WO2022074422A1 - Phytochemical arrangement and method - Google Patents

Phytochemical arrangement and method Download PDF

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Publication number
WO2022074422A1
WO2022074422A1 PCT/IB2020/059332 IB2020059332W WO2022074422A1 WO 2022074422 A1 WO2022074422 A1 WO 2022074422A1 IB 2020059332 W IB2020059332 W IB 2020059332W WO 2022074422 A1 WO2022074422 A1 WO 2022074422A1
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WIPO (PCT)
Prior art keywords
phytochemical
consumable
plant
matrix
disease
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PCT/IB2020/059332
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French (fr)
Inventor
Paul Bertus HAYES
Timothy John BOND
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Stone Tree International Limited
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Priority to PCT/IB2020/059332 priority Critical patent/WO2022074422A1/en
Publication of WO2022074422A1 publication Critical patent/WO2022074422A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/82—Theaceae (Tea family), e.g. camellia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A61K9/0058—Chewing gums
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

Definitions

  • the present invention relates to a phytochemical arrangement and method.
  • the present invention relates to a phytochemical arrangement and method for delivery of phytochemicals and for incorporating plant-based actives with improved phytochemical release profile to provide for a consumable with prophylactic and/or therapeutic property.
  • the first line of defence is the skin as well as mucous membranes. Both the skin, as well as the mucous membranes aim to stop foreign materials from entering the body. They act as physical barriers to prevent microbes, e.g. bacteria and viruses from infecting the cells. In order for the mucous membranes in the mouth and respiratory system to effectively function as a barrier to entry, these areas need to be kept constantly moisturised (wet) and the way that this is accomplished, is via the secretion of sufficient volumes of mucus, which in the mouth is called saliva.
  • Saliva is an extracellular fluid produced and secreted by salivary glands in the mouth. It fulfils a number of very important roles in addition to the important role of protecting the oral mucosa, e.g. pre-digesting dietary starches and fats; neutralising pH, thereby protecting teeth from bacterial decay; lubricating food, thus permitting swallowing; acting as taste transfer medium for flavours to receptor cells etc.
  • the protective abilities of saliva are limited and as consequently humans (as well as animals) are prone to opportunistic infections from viruses, as well as bacteria. Influenza is a virus-borne disease with a high mortality rate throughout the world. It is commonly spread by interpersonal and contact-infection from infected people or surfaces.
  • Aerosols released by infected individuals during sneezing may be atomised and transferred to objects/s objects or remain airborne due to their small size. Once airborne, the droplets can enter the respiratory tract or system e.g. through the nose or mouth, where the virus gets into contact with the mucosal surfaces where they can then infect and/or multiply. Once the viruses have multiplied within the cells of an infected host, they may once again be released - potentially starting another cycle of infection.
  • the best method to protect oneself from a viral infection is by preventing infection altogether. This may be accomplished by life-style changes such as washing hands frequently; wearing gloves and/or wearing a face mask; limiting interpersonal contact, i.e. practicing social distancing; not touching the face etc. Unfortunately, this is not always effective or a sustainable practice. In addition, many infected people may (unknowingly) spread the virus as they themselves do not have any symptoms and are unaware of the fact that they are infected, thus spreading the virus.
  • Vaccination is an effective way to prevent some diseases.
  • a vaccine helps the body’s immune system to recognize and fight pathogens which then keeps us safe from the diseases they cause.
  • Some viruses may be prevented altogether by way of vaccination, e.g. polio, measles, tetanus, diphtheria, meningitis etc.
  • the efficacy of vaccines against viruses that mutate, such as influenza are unfortunately limited. This is due to the fact that vaccines are based on previous viral strains and therefore no effective vaccine exist for novel - or newly mutated viruses. Consequently, symptomatic therapies rather than preventative therapies are predominantly used as a treatment for influenza virus infections.
  • the Tea Plant (Camellia species) family contains numerous phytochemical components which has shown benefits on human health, including on the immune system. These benefits are attributed to polyphenols - principally the flavonoids.
  • the predominant groups of flavonoids are catechins, mainly in Green (unfermented or non-aerated) tea and/or oligomeric thearubigins (TR’s) /dimeric theaflavins, mainly in Black (fermented or aerated) tea.
  • Plant based actives Similar to Green Tea (Camellia spp) plant family, a number of other plant families also contain high levels of polyphenols and/or other phytochemicals (“plant based actives”) with potential beneficial effects on health and on the immune system, including potentially against viruses and bacteria - as a number of laboratory tests have proven on an in vitro level. These plant families are well known and include botanicals, herbals and herbal teas.
  • the conventional method for preparation and consumption of teas/herbal teas are by way of hot water infusions where plant-based actives within the plant material are at least partially extracted. Usually these infusions are to the preference of the consumer and/or due to external factors, such as time or convenience restraints etc.
  • Prepared beverages are conventionally consumed hot, with or without additives such as milk or sweetener, usually within a relatively short period of time, i.e. before the hot beverage gets cold.
  • the concentration level of the plantbased actives during the consumption of a beverage remains stable but diminishes thereafter as it becomes diluted with saliva following the drinking phase.
  • some botanicals or herbals are prepared and consumed as a hot water infusion. Others may be extracted by solvent (e.g. water/ethanol mix) to render a tincture for consumption.
  • solvent e.g. water/ethanol mix
  • Forms of administration/consumption may also include pre-made extracts incorporated within e.g. “fizzy” tablets containing plant-based actives, ingestion or inhalation of actives via nasal spray or from finely milled materials, etc.
  • the conventional methods for consumption of teas, herbal teas, botanicals and their derivatives therefor favour or reflect customs, established taste preference, time and/or convenience constraints, ease of application/use, commercial availability etc.
  • the period of exposure of plant based actives onto (especially) mucous cells within the mouth, (upper) respiratory tract or system and/or throat does not receive any consideration.
  • the beneficial contact period of plant based actives is limited to the period during, and shortly following the consumption of the beverage - which is not necessarily the period when a protective action would be required based on a specific risk, such as being exposed to an area of high(er) risk for infection, e.g. within a crowded area.
  • plant based actives are not optimised in terms of a required or therapeutic dosage and once a protective coating has been acquired on mucosal surfaces, the “excess” amount of plant based actives are not utilised but (usually) consumed, which may lead to a surplus of specific phytochemical constituents which, in some instances, may be (or perceived to be) harmful or deleterious, or which may be undesirable, e.g. caffeine.
  • time-release mechanism for the targeted release of different components
  • these may include so called modified-release dosages.
  • Delayed- release dosage is where a drug is delayed after its administration.
  • Extended-release dosage is where drugs are released over a prolonged period.
  • sustained-release or controlled- release dosage is designed to release actives at a predetermined rate to maintain a constant drug concentration.
  • numerous timed based release mechanisms can also be found, especially in the confectionary (“candy”) and gum industry.
  • sweets/confections that incorporate a method of manufacture and/or components which release flavourings and/or ingredients over an extended period of time.
  • These may include lozenges (generally utilised also within the pharmaceutical industry), for example long lasting breath fresheners, multi-layer candy balls, such as “jawbreakers” etc.
  • Flavour and ingredient release depend on type, formulations, size thereof etc and in some cases active ingredients may be released over a very substantial period of time.
  • Chewing gum formulations normally include a gum base, softeners, sweeteners, and flavourings.
  • the gum base is a synthetic elastomer and is responsible for the chewy texture of gum, as well as its stickiness.
  • Flavour and taste delivery are extended throughout the chewing process by timed release of different flavour components due to the physical, as well as chemical properties of many of the chewing gum's ingredients. In some instances, encapsulated flavours may be released for 30-45 minutes etc. There are also numerous combinations, where candy balls are combined with chewing gum to make it last longer or to offer an enhanced product etc.
  • Some of these products come in the form of traditional leaf products (including infusible tea bags) and some products are in the form of leaf-derived extracts (including from tea) which may be formulated (for example) as herbal-based lozenges etc.
  • Some products claim efficacy on a number of levels, including enhancing the immune system and in some instances also claim therapeutic or remedial action by offering therapeutic or symptomatic relief from ailments such as sore throats, suppressing coughs etc, but they offer no prophylactic action to potentially prevent disease.
  • plant-based actives e.g. polyphenols and/or other phytochemicals
  • plant families or plant species suggested for application in accordance with this invention are those which are well known within the plant kingdom as containing actives which may inhibit and/or prevent pathogens from causing infections. There are however potentially a vast number of other plant species and/or plant families with actives that may have a similar benefit and although not specifically mentioned within this invention, the invention would apply to them equally.
  • a dosage or inclusion rate of plant-based actives in accordance with this invention would differ between different plant species, specific form and concentration levels within which they are utilised and that a dosage is therefore strongly species and/or form and/or concentration level dependant.
  • a phytochemical arrangement for phytochemical delivery of plant based actives includes means for combining suitable plant material with suitable matrix to form a consumable that delivers a regulated therapeutic dosage of plant based actives over a controlled period on mucosal susceptible areas so as to substantially reduce and/or inhibit and/or prevent disease-causing pathogens from causing human disease.
  • a method for the manufacture of an improved phytochemical delivery system of plant based actives includes the steps of combining suitable plant material with suitable matrix to form a consumable that delivers a regulated therapeutic dosage of plant based actives over a controlled period on mucosal susceptible areas so as to substantially reduce and/or inhibit and/or prevent disease-causing pathogens from causing human disease.
  • the suitable plant material may contain plant-based actives with beneficial phytochemical components.
  • the phytochemical components may be anti-viral.
  • the phytochemical components may be anti-bacterial.
  • the phytochemical components may be immune supportive.
  • the phytochemical components may inhibit disease-causing pathogens in vitro.
  • the phytochemical components may inhibit disease-causing pathogens in vivo.
  • the phytochemical components may kill disease-causing pathogens in vitro.
  • the phytochemical components may kill disease-causing pathogens in vivo.
  • the disease-causing pathogens may be viruses.
  • the disease-causing pathogens may be bacteria.
  • the plant material may be augmented to enhance phytochemical activity, including milling.
  • the plant material may be augmented to enhance phytochemical activity, including converting into an extract.
  • the plant material may be processed, including isolation and/or purification and/or removal of phytochemical components.
  • the plant material may be processed to conform to a phytochemical component(s) standard.
  • the phytochemical component(s) standard may deliver a minimum amount of- or concentration level of phytochemical components required to inhibit and/or kill disease-causing pathogens in vitro.
  • the phytochemical component(s) standard may deliver a minimum amount of- or concentration level of phytochemical components required to inhibit and/or kill disease-causing pathogens in vivo.
  • the phytochemical component(s) standard may be the maximum amount of- or concentration level of phytochemical components beyond which no additional benefit is realised.
  • the phytochemical component(s) standard may be the maximum permissible amount of- or concentration level of phytochemical components so as not have a deleterious health effect.
  • the plant material may be of at least one plant family containing plant-based actives which may inhibit and/or prevent pathogens from causing infections.
  • the plant material may be of the plant family Theaceae.
  • the plant material may be of the plant family Aquifoliaceae.
  • the plant material may be of the plant family Fabaceae.
  • the plant material may be of the plant family Zingiberaceae.
  • the plant material may be of the plant family Asteraceae.
  • the plant material may be of the plant family Oleaceae.
  • the plant material may be of the plant family Lauraceae.
  • the plant material may be of the plant family Myrtaceae.
  • the plant material may be of the plant family Rubiaceae.
  • the plant material may be of the plant family Lamiaceae.
  • the plant material may be of the plant family Fagaceae.
  • the plant material may be of the plant family Geraniaceae.
  • the plant material may be of the plant family Caprifoliaceae.
  • the plant material may be of the plant family Bromeliaceae.
  • the plant material may be of the plant family Pinaceae.
  • the plant material may be in a non-aerated or unfermented state.
  • the plant material may be in a semi-aerated or semi-fermented state.
  • the plant material may be in an aerated or fermented state.
  • the matrix may regulate and/or improve the rate of delivery or release of phytochemical components.
  • the matrix may be released together with the phytochemical components.
  • the matrix may be from natural-, processed-, or synthetic origin.
  • the matrix may assist with coating and/or or binding to cells, tissues, and organs.
  • the matrix may assist with or improve the adsorption of phytochemical components onto cells, tissues, or organs.
  • the matrix may assist with or improve the absorption of phytochemical components into cells, tissues, or organs.
  • the matrix may assist with fixating or entrapping disease-causing pathogens.
  • the matrix may assist with inhibiting disease-causing pathogens.
  • the matrix may be a food- and/or pharmaceutical additive.
  • the food- and/or pharmaceutical additive may be a texturiser and/or emulsifier and/or stabiliser and/or thickener and/or gelling agent and/or mucilage.
  • the food- and/or pharmaceutical additive may be a polysaccharide (starch, veg etab I e/p I antbased gum), pectin or protein.
  • the matrix may be a bio-polymer.
  • the matrix may be a plant material.
  • the matrix may conform to a minimum required concentration level or minimum required amount to ensure efficacy in application.
  • the consumable may be a foodstuff.
  • the consumable may be a confectionary, e.g. a sweet and/or chewing gum.
  • the consumable may be a purpose made- or functional beverage.
  • the consumable may be an alcohol-containing beverage, e.g. a beer or a cider.
  • the consumable may be a spray or inhalant or nebule for nasal and/or oral and/or throat application.
  • the consumable may be a base or concentrate, including a nutritional or dietary supplement, e.g. in a powder or syrup which may be mixed or diluted with a carrier or solvent prior to use.
  • the consumable may be an oral and/or nasal and/or throat release device or mechanism designed for ingestion or digestion including a compound which may dissolve or release phytochemical components (including from so called “sustained-release” or “controlled- release” dosage device or mechanism) as conventionally found in the drug and/or pharmaceutical industry.
  • the consumable may be an oral release device or mechanism as conventionally found in the drug and/or pharmaceutical industry, not designed for ingestion or digestion but equipped with a “sustained-release” or “controlled-release” dosage device or mechanism.
  • the consumable may be a personal care product.
  • the consumable may include further ingredients to enhance taste, appearance or assist in efficacy.
  • the consumable may be fortified with vitamins or minerals.
  • the consumable may be suitable for adults and/or children.
  • the consumable may be a matrix.
  • the regulated therapeutic dosage of plant-based actives may deliver the minimum amount of- or concentration level of phytochemical components required to inhibit and/or kill diseasecausing pathogens in vitro.
  • the regulated therapeutic dosage of plant-based actives may deliver the minimum amount of- or concentration level of phytochemical components required to inhibit and/or kill diseasecausing pathogens in vivo as measured in saliva and/or on mucosal susceptible areas.
  • the regulated therapeutic dosage of plant-based actives may be the maximum amount of- or concentration level of phytochemical components beyond which no additional benefit is realised.
  • the regulated therapeutic dosage of plant-based actives may be the maximum permissible amount of- or concentration level of phytochemical components that does not have a deleterious effect on human health.
  • the regulated therapeutic dosage may act as a prophylactic against disease-causing pathogens.
  • the regulated therapeutic dosage may act as a prophylactic against spreading diseasecausing pathogens.
  • the regulated therapeutic dosage may optimize utilisation of plant-based actives within the consumable.
  • the regulated therapeutic dosage may lower risk of infection from disease-causing pathogens in high risk areas or situations.
  • the controlled period may be the period when consumption/usage of the consumable may be required.
  • the controlled period may be a protracted period.
  • the protracted period may be the period of consumption or usage of the consumable in accordance with its intended or prescribed use in comparison to the period for consuming a serving of tea, herbal tea, botanical or their derivative.
  • the protracted period may be at least 10 minutes after consumption/usage of the consumable provided that it is not accidentally or intentionally eroded or washed away.
  • the mucosal susceptible areas may be mucosal cells, tissues and organs located within the nose and/or mouth and/or throat and/or upper respiratory system or tract.
  • the human disease may be a viral infection.
  • the viral infection may be a cold.
  • the viral infection may be flu (influenza).
  • the human disease may be a bacterial infection.
  • a processing arrangement for the manufacture of an improved delivery system for plant based actives includes manufacturing means to process plant material and matrix into a consumable; plant material supply means and matrix supply means to supply plant material and matrix to the manufacturing means; transport means to transport plant material and matrix into and within the manufacturing means and consumable onto packaging.
  • the manufacturing means may include specialist processing and manufacturing equipment conventionally used within the tea and/or herbal industries.
  • the manufacturing means may include specialist processing and manufacturing equipment conventionally used within the food and beverage industries.
  • the manufacturing means may include specialist processing and manufacturing equipment conventionally used within the candy and gum making industries.
  • the manufacturing means may include specialist processing and manufacturing equipment conventionally used within the pharmaceutical industry.
  • the plant material supply means may include plant material augmenting means.
  • the augmenting means may be milling and/or extracts processing means.
  • the augmenting means may include isolation- and/or purifying means for processing plant materials in different stages, e.g. raw materials, or in-process materials, including means to add or remove specific phytochemical components.
  • a consumable with an improved phytochemical delivery system comprises of plant based actives from suitable plant material and a matrix which when consumed delivers a controlled therapeutic dosage of plant based actives over a controlled period of time on mucosal susceptible areas of a non-infected individual thereby acting as prophylactic to reduce and/or inhibit and/or prevent disease-causing pathogens from causing an infection.
  • a consumable with an improved phytochemical delivery system comprises of plant based actives from suitable plant material and a matrix which when consumed deliver a controlled therapeutic dosage of plant based actives over a controlled period of time on mucosal susceptible areas of an infected individual thereby acting as prophylactic to reduce and/or inhibit and/or prevent disease-causing pathogens from causing an infection.
  • a consumable with an improved phytochemical delivery system may decrease the risk of contamination and/or infection in high risk areas or situations.
  • a consumable with an improved phytochemical delivery system comprises of plant based actives from suitable plant material and a matrix which when consumed deliver a controlled therapeutic dosage of plant based actives over a controlled period of time on mucosal susceptible areas that may have a beneficial effect on the immune system.
  • a consumable with an improved phytochemical delivery system may incorporate further natural and/or synthetic actives, minerals and/or vitamins and/or other ingredients to enhance efficacy of product and/or application.
  • the chewing gum is designed to deliver a dosage of 200mg of phytochemicals over a period of approximately 45 minutes, acting not only as a consumable, but also a secondary matrix.
  • a high-quality green tea extract is manufactured from fresh plant material, extracted using a combination of water as well as water/ethanol mix as solvents, which is then partially concentrated.
  • To part of the partially concentrated extract comprising of 150mg/ml total catechins is added pectin and this product is stored in liquid form at 0°C.
  • To the remainder of the partial concentrate is added maltodextrin, a mixture of plant-based gums and natural biopolymer which is spray dried to render a green tea powdered extract comprising of a 200mg total catechins per gram of spray dried powder.
  • the main functions of the pectin is to provide coating/adhesive function of green tea phytochemicals onto mucosal cells, whilst the matrix of maltodextrin, plant based gums and natural biopolymer provides a timed-release action for the green tea phytochemicals, as well as a coating/adhesive function of the phytochemicals onto mucosal cells.
  • the minimum phytochemical component(s) standard required to inhibit and/or kill diseasecausing pathogens is approximately 0.7mg/ml of catechins within a (green tea) beverage.
  • the maximum phytochemical component(s) standard permissible in terms of quantity and concentration level of phytochemical components so as not have a deleterious health effect is 800mg/day or less of catechins.
  • plant based actives (catechins) are incorporated as a liquid concentrate (together with other ingredients) into the soft centre and 175mg spray dried extract within the gum base, thus offering 200mg total of phytochemicals within a multistage delivery system.
  • 25mg of plant-based actives are liberated from the soft centre by the chewing action over a 3 - 5-minute period.
  • This equals a concentration level of between 1 mg/ml and 2mg/ml as measured in the saliva, based on 4ml - 5ml of saliva secretion per minute.
  • This concentration level is substantially higher than the minimum phytochemical component standard of 0.7mg/ml required to inhibit and/or kill disease-causing pathogens in vivo, ensuring potentially a very effective coverage of plant based actives and matrix (maltodextrin, plant based gums and natural biopolymer) onto the mucous cells and tissues of the mouth, tongue, throat etc.
  • the remainder of the phytochemicals (175mg) together with matrix are released from within the gum base via chewing (“mastication”) over a period of approximately 40 minutes via physical chewing of the gum, as well as the controlled-release technology within the spray dried matrix.
  • the release of the maltodextrin, plant-based gums and natural biopolymer coincide with the plant-based actives to ensure coating onto the mucous membranes of the mouth, tongue throat etc.
  • the average concentration level of phytochemicals within the saliva equals 0.875mg/ml to 1.09g/ml based on an average of 4ml - 5ml of saliva secretion per minute. This concentration level is between 25% and 56.25% higher than the minimum phytochemical component standard of 0.7mg/ml required to inhibit and/or kill disease-causing pathogens in vivo.
  • the matrix further assists in the phytochemicals affixing onto the mucous membranes for an additional period of at least 10 minutes post consumption of the chewing gum.
  • the consumable in terms of this embodiment succeeds in providing phytochemical components at a therapeutic rate for a substantially longer period of time and at a substantially controlled rate of release which may prophylactically reduce and/or inhibit and/or prevent disease-causing pathogens from causing an infection and which may have a beneficial effect on the immune system.
  • an improved delivery system using plant based actives of Green Tea (Camellia sinensis) as processed per the first embodiment, together with a mixture of finely milled ( ⁇ 40 micron) herbal teas consisting of both fermented and unfermented Honeybush (Cyclopia spp) and Rooibos (Aspalathus linearis) and matrix within herbal lozenges (“consumable”).
  • Green Tea Cromellia sinensis
  • a mixture of finely milled ( ⁇ 40 micron) herbal teas consisting of both fermented and unfermented Honeybush (Cyclopia spp) and Rooibos (Aspalathus linearis) and matrix within herbal lozenges (“consumable”).
  • the milled herbal teas act as a secondary source of phytochemicals and matrix controlling the release of phytochemicals, as well as a natural flavour.
  • a mixture of carrageenan, pectin and carboxymethyl cellulose is used as a primary matrix to assist the phytochemicals to affix to the mucous membrane of the mouth and throat.
  • the green tea extract, together with milled herbal teas, matrix and other ingredients are processed in accordance with conventional methods followed within the sweets/candy or pharmaceutical industries to render lozenges containing plant-based actives (“consumable”).
  • the minimum phytochemical component(s) standard required to inhibit and/or kill diseasecausing pathogens is approximately 0.7mg/ml of catechins within a (green tea) beverage and the lozenges are formulated to liberate matrix and phytochemicals (based solely on green tea) at the minimum dosage required to inactivate pathogens on an in vivo basis whilst taking into consideration the dilution effect of saliva being secreted at an average of 4 - 5ml per minute.
  • the consumption period of the lozenge is designed to be 25 minutes and the amount of green tea phytochemicals (catechins) required per lozenge is 87.5mg (0.7mg/ml x 5ml saliva/min x 25minutes).
  • an effective and continued release of phytochemical components in comparison to phytochemicals that would have been consumed by way of a hot water beverage (which may conventionally be within 10 - 15 minutes period) with the matrix further assisting the fixation of phytochemicals to the mucous membranes during, as well as for an additional period of at least 10 minutes post consumption of the lozenge as measured on the mucous membranes of the mouth.
  • the consumable in terms of this embodiment not only succeeds in providing phytochemical components at a minimum phytochemical component standard to act as prophylactic to reduce and/or inhibit and/or prevent disease-causing pathogens from causing an infection whilst potentially also having a beneficial effect on the immune system, but the consumable would be safe to be used over a substantially protracted period of time as a total of 9 lozenges consumed within a single day is still substantially within the maximum phytochemical component(s) standard permissible in terms of quantity and concentration level of phytochemical components so as not have a deleterious health effect, which is 800mg/day or less of catechins.

Abstract

The invention discloses methods of manufacturing oral consumable products comprising green tea extracts and a suitable matrix for reducing and/or inhibiting the activity of pathogens in the oral cavity, and consumables thereof.

Description

PHYTOCHEMICAL ARRANGEMENT AND METHOD
FIELD OF INVENTION
The present invention relates to a phytochemical arrangement and method.
More particularly, the present invention relates to a phytochemical arrangement and method for delivery of phytochemicals and for incorporating plant-based actives with improved phytochemical release profile to provide for a consumable with prophylactic and/or therapeutic property.
BACKGROUND TO INVENTION
Within the human body, there is a continuous battle between invading pathogens and the host. The first line of defence is the skin as well as mucous membranes. Both the skin, as well as the mucous membranes aim to stop foreign materials from entering the body. They act as physical barriers to prevent microbes, e.g. bacteria and viruses from infecting the cells. In order for the mucous membranes in the mouth and respiratory system to effectively function as a barrier to entry, these areas need to be kept constantly moisturised (wet) and the way that this is accomplished, is via the secretion of sufficient volumes of mucus, which in the mouth is called saliva.
Saliva is an extracellular fluid produced and secreted by salivary glands in the mouth. It fulfils a number of very important roles in addition to the important role of protecting the oral mucosa, e.g. pre-digesting dietary starches and fats; neutralising pH, thereby protecting teeth from bacterial decay; lubricating food, thus permitting swallowing; acting as taste transfer medium for flavours to receptor cells etc. Unfortunately, the protective abilities of saliva are limited and as consequently humans (as well as animals) are prone to opportunistic infections from viruses, as well as bacteria. Influenza is a virus-borne disease with a high mortality rate throughout the world. It is commonly spread by interpersonal and contact-infection from infected people or surfaces. Aerosols released by infected individuals during sneezing may be atomised and transferred to objects/s objects or remain airborne due to their small size. Once airborne, the droplets can enter the respiratory tract or system e.g. through the nose or mouth, where the virus gets into contact with the mucosal surfaces where they can then infect and/or multiply. Once the viruses have multiplied within the cells of an infected host, they may once again be released - potentially starting another cycle of infection.
The best method to protect oneself from a viral infection is by preventing infection altogether. This may be accomplished by life-style changes such as washing hands frequently; wearing gloves and/or wearing a face mask; limiting interpersonal contact, i.e. practicing social distancing; not touching the face etc. Unfortunately, this is not always effective or a sustainable practice. In addition, many infected people may (unknowingly) spread the virus as they themselves do not have any symptoms and are unaware of the fact that they are infected, thus spreading the virus.
Vaccination is an effective way to prevent some diseases. A vaccine helps the body’s immune system to recognize and fight pathogens which then keeps us safe from the diseases they cause. Some viruses may be prevented altogether by way of vaccination, e.g. polio, measles, tetanus, diphtheria, meningitis etc. However, the efficacy of vaccines against viruses that mutate, such as influenza, are unfortunately limited. This is due to the fact that vaccines are based on previous viral strains and therefore no effective vaccine exist for novel - or newly mutated viruses. Consequently, symptomatic therapies rather than preventative therapies are predominantly used as a treatment for influenza virus infections. The Tea Plant (Camellia species) family contains numerous phytochemical components which has shown benefits on human health, including on the immune system. These benefits are attributed to polyphenols - principally the flavonoids. The predominant groups of flavonoids are catechins, mainly in Green (unfermented or non-aerated) tea and/or oligomeric thearubigins (TR’s) /dimeric theaflavins, mainly in Black (fermented or aerated) tea.
Similar to Green Tea (Camellia spp) plant family, a number of other plant families also contain high levels of polyphenols and/or other phytochemicals (“plant based actives”) with potential beneficial effects on health and on the immune system, including potentially against viruses and bacteria - as a number of laboratory tests have proven on an in vitro level. These plant families are well known and include botanicals, herbals and herbal teas.
The conventional method for preparation and consumption of teas/herbal teas are by way of hot water infusions where plant-based actives within the plant material are at least partially extracted. Usually these infusions are to the preference of the consumer and/or due to external factors, such as time or convenience restraints etc. Prepared beverages are conventionally consumed hot, with or without additives such as milk or sweetener, usually within a relatively short period of time, i.e. before the hot beverage gets cold. The concentration level of the plantbased actives during the consumption of a beverage remains stable but diminishes thereafter as it becomes diluted with saliva following the drinking phase.
In a similar fashion, some botanicals or herbals are prepared and consumed as a hot water infusion. Others may be extracted by solvent (e.g. water/ethanol mix) to render a tincture for consumption. Forms of administration/consumption may also include pre-made extracts incorporated within e.g. “fizzy” tablets containing plant-based actives, ingestion or inhalation of actives via nasal spray or from finely milled materials, etc. The conventional methods for consumption of teas, herbal teas, botanicals and their derivatives therefor favour or reflect customs, established taste preference, time and/or convenience constraints, ease of application/use, commercial availability etc. whilst an optimal concentration level of plant based actives, the period of exposure of plant based actives onto (especially) mucous cells within the mouth, (upper) respiratory tract or system and/or throat does not receive any consideration. In addition, the beneficial contact period of plant based actives is limited to the period during, and shortly following the consumption of the beverage - which is not necessarily the period when a protective action would be required based on a specific risk, such as being exposed to an area of high(er) risk for infection, e.g. within a crowded area.
Furthermore, plant based actives are not optimised in terms of a required or therapeutic dosage and once a protective coating has been acquired on mucosal surfaces, the “excess” amount of plant based actives are not utilised but (usually) consumed, which may lead to a surplus of specific phytochemical constituents which, in some instances, may be (or perceived to be) harmful or deleterious, or which may be undesirable, e.g. caffeine.
There are various consumables that have a time-release mechanism for the targeted release of different components, such as found within the pharmaceutical-, but also within the food & beverage industries. Within the pharmaceutical industry, a number of timed based release mechanisms are known, and these may include so called modified-release dosages. “Delayed- release dosage” is where a drug is delayed after its administration. “Extended-release dosage” is where drugs are released over a prolonged period. “Sustained-release” or “controlled- release dosage” is designed to release actives at a predetermined rate to maintain a constant drug concentration. Within the foodstuffs industry, numerous timed based release mechanisms can also be found, especially in the confectionary (“candy”) and gum industry. There are many types of sweets/confections that incorporate a method of manufacture and/or components which release flavourings and/or ingredients over an extended period of time. These may include lozenges (generally utilised also within the pharmaceutical industry), for example long lasting breath fresheners, multi-layer candy balls, such as “jawbreakers” etc. Flavour and ingredient release depend on type, formulations, size thereof etc and in some cases active ingredients may be released over a very substantial period of time.
Chewing gum formulations normally include a gum base, softeners, sweeteners, and flavourings. In most formulations, the gum base is a synthetic elastomer and is responsible for the chewy texture of gum, as well as its stickiness. Flavour and taste delivery are extended throughout the chewing process by timed release of different flavour components due to the physical, as well as chemical properties of many of the chewing gum's ingredients. In some instances, encapsulated flavours may be released for 30-45 minutes etc. There are also numerous combinations, where candy balls are combined with chewing gum to make it last longer or to offer an enhanced product etc.
Also, within the food and beverage and pharmaceutical industries there are several widely used additives which act as emulsifiers, binders or coaters, stabilisers, thickeners, gelling agents etc. Their roles within these industries are to impart functional properties to the products within which they are utilised. They are conventionally from plant or animal origin and include products such as modified starch, modified cellulose, carrageenan, xanthan gum, mucilage’s, gelatin etc. Some of these food additives could also act in a similar way as a time based or modified release mechanisms when utilised. Within the complementary and alternative medication industry, which includes herbal remedies or “medicinal herbs”, there are several well established (commercial) products which incorporate plant-based actives. Some of these products come in the form of traditional leaf products (including infusible tea bags) and some products are in the form of leaf-derived extracts (including from tea) which may be formulated (for example) as herbal-based lozenges etc. Some products claim efficacy on a number of levels, including enhancing the immune system and in some instances also claim therapeutic or remedial action by offering therapeutic or symptomatic relief from ailments such as sore throats, suppressing coughs etc, but they offer no prophylactic action to potentially prevent disease.
It is the object of this invention to suggest a novel phytochemical arrangement and method.
It is another object of this invention to suggest method for the manufacture of an improved delivery system of plant-based actives (e.g. polyphenols and/or other phytochemicals) to substantially reduce and/or inhibit and/or prevent pathogens from causing infections and human disease.
It is another object of this invention to suggest plant families or plant species for application as source for plant-based actives.
It is a further object of this invention to suggest a minimum dosage or inclusion rate of plantbased actives, a so-called minimum phytochemical component(s) standard or minimum inhibitory concentration required to inhibit and/or kill disease-causing pathogens.
It is still a further object of this invention to suggest a maximum dosage or inclusion rate of plant-based actives, a so-called maximum phytochemical component(s) standard, which suggests a maximum inclusion rate or permissible dosage of plant based actives beyond which no additional benefit is realised or so as not have a deleterious health effect. It should be noted that medical and/or physiological descriptions, as well as the background on the food and beverage product manufacture set out within this invention are described in a rather simple manner and intended for illustrative purposes.
It should further be noted that the plant families or plant species suggested for application in accordance with this invention are those which are well known within the plant kingdom as containing actives which may inhibit and/or prevent pathogens from causing infections. There are however potentially a vast number of other plant species and/or plant families with actives that may have a similar benefit and although not specifically mentioned within this invention, the invention would apply to them equally.
In addition, it should be noted that a dosage or inclusion rate of plant-based actives in accordance with this invention would differ between different plant species, specific form and concentration levels within which they are utilised and that a dosage is therefore strongly species and/or form and/or concentration level dependant.
It should also be noted that in accordance with this invention, the phrases of “plant-based actives” and “phytochemical components” are used throughout this invention and may be interpreted as alternative forms with substantially similar meaning.
SUMMARY OF INVENTION
According to the invention, a phytochemical arrangement for phytochemical delivery of plant based actives includes means for combining suitable plant material with suitable matrix to form a consumable that delivers a regulated therapeutic dosage of plant based actives over a controlled period on mucosal susceptible areas so as to substantially reduce and/or inhibit and/or prevent disease-causing pathogens from causing human disease. Also according to the invention, a method for the manufacture of an improved phytochemical delivery system of plant based actives includes the steps of combining suitable plant material with suitable matrix to form a consumable that delivers a regulated therapeutic dosage of plant based actives over a controlled period on mucosal susceptible areas so as to substantially reduce and/or inhibit and/or prevent disease-causing pathogens from causing human disease.
The suitable plant material may contain plant-based actives with beneficial phytochemical components.
The phytochemical components may be anti-viral.
The phytochemical components may be anti-bacterial.
The phytochemical components may be immune supportive.
The phytochemical components may inhibit disease-causing pathogens in vitro.
The phytochemical components may inhibit disease-causing pathogens in vivo.
The phytochemical components may kill disease-causing pathogens in vitro.
The phytochemical components may kill disease-causing pathogens in vivo.
The disease-causing pathogens may be viruses.
The disease-causing pathogens may be bacteria.
The plant material may be augmented to enhance phytochemical activity, including milling.
The plant material may be augmented to enhance phytochemical activity, including converting into an extract. The plant material may be processed, including isolation and/or purification and/or removal of phytochemical components.
The plant material may be processed to conform to a phytochemical component(s) standard.
The phytochemical component(s) standard may deliver a minimum amount of- or concentration level of phytochemical components required to inhibit and/or kill disease-causing pathogens in vitro.
The phytochemical component(s) standard may deliver a minimum amount of- or concentration level of phytochemical components required to inhibit and/or kill disease-causing pathogens in vivo.
The phytochemical component(s) standard may be the maximum amount of- or concentration level of phytochemical components beyond which no additional benefit is realised.
The phytochemical component(s) standard may be the maximum permissible amount of- or concentration level of phytochemical components so as not have a deleterious health effect.
The plant material may be of at least one plant family containing plant-based actives which may inhibit and/or prevent pathogens from causing infections.
The plant material may be of the plant family Theaceae.
The plant material may be of the plant family Aquifoliaceae.
The plant material may be of the plant family Fabaceae.
The plant material may be of the plant family Zingiberaceae.
The plant material may be of the plant family Asteraceae. The plant material may be of the plant family Oleaceae.
The plant material may be of the plant family Lauraceae.
The plant material may be of the plant family Myrtaceae.
The plant material may be of the plant family Rubiaceae.
The plant material may be of the plant family Lamiaceae.
The plant material may be of the plant family Fagaceae.
The plant material may be of the plant family Geraniaceae.
The plant material may be of the plant family Caprifoliaceae.
The plant material may be of the plant family Bromeliaceae.
The plant material may be of the plant family Pinaceae.
The plant material may be in a non-aerated or unfermented state.
The plant material may be in a semi-aerated or semi-fermented state.
The plant material may be in an aerated or fermented state.
The matrix may regulate and/or improve the rate of delivery or release of phytochemical components.
The matrix may be released together with the phytochemical components.
The matrix may be from natural-, processed-, or synthetic origin.
The matrix may assist with coating and/or or binding to cells, tissues, and organs. The matrix may assist with or improve the adsorption of phytochemical components onto cells, tissues, or organs.
The matrix may assist with or improve the absorption of phytochemical components into cells, tissues, or organs.
The matrix may assist with fixating or entrapping disease-causing pathogens.
The matrix may assist with inhibiting disease-causing pathogens.
The matrix may be a food- and/or pharmaceutical additive.
The food- and/or pharmaceutical additive may be a texturiser and/or emulsifier and/or stabiliser and/or thickener and/or gelling agent and/or mucilage.
The food- and/or pharmaceutical additive may be a polysaccharide (starch, veg etab I e/p I antbased gum), pectin or protein.
The matrix may be a bio-polymer.
The matrix may be a plant material.
The matrix may conform to a minimum required concentration level or minimum required amount to ensure efficacy in application.
The consumable may be a foodstuff.
The consumable may be a confectionary, e.g. a sweet and/or chewing gum.
The consumable may be a purpose made- or functional beverage.
The consumable may be an alcohol-containing beverage, e.g. a beer or a cider. The consumable may be a spray or inhalant or nebule for nasal and/or oral and/or throat application.
The consumable may be a base or concentrate, including a nutritional or dietary supplement, e.g. in a powder or syrup which may be mixed or diluted with a carrier or solvent prior to use.
The consumable may be an oral and/or nasal and/or throat release device or mechanism designed for ingestion or digestion including a compound which may dissolve or release phytochemical components (including from so called “sustained-release” or “controlled- release” dosage device or mechanism) as conventionally found in the drug and/or pharmaceutical industry.
The consumable may be an oral release device or mechanism as conventionally found in the drug and/or pharmaceutical industry, not designed for ingestion or digestion but equipped with a “sustained-release” or “controlled-release” dosage device or mechanism.
The consumable may be a personal care product.
The consumable may include further ingredients to enhance taste, appearance or assist in efficacy.
The consumable may be fortified with vitamins or minerals.
The consumable may be suitable for adults and/or children.
The consumable may be a matrix.
The regulated therapeutic dosage of plant-based actives may deliver the minimum amount of- or concentration level of phytochemical components required to inhibit and/or kill diseasecausing pathogens in vitro. The regulated therapeutic dosage of plant-based actives may deliver the minimum amount of- or concentration level of phytochemical components required to inhibit and/or kill diseasecausing pathogens in vivo as measured in saliva and/or on mucosal susceptible areas.
The regulated therapeutic dosage of plant-based actives may be the maximum amount of- or concentration level of phytochemical components beyond which no additional benefit is realised.
The regulated therapeutic dosage of plant-based actives may be the maximum permissible amount of- or concentration level of phytochemical components that does not have a deleterious effect on human health.
The regulated therapeutic dosage may act as a prophylactic against disease-causing pathogens.
The regulated therapeutic dosage may act as a prophylactic against spreading diseasecausing pathogens.
The regulated therapeutic dosage may optimize utilisation of plant-based actives within the consumable.
The regulated therapeutic dosage may lower risk of infection from disease-causing pathogens in high risk areas or situations.
The controlled period may be the period when consumption/usage of the consumable may be required.
The controlled period may be a protracted period. The protracted period may be the period of consumption or usage of the consumable in accordance with its intended or prescribed use in comparison to the period for consuming a serving of tea, herbal tea, botanical or their derivative.
The protracted period may be at least 10 minutes after consumption/usage of the consumable provided that it is not accidentally or intentionally eroded or washed away.
The mucosal susceptible areas may be mucosal cells, tissues and organs located within the nose and/or mouth and/or throat and/or upper respiratory system or tract.
The human disease may be a viral infection.
The viral infection may be a cold.
The viral infection may be flu (influenza).
The human disease may be a bacterial infection.
Further according to the invention a processing arrangement for the manufacture of an improved delivery system for plant based actives includes manufacturing means to process plant material and matrix into a consumable; plant material supply means and matrix supply means to supply plant material and matrix to the manufacturing means; transport means to transport plant material and matrix into and within the manufacturing means and consumable onto packaging.
The manufacturing means may include specialist processing and manufacturing equipment conventionally used within the tea and/or herbal industries.
The manufacturing means may include specialist processing and manufacturing equipment conventionally used within the food and beverage industries. The manufacturing means may include specialist processing and manufacturing equipment conventionally used within the candy and gum making industries.
The manufacturing means may include specialist processing and manufacturing equipment conventionally used within the pharmaceutical industry.
The plant material supply means may include plant material augmenting means.
The augmenting means may be milling and/or extracts processing means.
The augmenting means may include isolation- and/or purifying means for processing plant materials in different stages, e.g. raw materials, or in-process materials, including means to add or remove specific phytochemical components.
According to the invention a consumable with an improved phytochemical delivery system comprises of plant based actives from suitable plant material and a matrix which when consumed delivers a controlled therapeutic dosage of plant based actives over a controlled period of time on mucosal susceptible areas of a non-infected individual thereby acting as prophylactic to reduce and/or inhibit and/or prevent disease-causing pathogens from causing an infection.
Also according to the invention a consumable with an improved phytochemical delivery system comprises of plant based actives from suitable plant material and a matrix which when consumed deliver a controlled therapeutic dosage of plant based actives over a controlled period of time on mucosal susceptible areas of an infected individual thereby acting as prophylactic to reduce and/or inhibit and/or prevent disease-causing pathogens from causing an infection. Further according to the invention, a consumable with an improved phytochemical delivery system may decrease the risk of contamination and/or infection in high risk areas or situations.
Still further according to the invention a consumable with an improved phytochemical delivery system comprises of plant based actives from suitable plant material and a matrix which when consumed deliver a controlled therapeutic dosage of plant based actives over a controlled period of time on mucosal susceptible areas that may have a beneficial effect on the immune system.
Also, according to the invention, a consumable with an improved phytochemical delivery system may incorporate further natural and/or synthetic actives, minerals and/or vitamins and/or other ingredients to enhance efficacy of product and/or application.
DETAILED DESCRIPTION OF THE INVENTION
In a first embodiment of the invention is provided an improved delivery system of plant based actives isolated from green tea (Camellia sinensis) Theaceae Plant Family combined with a matrix consisting of maltodextrin, plant based gums and a natural biopolymer within a chewing gum consumable.
The chewing gum is designed to deliver a dosage of 200mg of phytochemicals over a period of approximately 45 minutes, acting not only as a consumable, but also a secondary matrix.
A high-quality green tea extract is manufactured from fresh plant material, extracted using a combination of water as well as water/ethanol mix as solvents, which is then partially concentrated. To part of the partially concentrated extract comprising of 150mg/ml total catechins is added pectin and this product is stored in liquid form at 0°C. To the remainder of the partial concentrate is added maltodextrin, a mixture of plant-based gums and natural biopolymer which is spray dried to render a green tea powdered extract comprising of a 200mg total catechins per gram of spray dried powder. The main functions of the pectin (matrix) is to provide coating/adhesive function of green tea phytochemicals onto mucosal cells, whilst the matrix of maltodextrin, plant based gums and natural biopolymer provides a timed-release action for the green tea phytochemicals, as well as a coating/adhesive function of the phytochemicals onto mucosal cells.
The minimum phytochemical component(s) standard required to inhibit and/or kill diseasecausing pathogens is approximately 0.7mg/ml of catechins within a (green tea) beverage.
The maximum phytochemical component(s) standard permissible in terms of quantity and concentration level of phytochemical components so as not have a deleterious health effect is 800mg/day or less of catechins.
For the present embodiment, 25mg of plant based actives (catechins) are incorporated as a liquid concentrate (together with other ingredients) into the soft centre and 175mg spray dried extract within the gum base, thus offering 200mg total of phytochemicals within a multistage delivery system.
During the first stage of delivery, 25mg of plant-based actives are liberated from the soft centre by the chewing action over a 3 - 5-minute period. This equals a concentration level of between 1 mg/ml and 2mg/ml as measured in the saliva, based on 4ml - 5ml of saliva secretion per minute. This concentration level is substantially higher than the minimum phytochemical component standard of 0.7mg/ml required to inhibit and/or kill disease-causing pathogens in vivo, ensuring potentially a very effective coverage of plant based actives and matrix (maltodextrin, plant based gums and natural biopolymer) onto the mucous cells and tissues of the mouth, tongue, throat etc. During the secondary stage of delivery, the remainder of the phytochemicals (175mg) together with matrix are released from within the gum base via chewing (“mastication”) over a period of approximately 40 minutes via physical chewing of the gum, as well as the controlled-release technology within the spray dried matrix. The release of the maltodextrin, plant-based gums and natural biopolymer coincide with the plant-based actives to ensure coating onto the mucous membranes of the mouth, tongue throat etc. The average concentration level of phytochemicals within the saliva equals 0.875mg/ml to 1.09g/ml based on an average of 4ml - 5ml of saliva secretion per minute. This concentration level is between 25% and 56.25% higher than the minimum phytochemical component standard of 0.7mg/ml required to inhibit and/or kill disease-causing pathogens in vivo.
In accordance with this embodiment is provided an enhanced method for the delivery of a therapeutic dosage of green tea phytochemicals for at least 45 minutes during consumption of the consumable in comparison to green tea phytochemicals conventionally delivered in a cup of tea (which may conventionally be consumed within 10 - 15 minutes). The matrix further assists in the phytochemicals affixing onto the mucous membranes for an additional period of at least 10 minutes post consumption of the chewing gum.
Thus, the consumable in terms of this embodiment succeeds in providing phytochemical components at a therapeutic rate for a substantially longer period of time and at a substantially controlled rate of release which may prophylactically reduce and/or inhibit and/or prevent disease-causing pathogens from causing an infection and which may have a beneficial effect on the immune system.
In a second embodiment of the invention is provided an improved delivery system using plant based actives of Green Tea (Camellia sinensis) as processed per the first embodiment, together with a mixture of finely milled (<40 micron) herbal teas consisting of both fermented and unfermented Honeybush (Cyclopia spp) and Rooibos (Aspalathus linearis) and matrix within herbal lozenges (“consumable”).
The milled herbal teas act as a secondary source of phytochemicals and matrix controlling the release of phytochemicals, as well as a natural flavour.
A mixture of carrageenan, pectin and carboxymethyl cellulose is used as a primary matrix to assist the phytochemicals to affix to the mucous membrane of the mouth and throat.
The green tea extract, together with milled herbal teas, matrix and other ingredients (including flavours and sweeteners etc.) are processed in accordance with conventional methods followed within the sweets/candy or pharmaceutical industries to render lozenges containing plant-based actives (“consumable”).
The minimum phytochemical component(s) standard required to inhibit and/or kill diseasecausing pathogens is approximately 0.7mg/ml of catechins within a (green tea) beverage and the lozenges are formulated to liberate matrix and phytochemicals (based solely on green tea) at the minimum dosage required to inactivate pathogens on an in vivo basis whilst taking into consideration the dilution effect of saliva being secreted at an average of 4 - 5ml per minute.
The consumption period of the lozenge is designed to be 25 minutes and the amount of green tea phytochemicals (catechins) required per lozenge is 87.5mg (0.7mg/ml x 5ml saliva/min x 25minutes). In accordance with this embodiment is provided an effective and continued release of phytochemical components in comparison to phytochemicals that would have been consumed by way of a hot water beverage (which may conventionally be within 10 - 15 minutes period) with the matrix further assisting the fixation of phytochemicals to the mucous membranes during, as well as for an additional period of at least 10 minutes post consumption of the lozenge as measured on the mucous membranes of the mouth.
Thus, the consumable in terms of this embodiment not only succeeds in providing phytochemical components at a minimum phytochemical component standard to act as prophylactic to reduce and/or inhibit and/or prevent disease-causing pathogens from causing an infection whilst potentially also having a beneficial effect on the immune system, but the consumable would be safe to be used over a substantially protracted period of time as a total of 9 lozenges consumed within a single day is still substantially within the maximum phytochemical component(s) standard permissible in terms of quantity and concentration level of phytochemical components so as not have a deleterious health effect, which is 800mg/day or less of catechins.

Claims

PATENT CLAIMS
1 . A method for the manufacture of an improved phytochemical delivery system of plantbased actives, which includes the step of combining suitable plant material with suitable matrix to form a consumable that delivers a regulated therapeutic dosage of plant based actives over a controlled period on mucosal susceptible areas so as to substantially reduce and/or inhibit and/or prevent disease-causing pathogens from causing human disease.
2. A method as claimed in claim 1 , in which the suitable plant material contains plantbased actives with beneficial phytochemical components.
3. A method as claimed in claim 1 or claim 2, in which the phytochemical components are anti-viral, anti-bacterial and/or immune supportive.
4. A method as claimed in any one of the preceding claims, in which the phytochemical components inhibit disease-causing pathogens in vitro, inhibit disease-causing pathogens in vivo, kill disease-causing pathogens in vitro and/or kill disease-causing pathogens in vivo.
5. A method as claimed in any one of the preceding claims, in which the disease-causing pathogens are viruses and/or bacteria.
6. A method as claimed in any one of the preceding claims, in which the plant material is augmented to enhance phytochemical activity, including milling.
7. A method as claimed in any one of the preceding claims, in which the plant material is augmented to enhance phytochemical activity, including converting into an extract.
8. A method as claimed in any one of the preceding claims, in which the plant material is processed, including isolation and/or purification and/or removal of phytochemical components. A method as claimed in any one of the preceding claims, in which the plant material is processed to conform to a phytochemical component(s) standard. A method as claimed in any one of the preceding claims, in which the phytochemical component(s) standard delivers a minimum amount of- or concentration level of phytochemical components required to inhibit and/or kill disease-causing pathogens in vitro. A method as claimed in any one of the preceding claims, in which the phytochemical component(s) standard delivers a minimum amount of- or concentration level of phytochemical components required to inhibit and/or kill disease-causing pathogens in vivo. A method as claimed in any one of the preceding claims, in which the phytochemical component(s) standard is the maximum amount of- or concentration level of phytochemical components beyond which no additional benefit is realised. A method as claimed in any one of the preceding claims, in which the phytochemical component(s) standard is the maximum permissible amount of- or concentration level of phytochemical components so as not have a deleterious health effect. A method as claimed in any one of the preceding claims, in which the plant material is at least one plant family containing plant-based actives which inhibit and/or prevent pathogens from causing infections. A method as claimed in any one of the preceding claims, in which the plant material is at least one selected from the following plant families: Theaceae, Aquifoliaceae, Fabaceae, Zingiberaceae, Asteraceae, Oleaceae, Lauraceae, Myrtaceae, Rubiaceae, Lamiaceae, Fagaceae, Geraniaceae, Caprifoliaceae, Bromeliaceae, and/or Pinaceae. A method as claimed in any one of the preceding claims, in which the plant material is in a non-aerated or unfermented state, a semi-aerated or semi-fermented state or an aerated or fermented state. A method as claimed in any one of the preceding claims, in which the matrix regulates and/or improves the rate of delivery or release of phytochemical components. A method as claimed in any one of the preceding claims, in which the matrix is released together with the phytochemical components. A method as claimed in any one of the preceding claims, in which the matrix is from natural-, processed-, or synthetic origin. A method as claimed in any one of the preceding claims, in which the matrix assists with coating and/or or binding to cells, tissues and organs. A method as claimed in any one of the preceding claims, in which the matrix assists with or improve the adsorption of phytochemical components onto cells, tissues or organs. A method as claimed in any one of the preceding claims, in which the matrix assists with or improve the absorption of phytochemical components into cells, tissues or organs. A method as claimed in any one of the preceding claims, in which the matrix assists with fixating or entrapping disease-causing pathogens. A method as claimed in any one of the preceding claims, in which the matrix assists with inhibiting disease-causing pathogens. A method as claimed in any one of the preceding claims, in which the matrix is a food- and/or pharmaceutical additive. A method as claimed in any one of the preceding claims, in which the food- and/or pharmaceutical additive may be a texturiser and/or emulsifier and/or stabiliser and/or thickener and/or gelling agent and/or mucilage. A method as claimed in any one of the preceding claims, in which the food- and/or pharmaceutical additive is a polysaccharide (starch, vegetable/plant-based gum), pectin or protein. A method as claimed in any one of the preceding claims, in which the matrix is a biopolymer. A method as claimed in any one of the preceding claims, in which the matrix is a plant material. A method as claimed in any one of the preceding claims, in which the matrix conforms to a minimum required concentration level or minimum required amount to ensure efficacy in application. A method as claimed in any one of the preceding claims, in which the consumable is a foodstuff. A method as claimed in any one of the preceding claims, in which the consumable is a confectionary, e.g. a sweet and/or chewing gum. A method as claimed in any one of the preceding claims, in which the consumable is a purpose made- or functional beverage. A method as claimed in any one of the preceding claims, in which the consumable is an alcohol-containing beverage, e.g. a beer or a cider. A method as claimed in any one of the preceding claims, in which the consumable is a spray or inhalant or nebule for nasal and/or oral and/or throat application. A method as claimed in any one of the preceding claims, in which the consumable is a base or concentrate, including a nutritional or dietary supplement, e.g. in a powder or syrup which may be mixed or diluted with a carrier or solvent prior to use. A method as claimed in any one of the preceding claims, in which the consumable is an oral and/or nasal and/or throat release device or mechanism designed for ingestion or digestion including a compound which may dissolve or release phytochemical components (including from so called “sustained-release” or “controlled-release” dosage device or mechanism) as conventionally found in the drug and/or pharmaceutical industry. A method as claimed in any one of the preceding claims, in which the consumable is an oral release device or mechanism as conventionally found in the drug and/or pharmaceutical industry, not designed for ingestion or digestion but equipped with a “sustained-release” or “controlled-release” dosage device or mechanism. A method as claimed in any one of the preceding claims, in which the consumable is a personal care product. A method as claimed in any one of the preceding claims, in which the consumable includes further ingredients to enhance taste, appearance or assist in efficacy. A method as claimed in any one of the preceding claims, in which the consumable is fortified with vitamins or minerals. A method as claimed in any one of the preceding claims, in which the consumable is suitable for adults and/or children. A method as claimed in any one of the preceding claims, in which the consumable is a matrix. A method as claimed in any one of the preceding claims, in which the regulated therapeutic dosage of plant based actives delivers a minimum amount of- or concentration level of phytochemical components required to inhibit and/or kill diseasecausing pathogens in vitro. A method as claimed in any one of the preceding claims, in which the regulated therapeutic dosage of plant based actives delivers the minimum amount of- or concentration level of phytochemical components required to inhibit and/or kill diseasecausing pathogens in vivo as measured in saliva and/or on mucosal susceptible areas. A method as claimed in any one of the preceding claims, in which the regulated therapeutic dosage of plant-based actives is the maximum amount of- or concentration level of phytochemical components beyond which no additional benefit is realised. A method as claimed in any one of the preceding claims, in which the regulated therapeutic dosage of plant-based actives is the maximum permissible amount of- or concentration level of phytochemical components that does not have a deleterious effect on human health. A method as claimed in any one of the preceding claims, in which the regulated therapeutic dosage acts as a prophylactic against disease-causing pathogens. A method as claimed in any one of the preceding claims, in which the regulated therapeutic dosage acts as a prophylactic against spreading disease-causing pathogens. A method as claimed in any one of the preceding claims, in which the regulated therapeutic dosage optimizes utilisation of plant-based actives within the consumable. A method as claimed in any one of the preceding claims, in which the regulated therapeutic dosage lowers risk of infection from disease-causing pathogens in high risk areas or situations. A method as claimed in any one of the preceding claims, in which the controlled period is the period when consumption/usage of the consumable is required. A method as claimed in any one of the preceding claims, in which the controlled period is a protracted period. A method as claimed in any one of the preceding claims, in which the protracted period is the period of consumption or usage of the consumable in accordance with its intended or prescribed use in comparison to the period for consuming a serving of tea, herbal tea, botanical or their derivative. A method as claimed in any one of the preceding claims, in which the protracted period is at least 10 minutes after consumption/usage of the consumable provided that it is not accidentally or intentionally eroded or washed away. A method as claimed in any one of the preceding claims, in which the mucosal susceptible areas are mucosal cells, tissues and organs located within the nose and/or mouth and/or throat and/or upper respiratory system or tract. A method as claimed in any one of the preceding claims, in which the human disease is a viral infection. A method as claimed in any one of the preceding claims, in which the viral infection is a cold. A method as claimed in any one of the preceding claims, in which the viral infection is flu (influenza). A method as claimed in any one of the preceding claims, in which the human disease is a bacterial infection. A processing arrangement for the manufacture of an improved delivery system for plant based actives, which includes manufacturing means to process plant material and matrix into a consumable; plant material supply means and matrix supply means to supply plant material and matrix to the manufacturing means; transport means to transport plant material and matrix into and within the manufacturing means and consumable onto packaging. An arrangement as claimed in claim 61 , in which the manufacturing means includes specialist processing and manufacturing equipment conventionally used within the tea and/or herbal industries. An arrangement as claimed in claim 61 or claim 62, in which the manufacturing means includes specialist processing and manufacturing equipment conventionally used within the food and beverage industries. An arrangement as claimed in any one of claims 61 to 63, in which the manufacturing means includes specialist processing and manufacturing equipment conventionally used within the candy and gum making industries. An arrangement as claimed in any one of claims 61 to 64, in which the manufacturing means includes specialist processing and manufacturing equipment conventionally used within the pharmaceutical industry. An arrangement as claimed in any one of claims 61 to 65, in which the plant material supply means includes plant material augmenting means. An arrangement as claimed in any one of claims 61 to 66, in which the augmenting means are milling and/or extracts processing means. An arrangement as claimed in any one of claims 61 to 67, in which the augmenting means include isolation- and/or purifying means for processing plant materials in different stages, e.g. raw materials or in-process materials, including means to add or remove specific phytochemical components. A consumable with an improved phytochemical delivery system, which includes plant based actives from suitable plant material and a matrix which when consumed delivers a controlled therapeutic dosage of plant based actives over a controlled period of time on mucosal susceptible areas of a non-infected individual thereby acting as prophylactic to reduce and/or inhibit and/or prevent disease-causing pathogens from causing an infection. A consumable with an improved phytochemical delivery system, which includes plant based actives from suitable plant material and a matrix which when consumed deliver a controlled therapeutic dosage of plant based actives over a controlled period of time on mucosal susceptible areas of an infected individual thereby acting as prophylactic to reduce and/or inhibit and/or prevent disease-causing pathogens from causing an infection. A consumable with an improved phytochemical delivery system, which is adapted decrease the risk of contamination and/or infection in high risk areas or situations. A consumable with an improved phytochemical delivery system, which includes plant based actives from suitable plant material and a matrix which when consumed deliver a controlled therapeutic dosage of plant based actives over a controlled period of time on mucosal susceptible areas that have a beneficial effect on the immune system. A consumable with an improved phytochemical delivery system, which includes natural and/or synthetic actives, minerals and/or vitamins and/or other ingredients to enhance efficacy of product and/or application. A consumable substantially as hereinbefore described. A method for the manufacture of an improved phytochemical delivery system of plantbased actives substantially as hereinbefore described. A method for the manufacture substantially as hereinbefore described. A processing arrangement for the manufacture of an improved delivery system for plant-based actives substantially as hereinbefore described. A processing arrangement substantially as hereinbefore described.
PCT/IB2020/059332 2020-10-05 2020-10-05 Phytochemical arrangement and method WO2022074422A1 (en)

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