WO2021107926A1 - Procédé de formulation de remplissage pour capsules dures, molles et liquides comprenant un mélange de polymère et de composant de remplissage destiné à migrer dans ou à travers une enveloppe de capsule, à fonctions pratiques - Google Patents

Procédé de formulation de remplissage pour capsules dures, molles et liquides comprenant un mélange de polymère et de composant de remplissage destiné à migrer dans ou à travers une enveloppe de capsule, à fonctions pratiques Download PDF

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Publication number
WO2021107926A1
WO2021107926A1 PCT/US2019/063244 US2019063244W WO2021107926A1 WO 2021107926 A1 WO2021107926 A1 WO 2021107926A1 US 2019063244 W US2019063244 W US 2019063244W WO 2021107926 A1 WO2021107926 A1 WO 2021107926A1
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WO
WIPO (PCT)
Prior art keywords
capsule
fill
mycoprotein
component
polymer
Prior art date
Application number
PCT/US2019/063244
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English (en)
Inventor
Connor LEACH
Original Assignee
Leach Connor
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
Application filed by Leach Connor filed Critical Leach Connor
Priority to PCT/US2019/063244 priority Critical patent/WO2021107926A1/fr
Publication of WO2021107926A1 publication Critical patent/WO2021107926A1/fr

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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
    • A61K9/4825—Proteins, e.g. gelatin
    • 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

Definitions

  • the present invention relates to improved forms of medicine in the pharmaceutical industry for medical usage and improved forms of supplements in the non-pharmaceutical industry for dietary usage.
  • Gelatin capsules are derived from genetically modified productions of animal connective tissues containing animal skin and crushed animal bones, and are subsequently made from boiled cattle, pigs, and fish that are slaughtered and hazardously transferred from point A to point B. Gelatin capsules have an exposed weakness to averagely humid temperatures and begin dissolving at 25°C and begin melting at 40°C.
  • HPMC Hydroxypropyl methylcellulose
  • a hypromellose capsule is three times the price of a gelatin capsule, and the most common cause of all allergic reactions to oral vaccinations identify gelatin as the allergen.
  • the present invention described provides a solution to the issues of gelatin capsules and hypromellose capsules from alternative mycoprotein capsules.
  • My coprotein is known as fungal protein, first produced in the UK during 1980, eleven years after Fungi was named as its own Kingdom.
  • Myco is the greek word for Fungus.
  • Fungi- Culture is the process of producing fungi in medicine.
  • Myco is made up of chitin, glucans, and protein.
  • Myco relates to humans as a more similar life form than plants, through storing food as glycogen, the same way an animal cell stores glucose.
  • mycoprotein has dietary fiber with significantly less lipids.
  • Mycoprotein has a lower protein mass than gelatin, which holds a higher quality of protein than beef.
  • Mycoprotein is naturally low in fats and saturates with zero cholesterol, zero calories, and zero mycotoxins.
  • Mycoprotein is Non-GMO, unlike gelatin and hypromellose, therefore mycoprotein is not genetically modified and is fundamentally vegetarian, and essentially vegan. All of which identifies the basic makeup of the mycoprotein capsule invention as a preferred digestive method.
  • Mycoprotein is a strain of fungi, consisting of 44% protein, scientifically defined as Fusarium venenatum A3/5 and Fusarium venenatum PTA-2684; organic and non-organic. Mycoprotein, when grown properly, has the potential to double its mass every five hours, which speeds the capsule manufacturing process. [0008] The chemical formula of mycoprotein is C25H42N603. Both mycoprotein strains, Fusarium venenatum A3/5 and Fusarium venenatum PTA-2684, are used within the fill formulation as a polymer to migrate into or through a capsule shell.
  • the invention described presents itself as a hard, soft, and liquid capsule, which are banded and or sealed on the exterior surface with pullulan, or left to remain non-sealed.
  • the aqueous solution of the fill formulation mixture is made up of a purified aqueous solvent (H20), sodium lauryl sulfate used as a lubricant agent, and sulfur dioxide used as a preservative agent.
  • H20 purified aqueous solvent
  • the aqueous solution is then mixed with a plasticizing agent, which is typically glycerol.
  • the mixture of the aqueous solution and plasticizing agent comprise the fill component with a viscosity level ranging from 800 to 1000 cPs.
  • the fill component is mixed with the mycoprotein polymer, Fusarium venenatum A3/5 and or Fusarium venenatum PTA-2684, which comprises the aqueous composition with a viscosity level ranging from 1500 to 3000 cPs.
  • the entire fill formulation method comprising the aqueous composition mixture will migrate into or through a capsule shell.
  • the dried composition of the mycoprotein capsule shell comprises a mycoprotein polymer, a glycerol plasticizer, excipients from solutions, and a purified H20 solvent, in weight percentage.
  • Fig. 1 is a graphical representation of a mushroom, which presents itself as the most identifiably basic conception of fungi.
  • the mycoprotein polymer within the fill formulation mixture to produce mycoprotein capsules is based upon fungi, and or fungus, which is defined in latin as myco.
  • the identifying letter (a) identifies the entirety of figure one.
  • Fig. 2 is a graphical representation of the chemical formula of mycoprotein, Fusarium venenatum A3/5 and or Fusarium venenatum PTA-2684, which are both strains of mycoprotein used as the polymer within the fill formulation mixture to produce mycoprotein capsules.
  • the identifying letter (b) identifies the entirety of figure two.
  • Fig. 3 is a graphical representation of a two-piece mycoprotein capsule sealed and or banded with an exterior plasticizing constituent.
  • the identifying letter (c) identifies the body of the capsule
  • the identifying letter (d) identifies the cap of the capsule.
  • Fig. 4 is a graphical representation of a two-piece, non-sealed, mycoprotein capsule that is also identified with the letter (c) identifying the body of the capsule shell, and is also identified with the letter (d) identifying the cap of the capsule shell.
  • Fig. 5 MYCOCAPS® by Pileus LLC, size XXX- V, (000-5).
  • Fig. 6 MYCOGELS® by Pileus LLC, size XXX-IV, (000-4).
  • the invention presented is a fill formulation mixture of a polymer, a plasticizing agent, and an aqueous solution.
  • the polymer selected for within the fill formulation mixture is mycoprotein.
  • the two strains of mycoprotein used in the fill formulation mixture are Fusarium venenatum A3/5 and or Fusarium venenatum PTA-2684; organic and non-organic.
  • the plasticizer typically used is glycerol.
  • Other plasticizing agents that can be used optionally within the fill matrix include acetyl tributyl citrate, acetyl triethyl citrate, acetylated monoglyceride, castor oil, coconut oil, dibutyl phthalate, dibutyl sebacate, diethyl phthalate, fructose, glucose, glucose syrup, glycerin, glycerine, non-crystalising solutions of sorbitol, polyethylene glycol (PEG 200-6000), polyglycerol, 2-propylene, propylene glycol, pullulan, sorbitol, triacetyl glycerine, tributyl citrate, triethyl citrate, xylitol, and mixtures thereof.
  • the aqueous solution is a mixture made up of a purified aqueous solvent (H20), sulfur dioxide used as a preservative agent, and sodium lauryl sulfate used as a lubricant agent.
  • the sodium lauryl sulfate has a pH of 7.5 to 8.5, and the plasticizing agent that is typically glycerol has a pH of about 7.
  • Other substitutes for usage as preservative agents include benzoic acid, choline chloride, metal propyl esters of para hydroxy-benzoic, organic acid sulfur dioxide, propane acid, silicone dioxide, sodium bisulfite, sodium chloride, sodium metabi sulfite, sorbic acid, and mixtures thereof.
  • lubricant agents include 2-butanol, hydroxypropyl-P-cyclodextrin, L-carvone, methyl-2-pentanone, methyl ethyl ketone, methyl n-propyl ketone, 2-pentanol, 2-propanol, sodium coco-sulfate, and mixtures thereof.
  • the mixture of the fill formulation process is as follows: As used herein, “v/v %” means by volume as percentage of total volume.
  • the aqueous solution comprises an aqueous solvent mixed with excipients.
  • the aqueous solvent is comprised of purified water (H20), and the excipients are fillers comprised of preservatives, lubricants, flavors, colors, an opacifier, and additional gelling agents.
  • the purified aqueous solvent is mixed at 94% to 97% (v/v), with sulfur dioxide at 2% to 4% (v/v), and sodium lauryl sulfate at 1% to 2% (v/v).
  • the flavor is added, or not added, as an excipient to the fill formulation method of the aqueous solution with sugar.
  • the sugar mixed into the completed aqueous solution is 0.2% to 2.5% (v/v).
  • sugars for potential usage include agave nectar, arabinose, barbados sugar, barley malt syrup, barley malt, barley sugar, beet sugar, birch syrup, brown sugar, buttered syrup, cane sugar, caramel, carob syrup, castor sugar, coconut sugar, confectioner’s sugar, corn syrup, date sugar, dehydrated cane juice, demerara sugar, dextrin, dextrose, disaccharide, evaporated cane juice, free sugar, fructose, fruit juice, fucose, galactose, glucose, golden syrup, granulated sugar, grape sugar, high fructose corn syrup, high maltose corn syrup, honey, icing sugar, inositol, inverted sugar syrup, jaggery lactose, malt extract, maltose, maltodextrin, mannose, maple sugar, molasses from sugar beats, molasses from sugar cane, monosaccharide, muscovado, non centrifugal cane sugar,
  • the coloring is added, or not added, as an excipient to the fill formulation method of the aqueous solution with dye.
  • the coloring additive dye and or pigment is mixed into the aqueous solution with a concentration level ranging from 0.001% to 1.5% (v/v).
  • Another process for dying the capsules is by performing a manual dipping and drying method of the exterior capsule shell into and out of a dye mixture.
  • the organic substitute for implementing colored dye into the aqueous solution is comprised of fruits and vegetables, which are raspberries for red coloring, mangos for yellow coloring, blackberries for purple coloring, carrots for orange coloring (beta-carotene), spinach for green coloring, and a combination of cabbage with added baking soda for blue coloring. All of which are organic food coloring agents used as additive dye within the aqueous solution.
  • the opacifier is added, or not added, to the mixture of the aqueous solution to create an opaquely nontransparent concentration from titanium dioxide used at 0.25% to 5% (v/v).
  • Additional gelling agents are added, or not added, such as calcium, magnesium, and potassium to form a more sufficient gel-like aqueous solution at 0.01% to 0.05% (v/v).
  • the aqueous solution comprises a viscosity level of 1 to 100 cPs.
  • the aqueous solution is mixed at 50% to 60% (v/v) with the plasticizing agent, typically glycerol, between 40% to 50% (v/v) comprising the fill component.
  • the fill component comprises a viscosity level of 800 to 1000 cPs.
  • w/v % means by volume as a percentage of the total weight.
  • the fill component at 35% to 70% (w/v) is mixed with the selected my coprotein polymer at 30% to 65% (w/v) ultimately comprising the aqueous composition.
  • the aqueous composition comprises a viscosity level of 1500 to 3000 cPs.
  • the my coprotein polymer within the aqueous composition for hard capsules makes up around 56% (w/v) with its fill component making up around 44% (w/v).
  • the my coprotein polymer within the aqueous composition for soft capsules makes up around 43% (w/v) with its fill component making up around 57% (w/v).
  • the my coprotein polymer within the aqueous composition for liquid capsules makes up around 30% (w/v) with its fill component making up around 70% (w/v).
  • w/w % means by weight as a percentage of the total weight.
  • the composition of the dry capsule shell comprises mycoprotein polymer at 30% to 56% (w/w), a plasticizer, typically glycerol, at 20% to 30% (w/w), purified water at 24% to 40% (w/w), and a solution of various excipients ranging from 0.5% to 1.5% (w/w).
  • the development of the mycoprotein capsule shell is sealed, or left to remain non-sealed.
  • the capsule seals encloses, holds, caters, harnesses, and preserves the drugs, medicine, supplements, and lack thereof, that are filled into the capsule shell for the preservative function of the mycoprotein capsules.
  • the representative placebo formulations, pharmaceutical dosages, therapeutic drugs, nutritional agents, and or dietary supplements for this function of mycoprotein capsules include, but are not limited to: Ace-inhibitors; acetaminophen; acetylsalicylic acid and its buffered form; acne drugs; albuterol and its salts; alkaline phosphatase; alkaloids; allantoin; aloe; aluminum acetate, amino acids; amino acid preparations; aminobenzoic acid; amoxicillin; ampicillin; amsalog; anabolic drugs; analgesics; anesthetics; anethole; angiogenesis inhibitors; amsacrine; antacids; antianginal drugs; anti-arrhythmias; anti-asthmatics; anti-cholesterolemics; anti convulsants; anti-depressants; anti-diarrhea preparations; anti-histamines; anti-hypertensive drugs; anti-infectives; anti-
  • Machines for stamping, labeling, and printing on the outer surface of the capsule shell are used, or not used, to determine the categorization of mycoprotein capsules with specific numbers and letters by portraying logos, names, symbols, and all forms of text in different fonts, designs, and colored text.
  • Organic forms of ink used for stamping, labeling, and printing on mycoprotein capsules are used from dark fruits, and non-organic labels are processed from food coloring ink.
  • the active agents within the mycoprotein capsules include, but are not limited to:
  • Enzyme inhibitors enzymes, glycoproteins, hormones, lipoproteins, organic and or non-organic pharmaceutical proteins, polynucleotides, polypeptides, polysaccharides, and nucleoproteins.
  • the animals that benefit from the effective agents in the mycoprotein capsules include, but are not limited to: Domesticated animals, farm animals, warm blooded mammals, and wild animals.
  • the fill formulation mixture of the mycoprotein polymer, the plasticizing agent, and the aqueous solution comprise the aqueous composition.
  • the aqueous composition is prepared for capsule manufacturing to process mycoprotein capsules through being heated above melting temperatures of 80°C for the allowance of the fill formulation to properly mix.
  • the aqueous composition is cooled down to gelling temperatures between 10°C and 30°C with a viscosity concentration level of 1500 to 3000 cPs. Any remaining unused mixture for production of the aqueous composition is reheated and held in holding tanks at 60°C, between molding processes, to prevent premature settling.
  • Dipping pins are preheated at 55°C to 95°C to be dipped into the aqueous composition where a film is obtained on the dipping pins after being removed from the aqueous composition.
  • the dipping pins are subject to a relative humidity of 25% to 55%.
  • the aqueous composition film is dried on the dipping pins above gelling temperatures for the aqueous composition film to obtain molded shapes of capsule shells from the dipping pins.
  • a capsule manufacturing machine continues the process of development by dipping, spinning, and drying the aqueous composition.
  • the capsule shells are removed from the pins and set aside onto a collet holding device for proper drying purposes, where knives trim the capsules of excess materials for the capsules to reach their appropriate shape, and all of the excess materials are sorted into a recycling.
  • Machine tests are run for any capsules that are deemed to be defective from a dent of a pinch through an automatic detection scanning and sorting process where the defective capsules are removed with a vacuum and transferred into recycling bins.
  • an exterior plasticizing process is performed by joining the capsule cap and body together by using a yeast film-forming agent, typically pullulan, and or other plasticizing agents such as glycerol, propylene glycol, 2-propylene, and mixtures thereof.
  • MYCOCAPS® are hard and soft capsules that work suitably in temperatures ranging from 5°C to 45°C with functions of inhabiting, preserving, and digesting.
  • MYCOGELS® are liquid capsules that work suitably in temperatures ranging from 10°C to 40°C, and are sufficiently suitable at 30°C, with shell durability in up to 75% humidity, and up 37°C before moisture absorption, with functions of inhabiting, preserving, and digesting.
  • Mycoprotein capsules work through digesting in the human body and digesting in the animal body. Therefore, the invention described works to hold medicine, herbs, vitamins, health supplements, prescription drugs, dietary supplements, nutraceuticals, veterinary products, cosmetic products, and foodstuffs for breaking down in the digestive system. The invention described will work to aid as a pharmaceutical capsule in the medical field and work to aid as a non-pharmaceutical capsule for dietary supplement usage.
  • the first working function of the mycoprotein capsule shell is for catering to the storage of medicine, drugs, supplements, vitamins, and lack thereof.
  • the second working function of the mycoprotein capsule is to dissolve in the human and animal body with application to the digestive system for releasing medicine, drugs, supplements, vitamins, and lack thereof.
  • the third working function of the mycoprotein capsule is to inhabit sustainable temperatures for workability prior to digestion, while storing medicine, drugs, supplements, vitamins, and lack thereof.
  • the fill formulation of the disclosed invention for how it is made can be accomplished without appropriate measurements of the aqueous composition.
  • the fill formulation can be made up of 50% mycoprotein and 50% purified water as a means to create the mycoprotein capsules, regardless of workability and imperfections, without lubricant and preservative functions, which would ultimately enable the success of molding from gelling agents and plasticizing agents.
  • Another alternative embodiment to the fill formulation of the disclosed invention for how it is made can be by dividing the mycoprotein, plasticizer, and water into any such thirds of 100% volume of the completed aqueous composition, or by dividing the mycoprotein, plasticizer, and water into any such thirds of 100% weight of the aqueous composition.
  • the fill formulation comprising the aqueous composition for the disclosed invention of how the mycoprotein capsules are made is approved by the FDA and is not regulated by the USD A, acknowledging the manufacturing, production, and consumption to be in legal bounds.
  • the disclosed invention seeks to provide significant health benefits for users digesting mycoprotein capsules. For example, a user will digest and dissolve mycoprotein capsules at a faster rate in their digestive system than gelatin or cellulose capsules. Furthermore, the disclosed invention will provide quicker release times of drugs, medicine, supplements, vitamins, and lack thereof, into the body during digestion after being consumed.
  • the disclosed invention satisfies specific needs of a user from a shell designed to be hard, soft, and liquid, as well as being sealed, or left to remain non-sealed, with up to ten different size alternatives.
  • the disclosed invention seeks to give the user a new digestive method for drugs, medicine, supplements, vitamins, and lack thereof, which will best fit the users diagnosis, anatomy, philosophy, and financial means.
  • the practice of the disclosed invention seeks to reduce the cost of the capsule market by providing cleaner and cheaper energy security needed for pharmaceutical companies from less expenditures, and will provide safer laboratories without usage of hazardous materials such as rotting animal corpses to make gelatin capsules.
  • the practice of the invention described will also provide implementations of water waste reductions that are currently excessive from creating genetically modified hypromellose and cellulose capsules.
  • the expressed production cycle of the disclosed invention seeks to utilize less time, space, and energy, while producing medicine to the world population quicker with a steadfast process of growing mycoprotein. Wherein, the world population will have more medicine available to the public, and in result, epidemic percentages will decrease.
  • An expressed function of the disclosed invention is to stabilize in moderate temperatures between 5°C to 45°C for successful inhabitability.
  • An expressed function of the disclosed invention is to preserve drugs, medicine, supplements, vitamins, and lack thereof.
  • An expressed function of the disclosed invention is to digest in the digestive system.
  • the disclosed invention seeks to prevent migration of a mycoprotein polymer based fill formulation migrating into or through a capsule shell for improved capsule integrity.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un procédé de formulation de remplissage pour des capsules dures, molles et liquides comprenant un polymère et un composant de remplissage, le polymère constitué de mycoprotéine étant mélangé avec un mélange de composants de remplissage constitué d'un agent plastifiant, d'un agent conservateur, d'un agent lubrifiant et d'eau purifiée, destiné à migrer dans ou à travers une enveloppe de capsule, avec des caractéristiques de fonctions pratiques.
PCT/US2019/063244 2019-11-26 2019-11-26 Procédé de formulation de remplissage pour capsules dures, molles et liquides comprenant un mélange de polymère et de composant de remplissage destiné à migrer dans ou à travers une enveloppe de capsule, à fonctions pratiques WO2021107926A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2019/063244 WO2021107926A1 (fr) 2019-11-26 2019-11-26 Procédé de formulation de remplissage pour capsules dures, molles et liquides comprenant un mélange de polymère et de composant de remplissage destiné à migrer dans ou à travers une enveloppe de capsule, à fonctions pratiques

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2019/063244 WO2021107926A1 (fr) 2019-11-26 2019-11-26 Procédé de formulation de remplissage pour capsules dures, molles et liquides comprenant un mélange de polymère et de composant de remplissage destiné à migrer dans ou à travers une enveloppe de capsule, à fonctions pratiques

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WO2021107926A1 true WO2021107926A1 (fr) 2021-06-03

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070141211A1 (en) * 2005-12-16 2007-06-21 Solae, Llc Encapsulated Phospholipid-Stabilized Oxidizable Material
US20190231701A1 (en) * 2017-01-05 2019-08-01 Pileus LLC Fill formulation method for hard, soft, and liquid capsules comprising the mixture of a polymer and a fill component that will migrate into or through a capsule shell with serviceable functions

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070141211A1 (en) * 2005-12-16 2007-06-21 Solae, Llc Encapsulated Phospholipid-Stabilized Oxidizable Material
US20190231701A1 (en) * 2017-01-05 2019-08-01 Pileus LLC Fill formulation method for hard, soft, and liquid capsules comprising the mixture of a polymer and a fill component that will migrate into or through a capsule shell with serviceable functions

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