KR20200018652A - 타액에 멜라토닌을 가용화하는 산성화제를 포함하는 구강 용해 멜라토닌 제제 - Google Patents

타액에 멜라토닌을 가용화하는 산성화제를 포함하는 구강 용해 멜라토닌 제제 Download PDF

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Publication number
KR20200018652A
KR20200018652A KR1020207001344A KR20207001344A KR20200018652A KR 20200018652 A KR20200018652 A KR 20200018652A KR 1020207001344 A KR1020207001344 A KR 1020207001344A KR 20207001344 A KR20207001344 A KR 20207001344A KR 20200018652 A KR20200018652 A KR 20200018652A
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KR
South Korea
Prior art keywords
formulation
saliva
composition
acid
disintegrant
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KR1020207001344A
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English (en)
Korean (ko)
Inventor
사이드 엠 샤
다니엘 하싼
프레드 하싼
패트릭 코르시노
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피지션즈 씰, 엘엘씨
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Publication of KR20200018652A publication Critical patent/KR20200018652A/ko
Withdrawn legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic 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
    • A61K31/403Heterocyclic 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
    • A61K31/404Indoles, e.g. pindolol
    • A61K31/4045Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY 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
    • A61K9/0056Mouth 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY 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
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007Drug-containing films, membranes or sheets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; 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)
KR1020207001344A 2017-06-20 2018-06-15 타액에 멜라토닌을 가용화하는 산성화제를 포함하는 구강 용해 멜라토닌 제제 Withdrawn KR20200018652A (ko)

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 (1)

Publication Number Publication Date
KR20200018652A true KR20200018652A (ko) 2020-02-19

Family

ID=64656010

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020207001344A Withdrawn KR20200018652A (ko) 2017-06-20 2018-06-15 타액에 멜라토닌을 가용화하는 산성화제를 포함하는 구강 용해 멜라토닌 제제

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

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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
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
CA3067822C (en) 2022-08-30
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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Date Code Title Description
PA0105 International application

Patent event date: 20200115

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
PC1203 Withdrawal of no request for examination