WO2024072792A1 - Cellulose derivative free capsule for herbal extracts - Google Patents

Cellulose derivative free capsule for herbal extracts Download PDF

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Publication number
WO2024072792A1
WO2024072792A1 PCT/US2023/033701 US2023033701W WO2024072792A1 WO 2024072792 A1 WO2024072792 A1 WO 2024072792A1 US 2023033701 W US2023033701 W US 2023033701W WO 2024072792 A1 WO2024072792 A1 WO 2024072792A1
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WO
WIPO (PCT)
Prior art keywords
plant
organic
capsule
cellulose derivative
herbal
Prior art date
Application number
PCT/US2023/033701
Other languages
French (fr)
Inventor
David Jeremy STEWART
Ido D. DAGAN
Greg Masters
Original Assignee
Gaia Herbs
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/372,209 external-priority patent/US20240099982A1/en
Application filed by Gaia Herbs filed Critical Gaia Herbs
Publication of WO2024072792A1 publication Critical patent/WO2024072792A1/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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS, COOKING OILS
    • A23D9/00—Other edible oils or fats, e.g. shortenings, cooking oils
    • A23D9/007—Other edible oils or fats, e.g. shortenings, cooking oils characterised by ingredients other than fatty acid triglycerides
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS, COOKING OILS
    • A23D9/00—Other edible oils or fats, e.g. shortenings, cooking oils
    • A23D9/02—Other edible oils or fats, e.g. shortenings, cooking oils characterised by the production or working-up
    • A23D9/04—Working-up
    • A23D9/05—Forming free-flowing pieces
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/269—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of microbial origin, e.g. xanthan or dextran
    • A23L29/274—Pullulan
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • 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)
    • A61K36/41—Crassulaceae (Stonecrop family)
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • 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)
    • A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • 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)
    • A61K36/67—Piperaceae (Pepper family), e.g. Jamaican pepper or kava
    • 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)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/148—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with compounds of unknown constitution, e.g. material from plants or 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4875—Compounds of unknown constitution, e.g. material from plants or animals

Definitions

  • the present invention relates to a capsule for herbal extracts which is devoid of cellulose derivatives.
  • Herbal extracts in powder or liquid form are a popular source of medical and nutritional support.
  • Herbal remedies, sometimes referred to as nutraceuticals or dietary supplements are alternatives or adjuncts to conventional pharmaceutical drugs.
  • cellulose derivative capsules based on hydroxypropyl methylcellulose are known.
  • HPMC hydroxypropyl methylcellulose
  • U.S. Patent No. 6,238,696 B1 to Wang, et al in which liquid extracts are provided in an HPMC or gelatin capsule.
  • HPMC and gelatin are, however, not typically organically derived.
  • the present invention provides a cellulose derivative free capsule that may be organic and plant-based.
  • the capsule includes organic pullulan, one or more herbal extracts in powder form or as an aqueous alcoholic extract, and a mixture of plantbased oil and plant-based lecithin.
  • the mixture of oil and lecithin may have a viscosity of 250 to 1000 cP at 25°C, and with the herbal extract may have a viscosity of 1000 to 2500 cP at 25°C.
  • a commercial implementation in accordance with the spirit and teachings of the present invention may be configured according to the needs of the particular application, whereby any aspect(s), feature(s), function(s), result(s), component(s), approach(es), or step(s) of the teachings related to any described embodiment of the present invention may be suitably omitted, included, adapted, mixed and matched, or improved and/or optimized by those skilled in the art, using their average skills and known techniques, to achieve the desired implementation that addresses the needs of the particular application.
  • an organic pullulan capsule encapsulating an herbal extract is provided.
  • the capsule may include one or more herbal extracts.
  • the extracts may be in powder form or as an aqueous alcohol extract.
  • the capsule may also include a mixture of a plant-based oil(s) and plant-based lecith in(s).
  • Suitable additional excipients may be added to the extract prior to encapsulation, and may include waxes (e.g., carnauba), fats, semi-solid and liquid polyols and the like.
  • the capsule may be a two-piece capsule manufactured utilizing conventional encapsulation equipment such as the encapsulators available from Shinogi.
  • the encapsulation may include removal of air using an inert gas such as nitrogen.
  • a capsule devoid of cellulose derivatives may be provided. “Devoid” of cellulose derivatives or “cellulose derivative-free” is intended to mean less than 1 percent, often less than 0.5 percent, and preferably 0 percent presence of cellulose derivatives.
  • the herbal extracts may be derived from herbal material in the form of whole leaf, stem, stalk, root and the like, and may be cut or ground prior to use or to extraction.
  • the herbal material may include, but not limited to one or more of kava, echinacea, St.
  • the extracts may be in solid powder form or may be extracted in one embodiment with an aqueous alcohol in different concentrations to provide an aqueous alcoholic herbal extract.
  • Suitable alcohols may include C1 to C3 alcohols like ethanol.
  • ethanol may be used.
  • the alcohol may be a co-solvent mixture such as a mixture of alcohol and water.
  • the alcohol mixture may be an ethanol solution ranging from about 70% w/v to about 90% w/v.
  • a 70% w/v ethanol solution may be used to extract the herbal material.
  • the herbal material is preferably percolated or macerated to facilitate extraction.
  • supercritical extraction e.g. with CO2
  • solvent extraction may be utilized instead of solvent extraction to extract the herbal material.
  • the capsule portion may preferably be organic pullulan.
  • Pullulan is a natural water soluble polysaccharide. Specifically, it is a polysaccharide polymer of a malttriose trimer made up of a-1 ,4-a-1 ,6-glucan.
  • Pullulan is an organic polymer and may be produced from starch by the fungus Auerobasidium pullulans. A method of production is described, for example, in U.S. Patent No. 10,894,971 B1. Pullulan functions as an oxygen barrier, disintegrates rapidly, and is stable. It is noted that pullulan is soluble in glycerin, thus use of glycerin should be avoided.
  • a source of organic pullulan is Bright Pharma Caps.
  • a lecithin/oil mixture may be included in the capsule and may function as an emulsifier.
  • the lecithin and oil may be both plant based, and preferably are organic.
  • Suitable plant-based lecithin sources may include corn lecithin, cottonseed oil lecithin, rapeseed lecithin, soybean lecithin and sunflower lecithin.
  • Suitable plant-based oils may be oils derived from corn, cottonseed, flaxseed, grapeseed, hemp oil, nuts (e.g., almond and peanut), olives, sunflower, soybean, safflower and sesame seed and the like.
  • the lecithin/oil mixture contributes to the overall viscosity.
  • the viscosity of the oil may be about 30 to 70 cP at 25°C and the viscosity of the lecithin may be greater than about 12,000 cP at 25°C.
  • the oil and lecithin mixture may have a viscosity of 250 to 1000 cP at 25 °C.
  • the ratio of plant based lecithin to plant based oil in one embodiment is about 4:1 to about 1 :4. In another embodiment only plant-based lecithin may be used.
  • the overall mixture including the herbal extract may have a viscosity of about 1000 - 2500 cP at 25°C.
  • the organic pullulan capsule may comprise about 5 to 40 percent herbal extract, and about 70 to 97 percent plant-based oil and plant-based lecithin mixture.
  • the capsule may also include about 0 to 10 percent excipients such as carnauba wax.
  • the two-piece capsules may be sealed using a sealant composition comprising about 10 to 25 percent by weight organic pullulan, 20 to 35 percent by weight of a short- chained alcohol such as ethanol and 50 to 75 percent by weight deionized water. In this manner, leakage of the extract, particularly in liquid form may be avoided if a two-piece capsule is utilized.
  • a capsule formed from organic pullulan from Bright Pharma Caps includes 15 percent by weight supercritical oregano leaf and 85 percent by weight of a 95/5 plantbased lecithin/olive oil mixture.
  • a capsule formed from organic pullulan from Bright Pharma Caps is filled with 20 percent by weight hydroethanolic extract of holy basil, schisandra berry and wild oats, 9 percent by weight Rhodiola rosea powdered extract, 7 percent by weight ashwagandha powdered extract, 2 percent by weight holy basil supercritical extract, and 62 percent by weight of a 50/50 plant-based lecithin/olive oil mixture.
  • a capsule formed from organic pullulan from Bright Pharma Caps is filled with 10 percent by weight hydroethanolic extract of ashwagandha, 23 percent by weight ashwagandha powdered extract, and 67 percent by weight of a 50/50 plant-based lecithin/olive oil mixture.
  • a capsule formed from organic pullulan from Bright Pharma Caps is filled with 35 percent by weight hydroethanolic extract of chaste tree berries, and 65 percent by weight of a 75/25 plant-based lecithin/olive oil mixture.
  • a capsule formed from organic pullulan from Bright Pharma Caps is filled with 30 percent by weight hydroethanolic extract of turmeric, 8 percent by weight curcuminoid powdered extract, 5 percent by weight turmeric supercritical extract, 1 percent by weight black pepper supercritical extract, and 56 percent by weight of a 75/25 plant-based lecithin/olive oil mixture.
  • a capsule formed from organic pullulan from Bright Pharma caps is filled with 20 percent by weight hydroethanolic extract of Rhodiola rosea and 80 percent by weight of an 87.5/12.5 plant-based lecithin/olive oil mixture.
  • the two-piece capsule is sealed with a sealant comprising 16 percent by weight organic pullulan powder, 28 percent by weight ethanol and 56 percent by weight deionized water.

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Abstract

The present invention provides a cellulose derivative free capsule that may be organic and plant-based. The capsule includes organic pullulan, one or more herbal extracts in a powder form or as an aqueous alcoholic extract, and a mixture of plantbased oil and plant-based lecithin. The mixture of oil and lecithin may have a viscosity of 250 to 1000 cP at 25°C, and with the herbal extract may have a viscosity of 1000 to 2500 cP at 25°C.

Description

CELLULOSE DERIVATIVE FREE CAPSULE FOR HERBAL EXTRACTS
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of priority to U.S. Non-Provisional Application Serial No. 18/372,209 filed September 25, 2023 and U.S. Provisional Application Serial No. 63/410,278 filed September 27, 2022.
FIELD OF THE INVENTION
[0002] The present invention relates to a capsule for herbal extracts which is devoid of cellulose derivatives.
BACKGROUND
[0003] Herbal extracts in powder or liquid form are a popular source of medical and nutritional support. Herbal remedies, sometimes referred to as nutraceuticals or dietary supplements are alternatives or adjuncts to conventional pharmaceutical drugs.
Various formulations for capsules and tables for herbal contracts are known. For example, cellulose derivative capsules based on hydroxypropyl methylcellulose (HPMC) are known. One example is described in U.S. Patent No. 6,238,696 B1 to Wang, et al, in which liquid extracts are provided in an HPMC or gelatin capsule. HPMC and gelatin are, however, not typically organically derived.
[0004] Thus it would be desirable to provide a capsule or the like for the delivery of an herbal extract or herbal extracts in a powder or liquid form that is devoid of cellulose derived materials and utilizes plant-based components.
SUMMARY
[0005] The present invention provides a cellulose derivative free capsule that may be organic and plant-based. The capsule includes organic pullulan, one or more herbal extracts in powder form or as an aqueous alcoholic extract, and a mixture of plantbased oil and plant-based lecithin. The mixture of oil and lecithin may have a viscosity of 250 to 1000 cP at 25°C, and with the herbal extract may have a viscosity of 1000 to 2500 cP at 25°C. DETAILED DESCRIPTION
[0006] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well as the singular forms, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one having ordinary skill in the art to which this invention belongs.
[0007] It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein. [0008] All patents, patent applications and publications referred to herein are incorporated by reference in their entirety. In case of a conflict in terminology, the present specification is controlling.
[0009] In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be evident, however, to one skilled in the art that the present invention may be practiced without these specific details. The present disclosure is to be considered as an exemplification of the invention and is not intended to limit the invention to the specific embodiments illustrated by the figures or description below. As is well known to those skilled in the art, many careful considerations and compromises typically must be made when designing for the optimal configuration of a commercial implementation of any system, and in particular, the embodiments of the present invention. A commercial implementation in accordance with the spirit and teachings of the present invention may be configured according to the needs of the particular application, whereby any aspect(s), feature(s), function(s), result(s), component(s), approach(es), or step(s) of the teachings related to any described embodiment of the present invention may be suitably omitted, included, adapted, mixed and matched, or improved and/or optimized by those skilled in the art, using their average skills and known techniques, to achieve the desired implementation that addresses the needs of the particular application.
[0010] As discussed above, an organic pullulan capsule encapsulating an herbal extract is provided. The capsule may include one or more herbal extracts. The extracts may be in powder form or as an aqueous alcohol extract. The capsule may also include a mixture of a plant-based oil(s) and plant-based lecith in(s). Suitable additional excipients may be added to the extract prior to encapsulation, and may include waxes (e.g., carnauba), fats, semi-solid and liquid polyols and the like.
[0011] The capsule may be a two-piece capsule manufactured utilizing conventional encapsulation equipment such as the encapsulators available from Shinogi. In one embodiment, the encapsulation may include removal of air using an inert gas such as nitrogen.
[0012] By utilizing organic pullulan, a capsule devoid of cellulose derivatives may be provided. “Devoid” of cellulose derivatives or “cellulose derivative-free” is intended to mean less than 1 percent, often less than 0.5 percent, and preferably 0 percent presence of cellulose derivatives.
[0013] The herbal extracts may be derived from herbal material in the form of whole leaf, stem, stalk, root and the like, and may be cut or ground prior to use or to extraction. The herbal material may include, but not limited to one or more of kava, echinacea, St. John’s wort, valerian root, milk thistle seed, Siberian ginseng, nettle leaf, holy basil, ginkgo, gotu kola, astragalus, goldenseal, dong quai, ginseng, bilberry, green tea, hawthorne, ginger, turmeric, Rhodiola rosea, black cohosh, cats claw, chamomile, dandelion, chaste tree berry, feverfew, garlic, horse chestnut, licorice, eyebright, yohimbe, valerian poppy, black pepper, arnica, black elderberry, ashwagandha, acacia, hemp, acai, allspice, skullcap, burdock and maca and various other herbal materials listed, for example in the Material Medica of Western Herbs by C. Fisher or Homoeopathic Materia Medica by H. Boericke.
[0014] The extracts may be in solid powder form or may be extracted in one embodiment with an aqueous alcohol in different concentrations to provide an aqueous alcoholic herbal extract. Suitable alcohols may include C1 to C3 alcohols like ethanol. Preferably, ethanol may be used. The alcohol may be a co-solvent mixture such as a mixture of alcohol and water. For example, the alcohol mixture may be an ethanol solution ranging from about 70% w/v to about 90% w/v. In a preferred embodiment, a 70% w/v ethanol solution may be used to extract the herbal material. During extraction, the herbal material is preferably percolated or macerated to facilitate extraction. In another embodiment, supercritical extraction (e.g. with CO2) may be utilized instead of solvent extraction to extract the herbal material.
[0015] The capsule portion may preferably be organic pullulan. Pullulan is a natural water soluble polysaccharide. Specifically, it is a polysaccharide polymer of a malttriose trimer made up of a-1 ,4-a-1 ,6-glucan. Pullulan is an organic polymer and may be produced from starch by the fungus Auerobasidium pullulans. A method of production is described, for example, in U.S. Patent No. 10,894,971 B1. Pullulan functions as an oxygen barrier, disintegrates rapidly, and is stable. It is noted that pullulan is soluble in glycerin, thus use of glycerin should be avoided. A source of organic pullulan is Bright Pharma Caps.
[0016] A lecithin/oil mixture may be included in the capsule and may function as an emulsifier. The lecithin and oil may be both plant based, and preferably are organic. Suitable plant-based lecithin sources may include corn lecithin, cottonseed oil lecithin, rapeseed lecithin, soybean lecithin and sunflower lecithin. Suitable plant-based oils may be oils derived from corn, cottonseed, flaxseed, grapeseed, hemp oil, nuts (e.g., almond and peanut), olives, sunflower, soybean, safflower and sesame seed and the like.
[0017] The lecithin/oil mixture contributes to the overall viscosity. The viscosity of the oil may be about 30 to 70 cP at 25°C and the viscosity of the lecithin may be greater than about 12,000 cP at 25°C. The oil and lecithin mixture may have a viscosity of 250 to 1000 cP at 25 °C. The ratio of plant based lecithin to plant based oil in one embodiment is about 4:1 to about 1 :4. In another embodiment only plant-based lecithin may be used. The overall mixture including the herbal extract may have a viscosity of about 1000 - 2500 cP at 25°C.
[0018] The organic pullulan capsule may comprise about 5 to 40 percent herbal extract, and about 70 to 97 percent plant-based oil and plant-based lecithin mixture. The capsule may also include about 0 to 10 percent excipients such as carnauba wax. The two-piece capsules may be sealed using a sealant composition comprising about 10 to 25 percent by weight organic pullulan, 20 to 35 percent by weight of a short- chained alcohol such as ethanol and 50 to 75 percent by weight deionized water. In this manner, leakage of the extract, particularly in liquid form may be avoided if a two-piece capsule is utilized.
[0019] The following examples are merely illustrative of the inventions and formulations thereof.
Examples
Example 1 Oil of Oregano
[0020] A capsule formed from organic pullulan from Bright Pharma Caps includes 15 percent by weight supercritical oregano leaf and 85 percent by weight of a 95/5 plantbased lecithin/olive oil mixture.
Example 2 Adrenal Health
[0021] A capsule formed from organic pullulan from Bright Pharma Caps is filled with 20 percent by weight hydroethanolic extract of holy basil, schisandra berry and wild oats, 9 percent by weight Rhodiola rosea powdered extract, 7 percent by weight ashwagandha powdered extract, 2 percent by weight holy basil supercritical extract, and 62 percent by weight of a 50/50 plant-based lecithin/olive oil mixture.
Example 3 Ashwagandha
[0022] A capsule formed from organic pullulan from Bright Pharma Caps is filled with 10 percent by weight hydroethanolic extract of ashwagandha, 23 percent by weight ashwagandha powdered extract, and 67 percent by weight of a 50/50 plant-based lecithin/olive oil mixture.
Example 4 Vitex™ (Chaste Tree)
[0023] A capsule formed from organic pullulan from Bright Pharma Caps is filled with 35 percent by weight hydroethanolic extract of chaste tree berries, and 65 percent by weight of a 75/25 plant-based lecithin/olive oil mixture.
Example s Turmeric
[0024] A capsule formed from organic pullulan from Bright Pharma Caps is filled with 30 percent by weight hydroethanolic extract of turmeric, 8 percent by weight curcuminoid powdered extract, 5 percent by weight turmeric supercritical extract, 1 percent by weight black pepper supercritical extract, and 56 percent by weight of a 75/25 plant-based lecithin/olive oil mixture.
Example 6 Rhodiola Rosea
[0025] A capsule formed from organic pullulan from Bright Pharma caps is filled with 20 percent by weight hydroethanolic extract of Rhodiola rosea and 80 percent by weight of an 87.5/12.5 plant-based lecithin/olive oil mixture. The two-piece capsule is sealed with a sealant comprising 16 percent by weight organic pullulan powder, 28 percent by weight ethanol and 56 percent by weight deionized water.
[0026] Although the present approach has been illustrated and described herein with reference to preferred embodiments and specific examples thereof, it will be readily apparent to those of ordinary skill in the art that other embodiments and examples may perform similar functions and/or achieve like results. All such equivalent embodiments and examples are within the spirit and scope of the present approach.

Claims

THAT WHICH IS CLAIMED IS:
1 . An organic or plant-based cellulose derivative free capsule encapsulating an herbal extract, the capsule comprising: a. organic pullulan; b. one or more herbal extracts as a powder or as an aqueous alcoholic extract, and c. a mixture of plant-based oil and a plant-based lecithin, wherein the viscosity of the one or more herbal extracts and mixture of plant-based oil and plant-based lecithin has a viscosity of about 1000 to 2500 cP at 25°C.
2. The organic and plant-based cellulose derivative free capsule of Claim 1 , wherein the ratio of plant-based oil to plant-based lecithin is about 4:1 to about 1 :4.
3. The organic and plant-based cellulose derivative free capsule of Claim 1 further comprising an excipient.
4. The organic and plant-based cellulose derivative free capsule of Claim 3, wherein the excipient is carnauba wax.
5. The organic and plant-based cellulose derivative free capsule of Claim 1 , wherein the one or more herbal extract is derived from a herbal plant material selected from the group consisting of kava, echinacea, St. John’s wort, valerian root, milk thistle seed, Siberian ginseng, nettle leaf, holy basil, ginkgo, gotu kola, astragalus, goldenseal, dong quai, ginseng, bilberry, green tea, hawthome, ginger, turmeric, Rhodiola rosea, black cohosh, cats claw, chamomile, dandelion, chaste tree berry, feverfew, garlic, horse chestnut, licorice, eyebright, yohimbe, valerian poppy, black pepper, arnica, black elderberry, ashwagandha, acacia, hemp, acai, allspice, skullcap, burdock and maca.
6. The organic and plant-based cellulose derivative free capsule of Claim 1 , wherein the herbal material is extracted using supercritical extraction.
7. A two-piece capsule encapsulating an herbal extract, the capsule being organic or plant-based cellulose derivative free, the two-piece capsule comprising organic pullulan as the capsule material, about 5 to 45 percent by weight of one or more herbal extracts in powder form or as an aqueous alcohol extract and about 40 to 97 percent by weight of a mixture of plant-based oil and plant-based lecithin in the capsule, and a sealant sealing the two-piece capsule together, the sealant comprising about 10 to 25 percent by weight organic pullulan, 20 to 35 percent by weight of a short-chained alcohol, and 50 to 75 percent by weight deionized water.
8. The organic and plant-based cellulose derivative free capsule of Claim 7, wherein the ratio of plant-based oil to plant-based lecithin is about 4:1 to about 1 :4.
9. The organic and plant-based cellulose derivative free capsule of Claim 7 further comprising an excipient.
10. The organic and plant-based cellulose derivative free capsule of Claim 9, wherein the excipient is carnauba wax.
11 . The organic and plant-based cellulose derivative free capsule of Claim 7, wherein the one or more herbal extract is derived from a herbal plant material selected from the group consisting of kava, echinacea, St. John’s wort, valerian root, milk thistle seed, Siberian ginseng, nettle leaf, holy basil, ginkgo, gotu kola, astragalus, goldenseal, dong quai, ginseng, bilberry, green tea, hawthorne, ginger, turmeric, Rhodiola rosea, black cohosh, cats claw, chamomile, dandelion, chaste tree berry, feverfew, garlic, horse chestnut, licorice, eyebright, yohimbe, valerian poppy, black pepper, arnica, black elderberry, ashwagandha, acacia, hemp, acai, allspice, skullcap, burdock and maca.
12. The organic and plant-based cellulose derivative free capsule of Claim 7, wherein the herbal material is extracted using supercritical extraction.
13. The organic and plant-based cellulose derivative free capsule of Claim 7, wherein the short-chained alcohol is ethanol.
PCT/US2023/033701 2022-09-27 2023-09-26 Cellulose derivative free capsule for herbal extracts WO2024072792A1 (en)

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US202263410278P 2022-09-27 2022-09-27
US63/410,278 2022-09-27
US18/372,209 US20240099982A1 (en) 2022-09-27 2023-09-25 Cellulose derivative free capsule for herbal extracts
US18/372,209 2023-09-25

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000325040A (en) * 1999-05-17 2000-11-28 Nonogawa Shoji Kk Learning/memory capacity-improving food
US6238696B1 (en) 2000-01-07 2001-05-29 Gaia Herbs, Inc. Process for providing herbal medicants in cellulose derivative capsules
JP2003313120A (en) * 2002-04-22 2003-11-06 Fancl Corp Capsule form food composition
WO2006070578A1 (en) * 2004-12-28 2006-07-06 Qualicaps Co., Ltd. Band seal for hard capsule
WO2014006532A1 (en) * 2012-07-02 2014-01-09 Dsm Ip Assets B.V. Capsules containing thymoquinone
US10894971B1 (en) 2019-06-26 2021-01-19 Lefan Capsule International Inc Method for the production of pullulan soft capsules
US20210379136A1 (en) * 2020-06-09 2021-12-09 Amorepacific Corporation Composition for improving respiratory health continuously exposed to particulate matter atmosphere

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000325040A (en) * 1999-05-17 2000-11-28 Nonogawa Shoji Kk Learning/memory capacity-improving food
US6238696B1 (en) 2000-01-07 2001-05-29 Gaia Herbs, Inc. Process for providing herbal medicants in cellulose derivative capsules
JP2003313120A (en) * 2002-04-22 2003-11-06 Fancl Corp Capsule form food composition
WO2006070578A1 (en) * 2004-12-28 2006-07-06 Qualicaps Co., Ltd. Band seal for hard capsule
WO2014006532A1 (en) * 2012-07-02 2014-01-09 Dsm Ip Assets B.V. Capsules containing thymoquinone
US10894971B1 (en) 2019-06-26 2021-01-19 Lefan Capsule International Inc Method for the production of pullulan soft capsules
US20210379136A1 (en) * 2020-06-09 2021-12-09 Amorepacific Corporation Composition for improving respiratory health continuously exposed to particulate matter atmosphere

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