WO2012071389A3 - Stable cannabinoid compositions and methods for making and storing them - Google Patents

Stable cannabinoid compositions and methods for making and storing them Download PDF

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Publication number
WO2012071389A3
WO2012071389A3 PCT/US2011/061803 US2011061803W WO2012071389A3 WO 2012071389 A3 WO2012071389 A3 WO 2012071389A3 US 2011061803 W US2011061803 W US 2011061803W WO 2012071389 A3 WO2012071389 A3 WO 2012071389A3
Authority
WO
WIPO (PCT)
Prior art keywords
composition
acid
solvent
making
storing
Prior art date
Application number
PCT/US2011/061803
Other languages
French (fr)
Other versions
WO2012071389A2 (en
Inventor
Ronald Rossi
Lee Jonathan Silverberg
Robert Hogan
Ramesh M. Shah
Original Assignee
Johnson Matthey Public Limited Company
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 Johnson Matthey Public Limited Company filed Critical Johnson Matthey Public Limited Company
Priority to EP11791403.6A priority Critical patent/EP2642982A2/en
Publication of WO2012071389A2 publication Critical patent/WO2012071389A2/en
Publication of WO2012071389A3 publication Critical patent/WO2012071389A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic 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
    • A61K31/352—Heterocyclic 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. methantheline 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

Abstract

A composition comprising a high purity cannabinoid, an acid, and a pharmaceutically- acceptable solvent achieves room temperature stability for over 24 months. The acid improves the stability of the composition and the solvent enhances the solubility of the acid, thereby allowing the acid to have an improved stabilizing effect on the highly pure cannabinoid. Preferably, the solvent is an alcohol and, more preferably, the composition contains an oil. A method for making the composition includes combining the cannabinoid and the solvent and evaporating a portion of the solvent, along with adding an acid to the composition, before, during, or after the evaporating step. A method for making and storing the composition includes storing the composition in a manner adapted to maintain its stability. Pharmaceutical dosage forms include a formulated composition, such as having the oil. A method of treating a subject comprises administering to the subject the dosage form.
PCT/US2011/061803 2010-11-22 2011-11-22 Stable cannabinoid compositions and methods for making and storing them WO2012071389A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP11791403.6A EP2642982A2 (en) 2010-11-22 2011-11-22 Stable cannabinoid compositions and methods for making and storing them

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US41611010P 2010-11-22 2010-11-22
US61/416,110 2010-11-22

Publications (2)

Publication Number Publication Date
WO2012071389A2 WO2012071389A2 (en) 2012-05-31
WO2012071389A3 true WO2012071389A3 (en) 2012-08-09

Family

ID=45094810

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2011/061803 WO2012071389A2 (en) 2010-11-22 2011-11-22 Stable cannabinoid compositions and methods for making and storing them

Country Status (2)

Country Link
EP (1) EP2642982A2 (en)
WO (1) WO2012071389A2 (en)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9259449B2 (en) 2014-01-07 2016-02-16 Joshua Michael Raderman Method for modifying THC content in a lipid-based extract of cannabis
US9632069B2 (en) 2014-02-05 2017-04-25 Vyripharm Llc Integrated systems and methods of evaluating cannabis and cannabinoid products for public safety, quality control and quality assurance purposes
US11911361B2 (en) 2014-05-29 2024-02-27 Radius Pharmaceuticals, Inc. Stable cannabinoid formulations
US11331279B2 (en) 2014-05-29 2022-05-17 Radius Pharmaceuticals, Inc. Stable cannabinoid formulations
AU2015266897B2 (en) * 2014-05-29 2020-07-30 Radius Pharmaceuticals, Inc. Stable cannabinoid formulations
MX2017009846A (en) 2015-01-31 2018-04-11 Constance Therapeutics Inc Methods for preparation of cannabis oil extracts and compositions.
DK3302437T3 (en) * 2015-05-28 2023-01-09 Radius Pharmaceuticals Inc STABLE CANNABINOID FORMULATIONS
BR102015024165A2 (en) * 2015-09-18 2017-03-28 Prati Donaduzzi & Cia Ltda oral pharmaceutical composition comprising cannabinoid, process for its preparation and use
MX2018006381A (en) 2015-11-24 2019-02-14 Constance Therapeutics Inc Cannabis oil compositions and methods for preparation thereof.
WO2019074959A1 (en) * 2017-10-09 2019-04-18 Constance Therapeutics, Inc. Cannabinoid composition and products including alpha-tocopherol
US20220226241A1 (en) * 2021-01-20 2022-07-21 Therabody, Inc. Stable organic cannabinoid oil blend formulations

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080139644A1 (en) * 2006-11-10 2008-06-12 Ronald Rossi Composition comprising (-)-delta9-trans-tetrahydrocannabinol
WO2009020666A1 (en) * 2007-08-06 2009-02-12 Insys Therapeutics Inc. Oral cannabinoid liquid formulations and methods of treatment

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6403126B1 (en) 1999-05-26 2002-06-11 Websar Innovations Inc. Cannabinoid extraction method
GB0112752D0 (en) 2001-05-25 2001-07-18 Johnson Matthey Plc Synthesis of cannabinoids
US20040229939A1 (en) 2003-02-14 2004-11-18 Chowdhury Dipak K. Tetrahydrocannabinol compositions and methods of manufacture and use thereof
GB0329635D0 (en) 2003-12-23 2004-01-28 Johnson Matthey Plc Process for purifying trans-tetrahydrocannabinol
CN101132781A (en) 2004-12-09 2008-02-27 茵西斯医疗公司 Room-temperature stable dronabinol formulations

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080139644A1 (en) * 2006-11-10 2008-06-12 Ronald Rossi Composition comprising (-)-delta9-trans-tetrahydrocannabinol
US8039509B2 (en) * 2006-11-10 2011-10-18 Johnson Matthey Public Limited Company Composition comprising (−)-Δ9-trans-tetrahydrocannabinol
WO2009020666A1 (en) * 2007-08-06 2009-02-12 Insys Therapeutics Inc. Oral cannabinoid liquid formulations and methods of treatment

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
CHRISTIAN LINDHOLST: "Long term stability of cannabis resin and cannabis extracts", AUSTRALIAN JOURNAL OF FORENSIC SCIENCES, vol. 42, no. 3, 5 July 2010 (2010-07-05), pages 181 - 190, XP055029938, ISSN: 0045-0618, DOI: 10.1080/00450610903258144 *
SOLVAY PHARMACEUTICALS INC.: "NDA 18-651/S-021; MARINOL (Dronabinol) capsules", September 2004 (2004-09-01), XP002671413, Retrieved from the Internet <URL:http://www.fda.gov/ohrms/dockets/dockets/05n0479/05N-0479-emc0004-04.pdf> [retrieved on 20120313] *

Also Published As

Publication number Publication date
WO2012071389A2 (en) 2012-05-31
EP2642982A2 (en) 2013-10-02

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