WO2022125794A1 - Composition and delivery system for immune system support - Google Patents
Composition and delivery system for immune system support Download PDFInfo
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- WO2022125794A1 WO2022125794A1 PCT/US2021/062646 US2021062646W WO2022125794A1 WO 2022125794 A1 WO2022125794 A1 WO 2022125794A1 US 2021062646 W US2021062646 W US 2021062646W WO 2022125794 A1 WO2022125794 A1 WO 2022125794A1
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Classifications
-
- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/30—Zinc; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
Definitions
- the field of this invention relates generally to medications and supplements for human and animal consumption, for improving health, supporting the immune system, and avoiding or shortening viral illnesses, such as the common cold and other upper respiratory infections.
- Embodiments disclosed herein include a composition of materials, such as for example, Echinacea, vitamin C, vitamin D, and zinc, in a targeted delivery system packaged in a preferred dose and dose schedule that optimizes their effectiveness.
- Some embodiments also include honey and a nanoparticle delivery system to further increase the efficacy of the medications and supplements.
- URIs upper respiratory infections
- Antibiotics have no effect on viruses. Rapid diagnostic tests assessing whether an infection is bacterial or not are generally limited to very specific bacterial strains and can be limited by their accuracy as well as user error.
- Formal bacterial culture via nasal or throat swab to assess bacterial growth takes 48-72 hours for the results. By the time a throat culture can be finalized, a bacterial infection may spread even further with serious consequences for the patient. This presents a better-to-be-safe-than-sorry situation for the provider.
- antibiotics Unfortunately, the over-prescription of antibiotics is not risk-free. Antibiotic misuse can have serious health implications for the individual taking them. In addition to not effectively treating the viral illness, the antibiotics can cause harm, for example in the form of eliminating normal bacteria that regulate critical physiological functions. The over-use of antibiotics can also lead to further health complications for the individual; as well as for the population. As another example, inappropriate antibiotic use can select for multi-drug resistant organisms, colloquially called "super bugs,” that cannot be eradicated by conventional methods. These "super bugs" pose a serious and growing worldwide health concern. Despite these dangers, many patients with URIs continue to come to their physicians and health care providers requesting antibiotics that cannot and should not be used to treat viral infections.
- Antiviral therapies for viral URIs to date remain limited, yet physicians and health care providers are left with the professional duty to intervene in their patient's illness in some manner. Some prescribe therapies designed to mitigate the symptoms of viral URI since there is generally no therapeutic cure. Many of the medicines in this class can have side effects, complications, and undesirable medication interactions that prescribers and patients must be careful to avoid. Given their limited options, providers may feel pressured to prescribe antibiotics for viral upper respiratory infections when they are not necessary, or when there is a question if the infection is viral or bacterial, as it better to be safe than ashamed. This practice, however, is leading to a situation of great concern in the health community. Indeed, it is now estimated that without behavioral changes to, and significantly reducing, antibiotic use, global death from drug resistant infections will surpass cancer-caused death very soon in the future.
- the composition is composed of an Echinacea capsule, preferably made of vegetable cellulose and honey with the Echinacea particles contained within a liposome and a zinc-vitamin C capsule or zinc-vitamin C- vitamin D capsule, preferably made of vegetable cellulose and honey with the zincvitamin C particles or the zinc-vitamin C-vitamin D particles contained within a Janus nanoparticle for increased zinc and vitamin C (and also vitamin D if present) absorption. Because of the liposome nanoparticle functioning similar to the physiological emulsifying agent bile, the absorption and therapeutic benefit of the composition is enhanced without the specific need for bile or chyme.
- a single dose is composed of one Echinacea capsule and one zinc- vitamin C capsule or zinc-vitamin C-vitamin D capsule.
- Echinacea, zinc, vitamin C and vitamin D in colds and flu, in the oral composition, amounts and dose schedule set forth herein optimize immune system support. Doses are scheduled with higher frequency at the initial onset of URI symptoms and are subsequently tapered off, preferably within 5 to 7 days.
- a preferred embodiment for the combination of ingredients and delivery is comprised of two capsules as a single dose taken in a dose schedule intended to maximize support of the patient's immune system.
- the first capsule contains Echinacea.
- the Echinacea dose range is 50 mg to 1000 mg.
- the Echinacea capsule dose is 550 mg of powdered Echinacea purpurea from the flower's root, seed, and aerial portions.
- the second capsule contains zinc and vitamin C or zinc, vitamin C and vitamin D.
- the dose range of the capsule is 3 mg to 150 mg of elemental zinc, 25 mg to 2000 mg of vitamin C, and 10 mcg to 50 mcg of vitamin D.
- zinc is delivered in the form of zinc acetate powder at a dose of 25 mg of elemental zinc and the vitamin C is delivered in the form of powder at a dose of 250 mg.
- 25 mcg of vitamin D is delivered in the form of D3 Cholecalciferol powder.
- Echinacea is a coneflower native to the Western Hemisphere. It is recognized that Echinacea supports the immune system's ability to clear infections by promoting T-cell activity. T-cell is critical to cell-mediated immunity. It is also recognized that Echinacea also stimulates interferon molecules in the immune system characterized by their antiviral properties.
- Zinc is an essential trace metal with a wide range of critical functions in the human body. These include processes fundamental to life such as metabolism, gene expression, and enzyme function. As such, zinc is involved in virtually every aspect of our immune system's function, including the production, maturation, and function of white blood cells.
- Vitamin C is a water-soluble vitamin critical to a wide range of metabolic reactions in the body, including the formation of collagen in bones, cartilage, muscle, and blood vessels, as well as the absorption of iron. Vitamin C is also found in high concentrations in cells of the immune system and is consumed during infections. It is thought that vitamin C is involved in the modulation of several immune cells that are involved in the clearance of viruses and bacteria as well as the propagation of cytokines that support the mounting of immune responses to infections.
- Vitamin D is a fat-soluble vitamin found in nearly every tissue of the body, including the immune system. It is understood that vitamin D is important in the modulation of several immune cells, including dendritic cells, B lymphocytes, T lymphocytes, and natural killer (NK) cells. Vitamin D is also important in the production of antimicrobial peptides.
- Bile salts function as emulsifying agents allowing the small intestine to improve absorption of fatty or lipophilic substances.
- these bile salts are not released in great concentrations without the presence of a significant amount of chyme containing partially digested food transiting from the stomach. This release of bile salts is at times further reduced from disease states, nutritional deficiencies, and surgeries such as liver surgery or gallbladder removal.
- Nanoparticles for therapeutic biomedical applications has allowed for the creation of particles containing therapeutic immunomodulators for URI treatment by creating a lipophilic interface that improves gut absorption of the medication in the presence or absence of bile salts and chyme. This allows for the effective targeted delivery of immunomodulatory preparations.
- Nanoparticles can be used to create a lipophilic interface to improve Echinacea, vitamin C, vitamin D, and zinc absorption while also providing a hydrophilic surface that allows the composition to be placed in hydrophilic solutions at the time of delivery while still maintaining enhanced absorption for optimizing therapeutic benefit.
- Honey can also be used as a stabilizing binder of lipophilic and hydrophilic compositions, while also having both antiviral and antibacterial properties.
- a preferred embodiment of this invention utilizes a vitamin and mineral- added herbal blend composition in a nanoparticle delivery system packaged in a dose schedule method that supports the immune system's clearance of infections while allowing for reducing inappropriate antibiotic use.
- two capsules containing the Echinacea and the combined zinc and vitamin C (also vitamin D in some embodiments) dose can be composed of any delivery vehicle that can effectively deliver all the components effectively into the bloodstream, including nanoparticles, such as a Janus nanoparticle, or honey capsule.
- the capsule is made of vegetable cellulose.
- Either capsule also contains an emulsifying agent that improves enteric absorption of capsule contents, such as a liposome, dendrimer, block co-polymer, or lecithin at a dose range of 100 mg to 500 mg.
- Lecithin can be soy lecithin.
- the capsules do not include or contain any soy lecithin.
- the combined zinc and vitamin C is delivered via liposome as the emulsifying agent inside the capsule.
- the combined zinc, vitamin C, and vitamin D is delivered via liposome as the emulsifying agent inside the capsule.
- the dose schedule is optimally initiated within 48 hours of the onset of URI symptoms. Doses are taken as often as every two hours and for as long as 14 days. In a preferred embodiment, doses are scheduled with higher frequency at the initial onset of URI symptoms and subsequently tapered off over 5 days. On day 1 , a single dose is taken every 6 hours, or 4 times a day. On day 2, a single dose is taken every 8 hours, or 3 times a day. On days 3 through 5, a single dose is taken every 12 hours, or 2 times a day. In a preferred embodiment, an extra single dose is provided to take immediately the next time URI symptoms begin to develop. By initiating the dose schedule at the earliest sign of localized symptoms, a generalized upper respiratory infection has the highest chance of being prevented.
- An orally administered composition delivery system comprising: a first capsule including 50 mg to 1000 mg of powdered root and powdered seed of Echinacea purpurea; and a second capsule including from 3 mg to 150 mg of elemental zinc, from 25 mg to 2000 mg of vitamin C, and 10 mcg to 50 mcg of vitamin D.
- Aspect 2 The orally administered composition delivery system of Aspect 1 , wherein the first capsule further comprises an enteric absorption agent.
- Aspect 3 The orally administered composition delivery system according to any of the preceding Aspects, wherein the second capsule further comprises an enteric absorption agent.
- Aspect 4 The orally administered composition delivery system according to any of the preceding Aspects, wherein the second capsule further comprises an enteric absorption agent.
- Aspect 5 The orally administered composition delivery system according to any of the preceding Aspects, wherein the first capsule further comprises liposomes.
- An orally administered composition delivery system comprising: a first capsule including 50 mg to 1000 mg of powdered root and powdered seed of Echinacea purpurea; and a second capsule including from 3 mg to 150 mg of elemental zinc, from 25 mg to 2000 mg of vitamin C, and an enteric absorption agent.
- Aspect 7 The orally administered composition delivery system according to any of the preceding Aspects, wherein the enteric absorption agent includes from 100 mg to 500 mg of lecithin.
- Aspect 8 The orally administered composition delivery system according to any of the preceding Aspects, wherein the lecithin is a non-soy-based lecithin.
- Aspect 9 The orally administered composition delivery system according to any of the preceding Aspects, wherein the lecithin is a sunflower lecithin.
- Aspect 10 The orally administered composition delivery system according to any of the preceding Aspects, wherein the second capsule further comprises 10 mcg to 50 mcg of vitamin D.
- An orally administered composition delivery system comprising: a first capsule including 50 mg to 1000 mg of powdered root and powdered seed of Echinacea purpurea, and an enteric absorption agent; and a second capsule including from 3 mg to 150 mg of elemental zinc, from 25 mg to 2000 mg of vitamin C.
- Aspect 12 The orally administered composition delivery system according to any of the preceding Aspects, wherein the enteric absorption agent includes from 100 mg to 500 mg of lecithin.
- Aspect 13 The orally administered composition delivery system according to any of the preceding Aspects, wherein the lecithin is a non-soy-based lecithin.
- Aspect 14 The orally administered composition delivery system according to any of the preceding Aspects, wherein the lecithin is a sunflower lecithin.
- Aspect 15 The orally administered composition delivery system according to any of the preceding Aspects, wherein the second capsule further comprises vitamin D.
- Aspect 16 The orally administered composition delivery system according to any of the preceding Aspects, wherein the second capsule further comprises a second enteric absorption agent.
- Aspect 17 The orally administered composition delivery system according to any of the preceding Aspects, wherein the second enteric absorption agent includes from 100 mg to 500 mg of lecithin.
- Aspect 18 The orally administered composition delivery system according to any of the preceding Aspects, wherein the second enteric absorption agent includes from 100 mg to 500 mg of non-soy-based lecithin.
- Aspect 19 The orally administered composition delivery system according to any of the preceding Aspects, wherein the second enteric absorption agent includes from 100 mg to 500 mg of sunflower lecithin.
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- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Inorganic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract
An oral composition of Echinacea, vitamin C, zinc, and perhaps also vitamin D in a nanoparticle delivery system and dose schedule method of consumption that supports the immune system while reducing inappropriate antibiotic use. In some embodiments, a single dose is composed of one Echinacea capsule and one zinc- vitamin C capsule or zinc-vitamin C-vitamin D capsule with the particle contents contained within a liposome that enhances enteric gut absorption and delivery, which can also include use of nanoparticles and honey-based materials. In some embodiments, one or more of the capsules includes an enteric absorption agent, such as a non-soy-based lecithin.
Description
COMPOSITION AND DELIVERY SYSTEM FOR IMMUNE SYSTEM SUPPORT
REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No. 63/124,339 filed December 11 , 2020, the disclosure of which is incorporated herein by reference in its entirety.
FIELD OF THE TECHNOLOGY
[0002] The field of this invention relates generally to medications and supplements for human and animal consumption, for improving health, supporting the immune system, and avoiding or shortening viral illnesses, such as the common cold and other upper respiratory infections. Embodiments disclosed herein include a composition of materials, such as for example, Echinacea, vitamin C, vitamin D, and zinc, in a targeted delivery system packaged in a preferred dose and dose schedule that optimizes their effectiveness. Some embodiments also include honey and a nanoparticle delivery system to further increase the efficacy of the medications and supplements.
BACKGROUND
[0003] A significant global public health problem today is the overuse and inappropriate use of antibiotics. Antibiotics are medicines designed primarily to treat, and in some cases, prevent, bacterial illnesses. A 2013 retrospective study conducted by the Centers for Disease Control found that in the year 2010, U.S. physicians and associated health care providers prescribed 258 million courses of antibiotics for a population of approximately 309 million Americans. This translates, on average, to 833 antibiotic prescriptions for every 1000 people.
[0004] One of the most common reasons that patients are prescribed antibiotics in a primary care setting is for upper respiratory infections (URIs). It is understood that URIs are the most common infectious disease among humans, and greater than 75% of URIs are not in fact caused by bacteria, but rather viruses. Antibiotics have no effect on viruses. Rapid diagnostic tests assessing whether an infection is bacterial or not are generally limited to very specific bacterial strains and can be limited by their accuracy as well as user error. Formal bacterial culture via nasal or throat swab to assess bacterial growth takes 48-72 hours for the results. By the time
a throat culture can be finalized, a bacterial infection may spread even further with serious consequences for the patient. This presents a better-to-be-safe-than-sorry situation for the provider. Thus, the diagnostic limitations coupled with patient pressure for a tangible solution from the healthcare provider are the primary drivers of inappropriate antibiotic prescriptions for viral illnesses. In fact, according to a June 2014 WebMD/Medscape survey, 95% of licensed medical prescribers in the United States admit to writing antibiotics when unclear of their necessity. The number one cited reason for this inappropriate use of antibiotics is patient expectation.
[0005] Consequently, the great majority of people taking antibiotics for URIs are receiving them unnecessarily while their actual disease is not being treated.
Inappropriate antibiotic prescription for respiratory tract indications is most prominent in adult patients. In one study, 46% of antibiotics written for respiratory tract infections were not indicated based on clinical guidelines.
[0006] Unfortunately, the over-prescription of antibiotics is not risk-free. Antibiotic misuse can have serious health implications for the individual taking them. In addition to not effectively treating the viral illness, the antibiotics can cause harm, for example in the form of eliminating normal bacteria that regulate critical physiological functions. The over-use of antibiotics can also lead to further health complications for the individual; as well as for the population. As another example, inappropriate antibiotic use can select for multi-drug resistant organisms, colloquially called "super bugs," that cannot be eradicated by conventional methods. These "super bugs" pose a serious and growing worldwide health concern. Despite these dangers, many patients with URIs continue to come to their physicians and health care providers requesting antibiotics that cannot and should not be used to treat viral infections.
[0007] Antiviral therapies for viral URIs to date remain limited, yet physicians and health care providers are left with the professional duty to intervene in their patient's illness in some manner. Some prescribe therapies designed to mitigate the symptoms of viral URI since there is generally no therapeutic cure. Many of the medicines in this class can have side effects, complications, and undesirable medication interactions that prescribers and patients must be careful to avoid. Given their limited options, providers may feel pressured to prescribe antibiotics for viral upper respiratory infections when they are not necessary, or when there is a question if the infection is viral or bacterial, as it better to be safe than sorry. This
practice, however, is leading to a situation of great concern in the health community. Indeed, it is now estimated that without behavioral changes to, and significantly reducing, antibiotic use, global death from drug resistant infections will surpass cancer-caused death very soon in the future.
[0008] Current management of URIs revolves primarily around symptom reduction such as Tylenol for fever or Sudafed for nasal congestion, but these commonplace medications are ineffective in treating or reducing the duration of illness.
SUMMARY
[0009] A composition of Echinacea, vitamin C, vitamin D, and zinc in a nanoparticle packaged for oral consumption in a varied dose schedule method of consumption that supports the immune system's clearance of infections, thereby allowing for reduced antibiotic use. The composition is composed of an Echinacea capsule, preferably made of vegetable cellulose and honey with the Echinacea particles contained within a liposome and a zinc-vitamin C capsule or zinc-vitamin C- vitamin D capsule, preferably made of vegetable cellulose and honey with the zincvitamin C particles or the zinc-vitamin C-vitamin D particles contained within a Janus nanoparticle for increased zinc and vitamin C (and also vitamin D if present) absorption. Because of the liposome nanoparticle functioning similar to the physiological emulsifying agent bile, the absorption and therapeutic benefit of the composition is enhanced without the specific need for bile or chyme.
[0010] A single dose is composed of one Echinacea capsule and one zinc- vitamin C capsule or zinc-vitamin C-vitamin D capsule. The use of Echinacea, zinc, vitamin C and vitamin D in colds and flu, in the oral composition, amounts and dose schedule set forth herein optimize immune system support. Doses are scheduled with higher frequency at the initial onset of URI symptoms and are subsequently tapered off, preferably within 5 to 7 days.
DETAILED DESCRIPTION
[0011] A preferred embodiment for the combination of ingredients and delivery is comprised of two capsules as a single dose taken in a dose schedule intended to maximize support of the patient's immune system. The first capsule contains Echinacea. The Echinacea dose range is 50 mg to 1000 mg. In a preferred
embodiment, the Echinacea capsule dose is 550 mg of powdered Echinacea purpurea from the flower's root, seed, and aerial portions. The second capsule contains zinc and vitamin C or zinc, vitamin C and vitamin D. The dose range of the capsule is 3 mg to 150 mg of elemental zinc, 25 mg to 2000 mg of vitamin C, and 10 mcg to 50 mcg of vitamin D. In a preferred embodiment, zinc is delivered in the form of zinc acetate powder at a dose of 25 mg of elemental zinc and the vitamin C is delivered in the form of powder at a dose of 250 mg. In a preferred embodiment, 25 mcg of vitamin D is delivered in the form of D3 Cholecalciferol powder.
[0012] Echinacea is a coneflower native to the Western Hemisphere. It is recognized that Echinacea supports the immune system's ability to clear infections by promoting T-cell activity. T-cell is critical to cell-mediated immunity. It is also recognized that Echinacea also stimulates interferon molecules in the immune system characterized by their antiviral properties.
[0013] Zinc is an essential trace metal with a wide range of critical functions in the human body. These include processes fundamental to life such as metabolism, gene expression, and enzyme function. As such, zinc is involved in virtually every aspect of our immune system's function, including the production, maturation, and function of white blood cells.
[0014] Vitamin C is a water-soluble vitamin critical to a wide range of metabolic reactions in the body, including the formation of collagen in bones, cartilage, muscle, and blood vessels, as well as the absorption of iron. Vitamin C is also found in high concentrations in cells of the immune system and is consumed during infections. It is thought that vitamin C is involved in the modulation of several immune cells that are involved in the clearance of viruses and bacteria as well as the propagation of cytokines that support the mounting of immune responses to infections.
[0015] Vitamin D is a fat-soluble vitamin found in nearly every tissue of the body, including the immune system. It is understood that vitamin D is important in the modulation of several immune cells, including dendritic cells, B lymphocytes, T lymphocytes, and natural killer (NK) cells. Vitamin D is also important in the production of antimicrobial peptides.
[0016] Advances in nanotechnology have created the opportunity to create novel methods to enhance the enteric uptake of immunomodulatory nutrients that support the immune system. These systems bridge the gap between hydrophilic and
lipophilic interfaces to enhance absorption and targeting to ultimately improve efficacy of these agents.
[0017] Normally, during digestion, the gallbladder releases bile salts. Bile salts function as emulsifying agents allowing the small intestine to improve absorption of fatty or lipophilic substances. However, these bile salts are not released in great concentrations without the presence of a significant amount of chyme containing partially digested food transiting from the stomach. This release of bile salts is at times further reduced from disease states, nutritional deficiencies, and surgeries such as liver surgery or gallbladder removal.
[0018] The development of nanoparticles for therapeutic biomedical applications has allowed for the creation of particles containing therapeutic immunomodulators for URI treatment by creating a lipophilic interface that improves gut absorption of the medication in the presence or absence of bile salts and chyme. This allows for the effective targeted delivery of immunomodulatory preparations. Nanoparticles can be used to create a lipophilic interface to improve Echinacea, vitamin C, vitamin D, and zinc absorption while also providing a hydrophilic surface that allows the composition to be placed in hydrophilic solutions at the time of delivery while still maintaining enhanced absorption for optimizing therapeutic benefit. Honey can also be used as a stabilizing binder of lipophilic and hydrophilic compositions, while also having both antiviral and antibacterial properties.
[0019] A preferred embodiment of this invention utilizes a vitamin and mineral- added herbal blend composition in a nanoparticle delivery system packaged in a dose schedule method that supports the immune system's clearance of infections while allowing for reducing inappropriate antibiotic use.
[0020] For example, two capsules containing the Echinacea and the combined zinc and vitamin C (also vitamin D in some embodiments) dose can be composed of any delivery vehicle that can effectively deliver all the components effectively into the bloodstream, including nanoparticles, such as a Janus nanoparticle, or honey capsule. In a preferred embodiment, the capsule is made of vegetable cellulose. Either capsule also contains an emulsifying agent that improves enteric absorption of capsule contents, such as a liposome, dendrimer, block co-polymer, or lecithin at a dose range of 100 mg to 500 mg. Lecithin can be soy lecithin. It would be preferable to use a non-soy lecithin, such as, for example, sunflower lecithin, as this can reduce
the risk of health issues for soy-sensitive users. Accordingly, in some embodiments, one or both of the capsules do not include or contain any soy lecithin. In some embodiments, the combined zinc and vitamin C is delivered via liposome as the emulsifying agent inside the capsule. In other embodiments, the combined zinc, vitamin C, and vitamin D is delivered via liposome as the emulsifying agent inside the capsule.
[0021] The dose schedule is optimally initiated within 48 hours of the onset of URI symptoms. Doses are taken as often as every two hours and for as long as 14 days. In a preferred embodiment, doses are scheduled with higher frequency at the initial onset of URI symptoms and subsequently tapered off over 5 days. On day 1 , a single dose is taken every 6 hours, or 4 times a day. On day 2, a single dose is taken every 8 hours, or 3 times a day. On days 3 through 5, a single dose is taken every 12 hours, or 2 times a day. In a preferred embodiment, an extra single dose is provided to take immediately the next time URI symptoms begin to develop. By initiating the dose schedule at the earliest sign of localized symptoms, a generalized upper respiratory infection has the highest chance of being prevented.
[0022] Aspects
[0023] Various Aspects are described below. It is to be understood that any one or more of the features recited in the following Aspect(s) can be combined with any one or more other Aspect(s).
[0024] Aspect 1 . An orally administered composition delivery system, comprising: a first capsule including 50 mg to 1000 mg of powdered root and powdered seed of Echinacea purpurea; and a second capsule including from 3 mg to 150 mg of elemental zinc, from 25 mg to 2000 mg of vitamin C, and 10 mcg to 50 mcg of vitamin D.
[0025] Aspect 2. The orally administered composition delivery system of Aspect 1 , wherein the first capsule further comprises an enteric absorption agent.
[0026] Aspect 3. The orally administered composition delivery system according to any of the preceding Aspects, wherein the second capsule further comprises an enteric absorption agent.
[0027] Aspect 4. The orally administered composition delivery system according to any of the preceding Aspects, wherein the second capsule further comprises an enteric absorption agent.
[0028] Aspect 5. The orally administered composition delivery system according to any of the preceding Aspects, wherein the first capsule further comprises liposomes.
[0029] Aspect 6. An orally administered composition delivery system, comprising: a first capsule including 50 mg to 1000 mg of powdered root and powdered seed of Echinacea purpurea; and a second capsule including from 3 mg to 150 mg of elemental zinc, from 25 mg to 2000 mg of vitamin C, and an enteric absorption agent.
[0030] Aspect 7. The orally administered composition delivery system according to any of the preceding Aspects, wherein the enteric absorption agent includes from 100 mg to 500 mg of lecithin.
[0031] Aspect 8. The orally administered composition delivery system according to any of the preceding Aspects, wherein the lecithin is a non-soy-based lecithin. [0032] Aspect 9. The orally administered composition delivery system according to any of the preceding Aspects, wherein the lecithin is a sunflower lecithin.
[0033] Aspect 10. The orally administered composition delivery system according to any of the preceding Aspects, wherein the second capsule further comprises 10 mcg to 50 mcg of vitamin D.
[0034] Aspect 11 . An orally administered composition delivery system, comprising: a first capsule including 50 mg to 1000 mg of powdered root and powdered seed of Echinacea purpurea, and an enteric absorption agent; and a second capsule including from 3 mg to 150 mg of elemental zinc, from 25 mg to 2000 mg of vitamin C.
[0035] Aspect 12. The orally administered composition delivery system according to any of the preceding Aspects, wherein the enteric absorption agent includes from 100 mg to 500 mg of lecithin.
[0036] Aspect 13. The orally administered composition delivery system according to any of the preceding Aspects, wherein the lecithin is a non-soy-based lecithin.
[0037] Aspect 14. The orally administered composition delivery system according to any of the preceding Aspects, wherein the lecithin is a sunflower lecithin.
[0038] Aspect 15. The orally administered composition delivery system according to any of the preceding Aspects, wherein the second capsule further comprises vitamin D.
[0039] Aspect 16. The orally administered composition delivery system according to any of the preceding Aspects, wherein the second capsule further comprises a second enteric absorption agent.
[0040] Aspect 17. The orally administered composition delivery system according to any of the preceding Aspects, wherein the second enteric absorption agent includes from 100 mg to 500 mg of lecithin.
[0041] Aspect 18. The orally administered composition delivery system according to any of the preceding Aspects, wherein the second enteric absorption agent includes from 100 mg to 500 mg of non-soy-based lecithin.
[0042] Aspect 19. The orally administered composition delivery system according to any of the preceding Aspects, wherein the second enteric absorption agent includes from 100 mg to 500 mg of sunflower lecithin.
[0043] It is to be understood that changes may be made in detail, especially in matters of the construction materials employed and the shape, size, and arrangement of parts without departing from the scope of the present disclosure.
This Specification and the embodiments described are examples, with the true scope and spirit of the disclosure being indicated by the claims that follow.
Claims
1 . An orally administered composition delivery system, comprising: a first capsule including 50 mg to 1000 mg of powdered root and powdered seed of Echinacea purpurea, and a second capsule including from 3 mg to 150 mg of elemental zinc, from 25 mg to 2000 mg of vitamin C, and 10 mcg to 50 mcg of vitamin D.
2. The orally administered composition delivery system of claim 1 , wherein the first capsule further comprises an enteric absorption agent.
3. The orally administered composition delivery system of claim 2, wherein the second capsule further comprises an enteric absorption agent.
4. The orally administered composition delivery system of claim 1 , wherein the second capsule further comprises an enteric absorption agent.
5. The orally administered composition delivery system of claim 1 , wherein the first capsule further comprises liposomes.
6. An orally administered composition delivery system, comprising: a first capsule including 50 mg to 1000 mg of powdered root and powdered seed of Echinacea purpurea, and a second capsule including from 3 mg to 150 mg of elemental zinc, from 25 mg to 2000 mg of vitamin C, and an enteric absorption agent.
7. The orally administered composition delivery system of claim 6, wherein the enteric absorption agent includes from 100 mg to 500 mg of lecithin.
8. The orally administered composition delivery system of claim 7, wherein the lecithin is a non-soy-based lecithin.
9. The orally administered composition delivery system of claim 7, wherein the lecithin is a sunflower lecithin.
10. The orally administered composition delivery system of claim 6, wherein the second capsule further comprises 10 mcg to 50 mcg of vitamin D.
- 9 -
11. An orally administered composition delivery system, comprising: a first capsule including 50 mg to 1000 mg of powdered root and powdered seed of Echinacea purpurea, and an enteric absorption agent; and a second capsule including from 3 mg to 150 mg of elemental zinc, from 25 mg to 2000 mg of vitamin C.
12. The orally administered composition delivery system of claim 11 , wherein the enteric absorption agent includes from 100 mg to 500 mg of lecithin.
13. The orally administered composition delivery system of claim 12, wherein the lecithin is a non-soy-based lecithin.
14. The orally administered composition delivery system of claim 12, wherein the lecithin is a sunflower lecithin.
15. The orally administered composition delivery system of claim 11 , wherein the second capsule further comprises vitamin D.
16. The orally administered composition delivery system of claim 11 , wherein the second capsule further comprises a second enteric absorption agent.
17. The orally administered composition delivery system of claim 16, wherein the second enteric absorption agent includes from 100 mg to 500 mg of lecithin.
18. The orally administered composition delivery system of claim 16, wherein the second enteric absorption agent includes from 100 mg to 500 mg of non-soy-based lecithin.
19. The orally administered composition delivery system of claim 16, wherein the second enteric absorption agent includes from 100 mg to 500 mg of sunflower lecithin.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063124339P | 2020-12-11 | 2020-12-11 | |
| US63/124,339 | 2020-12-11 |
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| Publication Number | Publication Date |
|---|---|
| WO2022125794A1 true WO2022125794A1 (en) | 2022-06-16 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2021/062646 WO2022125794A1 (en) | 2020-12-11 | 2021-12-09 | Composition and delivery system for immune system support |
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| US20180071352A1 (en) * | 2015-09-15 | 2018-03-15 | Sarath Malepati | Composition and methods of use for immune system support |
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| JP2004091349A (en) * | 2002-08-30 | 2004-03-25 | Fancl Corp | Infectious disease-preventing and/or treating composition |
| EP1520584A1 (en) * | 2003-10-01 | 2005-04-06 | Boehringer Ingelheim International GmbH | Composition for the activation of the immune system |
| EP1857112B1 (en) * | 2005-03-09 | 2013-05-15 | Sunstar Inc. | Anticancer composition comprising liposomes containing phytosterols |
| CN105663204A (en) * | 2014-11-19 | 2016-06-15 | 青岛加云华海健康科技有限公司 | Composition and preparation capable of improving immune function, resisting fatigue and treating cold as well as preparation method and application of composition |
| US20180071352A1 (en) * | 2015-09-15 | 2018-03-15 | Sarath Malepati | Composition and methods of use for immune system support |
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