Consumable gel delivery method for health ingredients - Patent Application 20070122999

Abstract

The present invention relates to a dosage form that is a drinkable gel and contains a 50 g or 75 g dose of one or more health ingredients other than glucose. The health ingredients are held in a delivery system that includes the following: water, a gelling agent that is a carbohydrate nonionic gelling polymer gelling agent and / or a multivalent ionic gelling polymer gelling agent, and a pH adjuster. The components are present in amounts that ensure hydration and the formation of a firm gel having a Bloom grade of 100 to 250, which can be sheared to make it more fluid upon ingestion so that it is a drinkable gel. The present invention further includes a method of ingesting the oral dosage form by squeezing and / or sucking the drinkable gel from a package that includes a spout (5) or a pouch (1) with a straw. [Selected Figure] Figure 1

Description

[Technical field]

[0001]

[0001] This invention relates to dosage forms containing one or more health ingredients, particularly (though not exclusively) nutritional ingredients.

[0002] The dosage form is in the form of a stable gel that is particularly capable of delivering multiple health ingredients in a single dosage form. The dosage form can be used in human or animal health.

[0002]

[0003] The dosage form can particularly (but not exclusively) deliver nutritional and other health ingredients in a single delivery vehicle, including high doses of water-soluble, water-insoluble and / or fat-soluble ingredients that may not themselves be particularly suitable for delivery by tablet or capsule.

[0003]

[0004] The dosage form has many advantages over current approaches to delivering health ingredients, and gels are particularly suitable for delivering nutrients, food supplements (including meal replacements) and medicines in many different situations. Summary of the Invention

[0004]

[0005] One of the most important factors in the successful development of a health product, especially a nutritional product, is ensuring patient compliance.

[0006] Currently, multiple product formats are used to deliver each of multiple, e.g., nutritional or other health components. The diverse nature and number of such products introduces significant variability in compliance.

[0005]

[0007] These health products, including nutritional and functional food products, may be preventative or therapeutic in nature. They include prescription products, over-the-counter (OTC) products, as well as functional foods and dietary supplements, including products containing, either alone or in combination, vitamins, minerals, elements, proteins, carbohydrates, lipids, plant-derived extracts, such as traditional Chinese medicines (TCM) or other indigenous medicines, etc.

[0006]

[0008] Lack of compliance can be the result, for example, of having to take multiple tablets, capsules or other dosage forms, such as a tablet containing multiple vitamins, a capsule containing omega-3, a drink containing soluble fiber, etc.

[0007]

[0009] Tablets and capsules can prove difficult to ingest (swallow), especially for certain patient groups such as children and the elderly. For large dose products or difficult to formulate or combination products, the large tablet size and multiple tablet doses create compliance issues.

[0008]

[0010] Other issues that affect patient compliance include the taste, smell or organoleptic feel of the product. Organoleptic properties can relate to the taste of the product, the consistency of the product, the texture of the product, the mouthfeel of the product, the longevity of the taste and any other organoleptic sensory aspects.

[0009]

[0011] Some products require a separate beverage to facilitate swallowing or to wash residues out of the mouth, or another solid composition to be co-administered.

[0012] Examples include sugar replacement products for hypoglycemia and whey proteins which disperse poorly in liquids and are required in large quantities.

[0010]

[0013] Also, a delivery device may be required to aid in consumption and delivery of the dose, such as a spoon, syringe or some other metering device. The requirement of such additional devices may adversely affect compliance.

[0011]

[0014] Other factors that influence effectiveness include packaging, chemical or physical stability of the composition, bioavailability of the ingredients, visual appeal and convenience of delivery.

[0015] Alternative dosage forms to capsules and tablets include beverages or gels containing liquids or semisolids.

[0012]

[0016] These "sports gels" are typically highly viscous pastes that contain thickening agents such as xanthan gum, but because they do not harden, these products leave a persistent residue on the tongue that can be uncomfortable and can irritate the oropharyngeal area, which can cause coughing or choking.

[0013]

[0017] These highly viscous paste or gel products are paste or gel products that have high internal resistance and a honey or ketchup-like consistency and will tend to flow but slowly. These known highly viscous pastes can be Newtonian or non-Newtonian fluids and can be shear thinning or shear thickening in nature. However, they all share the property that they will deform plastically under stress despite some resistance (even when such behavior is also known to have a threshold such as Bingham plastic behavior). Typically, these viscous pastes have a measurable viscosity between about 5000 and about 50,000 cP.

[0014]

[0018] The term "hardening" as used herein refers to a jelly material that does not behave plastically upon stress, but rather behaves elastically upon stress up to the point of failure where the structure of the jelly breaks down and irreversibly creates new interfaces.

[0015]

[0019] The Applicant has previously developed a novel glucose-containing product for facilitating the delivery of a 50 g or 75 g dose of glucose for performing a glucose tolerance (or similar) test, as disclosed in WO 2017 / 075672, which dose is dissolved in 100 ml of water and gelled using a mixture of agar (0.75 g) and locust bean gum (0.25 g).

[0016]

[0020] Glucose is dissolved in water and gelled using one or more carbohydrate-based gelling agents: agar or agar-agar and locust bean gum.

[0021] This new dosage form had the advantage over existing liquid administration test forms that the strong sweet taste of glucose was masked so that subjects taking the glucose would not suffer from nausea, morbidity, vomiting, fainting and other forms of stress, and the dose was delivered in a smaller volume than traditional liquid tests.

[0017]

[0022] Applicants have now determined that this general approach of using a hardening gel to produce a delivery form with a defined bloom grade can be applied more broadly to facilitate the delivery of a wide range of health components other than, for example, a fixed dose of glucose for diagnostic purposes.

[0018]

[0023] They further determined that significant additional benefits can be obtained by using specific combinations of gelling agents. Disclosure of the Summary of the Invention

[0024] According to a first aspect of the present invention, there is provided an oral dosage form comprising a 50g or 75g dose of one or more health ingredients other than glucose, which is a drinkable gel, wherein the health ingredients are: ·water, a gelling agent which is a carbohydrate nonionic gelling polymer gelling agent and / or a polyvalent ionic gelling polymer gelling agent, and pH regulator wherein the components are present in amounts to ensure hydration and the formation of a firm gel having a Bloom grade of 100-250, which can be sheared to make it more fluid when ingested such that it is a drinkable gel.

[0019]

[0025] Firm gels are "set" gels or jellies that are characterized in industrial and scientific contexts by the Bloom test, which is used to provide a measure of the relative firmness and strength of these gels. The test was devised in 1925 by Oscar T. Bloom. The test determines the weight in grams required for a specified plunger (usually a plunger with a diameter of 0.5 inches (11 mm)) at a specified temperature to depress the surface of the gel 4 mm without irreversibly destroying the gel and creating a new interface. The result is the Bloom grade. Higher numbers indicate a firmer product. For example, gelatin used in foods typically ranges from 125 Bloom to 250 Bloom.

[0020]

[0026] For the purposes of this document, the terms gel and jelly are interchangeable.

[0027] Hardened gels or jellies are somewhat elastic, meaning that they deform under stress, but when the stress is released, they substantially return to their original form. For example, if pressed gently against the bottom of a spoon, a hardened jelly will be pushed down, but when the spoon is removed, the original surface will return to its original position. It is not plastic, whereby a surface is deformed under the same stress and then once the pressure is removed, it will remain deformed. A hardened gel or jelly will break irreversibly and create a new interface, rather than deforming plastically, if the stress is further increased beyond its breaking point.

[0021]

[0028] The oral dosage forms of the invention may typically be provided in volumes of 25 ml to 250 ml depending on the application and are delivered from a container, typically a pouch, through a spout or straw such that the sucking action shears the gel so that it becomes more fluid, creating new interfaces and sometimes with the release of some water.

[0022]

[0029] The shear and creation of new interfaces has the advantage that it aids delivery while maintaining taste masking.

[0030] According to a second aspect of the present invention there is provided an oral dosage form comprising one or more health ingredients, the oral dosage form being a drinkable gel, wherein the health ingredients are selected from the group consisting of: ·water, a first gelling agent which is a carbohydrate non-ionic gelling polymer gelling agent; a second gelling agent which is a multivalent ion-gelling polymeric gelling agent, and pH regulator wherein the components are present in amounts to ensure hydration and the formation of a firm gel having a Bloom grade of 100-250, which can be sheared to make it more fluid when ingested such that it is a drinkable gel.

[0023]

[0031] In both the first and second aspects of the invention, the oral dosage form is delivered, sucked or squeezed through a narrow opening such as a spout or straw, and the resulting delivery force and / or mouth action shears the gel, resulting in the creation of a new interface, facilitating ingestion of the formulation by drinking.

[0024]

[0032] The carbohydrate gelling agent can be one of an agarose-based polymeric gelling agent or locust bean gum. Most preferably, it is an agarose-based polymeric gelling agent, such as agar.

[0025]

[0033] The carbohydrate gelling agent used can advantageously also act as an emulsifier so that significant additional emulsifiers are not required in formulations containing non-polar ingredients such as lipids, e.g. omega oils and water-insoluble vitamins, e.g. vitamin D and vitamin E.

[0026]

[0034] The multivalent ionic gelling polymer is most preferably an alginate-based polymeric gelling agent, such as, but not limited to, calcium alginate. Alternatives include guar gum, gellan gum, xanthan gum, pectin and kudzu.

[0027]

[0035] In a particularly preferred embodiment, the gelling agent comprises agar as the primary gelling agent and calcium alginate as the secondary gelling agent. This combination has proven to be particularly versatile, allowing two or more combinations of water-soluble, water-insoluble and / or lipid-based ingredients to be combined together in a single dosage form.

[0028]

[0036] These two fundamentally different gelling agents provide the set gel structure through different interaction mechanisms. The advantage of the combination is its versatility as a base, as it overcomes scenarios where gelation would otherwise be inhibited by the presence of different components.

[0029]

[0037] Agar consists of a mixture of two polysaccharides: agarose and agaropectin, with agarose constituting about 70% of the mixture. Agarose is a linear polymer composed of repeating units of agarobiose, a disaccharide composed of D-galactose and 3,6-anhydro-L-galactopyranose. Agaropectin is present in smaller amounts and is a heterogeneous mixture of smaller molecules composed of alternating units of D-galactose and L-galactose heavily modified with acidic side groups such as sulfate and pyruvate. Any known variant of agar can be used in the present invention.

[0030]

[0038] Agar exhibits hysteresis, melting at 85°C and solidifying at 32°C-40°C. This property gives it a good balance between easy melting and good gel stability at relatively high temperatures. Agar is more suitable than other carbohydrate-based solidifying agents, such as gelatin, which also melt around this temperature.

[0031]

[0039] Gelling also helps to provide stability at room temperature (and higher), meaning that cold storage can be avoided.

[0040] The most common alginate used in food is sodium alginate. To form a gel, sodium alginate needs to come into contact with a divalent ion such as calcium (Ca2+). When sodium alginate is added to a solution of a calcium salt, such as chloride or citrate, a gel is formed as sodium ions (Na+) are exchanged for calcium ions (Ca2+) and the polymers are cross-linked. Divalent ions, such as calcium, can form cross-links between alginate polymers because they can form two bonds, while monovalent ions, such as sodium, can only form one bond. The longer the alginate is in contact with the divalent ion solution, the harder the gel will be because more cross-links will be formed. Also, depending on the concentration of the divalent ions, the gel is either thermoreversible (at low concentrations) or thermoirreversible (at high concentrations).

[0032]

[0041] Alginic acid is a linear copolymer with (1-4) linked homopolymeric blocks of β-D-mannuronate (M) and its C-5 epimer, α-L-guluronate (G), which are covalently linked together in different sequences or blocks.

[0033]

[0042] Sodium alginate is the sodium salt of alginic acid. Its empirical formula is NaC6H7O6. Sodium alginate is a gum extracted from the cell walls of brown algae.

[0034]

[0043] Potassium alginate is a chemical compound that is the potassium salt of alginic acid. Its empirical chemical formula is KC6H7O6.

[0044] Calcium alginate is made by removing the sodium ions from sodium alginate and replacing them with calcium, and has the chemical formula C 12 H 14 CaO 12 has.

[0035]

[0045] The gel formulation of the present invention comprises: i) Water-soluble components; ii) water-insoluble components; and iii) lipids; or iv) Meal replacements or their essential components, such as proteins, carbohydrates, fats, minerals, vitamins and fibre or combinations thereof; can be used to deliver one or more of the following:

[0036]

[0046] In a first embodiment, the dosage form of the present invention has proven highly effective in facilitating the delivery of a rapidly released sugar, e.g., glucose, to address "hypoglycemic events" in diabetic patients. The sugar is most preferably delivered together with one or more other health beneficial ingredients and can be tailored to "at risk" subject groups, e.g.: children, adults, pregnant women or the elderly.

[0037]

[0047] Typically, but not necessarily, a dose of 1 g to 40 g of ingredient is delivered in a volume of 25 to 45 ml of gel.

[0048] Delivery of a single ingredient or agent or main ingredient or agent in this manner (containing a much lower amount of active substance) may have benefits in other emergency type situations such as, for example, epilepsy, allergic reactions, migraines, chest pain, asthma, etc.

[0038]

[0049] The base gel formulation can be used to load multiple health ingredients, including pharmaceuticals, into an easy-to-ingest and easy-to-use dosage form, which can hold ingredients that would typically be difficult to combine into a single dosage form due to their different properties, and can be orally administered by squeezing or sucking the gel from its container.

[0039]

[0050] In a second embodiment, the dosage form includes health ingredients intended to address specific health needs of a targeted subject group, for example based on lifestyle. Non-limiting examples include:

[0051] Students - Here, the gel is formulated to aid in studying and can contain nutrients to enhance brain cell function and increase attention, memory, concentration, focus and perseverance. It can also help reduce stress;

[0052] Outdoor Workers – Here, the gel is formulated to provide natural anti-inflammatories and antioxidants, aid in muscle relaxation and recovery after work, and also aid in providing alertness, focus and energy;

[0053] Office workers – here, the gel is formulated to increase focus and perseverance;

[0054] Shift Workers – Here, the gel is formulated to kick-start the melatonin pathway for circadian rhythm control, while also providing nutrients and antioxidants to aid in brain and muscle recovery;

[0055] Underground Workers - Here, the gel is formulated to assist with the physical demands of the job, boosting alertness, endurance and recovery while compensating for sun loss with Vitamin D.

[0040]

[0056] Travelers - where the gel is formulated to reduce travel-related stress, fatigue and jet lag and aid in circadian rhythm regulation;

[0057] Sportsmen – Here, the gel is formulated to boost energy, focus, attention and reaction time so people can perform to their best potential right from the start of a match or practice;

[0058] Seniors – Here, the gel is designed to activate curcumin-based pathways to improve memory and brain function, with additional nutrients targeted at joints, bones and vision;

[0059] Drivers - Here, the gel is formulated to enhance brain cell function and support the physical demands of long-distance transport travel. It boosts alertness and endurance while compensating for lack of sunlight with Vitamin D.

[0041]

[0060] Clearly, this is just one example of a family where an easy to ingest gel product benefits from the fact that it can contain a range of healthy ingredients in a relatively small volume (generally less than 50ml, preferably around 30-40ml).

[0042]

[0061] Other examples include the addition of stimulants such as caffeine, and the development of products to aid sleep, combat hangovers, and enhance sexual performance.

[0062] In a third embodiment, the dosage form includes a dietary ingredient intended to provide a meal replacement.

[0043]

[0063] In this embodiment, there is a particular focus on delivering carbohydrates, proteins and fats in addition to vitamins and minerals.

[0064] In this and other embodiments, it is desirable to ensure that the gel contains a sufficient amount of the desired ingredient to be effective. Typically, the gel of the present invention seeks to provide the Recommended Daily Intake (RDI) of one or more ingredients or at least a substantial fraction thereof, such as 33% (one third dose), 50% (half dose) or in some cases 100% of the full daily amount. Alternatively, the amount can be referred to as the Adequate Intake (AI).

[0044]

[0065] This data is presented below in Tables 1-4, which show the RDIs or AIs for key components by group, sex and age. Table 1 provides a diagram regarding protein and dietary fat; Table 2 provides figures regarding carbohydrates, dietary fiber, and water; Tables 3a, b and c provide diagrams regarding vitamins; and Tables 4a, b and c provide diagrams regarding minerals.

[0045]

[0066]

[0046] [Table 1]

[0047]

[0067]

[0048] [Table 2]

[0049]

[0068]

[0050] [Table 3]

[0051]

[0069]

[0052] [Table 4]

[0053]

[0070]

[0054] [Table 5]

[0055]

[0071]

[0056] [Table 6]

[0057]

[0072]

[0058] [Table 7]

[0059]

[0073]

[0060] [Table 8]

[0061]

[0074] The protein optionally includes milk protein concentrate, whey protein concentrate, soy protein isolate and sodium caseinate, which may further include amino acids such as one or more of L-glutamine, L-glycine, L-leucine, L-isoleucine, L-valine, beta-alanine, L-arginine and taurine.

[0062]

[0075] Carbohydrates optionally include, for example, maltodextrin, inulin, fructose and glucose syrup.

[0076] Dietary fats optionally include vegetable fats and oils, fish oils, coconut oil, mono- and diglycerides of fatty acids, and lecithin.

[0063]

[0077] Vitamins may include Vitamin C (Ascorbic Acid), Vitamin K (Menaquinone-7), Vitamin E (dl-alpha-tocopheryl acetate), Niacin (Niacinamide), Vitamin A (Retinyl Acetate), Pantothenic Acid (D-Calcium Pantothenate), D-Biotin, Folic Acid, Vitamin D (Cholecalciferol), Vitamin B6 (Pyridoxine Hydrochloride), Riboflavin (Riboflavin 5-Sodium Phosphate), Thiamin (Thiamine Hydrochloride), Vitamin B12 (Cyanocobalamin), Creatine Monohydrate, Beta-Carotene, Lutein, Lycopene Oleoresin, Choline Chloride, L-Carnitine, Nicotinamide, D-Calcium Pantothenate, Riboflavin, Pyridoxine Hydrochloride, Pteroylmonoglutamic Acid, Phytomenadione, Resveratrol, Alpha-Ketoglutaric Acid, Calcium Hydroxymethylbutyrate (HMB), and Tricreatine Malate.

[0064]

[0078] Minerals optionally include essential and trace mineral sources and salts, such as one or more of the following: tripotassium citrate, sodium chloride, trisodium citrate, magnesium oxide, zinc gluconate, ferrous fumarate, manganese gluconate, copper gluconate, potassium iodide, sodium molybdate, chromium picolinate, sodium selenite, chromium chloride, potassium iodide, sodium fluoride, sodium chloride, potassium chloride, calcium hydroxide, sodium ascorbate, magnesium hydroxide, potassium hydroxide, ferrous lactate, zinc sulfate, manganese sulfate, and phosphates, such as one or more of sodium triphosphate, tricalcium phosphate, potassium phosphate.

[0065]

[0079] Other components may be included:

[0080] An antioxidant, such as one or more of ascorbyl palmitate, alpha tocopherol.

[0066]

[0081] A pH adjusting agent, such as one or more of citric acid and ascorbic acid, and

[0082] Flavorings and sweeteners.

[0083] Thus, the gel can be used for disaster relief and airdropped or otherwise delivered to where it is needed.

[0067]

[0084] Generally, these gel packages may be manufactured in larger volumes having sizes of up to 250 ml, but more typically between 75 ml and 150 ml, and will contain one-quarter to one-half of the recommended daily intake of important nutritional components such as protein, carbohydrates and dietary fats as well as possibly further important vitamins and minerals as indicated by reference to the table above.

[0068]

[0085] Alternatively, minimal or specialty nutritional meals can be produced to assist those who are losing weight, and specialty meal / nutritional products can be produced, for example for elite athletes or gym goers seeking low carbohydrate or high protein products, pre / post workout products or any variations thereof, particularly products containing carbohydrates, protein and / or fat in given combinations and relative amounts.

[0069]

[0086] As previously mentioned, the preferred gels can be used as delivery vehicles for delivering water soluble ingredients, water insoluble ingredients and lipids.

[0087] In a fourth embodiment, the gels of the present invention are used to deliver ingredients in the form of entrapped stable emulsions.

[0070]

[0088] The lipid components, such as omega-3 or water-insoluble vitamins, are emulsified with water, usually with stirring, and then gelled. Additional emulsifiers can be added to facilitate emulsification before gelling.

[0071]

[0089] Representative food grade or pharmaceutical grade emulsifiers are added, such as lecithin, monoglycerides of fatty acids and esters of mono- and diglycerides of fatty acids.

[0090] In a fifth embodiment, the gels of the present invention are used to deliver ingredients in the form of stable solid particulate suspensions or dispersions.

[0072]

[0091] Preferably, the solid particles are nano-sized particles (greater than 1 nanometer and less than 1 micron).

[0092] In a sixth embodiment, the gel of the present invention is used to deliver an ingredient in the form of a solution.

[0073]

[0093] Of course, in the seventh embodiment (which is a particularly preferred embodiment), the oral dosage form of the present invention may be used to combine health ingredients from any combination of the fourth, fifth and sixth aspects in a single dosage form.

[0074]

[0094] Advantageously, the present invention allows large amounts (e.g., more than 500 mg) of different nutrients to be delivered in an easy-to-use format where pills and capsules may not be possible or impractical, or would be undesirably large. Furthermore, the present invention allows for the formulation of liquid nutrients that would not be sufficiently stable in water alone, but are stable in gel format. Thus, the provision of multi-phase combinations is particularly advantageous. For example, some ingredients may be more stable in the solid phase, as a suspension or dispersion, or as an oil-in-water emulsion. The formed hardened gel can trap and immobilize the multiple phases, enhancing stability and also masking taste, for example. The hardened gel is easily sheared during delivery to form new wet interfaces, thereby facilitating delivery.

[0075]

[0095] By combining two functionally distinct gelling agents, Applicant has achieved a novel robust firm gel platform that allows for the delivery of a wide range of healthy ingredients with enhanced properties such as improved ingredient loading, taste masking, versatility, etc., and by trapping them in a firm gel that is sheared upon delivery and ingestion, the product is highly easy to swallow, overcoming the problem of dysphasia.

[0076]

[0096] In its stored state, the formulation is in a firm jelly form and is stable at room temperature, but when sucked or otherwise subjected to gentle force, it shears to create new wet interfaces that facilitate swallowing. Swallowing is facilitated because the gel interfaces created are slippery since they are inherently wet due to the water in their structure.

[0077]

[0097] Unlike known viscous paste gel formulations, the set firm gels leave minimal residue other than a thin film of water, making them much easier to swallow as set gels than other solid / semi-solid formats. The novel formulations of the present invention can be flavored to further enhance taste masking.

[0078]

[0098] This novel formulation provides a chemically and physically stable matrix that can be used to entrap water soluble components, water insoluble lipids and lipophilic components alike.

[0079]

[0099] As a result of entrapment, surface contact with the taste buds is reduced. Unlike viscous paste gels, the gels of the present invention provide minimal residue other than displaced water and are very easy to swallow as the set jelly is believed to shear upon inhalation, as opposed to alternative solid / semi-solid formats that are plastic (not elastic).

[0080]

[0100] Advantageously, as they are sheared, they release their constituents rapidly, even at high doses, and do so while providing taste masking.

[0101] Unlike tablets or capsules, the platform is highly flexible in that it allows different health ingredients to be delivered in combination in a single dosage form, which has advantages over currently offered alternatives.

[0081]

[0102] Products such as glucose products that address hypoglycemic episodes can be used with wearable devices and digital support programs to improve health management. Thus, the products can be used with digital apps and wearables, such as Fitbit, that allow subjects to better manage their disease, such as diabetes, by tracking symptoms and indicators, along with medications / health products being taken. This provides for better informed subjects as well as increased compliance and improved clinical / health outcomes.

[0082]

[0103] Advantageously, the present invention allows for delivery in a form that does not require a separate drink, unlike tablets or capsules that require a drink to aid in swallowing, and unlike most athletic gels that might better be described as thick pastes that require additional fluids due to the texture from the paste residue.

[0083]

[0104] The presence of alginate means that some beneficial calcium salts are incorporated as part of the gelling process. Thus, for formulations directed at bone health, calcium and / or magnesium salts (e.g. calcium citrate or calcium carbonate) will aid in gelling by complexation. Calcium citrate can also enhance flavour. Calcium bicarbonate can induce an effervescent action, which can provide an appealing taste sensation.

[0084]

[0105] Solid suspensions can contain nano-fine materials, such as curcumin or glucosamine, in forms that may enhance their bioavailability.

[0106] Agar and locust bean gum harden well, but the appearance is not attractive. Agar and xanthan gum provide a clearer gel without colored specks. However, agar and alginate gels are most preferred because they appear visually very clear, but more importantly, the alginate crosslinking provides a more structured gel with a different gelling mechanism than carbohydrate non-ionic gelling polymers, which improves versatility and performance.

[0085]

[0107] However, the addition of Ca, Mg and Zn salts, such as chlorides or citrates, interferes with the hardening of agar and some other gum polymers. Therefore, to obtain good hardening results, agar and alginate should be used in a specific ratio (w / w). The preferred ratio favors an excess of agar to alginate, so that an agar to alginate ratio of 8:1 to 1:1, more preferably 5:1 to 1:1, and most preferably about 3:1 is preferred. Agar acts as an emulsifier and gelling agent, while alginate forms a structured gel with metal 2+ ions (Ca2+, Mg2+, Zn2+) and counteracts the action of these ions when only agar is present.

[0086]

[0108] Agar and alginate are both suitable for vegans, vegetarians and most religious diets, whereas gelatin is not, due to its animal protein, usually obtained from pigs.

[0087]

[0109] The advantage of combining agar and alginate gels is that they are less sensitive to the effects of temperature than other gelling agents. They are also less affected by components that can inhibit gelation, such as oils, changes in pH, and high concentrations of complex carbohydrates, such as maltodextrins. Agar and alginate gels also tend to set faster, which is an advantage in manufacturing, facilitating faster and more robust manufacturing.

[0088]

[0110] The lipids used in the practice of the present invention include any suitable food-grade oils of animal or vegetable origin.Non-limiting examples include corn oil, olive oil, sunflower oil, coconut oil and fish or algae oil.Fish oil and algae oil are particularly advantageous as a source of omega-3, especially DHA and EPA, both of which are important dietary components.The lipid material can advantageously include lipid vitamins, such as either vitamin D or vitamin E.

[0089]

[0111] Flavor components can be included. Any food grade flavor can be used, such as lemon, lime, orange, passion fruit or fruit including vanilla, or mint, or rose water. Flavor oils can also be used, such as palm oil.

[0090]

[0112] Additionally - compliance with veterinary products for animal species, such as pets, livestock or other domesticated animals, is a challenge as it can be very challenging for animal caretakers to ensure that the animal consumes oral delivery forms such as tablets or capsules or powders.

[0091]

[0113] The benefit may also be provided for improved compliance of veterinary products.

[0114] Benefits of the present invention include: · Taste Masking: The gel of the present invention allows any mixture of nutrients as well as most bad, strong and unpleasant flavors - e.g. bitter, sweet, fish oil, curcumin (spice / pepper) to be masked.

[0092] · Large amounts of nutrients can be combined in one easy-to-consume dosage form: Multiple ingredients and large doses can be combined in a single dosage form. Overcomes the risk of choking posed by large tablets: Gels are much easier to swallow than pills. The format helps all swallowing problems, whether they are children or the elderly, or simply people with a predisposition to swallowing problems.

[0093] Fast-acting or targeted delivery: The hardened gel allows the relevant nutrients to be released quickly in the relevant parts of the digestive system. Even for large doses, these are fast-acting - for example, glucose can be released quickly in response to a hypoglycemic event.

[0094] Stable at room temperature. The gel nature provides stability without the need for cold storage. Contains water as an ingredient. The presence of "trapped" yet "releasable" water ensures that hydration is achieved and no additional fluid is required to allow the product to be swallowed. This also aids digestion and provides an improved texture.

[0095]

[0115] Aspects of the present invention are further described herein below with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0096] [Figure 1] FIG. 1 is a diagram of a dispensing dosage form of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0097]

[0116] A preferred base gel (25 ml) into which multiple health or well-being promoting ingredients (not shown), particularly nutritional ingredients, are added includes agar and alginate as shown in Table 5 below:

[0098] [Table 9]

[0099]

[0117] Note - weights are adjusted depending on the amount of formulation desired and are provided here for 25 mL of water.

[0118] The pH is adjusted to a pH of about 5.0, which is within the stable pH range for the primary gelling agent, agar.

[0100]

[0119] Calcium ascorbate can be replaced by an equivalent amount of calcium citrate or another divalent anion salt.

[0120] It will be understood that this particular example is merely illustrative and that the ingredients and their respective amounts will vary depending on the health ingredients to be added as exemplified in Examples 2-8.

[0101]

[0121] A general process for the preparation of a gel formulation is shown in Example 1 below: EXAMPLES

[0102] Example 1

[0122] Any water-soluble ingredients are first dissolved in food-grade water. These may include nutrients such as glucose as well as preservatives and dilute acids (to adjust pH). A typical preservative is potassium sorbate, and a typical pH adjuster is a weak acid such as citric acid, ascorbic acid, acetic acid, or dilute HCl.

[0103]

[0123] The solution is preferably stirred and heated to near boiling to facilitate efficient addition of the gelling agent(s). The agar and sodium alginate are added slowly with consistent, even stirring to gradually hydrate them, ensuring satisfactory dispersion or dissolution. The dispersion or solution is maintained at or near boiling for a sufficient time (4-5 minutes) to ensure proper hydration, especially of the agar. It is then filled into sachets and allowed to cool so that it forms a firm gel.

[0104]

[0124] The sachet can be as illustrated in Figure 1. The pouch (1) is formed, for example, from plastic or foil layers that are sealed together around a rim (3) incorporating a filling and dispensing opening including a stopper (4), a spout (5) and a lid (6). The pouch is filled through the spout (5) and secured with a lid (6), which can be provided with a frangible seal. In use, a subject drinks the gel by removing the lid and squeezing or sucking it out of the pouch (1) through the spout (5).

[0105]

[0125] When preparing gels, it is desirable to limit the heating period to minimize water loss from evaporation, as excessive evaporation can result in product variability.

[0126] Preferably, agar is used at a concentration of 0.001 g (1 mg) to 0.02 g (20 mg) per gram of water, more preferably 0.005 g (5 mg) to 0.01 mg (10 mg) per gram of water, and most preferably 0.006 g (6 mg) to 0.009 g (9 mg) per gram of water (corresponding to 1 ml).

[0106]

[0127] Preferably, the alginate is used at a concentration of 0.0005g (0.5mg) to 0.01g (10mg) per gram of water, more preferably 0.001g (1mg) to 0.008g (8mg) per gram of water, and most preferably 0.001g (1mg) to 0.005g (5mg) per gram of water.

[0107]

[0128] A source of divalent ions is added to promote the formation of alginate gel. Suitable ingredients include calcium, zinc and / or magnesium salts. For example, calcium citrate, magnesium citrate or zinc citrate are suitable forms of soluble salts and can also provide mineral supplementation. However, other salts can also be used.

[0108]

[0129] While hot, any lipid components may be added, as permitted or recommended, to facilitate the formation of a suitable emulsion. Typically, lipid levels may be added at a concentration of 0.1-10% w / w of water, more preferably 1%-5% of water, and most preferably 3mg-5mg per gram of water.

[0109]

[0130] A mechanical homogenizer, such as a Silverson homogenizer, can be conveniently used to facilitate the formation of the emulsion. Any known food-grade emulsifier, such as lecithin, can be added to improve the quality and physical stability of the emulsion. Preferably, the emulsifier is of non-animal origin, such as soy lecithin, rather than egg lecithin.

[0110]

[0131] In an advantageous process, the emulsions can be made as separate cold water mixed precursors and combined with separate hot water agar-alginate precursors (with the water divided appropriately) to speed up cooling and gel formation.

[0111]

[0132] Further components of the solid suspension can be dispersed in the water composition. If the nutritional component is neither water-soluble nor fat-soluble, it can be prepared as a dispersion in either lipid or water. It is advantageous if this component is ground to a fine particle size, since this can improve suspension stability and also improve bioavailability. Advantageously, the insoluble component can be ground in wet or dry conditions, ball milled, or media milled or nano milled, or ground in a high shear homogenizer. Grinding can also be carried out in the presence of grinding aids, such as leucine, sodium lauryl sulfate, and metal stearates.

[0112]

[0133] After heating, the liquid formulation can be measured while hot into the desired container and allowed to set as a gel.

[0134] More specifically, for example for a product for hypoglycemia, the following is initiated during the manufacturing process:

[0135] The pH is ideally adjusted to between 4 and 6, most preferably around 5. This is within the stable pH range of the primary gelling agent, agar.

[0113]

[0136] Generally, the ratio of HCl:water is 0.80:100.00 mL. For example, if 40 mL of water is added to the gel, 0.32 mL of 0.1 M HCl is also added. If HCl is not permitted for use in commercial manufacture, an alternative organic acid, such as citric acid or acetic acid, is selected.

[0114]

[0137] The manufacturing process of the gel includes the following steps:

[0138] Weigh out appropriate scaled quantities of non-gelling agents (e.g., glucose, sorbic acid, water) and add them to a suitable mixing vessel, for example in the following order: glucose (or other carbohydrate) if required; sorbic acid or other preservative if required; and food grade water. Using a suitable dispenser, hydrochloric acid (or alternative acid) is added to the vessel.

[0115]

[0139] Apply consistent stirring, for example at laboratory scale this is a magnetic stir bar. Cover to minimize evaporation and water loss.

[0140] Preweigh out the specified nutrients required for the composition. Mix these non-gelling ingredients with the contents of the container while applying heat. Add one nutrient at a time to the container, allow it to disperse and dissolve thoroughly, then add the next nutrient. When all nutrients have been added, allow to mix for an additional 2-3 minutes.

[0116]

[0141] Pre-weigh the gelling agents (agar and sodium alginate).

[0142] Once all the gelling agent has been added, stir for an additional 2-3 minutes to ensure that all incorporated agents are no longer visible. If insoluble components are used, incorporate using a homogenizer.

[0117]

[0143] If an oil / lipid component is used, immediately after removing from heat and before cooling, add the oil / lipid material and mechanically emulsify with a homogenizer until a suitable milky appearance is achieved.

[0118]

[0144] The formulation is cooled and allowed to gel.

[0145] The Bloom test is used to characterize the grade of the resulting cured gel. Preferably, bloom grades of at least 80-90, 100, 110, 120, 130 and 140 are obtained.

[0119]

[0146] Preferably, a bloom grade of less than 250, less than 220, or from less than 200 to less than 180 is obtained.

[0147] An optimum bloom grade of 140 to 180 is desirable.

[0120]

[0148] In a preferred embodiment, the present invention provides a unique platform for the delivery of multiple health ingredients through the use of two types of gelling agents with different gelling mechanisms, specifically agar and alginate. The use of ionic gelling agents counteracts the gel-inhibiting effect that different health ingredients (e.g. oils, divalent ions, polysaccharides) may have on carbohydrate gelling agents such as agar.

[0121]

[0149] This enhanced gel platform, which is the subject of the second aspect of the present invention, will now be further described with reference to some exemplary formulations which relate in particular to the third to fifth aspects of the present invention.

[0122]

[0150] A number of formulations address hypoglycemic events. The following variants (Examples 2-5) are demonstrated with a number of additives in addition to glucose, including examples that include the addition of lipids, water-insoluble vitamins, trace elements and minerals.

[0123] Example 2

[0151] Child-specific gels for hypoglycemia as in Table 6.

[0124] [Table 10]

[0125] [Table 11]

[0126] Example 3

[0152] Basic adult gel for hypoglycemia as per Table 7.

[0127] [Table 12]

[0128] Example 4

[0153] Pregnancy specific gels for hypoglycemia as per Table 8.

[0129] [Table 13]

[0130] [Table 14]

[0131] Example 5

[0154] Elderly specific gels for hypoglycemia as per Table 9.

[0132] [Table 15]

[0133] [Table 16]

[0134]

[0155] In addition to the example using glucose, several examples illustrating the fourth aspect of the invention were prepared. The following variants (examples 6 and 7) are illustrative: Example 6

[0156] Travel (pre-flight) gel formulation as in Table 10.

[0135] [Table 17]

[0136] Example 7

[0157] Travel (post-flight) gel formulation as in Table 11.

[0137] [Table 18]

[0138] Example 8

[0158] A meal replacement gel designed for use in remote areas or in disaster impact mitigation is exemplified with reference to Table 12.

[0139]

[0159] Basic gel composition (to be scaled according to nutrients added).

[0140] [Table 19]

[0141]

[0160] Into the base gel are introduced nutritional components from the following groups:

[0161] Protein, optionally including one or more of the following: milk protein concentrate, whey protein concentrate, soy protein isolate, sodium caseinate in an amount meeting the minimum RDI or a percentage thereof, e.g., 50% (twice daily) or 33% (three times daily), and amino acids, optionally including one or more of the following: L-glutamine, L-glycine, L-leucine, L-isoleucine, L-valine, beta-alanine, L-arginine, and taurine.

[0142]

[0162] Carbohydrates and sugars optionally including one or more of the following: maltodextrin, inulin, fructose and glucose syrup in an amount that meets the minimum RDI or a percentage thereof, for example 50% (twice daily) or 33% (three times daily).

[0143]

[0163] Dietary fats optionally including one or more of the following: vegetable fats and oils, fish oil, coconut oil, mono- and diglycerides of fatty acids, and lecithin in an amount that meets the minimum RDI or a percentage thereof, for example 50% (twice daily) or 33% (three times daily).

[0144]

[0164] In addition to these three core energy providing groups, the product may further contain one or more essential nutritional ingredients from the following groups:

[0165] Vitamins, optionally including one or more of the following: Vitamin C (ascorbic acid), Vitamin K (menaquinone-7), Vitamin E (dl-alpha tocopheryl acetate), Niacin (niacinamide), Vitamin A (retinyl acetate), Pantothenic acid (D-calcium pantothenate), D-biotin, folic acid, Vitamin D (cholecalciferol), Vitamin B6 (pyridoxine hydrochloride), Riboflavin (riboflavin 5-sodium phosphate), Thiamin (thiamine hydrochloride), Vitamin B12 (cyanocobalamin), Creatine monohydrate, beta-carotene, lutein, lycopene oleoresin, choline chloride, L-carnitine, nicotinamide, D-calcium pantothenate, riboflavin, pyridoxine hydrochloride, pteroylmonoglutamic acid, phytomenadione, resveratrol, alpha-ketoglutaric acid, calcium hydroxymethylbutyrate (HMB), and tricreatine malate; and

[0166] Essential minerals, sources and salts, optionally including one or more of the following: tripotassium citrate, sodium chloride, trisodium citrate, magnesium oxide, zinc gluconate, ferrous fumarate, manganese gluconate, copper gluconate, potassium iodide, sodium molybdate, chromium picolinate, sodium selenite, chromium chloride, potassium iodide, sodium fluoride, sodium chloride, potassium chloride, calcium hydroxide, sodium ascorbate, magnesium hydroxide, potassium hydroxide, ferrous lactate, zinc sulfate, and manganese sulfate, and optionally one or more of the following: sodium triphosphate, tricalcium phosphate, and potassium phosphate.

[0145]

[0167] These additional optional ingredients may be further supplemented with:

[0168] Antioxidants optionally including ascorbyl palmitate and alpha tocopherol.

[0146]

[0169] Flavorings and sweeteners and pH adjusters, such as: citric acid or ascorbic acid.

[0170] It will be understood that skilled nutritionists will be able to formulate multiple variations of the above using their general skill and knowledge to address a variety of needs, including making specific whole meal formulations for adults, children and infants, and that Example 8 is intended only to reflect the possibilities open to one of ordinary skill in the art.

Claims

1. 1. An oral dosage form comprising one or more health ingredients, the health ingredients being selected from the group consisting of: ·water, a primary gelling agent which is agar; a secondary gelling agent which is an alginate; a source of divalent ions for gelling alginate, and ・pH adjuster and wherein the delivery system comprises the agar is present in a concentration of 0.001 g to 0.02 g per gram of water; the alginate is present at a concentration of 0.0005 g to 0.01 g per gram of water; The ingredients are present in amounts to ensure hydration and the formation of a firm gel having a Bloom grade of 100-250, and which when ingested is sheared to become more fluid such that it is a drinkable gel. A dosage form having a pH in the range of 4-6.

2. 2. The dosage form of claim 1, wherein said agar and said alginate are present in an excess ratio of from 5:1 to 1:

1.

3. 3. The dosage form of claim 1 or 2, further comprising one or more preservatives.

4. 4. The dosage form of claim 3, wherein said preservative is sorbic acid.

5. 5. The dosage form of any one of claims 1 to 4, comprising one or more water-soluble health ingredients selected from the group consisting of or including water-soluble vitamins, carbohydrates, sugars and amino acids.

6. 5. A dosage form according to any one of claims 1 to 4, comprising one or more water insoluble health ingredients selected from the group consisting of or comprising a dispersion or suspension forming health ingredient.

7. 7. The dosage form of claim 6, wherein the dispersion or suspension forming health ingredient comprises or is selected from the group consisting of water insoluble trace elements, proteins, minerals and plant extracts.

8. 5. A dosage form according to any one of claims 1 to 4 comprising one or more fat soluble health ingredients, the one or more fat soluble health ingredients comprising or selected from the group consisting of oils, fish and algal oils, DHA, EPA and fat soluble vitamins D and E.

9. 9. The dosage form of claim 8, further comprising an emulsifier.

10. 5. The dosage form of any one of claims 1 to 4, comprising 1 g to 40 g of glucose in a gel volume of less than 250 ml.

11. A dosage form according to any one of claims 1 to 4, further comprising one or more of carbohydrates, proteins, fats, vitamins, minerals, lipids, trace elements and plant extracts.

12. A dosage form according to any one of claims 1 to 4, comprising a meal replacement containing at least one third of the recommended daily intake of protein, carbohydrate and fat.

13. 13. The dosage form of claim 12, comprising at least one-third of the recommended daily intake of protein, carbohydrate and / or fat.

14. The dosage form according to any one of claims 1 to 13, packaged in a pouch (1) having a spout (5) or having a straw to facilitate intake of the gel formulation by squeezing and / or sucking.

15. 15. The dosage form of claim 14 for use in a method for the delivery of a large dose combination of two or more health ingredients selected from water soluble, water insoluble and / or lipid based ingredients, the method comprising ingesting the dosage form by squeezing and / or sucking the drinkable gel from a packaging.

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