CA3067822C - Orally dissolving melatonin formulation with acidifying agent that renders melatonin soluble in saliva - Google Patents

Orally dissolving melatonin formulation with acidifying agent that renders melatonin soluble in saliva Download PDF

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Publication number
CA3067822C
CA3067822C CA3067822A CA3067822A CA3067822C CA 3067822 C CA3067822 C CA 3067822C CA 3067822 A CA3067822 A CA 3067822A CA 3067822 A CA3067822 A CA 3067822A CA 3067822 C CA3067822 C CA 3067822C
Authority
CA
Canada
Prior art keywords
dosage form
saliva
composition
acid
disintegrant
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
CA3067822A
Other languages
English (en)
French (fr)
Other versions
CA3067822A1 (en
Inventor
Syed M. Shah
Daniel HASSAN
Fred Hassan
Patrick Corsino
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.)
Societe des Produits Nestle SA
Original Assignee
Societe des Produits Nestle SA
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 Societe des Produits Nestle SA filed Critical Societe des Produits Nestle SA
Publication of CA3067822A1 publication Critical patent/CA3067822A1/en
Application granted granted Critical
Publication of CA3067822C publication Critical patent/CA3067822C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Anesthesiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA3067822A 2017-06-20 2018-06-15 Orally dissolving melatonin formulation with acidifying agent that renders melatonin soluble in saliva Active CA3067822C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762522473P 2017-06-20 2017-06-20
US62/522,473 2017-06-20
PCT/US2018/037698 WO2018236678A1 (en) 2017-06-20 2018-06-15 Orally dissolving melatonin formulation with acidifying agent that renders melatonin soluble in saliva

Publications (2)

Publication Number Publication Date
CA3067822A1 CA3067822A1 (en) 2018-12-27
CA3067822C true CA3067822C (en) 2022-08-30

Family

ID=64656010

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3067822A Active CA3067822C (en) 2017-06-20 2018-06-15 Orally dissolving melatonin formulation with acidifying agent that renders melatonin soluble in saliva

Country Status (13)

Country Link
US (4) US10500280B2 (https=)
EP (1) EP3641759B1 (https=)
JP (1) JP7297685B2 (https=)
KR (1) KR20200018652A (https=)
CN (1) CN110913853A (https=)
AU (1) AU2018289284A1 (https=)
BR (2) BR122021012549B8 (https=)
CA (1) CA3067822C (https=)
ES (1) ES2979335T3 (https=)
MX (1) MX2019015733A (https=)
RU (1) RU2020101742A (https=)
SG (1) SG11201912172YA (https=)
WO (1) WO2018236678A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG11201912172YA (en) 2017-06-20 2020-01-30 Physicians Seal Llc Orally dissolving melatonin formulation with acidifying agent that renders melatonin soluble in saliva
US10828254B2 (en) 2018-09-28 2020-11-10 Intelgenx Corp. Oral film formulation for modulating absorption profile
CN112426408B (zh) * 2020-12-08 2023-12-19 广州帝奇医药技术有限公司 一种褪黑素组合物及其制备工艺
WO2022170442A1 (en) * 2021-02-12 2022-08-18 Intelgenx Corp. Novel tryptamine oral film formulation
CA3221463A1 (en) * 2021-06-09 2022-12-15 Agb-Pharma Ab Melatonin formulation in solid dosage form
US12440472B2 (en) 2021-06-16 2025-10-14 Intelgenx Corp. Stable tryptamine oral films

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030091629A1 (en) 1998-03-27 2003-05-15 Cima Labs Inc. Sublingual buccal effervescent
US6730330B2 (en) 2001-02-14 2004-05-04 Gw Pharma Limited Pharmaceutical formulations
WO2003074029A1 (en) * 2002-03-07 2003-09-12 Vectura Limited Fast melt multiparticulate formulations for oral delivery
CA2551637A1 (en) 2003-12-24 2005-07-14 Sepracor Inc. Melatonin combination therapy for improving sleep quality
JP5179757B2 (ja) 2004-02-17 2013-04-10 トランセプト ファーマシューティカルズ， インコーポレイティド 口腔粘膜を介して催眠剤をデリバリーするための組成物及びその使用方法
US20090047347A1 (en) 2005-07-29 2009-02-19 Aegis Therapeutics, Inc. Compositions for Drug Administration
CA2582299A1 (en) 2004-10-05 2006-04-13 Altana Pharma Ag Oral pharmaceutical preparation for proton pump antagonists
CN101132769A (zh) * 2005-02-10 2008-02-27 奥瑞克索股份公司 用于药物的跨黏膜给药的药物组合物
JP2009527504A (ja) 2006-02-23 2009-07-30 イオメディックス スリープ インターナショナル エスアールエル 良質な睡眠の誘導および維持のための組成物および方法
IL175338A0 (en) * 2006-05-01 2006-09-05 Biota Ltd Orally administrable films and preparation thereof
US20080171085A1 (en) 2007-01-11 2008-07-17 Natrol, Inc. Novel biphasic delivery system for a pharmaceutical or nutraceutical composition and method of administration
RU2485949C2 (ru) 2007-04-11 2013-06-27 Фармасьютикал Продакшнс Инк Таблетка мелатонина и способы изготовления и применения
US20080260823A1 (en) * 2007-04-20 2008-10-23 Sciele Pharma, Inc. Orally disintegrating tablet comprising glycopyrrolate for treating sialorrhea
CA2685591A1 (en) 2007-05-01 2008-11-06 Sigmoid Pharma Limited Pharmaceutical nimodipine compositions
KR100905027B1 (ko) 2007-10-03 2009-06-30 (주)씨엘팜 식용 필름
EP2265259A1 (en) * 2008-04-25 2010-12-29 Cadila Healthcare Limited Rapidly disintegrating oral compositions of tramadol
US8691275B2 (en) * 2011-01-28 2014-04-08 Zx Pharma, Llc Controlled-release melatonin compositions and related methods
US20120213855A1 (en) 2011-02-17 2012-08-23 Cima Labs Inc. Dosage forms for weakly ionizable compounds
US20120315337A1 (en) * 2011-06-07 2012-12-13 Shah Syed Multiparticulate 5-htp compositions and related methods
US20130052234A1 (en) * 2011-08-25 2013-02-28 Purebrands LLC Edible strips
ES2457718B1 (es) 2012-09-24 2015-04-16 Universidad De Granada Composición farmacéutica bucodispersable de melatonina
US20140303227A1 (en) 2013-03-14 2014-10-09 Pharmaceutical Productions Inc. Transmucosal hormone delivery system
EP3265140B1 (en) * 2015-03-02 2021-05-12 Medlab Clinical U.S., Inc. Transmucosal and transdermal delivery systems
SG11201912172YA (en) * 2017-06-20 2020-01-30 Physicians Seal Llc Orally dissolving melatonin formulation with acidifying agent that renders melatonin soluble in saliva

Also Published As

Publication number Publication date
US10500280B2 (en) 2019-12-10
EP3641759B1 (en) 2024-04-03
JP7297685B2 (ja) 2023-06-26
CN110913853A (zh) 2020-03-24
KR20200018652A (ko) 2020-02-19
ES2979335T3 (es) 2024-09-25
US20200268887A1 (en) 2020-08-27
US11224658B2 (en) 2022-01-18
BR112019027286B1 (pt) 2022-02-22
US11224657B2 (en) 2022-01-18
BR122021012549B8 (pt) 2022-10-25
US20180360967A1 (en) 2018-12-20
WO2018236678A1 (en) 2018-12-27
SG11201912172YA (en) 2020-01-30
RU2020101742A (ru) 2021-07-20
EP3641759A1 (en) 2020-04-29
JP2020524162A (ja) 2020-08-13
CA3067822A1 (en) 2018-12-27
US20200268886A1 (en) 2020-08-27
BR112019027286A2 (pt) 2020-07-21
EP3641759A4 (en) 2021-03-24
BR122021012549B1 (pt) 2022-02-22
US10960075B2 (en) 2021-03-30
AU2018289284A1 (en) 2020-01-16
MX2019015733A (es) 2020-02-20
US20200069803A1 (en) 2020-03-05

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