BR112019027286B1 - Composição de dissolução oral de melatonina com agente acidificante que torna melatonina solúvel em saliva - Google Patents

Composição de dissolução oral de melatonina com agente acidificante que torna melatonina solúvel em saliva Download PDF

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Publication number
BR112019027286B1
BR112019027286B1 BR112019027286-0A BR112019027286A BR112019027286B1 BR 112019027286 B1 BR112019027286 B1 BR 112019027286B1 BR 112019027286 A BR112019027286 A BR 112019027286A BR 112019027286 B1 BR112019027286 B1 BR 112019027286B1
Authority
BR
Brazil
Prior art keywords
dosage form
saliva
melatonin
disintegrant
acid
Prior art date
Application number
BR112019027286-0A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112019027286A2 (pt
Inventor
Syed M. Shah
Daniel Hassan
Fred Hassan
Patrick Corsino
Original Assignee
Société Des Produits Nestlé S.A
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 Société Des Produits Nestlé S.A filed Critical Société Des Produits Nestlé S.A
Priority to BR122021012549A priority Critical patent/BR122021012549B8/pt
Publication of BR112019027286A2 publication Critical patent/BR112019027286A2/pt
Publication of BR112019027286B1 publication Critical patent/BR112019027286B1/pt

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Classifications

    • 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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Anesthesiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
BR112019027286-0A 2017-06-20 2018-06-15 Composição de dissolução oral de melatonina com agente acidificante que torna melatonina solúvel em saliva BR112019027286B1 (pt)

Priority Applications (1)

Application Number Priority Date Filing Date Title
BR122021012549A BR122021012549B8 (pt) 2017-06-20 2018-06-15 Composição de dissolução oral de melatonina com agente acidificante que torna melatonina solúvel em saliva

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
BR112019027286A2 BR112019027286A2 (pt) 2020-07-21
BR112019027286B1 true BR112019027286B1 (pt) 2022-02-22

Family

ID=64656010

Family Applications (2)

Application Number Title Priority Date Filing Date
BR112019027286-0A BR112019027286B1 (pt) 2017-06-20 2018-06-15 Composição de dissolução oral de melatonina com agente acidificante que torna melatonina solúvel em saliva
BR122021012549A BR122021012549B8 (pt) 2017-06-20 2018-06-15 Composição de dissolução oral de melatonina com agente acidificante que torna melatonina solúvel em saliva

Family Applications After (1)

Application Number Title Priority Date Filing Date
BR122021012549A BR122021012549B8 (pt) 2017-06-20 2018-06-15 Composição de dissolução oral de melatonina com agente acidificante que torna melatonina solúvel em 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) BR112019027286B1 (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
BR112019027286B1 (pt) * 2017-06-20 2022-02-22 Société Des Produits Nestlé S.A Composição de dissolução oral de melatonina com agente acidificante que torna melatonina solúvel em 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
US20240189331A1 (en) * 2021-02-12 2024-06-13 Intelgenx Corp. Novel tryptamine oral film formulation
AU2022288129A1 (en) * 2021-06-09 2024-01-18 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
EP1696959A2 (en) 2003-12-24 2006-09-06 Sepracor, Inc. Melatonin combination therapy for improving sleep quality
EP1715853A4 (en) 2004-02-17 2012-07-18 Transcept Pharmaceuticals Inc COMPOSITIONS FOR THE DISTRIBUTION OF HYPNOTICS IN THE FIELD OF MUNICHCHLEIMHÄUTE AND USE METHOD THEREOF
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
US20080317863A1 (en) * 2005-02-10 2008-12-25 Christer Nystrom Pharmaceutical Compositions Useful in the Transmucosal Administration of Drugs
EP1991241A4 (en) 2006-02-23 2009-07-08 Iomedix Sleep Internat Srl COMPOSITIONS AND METHODS FOR INTRODUCING AND MAINTAINING HIGH-QUALITY SLEEPING
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
ES2575549T3 (es) 2007-04-11 2016-06-29 John A. Mccarty Comprimido de melatonina y métodos de preparación y uso
US20080260823A1 (en) * 2007-04-20 2008-10-23 Sciele Pharma, Inc. Orally disintegrating tablet comprising glycopyrrolate for treating sialorrhea
WO2008132712A2 (en) 2007-05-01 2008-11-06 Sigmoid Pharma Limited Combination pharmaceutical 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
WO2012103411A2 (en) * 2011-01-28 2012-08-02 Zx Pharma, Llc Controlled-release melatonin composition and related methods
US20120213855A1 (en) 2011-02-17 2012-08-23 Cima Labs Inc. Dosage forms for weakly ionizable compounds
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WO2013028333A1 (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
SMT202100418T1 (it) * 2015-03-02 2021-11-12 Medlab Clinical U S Inc Sistemi di erogazione transmucosali e transdermici
BR112019027286B1 (pt) * 2017-06-20 2022-02-22 Société Des Produits Nestlé S.A Composição de dissolução oral de melatonina com agente acidificante que torna melatonina solúvel em saliva

Also Published As

Publication number Publication date
CA3067822C (en) 2022-08-30
BR122021012549B1 (pt) 2022-02-22
CN110913853A (zh) 2020-03-24
JP2020524162A (ja) 2020-08-13
US20200268886A1 (en) 2020-08-27
SG11201912172YA (en) 2020-01-30
EP3641759A4 (en) 2021-03-24
US20180360967A1 (en) 2018-12-20
CA3067822A1 (en) 2018-12-27
BR122021012549B8 (pt) 2022-10-25
US11224658B2 (en) 2022-01-18
US20200069803A1 (en) 2020-03-05
JP7297685B2 (ja) 2023-06-26
AU2018289284A1 (en) 2020-01-16
BR112019027286A2 (pt) 2020-07-21
WO2018236678A1 (en) 2018-12-27
ES2979335T3 (es) 2024-09-25
EP3641759B1 (en) 2024-04-03
US10500280B2 (en) 2019-12-10
US20200268887A1 (en) 2020-08-27
RU2020101742A (ru) 2021-07-20
US11224657B2 (en) 2022-01-18
MX2019015733A (es) 2020-02-20
EP3641759A1 (en) 2020-04-29
US10960075B2 (en) 2021-03-30
KR20200018652A (ko) 2020-02-19

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Legal Events

Date Code Title Description
B350 Update of information on the portal [chapter 15.35 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B25A Requested transfer of rights approved

Owner name: SOCIETE DES PRODUITS NESTLE S.A. (CH)

B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 15/06/2018, OBSERVADAS AS CONDICOES LEGAIS.