JP2020517727A - 安定なカンナビノイド製剤 - Google Patents

安定なカンナビノイド製剤 Download PDF

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Publication number
JP2020517727A
JP2020517727A JP2019558668A JP2019558668A JP2020517727A JP 2020517727 A JP2020517727 A JP 2020517727A JP 2019558668 A JP2019558668 A JP 2019558668A JP 2019558668 A JP2019558668 A JP 2019558668A JP 2020517727 A JP2020517727 A JP 2020517727A
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JP
Japan
Prior art keywords
cannabidiol
formulation
patient
administering
dose
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2019558668A
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English (en)
Japanese (ja)
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JP2020517727A5 (enExample
Inventor
バンガラ，キラン・クマール
リー，ホワグワン
イェン，ニンシン
グエン，ヒュン・キュー
ゴスコンダ，ベンカット・アール
Original Assignee
インシス・ディベロップメント・カンパニー・インコーポレイテッド
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US15/499,178 external-priority patent/US20170224634A1/en
Application filed by インシス・ディベロップメント・カンパニー・インコーポレイテッド filed Critical インシス・ディベロップメント・カンパニー・インコーポレイテッド
Publication of JP2020517727A publication Critical patent/JP2020517727A/ja
Publication of JP2020517727A5 publication Critical patent/JP2020517727A5/ja
Priority to JP2022089421A priority Critical patent/JP2022130390A/ja
Priority to JP2024113145A priority patent/JP2024161363A/ja
Priority to JP2025077149A priority patent/JP2025118787A/ja
Priority to JP2025077148A priority patent/JP2025118786A/ja
Pending legal-status Critical Current

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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • 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
    • A61K31/658—Medicinal preparations containing organic active ingredients o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Child & Adolescent Psychology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2019558668A 2017-04-27 2017-09-22 安定なカンナビノイド製剤 Pending JP2020517727A (ja)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2022089421A JP2022130390A (ja) 2017-04-27 2022-06-01 安定なカンナビノイド製剤
JP2024113145A JP2024161363A (ja) 2017-04-27 2024-07-16 安定なカンナビノイド製剤
JP2025077149A JP2025118787A (ja) 2017-04-27 2025-05-07 安定なカンナビノイド製剤
JP2025077148A JP2025118786A (ja) 2017-04-27 2025-05-07 安定なカンナビノイド製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US15/499,178 US20170224634A1 (en) 2014-05-29 2017-04-27 Stable cannabinoid formulations
US15/499,178 2017-04-27
PCT/US2017/052897 WO2018200024A1 (en) 2017-04-27 2017-09-22 Stable cannabinoid formulations

Related Child Applications (2)

Application Number Title Priority Date Filing Date
JP2022089421A Division JP2022130390A (ja) 2017-04-27 2022-06-01 安定なカンナビノイド製剤
JP2024113145A Division JP2024161363A (ja) 2017-04-27 2024-07-16 安定なカンナビノイド製剤

Publications (2)

Publication Number Publication Date
JP2020517727A true JP2020517727A (ja) 2020-06-18
JP2020517727A5 JP2020517727A5 (enExample) 2020-11-12

Family

ID=63920361

Family Applications (5)

Application Number Title Priority Date Filing Date
JP2019558668A Pending JP2020517727A (ja) 2017-04-27 2017-09-22 安定なカンナビノイド製剤
JP2022089421A Pending JP2022130390A (ja) 2017-04-27 2022-06-01 安定なカンナビノイド製剤
JP2024113145A Pending JP2024161363A (ja) 2017-04-27 2024-07-16 安定なカンナビノイド製剤
JP2025077149A Pending JP2025118787A (ja) 2017-04-27 2025-05-07 安定なカンナビノイド製剤
JP2025077148A Pending JP2025118786A (ja) 2017-04-27 2025-05-07 安定なカンナビノイド製剤

Family Applications After (4)

Application Number Title Priority Date Filing Date
JP2022089421A Pending JP2022130390A (ja) 2017-04-27 2022-06-01 安定なカンナビノイド製剤
JP2024113145A Pending JP2024161363A (ja) 2017-04-27 2024-07-16 安定なカンナビノイド製剤
JP2025077149A Pending JP2025118787A (ja) 2017-04-27 2025-05-07 安定なカンナビノイド製剤
JP2025077148A Pending JP2025118786A (ja) 2017-04-27 2025-05-07 安定なカンナビノイド製剤

Country Status (4)

Country Link
EP (2) EP4516355A3 (enExample)
JP (5) JP2020517727A (enExample)
CA (1) CA3062814C (enExample)
WO (1) WO2018200024A1 (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022130390A (ja) * 2017-04-27 2022-09-06 フレッシュ・カット・ディベロップメント・エル・エル・シー 安定なカンナビノイド製剤
JP2023546649A (ja) * 2020-09-24 2023-11-07 ニコベンチャーズ トレーディング リミテッド 製剤
JP2023546648A (ja) * 2020-09-24 2023-11-07 ニコベンチャーズ トレーディング リミテッド 包装された製剤

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2530001B (en) 2014-06-17 2019-01-16 Gw Pharma Ltd Use of cannabidiol in the reduction of convulsive seizure frequency in treatment-resistant epilepsy
GB2531282A (en) 2014-10-14 2016-04-20 Gw Pharma Ltd Use of cannabinoids in the treatment of epilepsy
GB2539472A (en) 2015-06-17 2016-12-21 Gw Res Ltd Use of cannabinoids in the treatment of epilepsy
GB2568929A (en) 2017-12-01 2019-06-05 Gw Res Ltd Use of cannabinoids in the treatment of epilepsy
MX2021006912A (es) 2018-12-11 2021-08-24 Disruption Labs Inc Composiciones para la administracion de agentes terapeuticos y metodos de uso y fabricacion de las mismas.
GB2584140A (en) * 2019-05-23 2020-11-25 Gw Res Ltd Use of cannabidiol in the treatment of epileptic spasms
MX2022002548A (es) * 2019-09-09 2022-03-22 Cardiol Therapeutics Inc Composiciones medicinales estables de cannabidiol.
CA3157812C (en) * 2019-10-25 2024-10-22 Cardiol Therapeutics Inc. CANNABIDIOL COMPOSITIONS INTENDED FOR USE IN THE TREATMENT OF HEART CONDITIONS
GB2588461A (en) * 2019-10-25 2021-04-28 Gw Res Ltd Use of cannabidiol preparations in the treatment of absence epilepsy
WO2023286047A1 (en) * 2021-07-13 2023-01-19 Epm (Ip), Inc. Cannabidiolic acid esters for treating prader-willi syndrome
US20250025482A1 (en) * 2021-07-28 2025-01-23 GW Research Limited Use of cannabidiol in the treatment of epilepsy
EP4601629A1 (en) * 2022-10-12 2025-08-20 Leiutis Pharmaceuticals LLP Novel liquid oral formulations of cannabidiol
CN115887426A (zh) * 2022-11-18 2023-04-04 中国人民解放军军事科学院军事医学研究院 大麻二酚在制备核辐射损伤后骨髓恢复药物中的应用
CN116444351A (zh) * 2022-11-18 2023-07-18 中国人民解放军军事科学院军事医学研究院 一种核辐射损伤中对小肠有保护作用的天然小分子化合物
CN116172988A (zh) * 2022-11-18 2023-05-30 中国人民解放军军事科学院军事医学研究院 大麻二酚用于制备急性放射病的药物的用途

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009538893A (ja) * 2006-06-01 2009-11-12 ジーダブリュー・ファーマ・リミテッド カンナビノイドの新規な使用
WO2016191651A1 (en) * 2015-05-28 2016-12-01 Insys Development Company, Inc. Stable cannabinoid formulations

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0514060A (pt) * 2004-08-03 2008-05-27 Orexigen Therapeutics Inc combinação de bupropion e um segundo composto para acarretar a perda de peso
CA2630241A1 (en) * 2005-11-23 2007-05-31 Ironwood Pharmaceuticals, Inc. Methods and compositions for the treatment of gastrointestinal disorders
WO2011057199A1 (en) * 2009-11-06 2011-05-12 Adenios, Inc. Compositions for treating cns disorders
WO2011150338A1 (en) * 2010-05-27 2011-12-01 Zafgen Corporation Methods of treating obesity
AU2015266897B2 (en) * 2014-05-29 2020-07-30 Fresh Cut Development, Llc Stable cannabinoid formulations
US11331279B2 (en) 2014-05-29 2022-05-17 Radius Pharmaceuticals, Inc. Stable cannabinoid formulations
US20160367496A1 (en) * 2014-05-29 2016-12-22 Insys Development Company, Inc. Stable cannabinoid formulations
US20160271252A1 (en) * 2014-05-29 2016-09-22 Insys Development Company, Inc. Stable cannabinoid formulations
EP4516355A3 (en) * 2017-04-27 2025-05-28 Fresh Cut Development, LLC Stable cannabinoid formulations

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009538893A (ja) * 2006-06-01 2009-11-12 ジーダブリュー・ファーマ・リミテッド カンナビノイドの新規な使用
WO2016191651A1 (en) * 2015-05-28 2016-12-01 Insys Development Company, Inc. Stable cannabinoid formulations

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"History of Changes for Study: NCT02844933, Cannabidiol Oral Solution for The Treatment of Subjects W", CLINICAL TRIALS.GOV ARCHIVE [ONLINE], JPN6022029773, 31 March 2017 (2017-03-31), ISSN: 0004826038 *
PHARMACOLOGY, BIOCHEMISTRY AND BEHAVIOR, vol. 98, JPN6021023816, 2011, pages 268 - 272, ISSN: 0004826037 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022130390A (ja) * 2017-04-27 2022-09-06 フレッシュ・カット・ディベロップメント・エル・エル・シー 安定なカンナビノイド製剤
JP2023546649A (ja) * 2020-09-24 2023-11-07 ニコベンチャーズ トレーディング リミテッド 製剤
JP2023546648A (ja) * 2020-09-24 2023-11-07 ニコベンチャーズ トレーディング リミテッド 包装された製剤
JP7752171B2 (ja) 2020-09-24 2025-10-09 ニコベンチャーズ トレーディング リミテッド 包装された製剤

Also Published As

Publication number Publication date
EP3615079B1 (en) 2025-02-12
JP2025118787A (ja) 2025-08-13
EP3615079C0 (en) 2025-02-12
CA3062814A1 (en) 2018-11-01
JP2024161363A (ja) 2024-11-19
EP4516355A3 (en) 2025-05-28
CA3062814C (en) 2023-11-14
EP3615079A4 (en) 2020-09-23
JP2025118786A (ja) 2025-08-13
WO2018200024A1 (en) 2018-11-01
EP3615079A1 (en) 2020-03-04
EP4516355A2 (en) 2025-03-05
JP2022130390A (ja) 2022-09-06

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