AU2013260246B2 - Granulate containing cannabinoid, method for its manufacture and oral dosage unit comprising such granulate - Google Patents

Granulate containing cannabinoid, method for its manufacture and oral dosage unit comprising such granulate Download PDF

Info

Publication number
AU2013260246B2
AU2013260246B2 AU2013260246A AU2013260246A AU2013260246B2 AU 2013260246 B2 AU2013260246 B2 AU 2013260246B2 AU 2013260246 A AU2013260246 A AU 2013260246A AU 2013260246 A AU2013260246 A AU 2013260246A AU 2013260246 B2 AU2013260246 B2 AU 2013260246B2
Authority
AU
Australia
Prior art keywords
granulate
cannabinoid
fatty acid
dosage unit
disorders
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.)
Active
Application number
AU2013260246A
Other languages
English (en)
Other versions
AU2013260246A1 (en
AU2013260246A2 (en
Inventor
Jan Albert De Vries
Maria Vanesa Fernandez Cid
Ana Maria HEREDIA LOPEZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Echo Pharmaceuticals BV
Original Assignee
Echo Pharmaceuticals BV
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 Echo Pharmaceuticals BV filed Critical Echo Pharmaceuticals BV
Publication of AU2013260246A1 publication Critical patent/AU2013260246A1/en
Publication of AU2013260246A2 publication Critical patent/AU2013260246A2/en
Application granted granted Critical
Publication of AU2013260246B2 publication Critical patent/AU2013260246B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • 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
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Psychiatry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Anesthesiology (AREA)
  • Pain & Pain Management (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2013260246A 2012-05-07 2013-05-03 Granulate containing cannabinoid, method for its manufacture and oral dosage unit comprising such granulate Active AU2013260246B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP12167006 2012-05-07
EP12167006.1 2012-05-07
PCT/NL2013/050341 WO2013169101A1 (en) 2012-05-07 2013-05-03 Granulate containing cannabinoid, method for its manufacture and oral dosage unit comprising such granulate

Publications (3)

Publication Number Publication Date
AU2013260246A1 AU2013260246A1 (en) 2014-11-27
AU2013260246A2 AU2013260246A2 (en) 2014-11-27
AU2013260246B2 true AU2013260246B2 (en) 2018-01-25

Family

ID=48468727

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2013260246A Active AU2013260246B2 (en) 2012-05-07 2013-05-03 Granulate containing cannabinoid, method for its manufacture and oral dosage unit comprising such granulate

Country Status (9)

Country Link
US (2) US20150132400A1 (enExample)
EP (1) EP2846768B1 (enExample)
JP (1) JP2015521175A (enExample)
CN (1) CN104363890B (enExample)
AU (1) AU2013260246B2 (enExample)
CA (1) CA2872689C (enExample)
ES (1) ES2600465T3 (enExample)
IN (1) IN2014DN09718A (enExample)
WO (1) WO2013169101A1 (enExample)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK2317852T3 (en) 2008-07-16 2015-03-23 Richter Gedeon Nyrt PHARMACEUTICAL FORMULATIONS CONTAINING dopamine receptor ligands
CA2952934A1 (en) 2014-06-26 2015-12-30 Island Breeze Systems Ca, Llc Mdi related products and methods of use
US9730911B2 (en) * 2014-10-21 2017-08-15 United Cannabis Corp. Cannabis extracts and methods of preparing and using same
WO2016205923A1 (en) * 2015-06-25 2016-12-29 Compressed Perforated Puck Technologies Inc. Ingestible plant source pill and method
BR102015024165A2 (pt) * 2015-09-18 2017-03-28 Prati Donaduzzi & Cia Ltda composição farmacêutica oral compreendendo canabinóide, processo para sua preparação e seu uso
CA2914611A1 (en) * 2015-12-09 2017-06-09 Mark Kwiecinski Compositions for improving safety of pharmaceutical formulations
US10555906B2 (en) 2016-02-11 2020-02-11 Gelpell Ag Oral solid cannabinoid formulations, methods for producing and using thereof
US10542770B2 (en) * 2016-03-18 2020-01-28 Aceso Wellness LLC Cannabinoid emulsion product and process for making the same
US11274087B2 (en) 2016-07-08 2022-03-15 Richter Gedeon Nyrt. Industrial process for the preparation of cariprazine
WO2019175290A1 (en) 2018-03-13 2019-09-19 Beckley Canopy Therapeutics Limited Cannabis or cannabis derived compositions for promoting cessation of chemical dependence
WO2019211772A1 (en) * 2018-05-03 2019-11-07 Radient Technologies Inc. Obtaining extracts in a solid form
WO2020010454A1 (en) * 2018-07-10 2020-01-16 Beleave Inc. Formulation of cannabinoid compounds
CA3108214A1 (en) * 2018-07-18 2020-01-23 Glatt Gmbh Extended release formulations of cannabinoids
US11254633B2 (en) 2018-10-05 2022-02-22 Jonas Alcirdas Navickas Cannabis thin layer decarboxylation
WO2020183436A1 (en) * 2019-03-13 2020-09-17 One World Cannabis Ltd. Dosage forms for oral delivery of cannabinoids, method of preparation and uses of same
US11547707B2 (en) 2019-04-10 2023-01-10 Richter Gedeon Nyrt. Carbamoyl cyclohexane derivatives for treating autism spectrum disorder
CA3040547C (en) 2019-04-17 2021-12-07 Medcan Pharma A/S Cannabinoid lozenge formulation
DE102019211195A1 (de) * 2019-07-26 2021-01-28 Add Advanced Drug Delivery Technologies Ltd. Verfahren und Vorrichtung zur Herstellung eines im Wesentlichen im wässrigen Milieu lösbaren Cannabinoid-Granulats
CA3274525A1 (en) * 2019-08-30 2025-10-31 Np Sa Loaded granules, their process of production and their uses
CN111202767A (zh) * 2019-09-04 2020-05-29 汉义生物科技（北京）有限公司 大麻全草提取物在改善tau蛋白和β-淀粉样蛋白病理损伤中应用
US20220016072A1 (en) * 2020-07-17 2022-01-20 Canna Chemistries Llc Solid delta9-tetrahydrocannabinol (delta9-thc) compositions
US12029718B2 (en) 2021-11-09 2024-07-09 Cct Sciences, Llc Process for production of essentially pure delta-9-tetrahydrocannabinol
IT202000027408A1 (it) * 2020-11-16 2022-05-16 Indena Spa Dispersioni solide di cannabidiolo
WO2023238122A1 (en) 2022-06-06 2023-12-14 Cannbiorex Pharma Ltd Formulations and oral dosage forms of lipophilic agents
JP7360526B1 (ja) * 2022-10-21 2023-10-12 第一工業製薬株式会社 組成物
JP7469550B1 (ja) * 2022-10-21 2024-04-16 第一工業製薬株式会社 固体組成物及びその製造方法
WO2025032115A1 (en) * 2023-08-08 2025-02-13 Avextra Portugal Sa Cannabinoid granule composition

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005004848A1 (en) * 2003-07-09 2005-01-20 Chong Kun Dang Pharmaceutical Corp. The solid dispersion of tacrolimus

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2298284A3 (en) 2001-02-14 2013-12-18 GW Pharma Limited Mucoadhesive pharmaceutical formulations
DE10341264A1 (de) * 2003-09-04 2005-03-24 Grünenthal GmbH Schmelzformulierte, multipartikuläre orale Darreichungsform
ES2536922T3 (es) 2006-09-15 2015-05-29 Echo Pharmaceuticals B.V. Unidad de dosificación para administración sublingual, bucal u oral de sustancias farmacéuticamente activas insolubles en agua
WO2008033023A2 (en) * 2006-09-15 2008-03-20 Echo Pharmaceuticals B.V. Granulate containing a pharmaceutically active substance and anemulsifier and method for its manufacture

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005004848A1 (en) * 2003-07-09 2005-01-20 Chong Kun Dang Pharmaceutical Corp. The solid dispersion of tacrolimus

Also Published As

Publication number Publication date
CA2872689A1 (en) 2013-11-14
ES2600465T3 (es) 2017-02-09
US20150132400A1 (en) 2015-05-14
JP2015521175A (ja) 2015-07-27
US9555019B2 (en) 2017-01-31
EP2846768A1 (en) 2015-03-18
EP2846768B1 (en) 2016-08-10
CN104363890A (zh) 2015-02-18
AU2013260246A1 (en) 2014-11-27
CA2872689C (en) 2021-03-30
WO2013169101A1 (en) 2013-11-14
AU2013260246A2 (en) 2014-11-27
CN104363890B (zh) 2018-01-26
IN2014DN09718A (enExample) 2015-07-31
US20160367522A1 (en) 2016-12-22

Similar Documents

Publication Publication Date Title
AU2013260246B2 (en) Granulate containing cannabinoid, method for its manufacture and oral dosage unit comprising such granulate
US12350371B2 (en) Immediate release formulations of cannabinoids
US10245237B2 (en) Compressed tablet containing cannabidiol, method for its manufacture and use of such tablet in oral treatment of psychosis or anxiety disorders
CN113939283A (zh) 大麻素制剂
CA2929325C (en) Compressed tablet containing .delta.9-tetrahydrocannabinol, method for its manufacture and use of such tablet in oral treatment
CN112638369A (zh) 固体自乳化药物组合物
JP2010503664A (ja) 水不溶性医薬活性物質の舌下、頬若しくは経口投与のための医薬投薬単位

Legal Events

Date Code Title Description
DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS AS SHOWN IN THE STATEMENT(S) FILED 07 NOV 2014

FGA Letters patent sealed or granted (standard patent)