as a stimulator of saliva production, and is entirely edible. State of the art

[0003] Various oral dosage forms of biologically active substances are known, such as tablets, capsules, powders, granules, lozenges, or chewing gum. Tablets and capsules generally require ingestion with liquid, while powders and granules have disadvantages in terms of dosage, taste, and handling.

[0004] Candies dissolve completely in the mouth and remain there only briefly. Chewing gum, while designed for longer chewing, is not swallowable and does not serve as an edible carrier matrix for biological substances.

[0005] Common snacks and carbohydrate-rich bars are usually chewed quickly and swallowed immediately. As a result, they only come into brief contact with saliva and are hardly predigested enzymatically. This leads to rapid absorption of the carbohydrates and a rapid rise in blood sugar levels, which is not always physiologically optimal. Objective of the invention

[0006] The object of the invention is to provide an edible, chewable dosage form that enables the oral ingestion of water-soluble substances without simultaneous liquid intake. The dosage form should prolong the chewing process and stimulate sustained salivation, so that the saliva serves as a solvent and transport medium for the released substances. Furthermore, the object is to provide a matrix that maintains its structural coherence during chewing and remains as an elastic chewing mass after the release of the water-soluble substances. The dosage form should consist of food-grade, preferably plant-based, base components, be sensorially acceptable and swallowable, and be producible using conventional food technology processes and suitable for economical, scalable production.Another object of the invention is to provide a dosage form that serves as a physiologically suitable carrier for biologically active substances and can also be used for the production of calorie-reduced chewable snacks. Summary of the invention

[0007] The invention relates to an edible, chewable matrix made of grain-based components with a cohesive, protein-based network structure. The matrix exhibits two-phase rheological behavior: First phase: The matrix has a dense, food-like consistency that allows for biting and initial chewing. Water-soluble substances located near the surface are released by the saliva produced during chewing. Second phase: An elastic, coherent chewing mass remains, which is not completely soluble in saliva and retains its structural integrity. The prolonged chewing motion causes sustained stimulation of physiological saliva secretion, thereby facilitating the absorption of the substances without simultaneous liquid intake. The matrix thus fulfills the function of both a carrier for the substances and a stimulator of saliva production and is completely edible.The chewable dosage form based on this matrix also has a reduced calorie density compared to conventional, rapidly disintegrating snacks. Properties of the matrix

[0008] The matrix is ​​elastically deformable under mechanical stress without losing its structural integrity. It differs significantly from conventional snacks, bars, or confectionery that quickly disintegrate or soften in the mouth, as well as from dried doughs, baked goods, fully soluble sweets, and chewing gum. The matrix remains chewable and coherent after the substances are released. After the water-soluble components are leached out, the matrix reduces its volume and transforms into an edible, elastic chewing mass that remains structurally stable for an extended period during chewing and stimulates pronounced salivation. Material composition

[0009] Protein fraction: 10-30 wt% of dry matter, plant-based, preferably from cereals (wheat, spelt), to form a load-bearing, elastic network. Carbohydrate fraction: 30-60 wt%, especially flours, milled products, starches, or mixtures, supports initial chewiness and food-like consistency. Soluble carbohydrates: small amounts for sensory enhancement without affecting the matrix structure. Water content: 8-12 wt%, ensures storage stability while maintaining chewability. Structural and functional properties 1. First phase: Compact, food-like mass; biting and initial chewing possible; surface substances are released by saliva. 2. Second phase: Elastic, coherent chewing mass remains; not completely soluble; prolonged chewing time of ≥1 minute, preferably 2-5 minutes. Physiological effect

[0010] Prolonged chewing increases saliva production; saliva serves as a transport medium for released substances, moistens and enzymatically pre-processes the matrix components, thereby supporting physiological absorption. Note regarding the manufacturing description

[0011] The following steps for manufacturing and structurally fixing the matrix body serve solely to illustrate possible embodiments. Manufacturing processes are not eligible for protection under a utility model and therefore do not constitute the subject matter of protection. The matrix body obtainable through the process is protected as the product. For this reason, the manufacturing steps are presented in a simplified, non-disclosing form. Production and thermal structural fixation of the matrix body

[0012] The dry components of the carbohydrate-containing and protein-forming fractions are combined to form a homogeneous starting mixture. With the addition of water, the mixture is processed into a malleable mass in which the protein-forming components are hydrated and structurally activated. The mass is then mechanically processed to form a dense, elastic, and coherent basic structure.

[0013] After a phase of structural pre-stabilization, the mass is shaped and subjected to a thermal treatment that fixes the formed network structure. This thermal structure fixing occurs under conditions that allow for the stabilization of elastic properties without causing baking-related or undesirable texture-altering effects. Upon completion of this process, the resulting matrix body exhibits an elastic, coherent, and chewable structure. arrangement of biologically active substances

[0014] Following structural fixation, functional components are arranged on the surface of the matrix. These include, in particular, biologically active substances, water-soluble components, flavorings, or combinations thereof. The arrangement is preferably in a water-soluble, surface-level region, allowing the substances to come into contact with saliva and be released during the initial chewing phase. The substances are fixed by means of an edible, water-soluble binder layer that dissolves at least partially during chewing without significantly affecting the structural properties of the matrix. The subsequent application of sensitive components increases their stability, while maintaining the extended chewing motion and physiological saliva stimulation.

Claims

[1] Edible, chewable dosage form with a coherent, structurally stable matrix body, characterized by , that the matrix body is formed from plant-based basic components which, as a result of targeted processing, form a dense, elastic network structure, whereby the matrix body exhibits a two-phase rheological behavior during chewing, such that in a first chewing phase, water-soluble substances located near the surface are released by the saliva produced, and in a second chewing phase, an elastic, coherent chewing mass remains, thereby enabling a prolonged chewing duration, a sustained stimulation of physiological saliva secretion, and the oral absorption of the substances without simultaneous liquid intake. [2] Dosage form according to claim 1, characterized by that the basic plant components are suitable for forming a coherent, elastic network structure. [3] Dosage form according to claim 2, characterized by that the basic components include flours, fractions thereof, protein-enriched milled products, pseudocereal-based raw materials or combinations thereof. [4] Dosage form according to any of the preceding claims, characterized by , that at least one biologically active, functional or flavoring substance is located on the surface of the matrix body or in a near-surface, saliva-soluble area. [5] Dosage form according to claim 4, characterized by that the substance is fixed to the matrix body by means of a water-soluble, edible binder layer. [6] Dosage form according to claim 4 or 5, characterized by that the substances are applied after completion of the structure-forming thermal treatment of the matrix body. [7] Dosage form according to any of the preceding claims, characterized bythat the matrix remains chewable for at least one minute after the release of the water-soluble substances. [8] Dosage form according to any of the preceding claims, characterized by , that the matrix body is designed for the oral delivery of water-soluble active components, in particular biologically active substances, food supplements or pharmacologically active substances, and is also suitable as a basis for the production of low-calorie dietary snack products.