BR122021012549B8 - 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

Info

Publication number
BR122021012549B8
BR122021012549B8 BR122021012549A BR122021012549A BR122021012549B8 BR 122021012549 B8 BR122021012549 B8 BR 122021012549B8 BR 122021012549 A BR122021012549 A BR 122021012549A BR 122021012549 A BR122021012549 A BR 122021012549A BR 122021012549 B8 BR122021012549 B8 BR 122021012549B8
Authority
BR
Brazil
Prior art keywords
saliva
melatonin
soluble
acidifying agent
oral
Prior art date
Application number
BR122021012549A
Other languages
English (en)
Other versions
BR122021012549B1 (pt
Inventor
M Shah Syed
Hassan Daniel
Hassan Fred
Corsino Patrick
Original Assignee
Physicians Seal Llc
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 Physicians Seal Llc, Nestle Sa filed Critical Physicians Seal Llc
Publication of BR122021012549B1 publication Critical patent/BR122021012549B1/pt
Publication of BR122021012549B8 publication Critical patent/BR122021012549B8/pt

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
    • A61K31/395—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
    • A61K47/06—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
    • 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
    • A61K9/2013—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
    • A61K9/2022—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)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (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)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Anesthesiology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

A presente invenção se refere a uma composição que inclui uma forma de dosagem farmacêutica configurada para desintegrar em saliva e manter um pH de 4 ou menos dentro da saliva durante o tempo que a forma de dosagem é dissolvida na mesma. A forma de dosagem inclui uma quantidade terapeuticamente eficaz de melatonina em uma matriz carreadora, um desintegrante e uma quantidade suficiente de ácido para conferir o pH à saliva. A quantidade de desintegrante é suficiente para fazer com que a forma de dosagem se desintegre completamente na saliva dentro de dez minutos a partir do contato com a saliva.
BR122021012549A 2017-06-20 2018-06-15 Composição de dissolução oral de melatonina com agente acidificante que torna melatonina solúvel em saliva BR122021012549B8 (pt)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201762522473P 2017-06-20 2017-06-20
US62/522,473 2017-06-20
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
PCT/US2018/037698 WO2018236678A1 (en) 2017-06-20 2018-06-15 ORAL DISSOLUTION MELATONIN FORMULATION WITH ACIDIFYING AGENT THAT MAKES MELATONIN SOLUBLE IN SALIVA

Publications (2)

Publication Number Publication Date
BR122021012549B1 BR122021012549B1 (pt) 2022-02-22
BR122021012549B8 true BR122021012549B8 (pt) 2022-10-25

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 Before (1)

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

Country Status (12)

Country Link
US (4) US10500280B2 (pt)
EP (1) EP3641759B1 (pt)
JP (1) JP7297685B2 (pt)
KR (1) KR20200018652A (pt)
CN (1) CN110913853A (pt)
AU (1) AU2018289284A1 (pt)
BR (2) BR112019027286B1 (pt)
CA (1) CA3067822C (pt)
MX (1) MX2019015733A (pt)
RU (1) RU2020101742A (pt)
SG (1) SG11201912172YA (pt)
WO (1) WO2018236678A1 (pt)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10500280B2 (en) * 2017-06-20 2019-12-10 Physician's Seal, LLC Orally dissolving melatonin formulation with acidifying agent that renders melatonin soluble in saliva
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
BR112023025866A2 (pt) * 2021-06-09 2024-02-27 Agb Pharma Ab Método para fabricação de uma formulação de melatonina de liberação rápida em forma de dosagem sólida, formulação de melatonina de liberação rápida, e, kit de partes

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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
WO2005063297A2 (en) 2003-12-24 2005-07-14 Sepracor Inc. Melatonin combination therapy for improving sleep quality
KR20130116378A (ko) 2004-02-17 2013-10-23 트랜스셉트 파마슈티칼스, 인코포레이티드 구강 점막을 가로지르는 수면제 전달용 조성물 및 이의 사용 방법
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AU2005291299A1 (en) * 2004-10-05 2006-04-13 Altana Pharma Ag Oral pharmaceutical preparation for proton pump antagonists
KR20070111497A (ko) * 2005-02-10 2007-11-21 오렉쏘 에이비 약의 경점막 투여에 유용한 새로운 약학 조성물
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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
MX2009010878A (es) 2007-04-11 2010-03-26 John A Mccarty Pastilla de melatonina y metodos de preparacion y uso.
US20080260823A1 (en) * 2007-04-20 2008-10-23 Sciele Pharma, Inc. Orally disintegrating tablet comprising glycopyrrolate for treating sialorrhea
JP2010526053A (ja) * 2007-05-01 2010-07-29 シグモイド・ファーマ・リミテッド ニモジピン医薬組成物
KR100905027B1 (ko) 2007-10-03 2009-06-30 (주)씨엘팜 식용 필름
WO2009130715A1 (en) * 2008-04-25 2009-10-29 Cadila Healtcare 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
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US20120315337A1 (en) * 2011-06-07 2012-12-13 Shah Syed Multiparticulate 5-htp compositions and related methods
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
SI3265140T1 (sl) * 2015-03-02 2021-11-30 Medlab Clinical U.S., Inc. Dostavni sistemi za dostavo skozi sluznico ali skozi kožo
US10500280B2 (en) * 2017-06-20 2019-12-10 Physician's 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
US20180360967A1 (en) 2018-12-20
WO2018236678A1 (en) 2018-12-27
JP2020524162A (ja) 2020-08-13
EP3641759A1 (en) 2020-04-29
RU2020101742A (ru) 2021-07-20
US11224658B2 (en) 2022-01-18
EP3641759A4 (en) 2021-03-24
US11224657B2 (en) 2022-01-18
AU2018289284A1 (en) 2020-01-16
BR112019027286B1 (pt) 2022-02-22
US10960075B2 (en) 2021-03-30
BR112019027286A2 (pt) 2020-07-21
CA3067822C (en) 2022-08-30
CA3067822A1 (en) 2018-12-27
US20200069803A1 (en) 2020-03-05
JP7297685B2 (ja) 2023-06-26
US20200268886A1 (en) 2020-08-27
MX2019015733A (es) 2020-02-20
BR122021012549B1 (pt) 2022-02-22
EP3641759B1 (en) 2024-04-03
CN110913853A (zh) 2020-03-24
KR20200018652A (ko) 2020-02-19
SG11201912172YA (en) 2020-01-30
US20200268887A1 (en) 2020-08-27

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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]
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.

B25A Requested transfer of rights approved

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