Heat-resistant, chewable oral formulation having an agar matrix and method for manufacturing the same

Abstract

The present invention defines a method for forming a chewable oral dosage form, such as a gum, having a pleasant flavor and texture. In particular, the present invention comprises a method for forming an oral dosage form comprising: a first step of hydrating a gelling agent of agar and locust bean gum; a second step of mixing an agar matrix component; a third step of mixing an active ingredient; a fourth step of manipulating the mixture; a fifth step of flavoring; a sixth step of molding and gelling; and a seventh step of demolding, degreasing, and drying. The oral dosage form according to the present invention also comprises an active ingredient and completes the composition by including an agar matrix and / or sugar combined with a gum such as locust bean gum; glycerol; inulin; a flavoring agent; citric acid; a coating agent; and water.

Description

Technology Field

[0001] The object of the present invention is a method for forming a chewable oral formulation, such as a gum, having characteristics similar to gelatin and a pleasant texture and taste.

[0002] In particular, the present invention comprises a first step of hydrating agar and locust bean gum gelling agent; a second step of incorporating an agar matrix component; a third step of incorporating an active component; a fourth step of cooking the mixture; a fifth step of flavoring; a sixth step of molding and gelling; and a seventh step of demolding, degreasing, and drying to provide a composition having an agar matrix and locust bean gum, and includes a method for forming an oral formulation with a texture that can be chewed and ingested without difficulty.

[0003] Similarly, the oral formulation according to the present invention comprises an active ingredient and / or a sugar combined with a gum such as locust bean gum; glycerin; inulin; a flavoring agent; citric acid; a coating agent; and water to complete the composition.

[0004] The molded formulation may incorporate a composition based on an active ingredient with nutraceutical or pharmaceutical properties that avoids crosslinking problems, and may incorporate an active ingredient having a melting point of 40°C or higher.

[0005] Similarly, this also includes chewable oral formulations suitable for the intake of active ingredients by vegetarians or people whose culture does not consume animal products.

[0006] Chewable oral formulations are made of an agar matrix and modified in texture so that any type of patient can chew and swallow them.

[0007] Agar matrix chewable oral formulations provide a strong rubbery texture upon deformation based, for example, on packaging, shipping, and ambient temperature.

[0008] With sufficient stability at a temperature of 40°C, which is important in tropical regions, the oral chewable formulation maintains its structure even under these conditions and at the same time maintains a soft texture when chewed, making it an easy alternative for general consumers to consume.

[0009] In addition, the oral masticatory formulation melts at average body temperature and offers excellent flavor release.

[0010] Therefore, a short-textured, chewable oral formulation is provided, forming a stable product that is easy to chew and ingest.

[0011] Above all, oral formulations include active nutritional components such as vitamins, minerals, natural products, plants, and herbs; and active pharmaceutical components such as drugs having therapeutic properties at the levels of the digestive and metabolic systems, cardiovascular, genitourinary and hormonal systems, musculoskeletal, nervous systems, anthelmintics, respiratory systems, analgesics, and antipyretics, and do not exclude all pharmacological substances and drugs considered in the index of drugs included in the Anatomical, Therapeutic, Chemical Classification System (ATC).

[0012] The chewable oral formulation of the agar matrix according to the present invention includes a formulation balanced in a mixture of the aforementioned components, and provides a matrix that can be industrially processed and has stability for a storage life of 2 years.

[0013] Accordingly, the present invention provides an oral form having excellent texture, visual form, and flavor capable of supplying a desired amount of active ingredient, making it applicable to the fields of nutrition or health. Background Technology

[0014] The practice of adding nutrients to easily consumable products dates back to the early 19th century, when French chemist Boussingault recommended adding iodine to table salt in South America to prevent goiter.

[0015] In 1918, Denmark fortified margarine with concentrated vitamin A, and in 1931, whole milk with vitamin D. In the case of cereal, fortification of breakfast cereal began in the mid-20th century, particularly in 1941.

[0016] Another product first manufactured under the name "fortified food" was a mixture of basic flour and fish meal to increase protein intake, and another food fortification process involved adding iodine to milk to prevent hypothyroidism in endemic regions.

[0017] Consumers are increasingly recognizing the need to consume foods that provide functional elements to a diet beneficial for health and well-being. Therefore, what is currently needed is a nutritionally enriched form that helps add good nutrition and meet the nutritional requirements of the human body.

[0018] In Latin America, child malnutrition is generally a recurring social problem affecting the majority of the population regardless of socioeconomic status. Nutritional deficiency is primarily caused by the insufficient intake of food containing nutrients necessary for the body (such as protein, vitamins, minerals, and antioxidants).

[0019] In addition, in some Latin American countries such as Colombia, it has been found that 32.2% of children aged 1-4 and 37.6% of children aged 5-12 suffer from anemia due to malnutrition (Instituto Colombiano de Bienestar Familiar ICBF, 2005), and generally, children are deficient in vitamins because they do not consume foods that provide a balanced diet.

[0020] Various oral formulations are known to have diverse sensory characteristics, and most have been rejected by consumers due to their appearance, taste, and texture.

[0021] There is a development of the latest technology as disclosed in European Patent EP1074183 (Aoki, Miwa et al.), which describes a food gelatin containing 0.3-1.2 wt% agar, 0.01-0.6 wt% xanthan gum, and 0.01-0.6 wt% locust bean gum as a gelling agent, characterized by having granules and a texture similar to sarcocarp, wherein the gelling agent is mixed in an amount exceeding the total amount of xanthan gum and locust bean gum at a ratio of xanthan gum to locust bean gum between 1:4 and 4:1, the mixture is heated to obtain a solution, the solution is then cooled to obtain a gel, and the resulting gel is frozen and thawed to obtain a gum. This development is feasible in the form of a gum and molding, but it is based on animal gelatin and is not suitable for all types of consumers due to its origin, appearance, taste, and texture.

[0022] Another development of this technology is defined in U.S. Patent US7067150 (Farber, Michael et al.), which discloses an oral delivery system for functional ingredients such as drugs, nutritional supplements, plants, and vitamins.

[0023] The delivery system comprises an ingestible matrix in which the functional ingredient is substantially uniformly and completely dispersed and, if the matrix contains one or more carbohydrates, the degradation of the functional ingredient is minimized; one or more sugars, sugar syrups and / or sugar alcohols; one or more hydrocolloids containing gelatin; one or more polyhydric alcohols; one or more monovalent or divalent cation sources; and water.

[0024] The combination of carbohydrates and hydrocolloids in the matrix allows the delivery system to easily retain the solvent components, preventing the solvent from separating from other components of the matrix.

[0025] The present invention also provides a method for manufacturing and using a delivery system. Since this development is also based on a matrix of oral formulations in gelatin of animal origin, it is not a suitable solution for all types of consumers.

[0026] As can be seen from the prior art above, oral formulations that are more accepted by consumers include gum made of gelatin, which is a desirable alternative in pharmaceutical or functional food formulations due to the gelling properties of gelatin. Suitable gelatin substitutes with gelling properties are starch, carrageenan, and agar.

[0027] Agar is an effective plant-derived gelling agent that can produce non-sticky gels with a crispy texture. Agar is Gelidium (Gelidium), Yukema (Euchema) and Gracilaria (Gracilaria) It is made from red algae containing [the ingredient] and, unlike other gelling agents, has special properties, making it applicable to various uses.

[0028] Black agar is situated in a highly dynamic market at the forefront of new consumer demands. Today's consumer trends are characterized by products labeled as verifiable (Non-GMO, Organic, Halal, Kosher), and plant-derived products possess larger verification facilities compared to animal-derived products. Other types of factors to evaluate include religious groups, ethnic groups, vegetarians / vegans, patients, and / or consumers based on health reasons related to their needs.

[0029] In addition, the stability and performance of agar, low sensitivity to heat or moisture, ability to avoid crosslinking, low sensitivity to pH, advantages over reduced water migration from the outside, and high mechanical strength, neutral taste, odorless, transparency / gloss, and easy to chew and consume, are established as alternatives of choice due to physical and chemical properties that favor the production process and generally promote consumer acceptance.

[0030] Meanwhile, with stress, fatigue, and sleep disorders recently becoming one of the biggest problems facing the population, there is a significant demand for the supply of vitamins, minerals, plant-based health functional food compositions, or simple pharmaceutical active ingredients that are easy to consume, and minerals and vitamins are natural alternatives to meet these needs.

[0031] In addition, several clinical and meta-analysis studies have been conducted showing that it has a significant effect on reducing migraines, decreasing the incidence of colorectal cancer, improving calcium absorption in bones, and relieving constipation. Since the daily magnesium intake of the population is insufficient due to changes in dietary habits and a decrease in the magnesium content of food, it is advisable to supplement it.

[0032] Chewable formulations are solutions for administering vitamins, minerals, plant-based health functional food compositions, or active ingredients of simple pharmaceutical properties that are easy to take.

[0033] Chewable formulations such as gums are a comfortable, available, and convenient alternative as dietary supplements because they can be taken at any time, do not require water, and are easy to swallow. However, for active ingredients with a melting point of 40°C or higher, commercially available chewable gel formulations are not a viable alternative.

[0034] Therefore, another important problem to be solved is to create a plant-based chewable oral gel formulation that includes a matrix capable of incorporating an active ingredient with a melting point of 40°C or higher, in addition to forming a plant-based chewable oral formulation, and to overcome the cross-linking problem common in gelatin-based formulations, and no alternative is provided in commercially available chewable gel formulations.

[0035] Purpose of the invention

[0036] Therefore, the first objective of the present invention is to avoid the disadvantages of the prior art.

[0037] More specifically, the primary objective of the present invention is to produce a chewable oral formulation with a plant matrix such as agar and to formulate a natural or synthetic compound having nutritional or pharmaceutical properties within said matrix, the sensory properties of which provide a better experience for consumers.

[0038] In particular, oral formulations having a plant matrix with similar properties compared to animal gelatin can overcome the common cross-linking problem in gelatin formulations and incorporate active ingredients with a melting point of 40°C or higher.

[0039] A less important objective is to form a chewable oral formulation suitable for vegans or people of culture who do not consume animal products, with a texture modified in a way that is easy to chew and easy to ingest for all types of patients.

[0040] Another important objective is to include an agar matrix chewable oral formulation that provides a strong rubbery texture when deformed based on packaging, transportation, and ambient temperature, has significant stability in tropical countries, maintains its shape, maintains a soft texture when chewed upon ingestion, and melts at body temperature while releasing flavor.

[0041] In particular, the object of the present invention is a method for forming a chewable oral formulation comprising: a first step of hydrating a gelling agent of agar and locust bean gum; a second step of incorporating an agar matrix component; a third step of incorporating an active component; a fourth step of manipulating the mixture; a fifth step of flavoring; a sixth step of casting and gelling; and a seventh step of demolding, degreasing, and drying.

[0042] Additionally, an important objective is to form a chewable oral formulation comprising an agar matrix combined with a gum such as locust bean gum and / or sugar; glycerin; inulin; flavoring agents; citric acid; coating agents and water, which comprises active ingredients such as vitamins, minerals, natural, plant and herbal products; and active pharmaceutical ingredients such as drugs having therapeutic properties at the level of the digestive and metabolic systems, cardiovascular, genitourinary and hormonal systems, musculoskeletal system, nervous system, anthelmintics, respiratory system, analgesics and antipyretics, and does not exclude all pharmacological substances and drugs considered in the index of drugs included in the Anatomical, Therapeutic, Chemical Classification System (ATC).

[0043] Novel features considered to be the basis of the present invention are described particularly in the appended claims, and additional advantages thereof will be better understood in the following detailed description together with preferred embodiments.

[0044] Detailed description of the invention

[0045] The object of the present invention is a chewable oral formulation comprising an agar matrix combined with a gum such as locust bean gum and / or sugar; glycerin; inulin; flavoring agent; citric acid; coating agent and water, which comprises active ingredients such as vitamins, minerals, natural, plant and herbal products; and active pharmaceutical ingredients.

[0046] In particular, the present invention includes an oral formulation having a plant matrix to provide a composition based on an active ingredient of functional food or pharmaceutical properties, so as to be able to incorporate an active ingredient having a melting point of 40°C or higher.

[0047] The agar matrix chewable oral formulation provides a rubbery texture that is resistant to deformation due to packaging, transportation, and ambient temperature, and is stable at a temperature of 40°C, which is important in tropical countries. The chewable oral formulation maintains its shape and, at the same time, maintains a soft texture when chewed upon ingestion and has excellent flavor release as it melts at body temperature.

[0048] Therefore, a short-texture, chewable oral formulation is formed, creating a product that is easy to chew and swallow. Agar is gelatin (Gelidium), Yukema (Euchema) and Gracilaria (Gracilaria) It is an unbranched polysaccharide obtained from the cell walls of various species of algae, and depending on the species, characteristic properties and colors are displayed.

[0049] Chemically, agar is a polymer of galactose subunits; it is the result of a mixture of two types of polysaccharides, agaropectin and agarose. The polysaccharides in agar are part of the structure of algal cell walls. In the presence of water, it exhibits gelatinous properties and is widely used as a culture medium in bacteriology.

[0050] However, the present invention aims to use agar for the development of a matrix that provides gelatinous properties to a composition that may contain functional food or pharmaceutical active ingredients. Gum, which is a part thereof, is a resinous substance and a water-soluble polysaccharide with sticky properties, a large molecular weight, and a complex structure. Its viscosity is solid, although it may vary depending on the origin or processing conditions, and it is characterized particularly by elasticity, gel-forming properties, and viscosity-increasing properties; due to these emulsifying, stabilizing, and thickening properties, it is widely used in the food and pharmaceutical industries. Some examples of gums for food and pharmaceutical uses include, but are not limited to, the following: gums extracted from marine plants (e.g., agar and alginate); gums extracted from the seeds of terrestrial plants; gums obtained from exudates of terrestrial plants (e.g., gum arabic, tragacanth gum, karob gum); gums obtained through microbiological processes such as xanthan gum; and other types of gums within this classification that are available and applicable in both industries. Carob gum, which is prominent in the present invention, is a coadjuvant agent that does not increase gel strength in a mixture with agar, but modifies the structure of agar to be similar to gelatin during the process and creates a less short structure at the time of biting.

[0051] For the present invention, the preparation of an oral chewable formulation was developed from a combination of a gelling agent such as agar and a gum such as locust bean gum. Carob gum dissolves in water at 80°C, agar dissolves at 75°C, the melting point of both occurs at 92°C (2,600 ml asl), and gelation begins at 75°C. The combination of agar and locust bean gum is provided under the trademark AGARO ID 300®.

[0052] As the solid content increases in mixtures containing such gelling agents, the gelation temperature also increases. The importance of the point at which gelation begins is that if the process involves the movement of the mixture, the gel that begins to form at high temperatures is sheared, and the final product exhibits a softer texture with low gel strength and a high likelihood of syneresis.

[0053] Various types of natural or artificial sweeteners are used in oral chewable formulations. These natural sweeteners include sugarcane sugar, tapioca syrup, and inulin-based sugars, and also include sweeteners such as stevia that stabilize the matrix of an agar-based gelling agent.

[0054] Sugar-based sweeteners such as sugarcane sugar, tapioca syrup, and inulin allow for a firm gel structure with optimal handling and sensory characteristics. A balance between matrix components and interactions with active ingredients are essential for obtaining a stable gel matrix. Other types of sweeteners are suitable for people with restrictions, such as diabetes.

[0055] Generally, the active ingredient may be selected from active pharmaceutical ingredients such as vitamins, minerals, natural, plant, and herbal products; and drugs having therapeutic properties at the level of the digestive and metabolic systems, cardiovascular, genitourinary and hormonal systems, musculoskeletal, nervous systems, anthelmintics, respiratory systems, analgesics, and antipyretics, and does not exclude all pharmacological substances and drugs considered in the index of the Anatomical, Therapeutic, Chemical Classification System (ATC).

[0056] Among the active ingredients that are particularly selective and suitable for forming the oral chewable formulation of the present invention are vitamins, for example, vitamin D2, vitamin A, vitamin C, vitamin D and derivatives and / or analogs thereof, vitamin E, B complex vitamins such as vitamin B1, B3, B5, B9 and B12, and vitamin K2, etc.

[0057] In addition, it includes probiotics, fruit extracts, plant extracts, minerals such as zinc, calcium, magnesium, iron, selenium, chromium, phosphorus, potassium, and copper; omega-3 fatty acids such as EPA and DHA, folic acid, iodine, biotin, choline, ginger, lutein, blueberries, and acerola, etc.

[0058] Also, a combination of saffron extract and vitamin D3 such as cholecalciferol; a combination of pyridoxine HCl, cyanocobalamin, and ginseng extract; magnesium citrate, melatonin, and Passiflora incarnata L Combination of; melissa officinalis and Combination of L-theanine; iridaceae Crocus sativus L and a combination of cholecalciferol; and ascorbic acid, zinc citrate and sambucus nigra It may include.

[0059] The method of the present invention comprises: (i) a first step of hydrating agar and a locust bean gum gelling agent, comprising mixing agar combined with locust bean gum (AGAROID 300®) in an amount between 0.1% and 4.0% of the total weight of the composition, particularly between 0.2% and 2.0%, and more particularly between 0.3% and 1.8%, with a sweetener in the range of 6% to 10% until a homogeneous mixture is obtained, and then adding a certain amount of water and stirring until the mixture is completely dissolved;

[0060] (ii) a second step of incorporating an agar matrix component, wherein glycerin between 1% and 3% of the total composition is added to the mixture of the first step (i), combined with liquid inulin between 7% and 12% of the total composition and inulin powder between 5% and 10% of the total composition, and optionally a sweetener between 20% and 28% of the total composition is mixed, and then stirred until completely dissolved;

[0061] (iii) A third step of incorporating the active ingredient, wherein the active ingredient and optionally between 7% and 10% of the total composition are pre-mixed until a uniform mixture is obtained, then added to the mixture of the second step (ii) and stirred until completely incorporated;

[0062] (iv) a fourth step of cooking the mixture obtained in the third step (iii), wherein the mixture is cooked at a temperature between 80°C and 100°C for 30 ± 5 minutes, and the solid must be between 72° and 74° Brix; and,

[0063] (v) A fifth step of flavoring, wherein the paste prepared in step 4 (iv) is transferred to a flavoring tank and black carrots in an amount between 0.1% and 1%, particularly between 0.2% and 0.4% are added in combination with a flavoring agent in an amount between 0.1% and 1%, particularly between 0.4% and 0.8%, and citric acid in an amount between 0.23% and 0.29%.

[0064] In the second step of ingredient incorporation, glycerin can be replaced with sorbitol or invert syrup. Similarly, potato starch can be used as an alternative to inulin for the same function. Likewise, the addition of citric acid imparts flavor balance to the product, where the acid is finally added in the fifth step and after all other added ingredients have been completely incorporated into the mixture.

[0065] Once the mixture is prepared, the molding of the final oral formulation must begin. The final oral formulation may include a shape and color based on the type of marketing or purpose. For this purpose, a highly stable wax-based coating agent is required that provides gloss, moisture resistance, and excellent lubricity to control adhesion between pieces. The coating agent may include a coating agent based on a mixture of natural oils, waxes, and / or sweeteners, mannitol, or powdered flavoring agents, and may be formulated with additionally combined flavoring agents.

[0066] Therefore, the method includes the following additional steps:

[0067] (vi) a sixth step of casting and gelation, in which the mixture of the fifth step is placed into a mold at a temperature between 75°C and 89°C and the temperature is lowered to between 2°C and 8°C for gelation; and,

[0068] (vii) A seventh step of demolding, degreasing, and drying, comprising degreasing after demolding, and then spreading the masticatory oral formulation on a drying rack or basket at a temperature of 30 ± 3 ℃ and a relative humidity of 25 ± 5%.

[0069] In step 6, the additional function of citric acid for flavoring is to increase the solubility of the active ingredient added in step 3. For gelation in step 6, cooling of the mold involves arranging various means, such as a cold room or an air tunnel, to induce the mold to gradually and slowly lower its temperature. For degreasing in step 7, the product in the basket is placed on a rotating drum and rotated to homogenize the fat on the surface of the chewable formulation.

[0070] For the seventh stage of drying, the drying tunnel has a relative humidity of 25±5%, a temperature between 30±3℃, and 0.15 m 3 It can be provided under special conditions of laminar wind speed of / second.

[0071] Optionally, the oral chewable formulation may be sweetened. For this purpose, the method also includes the following:

[0072] (viii) Step 8 of sweetening and packaging, in which a dry, chewable oral formulation is introduced into a sweetening device and a sweetener is added until coating is complete, and for this purpose, the steam is set at a rate of 1 to 5 kg unit / min between 275 Pa and 413 Pa, and the sweetener is inspected and packaged once 6% to 10% is sweetened.

[0073] Based on the method described above, a composition is completed comprising an agar matrix combined with locust bean gum and / or sugar; glycerin; liquid inulin and powdered inulin; active ingredients such as vitamins or minerals; flavoring agents; citric acid; coating agents and water, and a chewable oral formulation is obtained.

[0074] The decisive point for obtaining a chewable oral formulation according to the present invention having hardness characteristics is to have the following correct points sequentially throughout the process without exhibiting a dilution phenomenon over time.

[0075] - Proper hydration of gelling agents.

[0076] - Implementation of established operating time and temperature.

[0077] - Maintaining the recommended temperature within the system to prevent gelation and subsequent shearing caused by the gel process.

[0078] - The drying process must be gradual and efficient at the same time so that excess water is removed to an established level.

[0079] By following the procedure while paying attention to the recommendations of each step, a solid and stable product can be obtained over time. Accordingly, a chewable oral formulation was formed to provide a composition prepared from magnesium having a textured agar matrix that can be effectively chewed and ingested.

[0080] One of the parameters representing the characteristics of an agar matrix masticatory dosage formulation is gel strength, which indicates firmness. Generally, gel strength is proportional to the agar concentration of the solution. Therefore, it has been experimentally proven that using agar with high gel strength allows for obtaining a masticatory formulation with the desired firmness even with a small amount of agar.

[0081] The oral chewable formulation may comprise a composition completed by combining an active ingredient in an amount between 0.1% and 85%, preferably between 10% and 60%, and more preferably between 25% and 35%; an agar gelling agent combined with locust bean gum in an amount between 0.1% and 4.0%; a sweetener in an amount between 6% and 30%; glycerin in an amount between 1% and 3%; liquid inulin in an amount between 7% and 12%; inulin powder in an amount between 5% and 10%; a flavoring agent in an amount between 0.1% and 1%; citric acid in an amount between 0.1% and 0.5%; a wax-based coating agent in an amount between 0.5% and 3%; black carrot in an amount between 0.1% and 1%; and water.

[0082] Above all, the flavoring agent of the masticatory formulation of the present invention may include the following:

[0083] Various flavors that humans can consume, such as strawberry, watermelon, mango, lemon, peppermint, orange, passion fruit, banana, coconut, acerola, blueberry, raisin, tangerine, papaya, grapefruit, acai, chamomile, and ginger.

[0084] In the same way, fruit extracts may include sweet fruits, citrus fruits, berries, combinations of fruits, and various extracts of all fruits and plant extracts having appropriate flavor characteristics.

[0085] The active ingredient may be selected from active pharmaceutical ingredients such as vitamins, minerals, natural, plant, and herbal products; and drugs having therapeutic properties at the level of the digestive and metabolic systems, cardiovascular, genitourinary and hormonal systems, musculoskeletal, nervous systems, anthelmintics, respiratory systems, analgesics, and antipyretics, and does not exclude all pharmacological substances and drugs considered in the index of drugs included in the ATC (Anatomical, Therapeutic, Chemical Classification System).

[0086] The active ingredient may include, in particular, vitamins, for example, vitamin D2, vitamin A, vitamin C, vitamin D and derivatives and / or analogs thereof, vitamin E, B complex vitamins such as vitamins B1, B3, B5, B9 and B12, and vitamin K2, etc.

[0087] In addition, it may include probiotics, fruit extracts, plant extracts, minerals such as zinc, calcium, magnesium, iron, selenium, chromium, phosphorus, potassium, and copper; omega-3 fatty acids such as EPA and DHA, folic acid, iodine, biotin, choline, ginger, lutein, blueberries, and acerola.

[0088] Example 1

[0089] In the example of the embodiment, the chewable oral formulation according to the present invention is combined with the active ingredients of Table 1 and may comprise an agar gelling agent combined with locust bean gum in the range of 0.1% to 4.0%; a sweetener in the range of 6% to 30%; glycerin in the range of 1% to 3%; liquid inulin in the range of 7% to 12%; inulin powder in the range of 5% to 10%; a flavoring agent in the range of 0.1% to 1%; citric acid in the range of 0.1% to 0.5%; a wax-based coating agent in the range of 0.5% to 3%; black carrot in the range of 0.1% to 1%; and water until the composition is complete.

[0090] Authored agar matrix Vitamin D2 Ergocalciferol Probiotics Bacillus coagulance Fruit and plant extracts Fruit and plant mixture

[0091] Example 2

[0092] Composition of the oral chewable formulation of Example 1 containing the active ingredients of Table 2.

[0093] Authored agar matrix Probiotics Bacillus coagulance Fruit and plant extracts Fruit and plant mixture

[0094] Example 3

[0095] Another example of a composition of the oral chewable formulation of Example 1 containing the active ingredients of Table 3.

[0096] Authored agar matrix Vitamin C Ascorbic acid zinc Zinc citrate

[0097] Example 4

[0098] A composition of the oral chewable formulation of Example 1 containing an active ingredient based on the fatty acids of Table 4.

[0099] Authored agar matrix Omega 3 Fish oil DHA Oh my EPA Oh my

[0100] Example 5

[0101] Composition of an oral chewable formulation containing active ingredients based on magnesium and vitamins of Table 5.

[0102] Authored agar matrix calcium calcium phosphate magnesium Magnesium citrate Vitamin D Cholecalciferol

[0103] Example 6

[0104] Composition of an oral chewable formulation containing an active ingredient based on Table 6.

[0105] Authored agar matrix Vitamin A Vitamin A palmitate Vitamin C Ascorbic acid Vitamin D Cholecalciferol Vitamin E d-α-tocopheryl acetate folic acid folic acid Vitamin B12 Cyanocobalamin Vitamin B5 Calcium D-pantothenic acid calcium tricalcium phosphate Iodine potassium iodide zinc zinc citrate

[0106] Example 7

[0107] Another example of a composition of the oral chewable formulation of Example 1 containing the active ingredients of Table 7.

[0108] Authored agar matrix Vitamin A beta-carotene Vitamin C Ascorbic acid Vitamin D2 Ergocalciferol Vitamin E d-α-tocopheryl acetate Vitamin K2 Menaquinone Vitamin B1 Thiamine nitrate Vitamin B3 Niacinamide Vitamin B6 Pyridoxine HCI Vitamin B9 Calcium Folate Vitamin B12 Cyanocobalamin biotin biotin Vitamin B5 Pantothenic acid Choline Choline tartrate Iodine potassium iodide magnesium Magnesium Oxide Selenium L-Selenomethionine zinc zinc citrate Probiotics Bacillus coagulans ginger ginger juice Fruits and plants Fruit and plant mixture

[0109] Example 8

[0110] A composition of the oral chewable formulation of Example 1 comprising a combination of the active ingredients of Table 8.

[0111] Authored agar matrix Vitamin A beta-carotene Vitamin C Ascorbic acid Vitamin D2 Ergocalciferol Vitamin E d-α-tocopheryl acetate Vitamin K2 Menaquinone Vitamin B1 Thiamine nitrate Vitamin B3 Niacinamide Vitamin B6 Pyridoxine HCI Vitamin B9 Calcium Folate Vitamin B12 Cyanocobalamin biotin biotin Vitamin B5 Pantothenic acid Choline Choline tartrate Iodine potassium iodide magnesium Magnesium Oxide Selenium L-Selenomethionine zinc zinc citrate Probiotics Bacillus coagulans Lutein Lutein blueberries Organic blueberries Fruits and plants Fruit and plant mixture

[0112] Example 9

[0113] Among many other options, a composition of the oral chewable formulation of Example 1 containing the active ingredient of Table 9.

[0114] Authored agar matrix Vitamin A beta-carotene Vitamin C Ascorbic acid Vitamin D2 Ergocalciferol Vitamin E d-α-tocopheryl acetate Vitamin K2 Menaquinone Vitamin B1 Thiamine nitrate Vitamin B3 Niacinamide Vitamin B6 Pyridoxine HCI Vitamin B9 Calcium Folate Vitamin B12 Cyanocobalamin biotin biotin Vitamin B5 Pantothenic acid Choline Choline tartrate Iodine potassium iodide magnesium Magnesium Oxide Selenium L-Selenomethionine zinc zinc citrate Probiotics Bacillus coagulans Acerola Organic Acerola Fruits and plants Fruit and plant mixture

[0115] Example 10

[0116] This example discloses a chewable oral composition of agar gum comprising the formulation of Example 1 and a composition containing the active ingredients of Table 10.

[0117] Authored agar matrix Vitamin B6 Pyridoxine HCI Vitamin B12 Cyanocobalamin ginseng Ginseng extract

[0118] Example 11

[0119] Another example of a composition comprising the oral chewable formulation of Example 1 and the active ingredients of Table 11.

[0120] Authored agar matrix magnesium Magnesium citrate Melatonin Melatonin Passionflower extract Passiflora incarnata L.

[0121] Example 12

[0122] An example of the chewable oral composition of Example 1 containing the active ingredients of Table 12.

[0123] Authored agar matrix Lemon balm extract Melissa officinalis L-theanine L-theanine

[0124] Example 13

[0125] An example of the chewable oral composition of Example 1 containing the active ingredients of Table 13.

[0126] Authored agar matrix Saffron extract Iridaceae Crocus sativus L. Vitamin D3 Cholecalciferol

[0127] Example 14

[0128] Another example of the chewable oral composition of Example 1 containing the active ingredient of Table 14.

[0129] Authored agar matrix Vitamin C Ascorbic acid zinc zinc citrate Elderberry Extract B Sambucus nigra

[0130] Example 15

[0131] The last example of the chewable oral composition of Example 1 containing the active ingredient of Table 15.

[0132] Authored agar matrix magnesium Magnesium citrate

[0133] Example 15, an agar gelling agent combined with magnesium citrate; particularly combined with locust bean gum in the range of 0.1% to 4.0%; a sweetener in the range of 6% to 30%; glycerin in the range of 1% to 3%; liquid inulin in the range of 7% to 12%; inulin powder in the range of 5% to 10%; a flavoring agent in the range of 0.1% to 1%; citric acid in the range of 0.1% to 0.5%; a wax-based coating agent in the range of 0.5% to 3%; black carrot in the range of 0.1% to 1%; and water until the composition is completed.

[0134] This Example 15 defines a composition specifically containing magnesium.

[0135] Magnesium is a mineral required for more than 300 biochemical functions in the human body, and there is currently a mineral deficiency in the daily diet.

[0136] In the present invention, magnesium had to exceed 20%, which generally causes high instability of the matrix due to the volume and low solubility of magnesium citrate in the latest technology gums, and according to the present invention, it was possible to construct an agar matrix chewable oral formulation containing between 28% and 32% magnesium citrate effectively.

[0137] The chewable oral formulation of the agar matrix according to the present invention includes a formulation balanced in a mixture of the aforementioned components, and provides a matrix that can be industrially processed and has stability for a storage life of 2 years.

[0138] Accordingly, the present invention provides an oral formulation having excellent texture, visual form, and flavor capable of supplying a desired amount of active ingredient, making it applicable to the fields of nutrition or health.

[0139] Only some preferred embodiments of the present invention have been illustrated as examples. In this regard, it will be understood that a method for preparing an agar matrix oral formulation having gelatin-like properties, a pleasant texture and taste, and a compositional arrangement can be selected from a number of alternatives without departing from the spirit of the present invention according to the following claims.

Claims

Claim 1 (i) a first step of hydrating agar and locust bean gum gelling agent, comprising mixing agar combined with locust bean gum in an amount between 0.1% and 4.0% of the total weight of the composition with a sweetener in an amount between 6% and 10% until a uniform mixture is obtained, and then adding a certain amount of water and stirring until the mixture is completely dissolved; (ii) a second step of incorporation of an agar matrix component, wherein glycerin between 1% and 3% of the total composition is added to the mixture of the first step (i), combined with liquid inulin between 7% and 12% of the total composition and inulin powder between 5% and 10% of the total composition, and a sweetener between 20% and 28% of the total composition is mixed and then stirred until completely dissolved; (iii) a third step of incorporation of an active ingredient, wherein the active ingredient and a sweetener between 7% and 10% of the total composition are pre-mixed until a homogeneous mixture is obtained, then added to the mixture of the second step (ii) and stirred until completely incorporated; (iv) a mixture obtained in the third step (iii) is processed at a temperature between 80° and 100° for 30 ± 5 minutes, wherein the solid must contain between 72° and 74° Brix. A method for forming a chewable oral formulation, characterized by comprising: a fourth step of cooking; and, (v) a fifth step of flavoring, wherein the mixture cooked in the fourth step (iv) is transferred to a flavoring tank and 0.1% to 1% of black carrot is added in combination with 0.1% to 1% of flavoring agent and 0.23% to 0.29% of citric acid. Claim 2 delete Claim 3 A method for forming a masticatory oral formulation according to claim 1, further comprising: (vi) a sixth step of casting and gelation, wherein the mixture of the fifth step (v) is placed into a mold at a temperature between 75°C and 89°C and the temperature is lowered to between 2°C and 8°C for gelation; and (vii) a seventh step of demolding, degreasing, and drying, wherein the demolding is followed by degreasing, and then drying the masticatory oral formulation at a temperature of 30 ± 3°C and a relative humidity of 25 ± 5%. Claim 4 A method for forming a chewable oral formulation according to claim 3, further comprising (viii) an 8th step of sweetening and packaging, wherein the dry chewable oral formulation is introduced into a sweetening device and a sweetener is added until coating is completed, and for this purpose, the steam is set at a rate of 1 to 5 kg unit / min between 275 Pa and 413 Pa, and once 6% to 10% of the sweetener is sweetened, the sweetener is inspected and packaged. Claim 5 delete Claim 6 delete Claim 7 delete Claim 8 delete Claim 9 In paragraph 3 or 4, the unit of the chewable oral formulation in drying of step 7 (vii) is at a relative humidity of 25 ± 5%, a temperature between 30 ± 3 ℃, and 0.15 m 3 A method for forming a chewable oral formulation characterized by dispersion into a drying tunnel under conditions of laminar flow wind speed of / seconds. Claim 10 An agar gelling agent combined with an active ingredient in the range of 10% to 60% of the total weight of the composition; combined with locust bean gum in the range of 0.1% to 4.0% of the total weight of the composition; a sweetener in the range of 6% to 30% of the total weight of the composition; glycerin in the range of 1% to 3% of the total weight of the composition; liquid inulin in the range of 7% to 12% of the total weight of the composition; powdered inulin in the range of 5% to 10% of the total weight of the composition; a flavoring agent in the range of 0.1% to 1% of the total weight of the composition; citric acid in the range of 0.1% to 0.5% of the total weight of the composition; a wax-based coating agent in the range of 0.5% to 3% of the total weight of the composition; black carrot in the range of 0.1% to 1% of the total weight of the composition; A composition comprising water, wherein the active ingredient is a B-complex vitamin selected from vitamin D2, vitamin A, vitamin C, vitamin D and derivatives and / or analogs thereof, vitamin E, vitamin B1, B3, B5, B9 and B12 and vitamin K2; probiotics; minerals selected from zinc, calcium, magnesium, iron, selenium, chromium, phosphorus, potassium, and copper; omega-3 fatty acids selected from EPA and DHA; and a chewable oral formulation selected from folic acid, iodine, lutein, or a combination thereof. Claim 11 delete Claim 12 A chewable oral formulation according to claim 10, characterized in that the flavoring agent is selected from strawberry, watermelon, mango, lemon, peppermint, orange, passion fruit, banana, coconut, acerola, blueberry, raisin, tangerine, papaya, grapefruit, acai, chamomile, and ginger, or a combination thereof. Claim 13 A chewable oral formulation according to claim 10, characterized in that the sweetener comprises cane sugar, tapioca syrup, and inulin-based sugar. Claim 14 delete Claim 15 delete Claim 16 delete Claim 17 delete Claim 18 delete Claim 19 delete Claim 20 delete Claim 21 delete Claim 22 delete Claim 23 delete Claim 24 delete Claim 25 delete Claim 26 delete