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Medicinal cannabis added in food

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US20120046351A1
US20120046351A1 US13199116 US201113199116A US2012046351A1 US 20120046351 A1 US20120046351 A1 US 20120046351A1 US 13199116 US13199116 US 13199116 US 201113199116 A US201113199116 A US 201113199116A US 2012046351 A1 US2012046351 A1 US 2012046351A1
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cannabis
thc
medicinal
δ
foodstuff
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Andrew David Hospodor
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Andrew David Hospodor
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; THEIR TREATMENT, NOT COVERED BY OTHER CLASSES
    • A23GCOCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G1/00Cocoa; Cocoa products, e.g. chocolate; Substitutes therefor
    • A23G1/30Cocoa products, e.g. chocolate; Substitutes therefor
    • A23G1/32Cocoa products, e.g. chocolate; Substitutes therefor characterised by the composition containing organic or inorganic compounds
    • A23G1/42Cocoa products, e.g. chocolate; Substitutes therefor characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; THEIR TREATMENT, NOT COVERED BY OTHER CLASSES
    • A23GCOCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G1/00Cocoa; Cocoa products, e.g. chocolate; Substitutes therefor
    • A23G1/30Cocoa products, e.g. chocolate; Substitutes therefor
    • A23G1/32Cocoa products, e.g. chocolate; Substitutes therefor characterised by the composition containing organic or inorganic compounds
    • A23G1/48Cocoa products, e.g. chocolate; Substitutes therefor characterised by the composition containing organic or inorganic compounds containing plants or parts thereof, e.g. fruits, seeds, extracts
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; THEIR TREATMENT, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A23B - A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105Plant extracts, their artificial duplicates or their derivatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. cannabinols, methantheline
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D73/00Packages comprising articles attached to cards, sheets, or webs
    • B65D73/0078Packages comprising articles attached to cards, sheets, or webs the articles being retained or enclosed in a folded-over or doubled card
    • B65D73/0085Packages comprising articles attached to cards, sheets, or webs the articles being retained or enclosed in a folded-over or doubled card within a window, hole or cut-out portion
    • B65D73/0092Packages comprising articles attached to cards, sheets, or webs the articles being retained or enclosed in a folded-over or doubled card within a window, hole or cut-out portion combined with a preformed enclosure, e.g. a bulb
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/36Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
    • B65D75/367Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed and forming several compartments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2575/00Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D2575/28Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associationg or interconnecting two or more sheets or blankes
    • B65D2575/30Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D2575/36One sheet or blank being recessed and the other formed or relatively stiff flat sheet material, e.g. blister packages
    • B65D2575/361Details
    • B65D2575/362Details with special means for gaining access to the contents
    • B65D2575/367Details with special means for gaining access to the contents through a preformed opening in the flat sheet, e.g. the opening being defined by weakened lines

Abstract

The invention is a product and a process wherein cannabinoids such as Medicinal Δ9-THC and/or other substances associated with medicinal cannabis, including yet not necessarily limited to cannbidiols, cannabigerol are added to a foodstuff where the medicinal cannabis is not evenly distributed throughout the foodstuff where the food stuff contains a known weight of medicinal cannabis. Another provision of the invention is providing controlled amounts or ratios of Δ9-THC as compared to CBD in or on a foodstuff.

Description

    CROSS REFERENCE TO RELATED APPLICATIONS
  • [0001]
    This application claims benefit of Provisional Patent Application No. 61/401,824 with a filing date of Aug. 19, 2010 Medicinal Cannabis in a Fatty Foodstuff, and patent application Ser. No. 13/065,980 filing date 04/04/Medicinal Cannabis Fatty Foodstuff in a Package Mold.
  • FEDERAL SUPPORT STATEMENT
  • [0002]
    Not Applicable
  • SEQUENCE LISTING
  • [0003]
    Not Applicable
  • BACKGROUND OF THE INVENTION
  • [0004]
    Raw cannabis contains tetrahydrocannabinol carboxylic acid (THC-COOH); this substance is also referred to as THC acid, Δ9-THC acid, THCA-A, or THCA.
  • [0005]
    The article that appears in the Journal of Chromatography “Innovative development and validation of an HPLC/DAD method for the qualitative determination of major cannabinoids in cannabis plant material” reference [1], see section 1.1; this article reports that THC-B is another form of THC acid that appears only in trace amounts in raw cannabis. This article also reports other substances in raw cannabis, including cannabidiolic acid (CBDA) and cannabigerolic acid (CBGA); a substance cannabinol (CBN) is also reported present in aged cannabis.
  • [0006]
    THC acid may be converted into the psychoactive substance Tetrahydrocannabinol (THC), also known as (Δ9-THC) through processes that decarboxylate the THC acid. Decarboxylation is a chemical reaction that converts an acid to a phenol and releases carbon-dioxide (CO2); a carbon atom is removed from a carbon chain.
  • [0007]
    Reference [1] also discusses and shows the decarboxylation of THC acid into Δ9-THC, the decarboxylation of cannabidiolic acid (CBDA) into cannibidiol (CBD), and the decarboxylation of cannabigerolic acid (CBGA) into cannabigerol (CBG). Decarboxylation occurs when cannabis is exposed to heat, light, cofactors or solvents.
  • [0008]
    Historical and anecdotal reports of the medicinal use of cannabis date back for millennia, in recent decades the psychoactive ingredient Δ9-THC has been extracted through a verity of processes; to date processes that decarboxylate of THCA-A into psychoactive Δ9-THC in controlled ways use toxic solvents; frequently a distillation process such as fractal distillation is then used to separate the toxic or flammable solvents from the active ingredient after decarboxylation.
  • [0009]
    THCA-A Decarboxylated into Δ9-THC in Controlled Ways Using Toxic or Flammable Solvents:
      • Related U.S. Pat. Nos. 6,365,416 B1 [2], 6,730,519 [3]; and patent publication US 2002/0039795 A1 [4] by Elsohly et. al. isolates Δ9-THC from cannabis base material using toxic non-polar organic solvents such as hexane, heptane, or iso-octane. U.S. Pat. No. 6,730,519 [3] was sponsored by a National Institute for Drug Abuse, Small Business Innovative Research grant; Related U.S. Pat. Nos. 6,365,416 [2] and 6,730,519 [3] in their Background of the Invention section provide excellent details regarding the medical use of Δ9-THC. the inventors conclude that extracting Δ9-THC from raw cannabis material is more cost effective than synthetically created FDA approved medicinal THC, and they reference prior art dating from 1942 through 1972 that relate to THC extraction or analysis of hashish and “red oil”; the processes referenced frequently use toxic or flammable elements such as carbon tetrachloride, benzene, N-dimethyl formamide/cyclohexane, or hexane.
      • U.S. Pat. Nos. 7,524,881 B2 [5], and 7,592,468 B2 [6] Goodwin et. Al. discloses processes that extract Δ9-THC from raw cannabis; this process converts THC acid into salt using non-polar solvents such as pentane, hexane, heptane, or octane; again toxic or flammable solvents are used.
  • [0012]
    GW pharmaceuticals of Great Britain has created a vaporized form of medicinal Δ9-THC called Savitex.
      • Savitex is administered with an inhaler, similar to an inhaler used to administer asthma medication. Information regarding the therapeutic use and mechanisms of action of Savitex can be found on GW pharmaceuticals website. Savitex is currently being studied for affectivity by patients with multiple sclerosis, cancer pain, and neuropathic pain.
      • GW pharmaceutical reports that the human body has receptors to frequently called CB1 and CB2 and that Δ9-THC bonds to CB1 (cannabinoid type1) receptors located in the human brain, where cannabidiol bonds to CB2 (cannabinoid type 2) receptors located in the human lymphatic system. The URLs below link to reports on GW Pharmaceuticals website, they describe that Savitex is being used medicinally and describe some of the mechanisms of action of medicinal cannabis; these reports have also been combined into reference [7]:
      • http://www.qwpharm.com/multiple-sclerosis.aspx
      • http://www.qwpharm.com/cancer-pain.aspx
      • http://www.gwpharm.com/neuropathic-pain.aspx
      • http://www.gwpharm.com/mechansims-action.aspx
      • The science related to how these various substances affects the human body is in its infancy, even so GW pharmaceuticals of Great Britain reports that the human body has receptors CB1 and CB2 to which Δ9-THC and CBD (cannabidiol) bond respectively. They also report that the human body has CB1 receptors predominately located in the human brain, and CB2 receptors located predominantly in the human lymphatic system.
      • Most reports indicate that psychoactive substance Δ9-THC is the primary active medicinal substance derived from cannabis; other substances contained within cannabis may however also have medicinal qualities. Some researchers suspect that cannabidiol (CBD) may mitigate pain; more scientific research is needed to understand how the various substances derived from cannabis affect the human body. GW Pharmaceuticals also state in their Mechanisms of Action “The combination of THC, CBD and essential oils in cannabis-based medicinal extracts may produce a therapeutic preparation whose benefits are greater than the sum of its parts”.
  • [0021]
    Reference [8] “Effects of canabidiol on schizophrenia-like symptoms in people who use cannabis”; from The British Journal of Psychiatry (2008) reports that Δ9-THC tends to “elevate levels of anxiety and psychotic symptoms in healthy individuals. In contrast, cannabidiol (CBD), another major constituent of some strains of cannabis, has been found to be anxiolytic and to have antipsychotic properties, and may be neuroprotective in humans”.
      • A key finding of this study [8]: “The TCH only group showed higher levels of positive schizophrenia-like symptoms compared with the no cannabinoid and the TCH+CBD groups . . . . This provides evidence of the divergent properties of cannabinoids and has important implications for research into the link between cannabis use and psychosis”.
  • [0023]
    Reference [9] Therapeutic Potential of Non-Psychotropic Cannabidiol in Ischemic Stroke; Hayakawa, Mishima, & Fujiwara; Dept. of Neuopharmacology, Faculty of Pharmaceutical Sciences, Fukuoka University, Published Jul. 8, 2010. Δ9-THC. This reference reviews various substances found within cannabis, it states in its introduction that “Cannabis contains over 60 different terpeno-phenol compounds that have been identified so far but the role and importance of many of these has yet to be fully understood”.
      • Reference [9] also states “cannabidiol (CBD), cannabigerol (CBG), cannabidvarin (CBDV) are known as non-psychoactive components of cannabis. These compounds have shown ant-inflammatory, immunosuppressive, analgesic, anxiolytic and anti-cancer effects”. This reference also discusses the neuroprotective abilities of CBD in stroke victims.
  • [0025]
    The above mentioned references [7]. [8], and [9] demonstrate that Δ9-THC is not the only substance contained within medicinal cannabis with therapeutic benefits to people. All of these references recommend additional study or mention that the effect of the substances contained within cannabis on humans is not fully understood. Variations of ratios of substances contained within medicinal cannabis are reported to have different effects; as in reference [8], adjusting the ratio Δ9-THC to CBD is shown to be critical in limiting anxiety and psychotic symptoms associated with the intake of high concentrations of Δ9-THC as compared to CBD. New substances and therapeutic uses of substances derived from cannabis are likely to be discovered as research in this field continues.
  • [0026]
    Reference [10] “Isolation of Δ9-THCA-A from hemp and analytical aspects concerning the determination of Δ9-THC in cannabis products”; Dussy, et al. Institute of Legal Medicine, Basel Switzerland, available online Aug. 18, 2004. This reference quantifies the amount of THC acid (THCA-A) that is converted into Δ9-THC when cannabis is smoked under various conditions: Section 2 reviews cannabis reduced into a concentrated THC acid (THCA-A) solution using solvents. Samples of the concentrate are then decarboxylated at various temperatures in a Gas Chromatography (GC) oven; some samples are then analyzed using High Performance Liquid Chromatography (HPLC). This disclosure discusses how various substances within medicinal cannabis may be transformed at different temperatures:
      • Partial decarboxylation of concentrated THCA-A in solution into Δ9-THC at 120 degrees C.
      • Significant decarboxylation of concentrated THCA-A in solution into Δ9-THC at 140 degrees C.
      • Nearly complete decarboxylation of concentrated THCA-A in solution into Δ9-THC at 160 degrees C. along with some degradation of Δ9-THC into cannabinol and dihydrocannabinol at 160 degrees C.
      • A significant percentage of Δ9-THC being degraded into cannabinol and dihydrocannabinol at 180 degrees C.
  • [0031]
    The decarboxylation of concentrated THCA-A in solution into Δ9-THC, and the degradation of Δ9-THC into cannabinol and dihydrocannabinol are shown to vary with temperature. Temperature controls are therefore one mechanism for controlling ratios of certain substances in medicinal cannabis.
  • [0032]
    Concentration ratios of THC acid (THCA-A) to cannabidiolic acid (CBDA) vary with the types cannabis selected; THCA-A decarboxylates into Δ9-THC, and CBDA decarboxylates into CBD.
  • [0033]
    Reference [11] is an example of cannabis related material available to the general public Wikipedia under “Cannabiniod” in August 2010. Many of the same substances discussed in previous references are also reviewed in reference [11].
  • [0034]
    Reference [12] Cannabis and Cannabis Extracts: Greater Than the sum of Their Parts?, by John M. McPartland and Ethan B. Russo; 2001 The Haworth Press, Inc. this reference reports the boiling temperature of cannabis related substances, the boiling temperatures reported include: Δ9-THC 157 degrees C., cannabidiol (CBD) 160-180 degrees C., cannabinol (CBN) 185 degrees C., and Δ8-THC 175-178 degrees C.
  • [0035]
    Reference [13] U.S. Pat. No. 7,674,922 “Process for Production of Delta-9-Tetrandrocannabinor, Burdick et al. Granted Mar. 9, 2010. This reference produces Δ9-THC using “ortanoaluminum-based Lewis acid catalyst”, a metallic based catalyst.
  • [0036]
    Reference [14] a drawing from www.Cannabis-Science.com showing chemical structures in cannabis related materials. The drawing is entitled “Cannabinoids”; the drawing shows an important aspect of cannabinoid science, Cannabidiol (CBD) can be converted into Δ9-THC. The chemical structures are very similar, they have the same molecular weight and the same chemical formula. Reference [15] patent application publication US 2008/0221339 by Webster et al. published Sep. 11, 2008 discusses the conversion of Cannabidiol (CBD) to Δ9-THC and Δ8-THC are discussed in; various toxic or flammable solvents are used in these processes; one cannabis related substance is converted another through a chemical process.
  • [0037]
    Reference [16] Hemp Husbandry, an excerpt from Chapter 6 Cannabinoid Chemistry: Robert A. Nelson, Copyright 2000; another excellent review of the chemistry of cannabis
  • Uncontrolled Crude Processes:
  • [0000]
      • Other processes have been used to extract Δ9-THC from raw cannabis in uncontrolled ways, some of these processes use toxic materials and others do not; frequently such processes attempt to produce a final product in a single uncontrolled crude step. Examples of such processes include the use of butane, a toxic solvent, to make the cannabis “red oil” commonly called hash oil. A method found on the internet reference [17] “How To Make Hash Oil from Marijuana” reviews the use of butane, here raw cannabis is saturated in butane, the butane reduces the raw cannabis into an oil that is separated from the plant material, the butane evaporates continuously during the process of reduction; a paper filter is used to separate the oil from plant material. The author also recommends a secondary process of mixing the oil with isopropyl alcohol, then evaporating the isopropyl alcohol overnight by letting it sit. The author of this reference believes that the isopropyl alcohol reduces the photosensitivity of THC contained within the oil. The process disclosed has no scientific controls, and shows disregard for laws relating to treating cannabis as a controlled substance or preparation of food products. The disclosure is provided as an example of uncontrolled methods that are available to the public.
      • In contrast, uncontrolled crude processes that use no toxic chemicals include simply baking cannabis into cookies or bread, or making a tea by steeping cannabis in hot water. Cannabis infused dairy butter can be made by melting dairy butter in a pot, adding raw cannabis and cooking the mixture for a period of time, up to 24 hours.
      • Hashish may be made without the use of toxic chemicals, “How to Made Wicked Hash” by Lisa Scammel and Bianca Sind [17] reviews various methods for separating THC acid infused trichomes from cannabis plant materials, forming it into blocks that are then covered in paper, and then heated in fry pan until the blocks melt; the processes reviewed are uncontrolled, and have no scientific controls, they include: “Flat Screening”, “Drum Machines”, “the blender method”, and “ice-water filtration” methods are reviewed. This reference is also provided as another example of uncontrolled crude methods that are available to the public. This disclosure also shows some disdain for laws relating to cannabis as a controlled substance.
      • Smoking, in the form of a cigarette or pipe, is the most frequently used uncontrolled process for decarboxylating cannabis.
      • The processes discussed above that rely on temperature simply use temperature yet do not control temperature; if the temperature is too low decarboxylation will be incomplete, if temperatures are too high decarboxylated substances within cannabis will be lost to evaporation. Temperature control is therefore characteristic of a process that relies on temperature to decarboxylate. This is why the “uncontrolled” processes reviewed above that rely on temperature are truly uncontrolled.
      • Processes discussed above that use toxic or flammable solvents in “uncontrolled” ways rely on saturating available cannabis with the toxic or flammable solvent then filtering oil from plant parts.
      • The process sprays a solvent through a tube filled with a volume of cannabis as described in reference [18] implies that more or less solvent will be required will be required to remove all of the trichombes from available cannabis; even small variables, such as how the cannabis is prepared will affect the efficiency of the solvent's ability to reduce the cannabis uniformly.
      • For example as the raw cannabis material density varies per unit length of the tube, the solvent's efficiency of reducing cannabis will vary because butane evaporates very quickly; the process simply is not capable of controlling how much solvent contacts a given volume of cannabis before it evaporates; thus the process is uncontrolled in at least this one way.
  • [0046]
    Reference [19] Patent Application Publication US 2008/0241339, “Hemp Food Product Base and Processes”, by Mitchell et al. Publication Date Oct. 2, 2008. The reference heats hemp seeds in water and then mills or grinds the seeds, the seeds are then added into soups, beverages, and foods; the seeds are reported to have no Δ9-THC or medicinal cannabis.
  • [0047]
    Recently, with the legalization of medical cannabis in 14 states, various edible cannabis products have become available; such products include cookies, biscuits, cooking oil, and dairy butter. These products are made without scientific controls by small producers because pharmaceutical companies do not produce edible cannabis products. Products like cookies or biscuits are eaten as is; products like cooling oil or dairy butter are usually added or cooked into other foods. Each one of these individual edible products have limitations the most significant one is uncontrolled dosage, cookies or biscuits contain cannabis fiber that often makes them green in color, and dairy products such as dairy butter spoil at room temperature.
  • BRIEF SUMMARY OF THE INVENTION
  • [0048]
    Provisional Patent application 61/401,824 filing date Aug. 19, 2010 Medicinal Cannabis in a Fatty Foodstuff and Utility patent application Ser. No. 13/065,980 filing date Apr. 4, 2011 Medicinal Cannabis Fatty Foodstuff in a Package Mold are hereby incorporated by reference into this specification.
  • [0049]
    The invention is a product and a process wherein cannabinoids such as Medicinal Δ9-THC and/or other substances associated with medicinal cannabis, including yet not necessarily limited to cannbidiols, cannabigerol are added to a foodstuff where the medicinal cannabis is not evenly distributed throughout the foodstuff where the foodstuff contains a known weight of medicinal cannabis. Another provision of the invention is providing controlled amounts or ratios of Δ9-THC as compared to CBD in or on a foodstuff.
  • [0050]
    An intermediate product containing medicinal cannabis, an extract, a topping, or a filling containing cannabinoids in a known concentration in a known volume are added into or onto a foodstuff where the medicinal cannabis is not evenly distributed throughout the foodstuff
  • [0051]
    The intermediate product, an extract has a known concentration of Δ9-THC, CBD, and other cannabinoids are known because a sample of it is measured at a scientific laboratory prior to incorporation into a food or it is produced by a process that guarantees a known concentration of medicinal cannabis per unit volume. Related provisional patent application No. 61,401,824 describes how such an intermediate product may be made through controlled decarboxylation. Such a process using a cannabis variety with known cannabinoid ratios would produce an extract with known rations. One gram of an intermediate product or extract that is 45% Δ9-THC and 10% CBD would contain 45 milligrams of Δ9-THC and 10 milligrams of CBD.
  • [0052]
    In one embodiment of the invention the intermediate product with a known concentration of medicinal cannabis per unit volume of the extract is added on top of a foodstuff or injected into a foodstuff. The foodstuff may be in the process of being prepared or be a prepared foodstuff. A measured volume of the intermediate product is measured and placed on a food or injected into a food. The intermediate product may be an extract or be a food topping or filling. Adding a known amount of an intermediate product with a known amount of medicinal cannabis into or onto a foodstuff means that a given foodstuff contains a known amount of medicinal cannabis. When the entire foodstuff is eaten a known amount of medicinal cannabis will be consumed.
  • [0053]
    Examples include yet are not limited to adding the intermediate product as a topping of a cake after it is cooked, or injecting it into a doughnut after the doughnut has been made. Another example is adding the intermediate product on top of a cookie before it is cooked. In instances where a foodstuff is cooked after the intermediate product has been being added to the foodstuff cooking temperatures must be less than the vaporization temperature of medicinal cannabis (less than 350 degrees F.), yet keeping the cooking temperature at or below the boiling temperature of medicinal cannabis (315 degrees F.) is preferred because vaporization begins at the boiling temperature.
  • [0054]
    Sometimes the intermediate product containing medicinal cannabis is an extract other times it may be a food filling or topping.
  • [0055]
    Another example of a foodstuff consistent with the invention are fatty foodstuffs including yet not limited to cocoa butter, and chocolates made by non-uniformly combining the fatty foodstuff with an intermediate product containing a known amount of medicinal cannabis.
  • DETAILED DESCRIPTION OF THE INVENTION
  • [0056]
    Provisional Patent application 61/401,824 filing date Aug. 19, 2010 Medicinal Cannabis in a Fatty Foodstuff and Utility patent application Ser. No. 13/065,980 filing date Apr. 4, 2011 Medicinal Cannabis Fatty Foodstuff in a Package Mold are hereby incorporated by reference into this specification.
  • [0057]
    The invention is a product and a process wherein cannabinoids such as Medicinal Δ9-THC and/or other substances associated with medicinal cannabis, including yet not necessarily limited to cannbidiols, cannabigerol are added to a foodstuff where the medicinal cannabis is not evenly distributed throughout the foodstuff where the foodstuff contains a known weight of medicinal cannabis. Another provision of the invention is providing controlled amounts or ratios of Δ9-THC as compared to CBD in or on a foodstuff.
  • [0058]
    An intermediate product containing medicinal cannabis, an extract, a topping, or a filling containing cannabinoids in a known concentration in a known volume are added into or onto a foodstuff where the medicinal cannabis is not evenly distributed throughout the foodstuff
  • [0059]
    The intermediate product, an extract has a known concentration of Δ9-THC, CBD, and other cannabinoids are known because a sample of it is measured at a scientific laboratory prior to incorporation into a food or it is produced by a process that guarantees a known concentration of medicinal cannabis per unit volume. Related provisional patent application No. 61,401,824 describes how such an intermediate product may be made through controlled decarboxylation. Such a process using a cannabis variety with known cannabinoid ratios would produce an extract with known rations. One gram of an intermediate product or extract that is 45% Δ9-THC and 10% CBD would contain 45 milligrams of Δ9-THC and 10 milligrams of CBD.
  • [0060]
    In one embodiment of the invention the intermediate product with a known concentration of medicinal cannabis per unit volume of the extract is added on top of a foodstuff or injected into a foodstuff. The foodstuff may be in the process of being prepared or be a prepared foodstuff. A measured volume of the intermediate product is measured and placed on a food or injected into a food. The intermediate product may be an extract or be a food topping or filling. Adding a known amount of an intermediate product with a known amount of medicinal cannabis into or onto a foodstuff means that a given foodstuff contains a known amount of medicinal cannabis. When the entire foodstuff is eaten a known amount of medicinal cannabis will be consumed.
  • [0061]
    Examples include yet are not limited to adding the intermediate product as a topping of a cake after it is cooked, or injecting it into a doughnut after the doughnut has been made. Another example is adding the intermediate product on top of a cookie before it is cooked. In instances where a foodstuff is cooked after the intermediate product has been being added to the foodstuff cooking temperatures must be less than the vaporization temperature of medicinal cannabis (less than 350 degrees F.), yet keeping the cooking temperature at or below the boiling temperature of medicinal cannabis (315 degrees F.) is preferred because vaporization begins at the boiling temperature.
  • [0062]
    Sometimes the intermediate product containing medicinal cannabis is an extract other times it may be a food filling or topping.
  • [0063]
    An example of making a topping with a known amount of medicinal cannabis per unit volume is shown below:
  • Strawberry Topping Ingredients:
  • [0000]
      • 1 pint strawberries, cleaned and stemmed; ⅓ cup white sugar; 1 teaspoon vanilla; an intermediate product or extract containing a known amount of medicinal cannabis.
  • Directions
  • [0000]
      • 1. Cut about ⅓ of the strawberries in half. In a saucepan over medium high heat, combine strawberries, sugar and vanilla. Cook, stirring occasionally, until sauce thickens, about 5 minutes. Measure or monitor the temperature making sure that the temperature does not exceed 315 degrees F. and add the extract containing a known amount of medicinal cannabis and mix thoroughly. Remove from heat. In a blender, puree about ⅓ of sauce, then mix back into remainder. Store in refrigerator.
  • [0066]
    The strawberry infused with medicinal cannabis may be added on top of a food or be injected into a food as a filling. An example of making a butter glaze consistent with this invention is described below.
  • Rum Butter Glaze Directions:
  • [0000]
      • To make the glaze: in a saucepan, combine ½ cup butter, ¼ cup water and 1 cup sugar. Apply heat, measure or monitor the temperature making sure it is not above 315 degrees F., and add an intermediate product containing a known amount of medicinal cannabis. Bring to a boil over medium heat and continue to boil for 5 minutes, stirring constantly., and then. Mix thoroughly. Remove from heat and stir in ½ cup rum.
  • [0068]
    Another example of a foodstuff consistent with the invention are foodstuffs that can be dispensed in liquid form, including yet not limited to fatty foodstuffs like cocoa butter, and chocolates made by non-uniformly combining the fatty foodstuff with an intermediate product containing a known amount of medicinal cannabis in a blend. Examples include yet are not limited to instances where the medicine is distributed in a swirl, as a center of a chocolate candy, or as a topping on a chocolate.
  • [0069]
    An example of this is where two substances, where the first substance chocolate, and second substance is an intermediate product containing a known amount of weight of medicinal cannabis per unit volume are dispensed to form individual chocolate foodstuff or candy of a desired size with a desired amount of medicine in each individual chocolate foodstuff. The blended chocolate foodstuff does not have a uniform amount of medicinal cannabis per unit volume of the foodstuff yet does contain a known amount of medicinal cannabis contained within the volume of the chocolate foodstuff.
  • [0070]
    These blended chocolates may be fabricated by passing the two substances through two separate nozzles: One nozzle dispensing a specific volume of chocolate and the other nozzle dispensing a specific volume of an intermediate product containing a known amount of weight of medicinal cannabis per unit volume forming a chocolate foodstuff with a known amount of medicinal cannabis in each chocolate foodstuff. Pumping these substances through peristaltic pumps, ultra-sonic pumps, or other pumps designed to pump controlled volumes of liquids are ideal for this application. These blends may stand alone or be injected into a mold or package.
  • [0071]
    Other toppings, fillings, or blends consistent with this invention include yet are not limited to chocolate syrup, food glazes, or even medicinal cannabis extracts.
  • [0072]
    The examples above describe products made by the process of combining a foodstuff with a known intermediate product. A significant intent of the invention is to provide a known amount of medicinal cannabis per individual foodstuff. Consuming the entire foodstuff will deliver a known amount of medicinal cannabis to a patient.
  • [0073]
    Specific concentrations of various cannabinoids may be rendered into a specific volume of a foodstuff. For example an extract containing predominantly tetrahydrocannabinol (Δ9-THC) may be rendered into a specific volume of a food producing a medicinal with maximum psychoactive effect. In another example a mixture of tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBN) in specific ratios could be rendered into a fatty foodstuff producing a medicinal with a balance of psychoactive and body effects.
  • [0074]
    Cannabis extracts contain a combination of cannabinoids and other materials including flavonoids, and waxy plant materials. Preferred extracts contain about 56% cannabinoids; in this instance 100% of the cannabinoids contained within the extract constitute 56% of the extract. Of that 100% of cannabinoids 33.33% might consist of tetrahydrocannabinol (Δ9-THC), 33.33% might contain cannabidiol (CBN), and 33.33% might contain other cannabinoids. Various combinations of cannabinoids may be contained within an extract from a certain type of cannabis plant, and extracts from different cannabis strains may be mixed to produce an extract with known amounts of cannabinoids per unit volume of the combined extract. Mixing extracts from known plant strains or cannabis extracts that have been analyzed in a laboratory provide a method for controlling the amount of tetrahydrocannabinol (Δ9-THC), cannabidiol (CBN), and other cannabinoids in the combined extract.
  • [0075]
    Concentrations of cannabinoids contained within the fatty foodstuff are controlled by knowing the concentration of cannabinoids in the extract, the volume of the extract, and the volume of the fatty foodstuff. Ratios of cannabinoids of interest include yet are not limited to:
  • [0076]
    A high percentage of tetrahydrocannabinol (Δ9-THC) as compared to other cannabinoids, where more than 80% of cannabinoids in an extract consist of Δ9-THC.
  • [0077]
    A mixture of tetrahydrocannabinol (Δ9-THC), and cannabidiol (CBN) in desired ratios.
  • [0078]
    An equal percentage of tetrahydrocannabinol (Δ9-THC), and cannabidiol (CBN).
  • [0079]
    A mixture of tetrahydrocannabinol (Δ9-THC), cannabidiol (CBN), and other cannabinoids in desired ratios.
  • [0080]
    Two or more extracts from different plant material may be mixed forming a cannabis extract with an average proportional concentration of the various cannabinoids per unit volume of extract. For example if two extracts of the same volume were mixed where cannabinoids in a first extract consisted of 95% of all cannabinoids were Δ9-THC and 5% of all cannabinoids were CBN, and where cannabinoids in the second extract consisted of 35% Δ9-THC, 35% consisted of CBN, and 30% consisted of other cannabinoids; the combined extract would contain: (95+35)/2 Δ9-THC; (5+35)/2 CBN; and 30/2 other cannabinoids: or 65% Δ9-THC; 20% CBN; and 15% other cannabinoids.
  • Example 2 of Mixing Extracts:
  • [0081]
    Extract 1: Volume 2 fluid oz comprised of 40% flavonoids & waxy materials: 60% total cannabinoids (95% of total cannabinoids are Δ9-THC, and 5% of total cannabinoids are CBN)
  • [0082]
    Extract 2: Volume 4 fluid oz, comprised of 40% flavonoids & waxy materials: 60% total cannabinoids (58% of total cannabinoids are Δ9-THC, and 42% of total cannabinoids are CBN)
  • [0083]
    Mixed cannabinoid content: Volume 6 fluid oz; (95*0.33333+58*0.66666) Δ9-THC; (5*0.33333+42*0.66666) CBN=(31.67+38.67) Δ9-THC; (1.66+28) CBN=70.34% Δ9-THC; 29.66% CBN.
  • [0084]
    Please note that the extracts do not consist of 100% cannabinoids, in the example above only 60% of the extracts consist of cannabinoids and 40% of the extracts above consist of flavonoids and waxy materials. Please also note that the calculations above have been normalized to a total cannabinoid content of 100%.
      • Therefore the total content of the mixed extract in Example 2 are 40% flavonoids and waxy materials; and 60% total cannabinoids (70.34*0.6) Δ9-THC and (29.66*0.6) CBN=40% flavonoids and waxy materials; and 42.204% Δ9-THC; 17.795% CBN.
      • This means that the 6 fluid ounce mixed extract contains (6*0.42204) fluid ounces of Δ9-THC; and (6*17.795) fluid ounces of CBN=2.53 fluid ounces of Δ9-THC; and 1.07 fluid ounces of CBN. Extracts of this nature allow foodstuffs with crafted amounts of specific cannabinoids in specific proportions to be fabricated.
      • Extracts may be mixed at temperatures less than 315 degrees F. before incorporation into a food, or they may be mixed with ingredients of the food when making the food. Extracts may be warmed before mixing.
  • BRIEF DESCRIPTION OF THE MANY VIEWS OF THE DRAWINGS
  • [0000]
      • FIG. 1 shows Basic Cannabinoid Structures:
        • THCA-A (THC acid), Decarboxylation is the loss of CO2 from a molecular structure; when THCA-A decarboxylates the psychoactive substance Δ9-THC is formed; Δ9-THC is depicted in FIG. 1.
        • CBN (cannabiniol) is also depicted; CBN is formed by degeneration of Δ9-THC.
        • CBDA (cannabidiolic acid) and CBD (cannabidiol) are also depicted in FIG. 1. When CBDA is decarboxylated CBD is formed.
        • Since CBD may be transformed into Δ9-THC, FIG. 1 also depicts that this Transformation relates to a small change in chemical structure.
        • Notes regarding the chemical formula and molecular weight of depicted cannabinoid structures:
          • CBD and Δ9-THC have the identical Chemical Formula C21H30O2; & Molecular Weight 314.5.
          • CBDA has a Chemical Formula C22H30O4; Molecular Weight 358.5.
          • CBN has a Chemical Formula C21H26O2, Molecular Weight 310.4.
  • REFERENCES
  • [0000]
    • [1] Journal of Chromatography 8,877 (2009) 4115-4124: “Innovative development and validation of an HPLC/DAD method for the qualitative determination of major cannabinoids in cannabis plant material”: Benjamin De Backer et al.
    • [2] U.S. Pat. No. 6,365,416 B1: “Method of Preparing Δ9-THC”, Elsohly et al. publication date Oct. 26, 1998.
    • [3] U.S. Pat. No. 6,730,519: “Method of Preparing Δ9-THC”, Elsohly et al. publication date Jul. 4, 2002.
    • [4] Patent Application Publication US 2002/0039795 A1 “Method of Preparing Δ9-THC”, Elsohly et al. patent date Apr. 2, 2002; filing date Oct. 26, 1998.
    • [5] U.S. Pat. No. 7,524,881 B2: “Production of Δ9-THC”, Goodwin et al. patent date Apr. 28, 2009.
    • [6] U.S. Pat. No. 7,592,468 B2: “Production of Δ9-THC”, Goodwin et al. patent date Sep. 22, 2009.
    • [7] GW pharmaceuticals of Great Britain Misc. reports on their website July 2010.
    • [8] “Effects of canabidiol on schizophrenia-like symptoms in people who use cannabis”; from The British Journal of Psychiatry (2008)
    • [9] Therapeutic Potential of Non-Psychotropic Cannabidiol in Ischemic Stroke; Hayakawa, Mishima, & Fujiwara; Dept. of Neuopharmacology, Faculty of Pharmaceutical Sciences, Fukuoka University, Published Jul. 8, 2010. Δ9-THC
    • [10] “Isolation of Δ9-THCA-A from hemp and analytical aspects concerning the determination of Δ9-THC in cannabis products”; Dussy, et al. Institute of Legal Medicine, Basel Switzerland, available online Aug. 18, 2004.
    • [11] Wikipedia “Cannabiniod” webpage, August 2010.
    • [12] Cannabis and Cannabis Extracts: Greater Than the sum of Their Parts?, by John M. McPartland and Ethan B. Russo; 2001 The Haworth Press, Inc.
    • [13] U.S. Pat. No. 7,674,922 “Process for Production of Delta-9-Tetrandrocannabinol”, Burdick et al. Granted Mar. 9, 2010
    • [14] www.Cannabis-Science.com August 2010, The drawing entitled “Cannabinoids”
    • [15] Patent Application Publication US 2008/0221339 by Webster et al. published Sep. 11, 2008.
    • [16] Hemp Husbandry, an excerpt from Chapter 6 Cannabinoid Chemistry: Robert A. Nelson, Copyright 2000
    • [17] “How To Make Hash oil From Marijuana”; author unknown, found on the internet July 2010.
    • [18] “How to Made Wicked Hash” by Lisa Scammel and Bianca Sind, written Wednesday May 22, 2002; found on www.cannabisculture.com in July 2010.
    • [19] Patent Application Publication US 2008/0241339, “Hemp Food Product Base and Processes”, by Mitchell et al. Publication Date Oct. 2, 2008.

Claims (9)

1. (canceled)
2. A foodstuff that has a known weight of medicinal cannabis wherein said medicinal cannabis is non-uniformly distributed in said foodstuff.
3. The foodstuff of claim 2 where said medicinal cannabis is on at least one side of said foodstuff.
4. The foodstuff of claim 2 where said medicinal cannabis is inside the said foodstuff.
5. The foodstuff of claim 2 where said intermediate product is blended with said foodstuff.
6. A process for making a foodstuff containing a known weight of medicinal cannabis comprising:
a) combining a cannabinoid containing intermediate product or controlled portion of a cannabinoid containing intermediate product with a known weight of cannabinoids with one or more foodstuffs, said controlled amount of cannabinoid containing intermediate product non-uniformly distributed in the volume of said one or more foodstuffs; and
b) heating said one or more foodstuffs combined with said cannabinoid containing intermediate product or portion of cannabinoid containing intermediate product with a known weight of cannabinoids to a temperature not exceeding the vaporization temperature of cannabinoids;
7. The process of claim 6 further comprising combining said cannabinoid containing intermediate product when said cannabinoid containing intermediate product is at an elevated temperature not exceeding the vaporization temperature of cannabinoids with said one or more foodstuffs.
8. A process for making a foodstuff containing a known weight of medicinal cannabis comprising heating a cannabinoid containing intermediate product with a known weight of cannabinoids to a temperature not exceeding the vaporization temperature of cannabinoids and combining it non-uniformly with one or more foodstuffs;
9. The process of claim 8 further comprising heating of said one or more foodstuffs prior to combining with said one or more foodstuffs and wherein the temperature of said one or more foodstuffs does not exceed the vaporization temperature of cannabinoids when combined with said cannabinoid containing intermediate product.
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