WO2023167803A1 - Method of manufacture of active ingredient infused gelatin capsule - Google Patents

Method of manufacture of active ingredient infused gelatin capsule Download PDF

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Publication number
WO2023167803A1
WO2023167803A1 PCT/US2023/013766 US2023013766W WO2023167803A1 WO 2023167803 A1 WO2023167803 A1 WO 2023167803A1 US 2023013766 W US2023013766 W US 2023013766W WO 2023167803 A1 WO2023167803 A1 WO 2023167803A1
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WO
WIPO (PCT)
Prior art keywords
mixture
amount
active ingredient
gelatin
weight
Prior art date
Application number
PCT/US2023/013766
Other languages
French (fr)
Inventor
Edward Oscar SITTNER
Original Assignee
Sittner Edward Oscar
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 Sittner Edward Oscar filed Critical Sittner Edward Oscar
Publication of WO2023167803A1 publication Critical patent/WO2023167803A1/en

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    • 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
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate

Definitions

  • the present invention is directed to a method of manufacture of gelatin capsules, and more particularly, to a method of manufacture of gelatin capsules in which micro doses of the active ingredient is incorporated in the gelatin material itself.
  • Gel caps have become ubiquitous for the administration of medicines and other active ingredients.
  • a gel cap is formed as a shell encapsulating an active ingredient, in liquid form, such as in a cold remedy or in solid form such as a headache or allergy remedy; each encapsulated in the gel cap shell.
  • a method for making an active ingredient infused solid gel cap begins by providing water heated to a first temperature.
  • the water is mixed to create a first mixture with glycerin and a psychedelic substance until the first mixture reaches a second temperature less than the first.
  • the amount of water by weight in the first mixture is greater than the amount of glycerin by weight in the first mixture which in turn is greater than the amount of psychedelic substance in the first mixture by weight.
  • An amount of gelatin is mixed into the first mixture until the mixture returns to the second temperature to create a second mixture.
  • the amount of gelatin in the second mixture by weight being greater than the amount of water by weight.
  • the second mixture being subject to a vacuum to remove bubbles form the second mixture.
  • the active ingredient infused solid gel cap further includes the second mixture being about 38.7% water by weight, about 18.4 % glycerin by weight and about 40% gelatin by weight.
  • the active ingredient comprising about 0.4 to 1.8 percent by weight of the gel cap.
  • the second mixture includes about 47% water by weight, about 11.8% percent glycerin by weight and about 39% gelatin by weight as mixed.
  • the active ingredient comprising about .3 to 1.2 percent by weight of the gel cap.
  • the water is distilled water and the gelatin is made form one of a bovine extract or a cassava root.
  • FIG. 1 is flow chart of the method for forming a micro dosing gel cap in accordance with a first embodiment of the invention.
  • FIG. 2 is flow chart of the method for forming a micro dosing gel cap in accordance with a second embodiment of the invention.
  • a gel cap may be formed in accordance with the invention in one of two ways, based on animal gelatin or based on vegan base gelatin in accordance with the invention.
  • a mixing container is heated to about 90°C in a step 100.
  • a first mixture is created by mixing distilled water with glycerin and a mushroom containing Psilocybin in the mixing container for a time period sufficient to raise the temperature of the mixture to about 75°C in a step 104. In the preferred embodiment the process takes about ten minutes.
  • An animal based gelatin is mixed into the first mixture, in a step 106, in the mixing container for about twenty minutes to form a second mixture, at which time mixing stops and the second mixture rests until the second mixture reaches a temperature of about 75°C in a step 108.
  • a vacuum is applied to the second mixture, in a step 110, to remove bubbles from the second mixture. The vacuum process is performed for about ten minutes.
  • the gelatin is a bovine gelatin.
  • the initial ingredients are provided and combined in proportions of about 38.7% water by weight, with about 18.4 % glycerin by weight and about 40% gelatin by weight. It should be noted that there may be some evaporation of the water during the process.
  • the active ingredient comprises about 0.4 to 1.13 percent by weight of the gel cap.
  • the mushroom containing Psilocybin can be in the form of a powder or extract.
  • about 23.7 Kg of distilled water is mixed with 11.3 Kg of glycerin, and between .226 to 1.13 kilograms of the mushroom and then 25 Kg of gelatin resulting in a batch of individual gel caps; each gel cap having 0.1 to 0.5 grams of the mushroom suspended therein.
  • a gel cap made in accordance a second embodiment of the invention in which the gelatin is a vegan gelatin.
  • a first mixture is created by mixing distilled water with glycerin and a mushroom containing Psilocybin in the mixing container to make a homogenous mixture, usually about a 10 minute time period in the absence of heat.
  • a gelatin formed from plants, cassava in one preferred embodiment is mixed into the first mixture under heat, in a step 202, to form a second mixture until the temperature reaches 95°C.
  • the second mixture is then mixed, in a step 204, for twenty minutes and then left to rest for about three or four minutes.
  • a vacuum is then applied in a step 206; first for three minutes while mixing to remove air bubbles.
  • the mixing is stopped while the vacuum is applied for an additional two minutes.
  • the second mixture is then pushed from the mixing apparatus under air pressure.
  • the gelatin is a vegetarian gelatin.
  • the initial ingredients for combining are provided as about 47.0% water by weight, with about 111.8 % glycerin by weight and about 49% gelatin by weight. Again during the process there may be some evaporation of the water.
  • the active ingredient comprises about .3 to 8 x 10' 3 percentby weight of the gel cap.
  • the mushroom containing Psilocybin can be in the form of a powder or extract.
  • the first embodiment in one non limiting example, about 23.7 Kg of distilled water is mixed with 11.3 Kg of glycerin, and between .226 to 1.13 kilograms of the mushroom and then 25 Kg of gelatin resulting in a batch of gel caps, each having 0.1 to 0.5 grams of the mushroom suspended therein.
  • the mushroom is homogenized prior to mixing with the gelatin, once the second, or final mixture, is created and pushed from the mixer it is spread into boxes as thin bands; between .7 and .8 millimeters thick. The temperature of the room when the sheets are formed is maintained at 80°C. Two bands are then stuck together and cut or stamped into gel caps containing the desired amount of active ingredient; mushroom containing Psilocybin. Flavoring may be added to the first or second mixture as desired.
  • a gel cap in accordance with the present invention By creating a gel cap in accordance with the present invention an accurate micro dose of an active ingredient can be can be consistently applied from capsule to capsule as the active ingredient is diffused within the gel material. Furthermore by formulating the gel in accordance with the invention a solid gel cap results which can deliver the active ingredient immediately upon chewing or after a delay if swallowed whole.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Mycology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Medicinal Preparation (AREA)
  • Jellies, Jams, And Syrups (AREA)

Abstract

A method for making an active ingredient infused solid gel cap begins by providing water heated to a first temperature. The water is mixed with glycerin and a psychedelic substance until the first mixture reaches a second temperature less than the first. The amount of water by weight is greater than the amount of glycerin by weight in the first mixture which in turn is greater than the amount of psychedelic substance by weight. An amount of gelatin is mixed into the first mixture until the mixture returns to the second temperature to create a second mixture. The amount of gelatin by weight being greater than the amount of water by weight.

Description

METHOD OF MANUFACTURE OF ACTIVE INGREDIENT INFUSED GELATIN
CAPSULE
Inventor: Edward Sittner
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority from United States Provisional Application No. 63/315,370 filed March 1, 2022; the contents and elements of which are herein incorporated by reference for all purposes.
BACKGROUND OF THE INVENTION
[0002] The present invention is directed to a method of manufacture of gelatin capsules, and more particularly, to a method of manufacture of gelatin capsules in which micro doses of the active ingredient is incorporated in the gelatin material itself.
[0003] Gelatin capsules, or “gel caps”, have become ubiquitous for the administration of medicines and other active ingredients. Currently, as known in the art, a gel cap is formed as a shell encapsulating an active ingredient, in liquid form, such as in a cold remedy or in solid form such as a headache or allergy remedy; each encapsulated in the gel cap shell.
[0004] While these prior art structures have been satisfactory, they suffer from several disadvantages that do not lend themselves to use with micro dosed drugs such as psychedelics. In solid form they do not lend themselves to correct micro dosing (substantially between 10 and 20 micrograms) of the ingredients because the active ingredient does not consistently homogeneously distribute though the liquid medium contained by the gel cap.
[0005] As a result, dosing is inconsistent across gel caps, resulting in inaccurate dosing potentially causing harm to the user. [0006] Accordingly, a method for making a gel cap which overcomes the shortcomings of the prior art by infusing the active ingredient in the gel cap itself is desired.
SUMMARY OF THE INVENTION
[0007] A method for making an active ingredient infused solid gel cap begins by providing water heated to a first temperature. The water is mixed to create a first mixture with glycerin and a psychedelic substance until the first mixture reaches a second temperature less than the first. The amount of water by weight in the first mixture is greater than the amount of glycerin by weight in the first mixture which in turn is greater than the amount of psychedelic substance in the first mixture by weight. An amount of gelatin is mixed into the first mixture until the mixture returns to the second temperature to create a second mixture. The amount of gelatin in the second mixture by weight being greater than the amount of water by weight. The second mixture being subject to a vacuum to remove bubbles form the second mixture.
[0008] In one embodiment of the active ingredient infused solid gel cap further includes the second mixture being about 38.7% water by weight, about 18.4 % glycerin by weight and about 40% gelatin by weight. The active ingredient comprising about 0.4 to 1.8 percent by weight of the gel cap.
[0009] In another embodiment of the active ingredient infused solid gel cap the second mixture includes about 47% water by weight, about 11.8% percent glycerin by weight and about 39% gelatin by weight as mixed. The active ingredient comprising about .3 to 1.2 percent by weight of the gel cap.
[0010] In one embodiment of the invention the water is distilled water and the gelatin is made form one of a bovine extract or a cassava root. BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The present disclosure will be better understood by reading the written description with reference to the accompanying drawing in which like reference numerals denote similar structure and refer to like elements throughout in which:
[0012] FIG. 1 is flow chart of the method for forming a micro dosing gel cap in accordance with a first embodiment of the invention; and
[0013] FIG. 2 is flow chart of the method for forming a micro dosing gel cap in accordance with a second embodiment of the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0014] A gel cap may be formed in accordance with the invention in one of two ways, based on animal gelatin or based on vegan base gelatin in accordance with the invention. To make the gel cap reference is made to the method of FIG. 1 in which a mixing container is heated to about 90°C in a step 100. In a step 102, when using an animal based gelatin, a first mixture is created by mixing distilled water with glycerin and a mushroom containing Psilocybin in the mixing container for a time period sufficient to raise the temperature of the mixture to about 75°C in a step 104. In the preferred embodiment the process takes about ten minutes.
[0015] An animal based gelatin is mixed into the first mixture, in a step 106, in the mixing container for about twenty minutes to form a second mixture, at which time mixing stops and the second mixture rests until the second mixture reaches a temperature of about 75°C in a step 108. A vacuum is applied to the second mixture, in a step 110, to remove bubbles from the second mixture. The vacuum process is performed for about ten minutes. [0016] In this embodiment the gelatin is a bovine gelatin. The initial ingredients are provided and combined in proportions of about 38.7% water by weight, with about 18.4 % glycerin by weight and about 40% gelatin by weight. It should be noted that there may be some evaporation of the water during the process. The active ingredient comprises about 0.4 to 1.13 percent by weight of the gel cap. The mushroom containing Psilocybin can be in the form of a powder or extract. In the first embodiment, in one non limiting example, about 23.7 Kg of distilled water is mixed with 11.3 Kg of glycerin, and between .226 to 1.13 kilograms of the mushroom and then 25 Kg of gelatin resulting in a batch of individual gel caps; each gel cap having 0.1 to 0.5 grams of the mushroom suspended therein.
[0017] Reference is now made to FIG. 2 in which a gel cap made in accordance a second embodiment of the invention is provided in which the gelatin is a vegan gelatin. In a first step 200, a first mixture is created by mixing distilled water with glycerin and a mushroom containing Psilocybin in the mixing container to make a homogenous mixture, usually about a 10 minute time period in the absence of heat. A gelatin formed from plants, cassava in one preferred embodiment, is mixed into the first mixture under heat, in a step 202, to form a second mixture until the temperature reaches 95°C. The second mixture is then mixed, in a step 204, for twenty minutes and then left to rest for about three or four minutes. A vacuum is then applied in a step 206; first for three minutes while mixing to remove air bubbles. The mixing is stopped while the vacuum is applied for an additional two minutes. The second mixture is then pushed from the mixing apparatus under air pressure.
[0018] In this embodiment the gelatin is a vegetarian gelatin. The initial ingredients for combining are provided as about 47.0% water by weight, with about 111.8 % glycerin by weight and about 49% gelatin by weight. Again during the process there may be some evaporation of the water. The active ingredient comprises about .3 to 8 x 10'3 percentby weight of the gel cap. The mushroom containing Psilocybin can be in the form of a powder or extract. In the first embodiment, in one non limiting example, about 23.7 Kg of distilled water is mixed with 11.3 Kg of glycerin, and between .226 to 1.13 kilograms of the mushroom and then 25 Kg of gelatin resulting in a batch of gel caps, each having 0.1 to 0.5 grams of the mushroom suspended therein.
[0019] In each embodiment it is important to homogenize to evenly distribute the active ingredient among each final capsule. Accordingly, the mushroom is homogenized prior to mixing with the gelatin, once the second, or final mixture, is created and pushed from the mixer it is spread into boxes as thin bands; between .7 and .8 millimeters thick. The temperature of the room when the sheets are formed is maintained at 80°C. Two bands are then stuck together and cut or stamped into gel caps containing the desired amount of active ingredient; mushroom containing Psilocybin. Flavoring may be added to the first or second mixture as desired.
[0020] By creating a gel cap in accordance with the present invention an accurate micro dose of an active ingredient can be can be consistently applied from capsule to capsule as the active ingredient is diffused within the gel material. Furthermore by formulating the gel in accordance with the invention a solid gel cap results which can deliver the active ingredient immediately upon chewing or after a delay if swallowed whole.
[0021] It will thus be seen that the objects set forth above, among those made apparent from the preceding description, are efficiently attained and, since certain changes may be made in carrying out the above method and in the construction set forth without departing from the spirit and scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.
[0022] It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall there between.

Claims

1. A method for making an active ingredient infused gel cap comprising the steps of: heating distilled water to a first temperature; mixing the distilled water with a glycerin and an active ingredient to create a first mixture until the first mixture reaches a second temperature, the second temperature being less than the first temperature; wherein an amount of the water in the first mixture is greater than an amount of the glycerin in the first mixture, and the amount of the glycerin in the first mixture being greater than an amount of the active ingredient in the first mixture; and mixing an amount of gelatin into the first mixture to create a second mixture; the amount of gelatin in the second mixture being greater than the amount of water in the first mixture by weight.
2. The method of claim 1, wherein the active ingredient is a mushroom containing Psilocybin.
3. The method of claim 1, wherein the gelatin is a bovine gel atin.
4. The method of claim 1, further comprising the step of submitting the second mixture to a vacuum.
5. The method of claim 1, further comprising the step of further comprising the step of homogenizing the active ingredient within the first mixture, prior to prior to mixing into the second mixture.
6. A method for making an active ingredient infused gel cap comprising the steps of: mixing an amount of distilled water with an amount of a glycerin and an active ingredient to create a first mixture; wherein an amount of the water in the first mixture is greater than an amount of the glycerin in the first mixture, and the amount of the glycerin in the first mixture being greater than an amount of the active ingredient in the first mixture by weight; mixing a gelatin into the first mixture to create a second mixture; and heating the gelatin and the first mixture to a predetermined temperature as the gelatin is mixed into the first mixture; the amount of gelatin in the second mixture being less than the amount of water in the first mixture by weight.
7. The method of claim 6, wherein the active ingredient is a mushroom containing Psilocybin
8. The method of claim 6, wherein the gelatin is a vegan gelatin.
9. The method of claim 5, further comprising the step of submitting the second mixture to a vacuum.
10. The method of claim 6, further comprising the step of submitting the second mixture to a vacuum.
11. The method of claim 1, further comprising the step of further comprising the step of homogenizing the active ingredient within the first mixture, prior to prior to mixing into the second mixture.
PCT/US2023/013766 2022-03-01 2023-02-24 Method of manufacture of active ingredient infused gelatin capsule WO2023167803A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263315370P 2022-03-01 2022-03-01
US63/315,370 2022-03-01

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5928664A (en) * 1998-02-11 1999-07-27 Fuisz Technologies Ltd. Consumable gummy delivery system
US20120301546A1 (en) * 2011-05-26 2012-11-29 Hassan Emadeldin M Acid-resistant soft gel compositions
US20130005740A1 (en) * 2009-08-05 2013-01-03 7267207 Canada Limited Corporation Process for preparation of over-the-counter gelatin or pectin-based drug delivery
US20150004226A1 (en) * 2011-12-22 2015-01-01 Erik K. Baes Gelatin/alginate delayed release capsules comprising omega-3 fatty acids, and methods and uses thereof
US20180353432A1 (en) * 2015-12-09 2018-12-13 Altergon S.A. SOFT GELATIN CAPSULES WITH pH-INDEPENDENT RELEASE
US20210015833A1 (en) * 2019-07-18 2021-01-21 Concept Matrix Solutions Oral soft gel capsule containing psychedelic compound
US20210401736A1 (en) * 2019-05-15 2021-12-30 Seattle Gummy Company Semi-solid chewable gel cannabinoid compositions and methods of making and using thereof
US20220339097A1 (en) * 2021-04-27 2022-10-27 Gelita Ag Discontinuous gummy delivery systems

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5928664A (en) * 1998-02-11 1999-07-27 Fuisz Technologies Ltd. Consumable gummy delivery system
US20130005740A1 (en) * 2009-08-05 2013-01-03 7267207 Canada Limited Corporation Process for preparation of over-the-counter gelatin or pectin-based drug delivery
US20120301546A1 (en) * 2011-05-26 2012-11-29 Hassan Emadeldin M Acid-resistant soft gel compositions
US20150004226A1 (en) * 2011-12-22 2015-01-01 Erik K. Baes Gelatin/alginate delayed release capsules comprising omega-3 fatty acids, and methods and uses thereof
US20180353432A1 (en) * 2015-12-09 2018-12-13 Altergon S.A. SOFT GELATIN CAPSULES WITH pH-INDEPENDENT RELEASE
US20210401736A1 (en) * 2019-05-15 2021-12-30 Seattle Gummy Company Semi-solid chewable gel cannabinoid compositions and methods of making and using thereof
US20210015833A1 (en) * 2019-07-18 2021-01-21 Concept Matrix Solutions Oral soft gel capsule containing psychedelic compound
US20220339097A1 (en) * 2021-04-27 2022-10-27 Gelita Ag Discontinuous gummy delivery systems

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