BR112018068665A2 - composições palatáveis incluindo o fenilbutirato de sódio e usos das mesmas - Google Patents

composições palatáveis incluindo o fenilbutirato de sódio e usos das mesmas

Info

Publication number
BR112018068665A2
BR112018068665A2 BR112018068665A BR112018068665A BR112018068665A2 BR 112018068665 A2 BR112018068665 A2 BR 112018068665A2 BR 112018068665 A BR112018068665 A BR 112018068665A BR 112018068665 A BR112018068665 A BR 112018068665A BR 112018068665 A2 BR112018068665 A2 BR 112018068665A2
Authority
BR
Brazil
Prior art keywords
including sodium
compositions including
sodium phenylbutyrate
palatable compositions
disease
Prior art date
Application number
BR112018068665A
Other languages
English (en)
Other versions
BR112018068665B1 (pt
Inventor
Christopher Schelling D
R Shockey Joshua
E Appel Leah
Original Assignee
Acer Therapeutics Inc
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 Acer Therapeutics Inc filed Critical Acer Therapeutics Inc
Publication of BR112018068665A2 publication Critical patent/BR112018068665A2/pt
Publication of BR112018068665B1 publication Critical patent/BR112018068665B1/pt

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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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/14—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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/501—Inorganic 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular 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
    • 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
    • A61P25/16—Anti-Parkinson drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Psychology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)

Abstract

a presente invenção apresenta composições farmacêuticas saborosas incluindo o fenilbutirato de sódio e métodos para o tratamento de erros congênitos do metabolismo (e.g., doença da urina do xarope de bordo ou distúrbios do ciclo da ureia), distúrbios neurodegenerativos, tais como a doença de parkinson, atrofia muscular espinhal, distonia ou miosite por corpos de inclusão com tais composições.
BR112018068665-4A 2016-03-15 2016-10-17 Composição farmacêutica de fenilbutirato de sódio, método de produção da mesma e seus usos BR112018068665B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662308614P 2016-03-15 2016-03-15
US62/308,614 2016-03-15
PCT/US2016/057415 WO2017160345A1 (en) 2016-03-15 2016-10-17 Palatable compositions including sodium phenylbutyrate and uses thereof

Publications (2)

Publication Number Publication Date
BR112018068665A2 true BR112018068665A2 (pt) 2019-02-05
BR112018068665B1 BR112018068665B1 (pt) 2023-12-26

Family

ID=59847918

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018068665-4A BR112018068665B1 (pt) 2016-03-15 2016-10-17 Composição farmacêutica de fenilbutirato de sódio, método de produção da mesma e seus usos

Country Status (21)

Country Link
US (5) US20170266115A1 (pt)
EP (2) EP3429559B1 (pt)
JP (2) JP7136763B2 (pt)
KR (1) KR20190008840A (pt)
AU (1) AU2016398029B2 (pt)
BR (1) BR112018068665B1 (pt)
CA (1) CA3017573A1 (pt)
DK (1) DK3429559T3 (pt)
ES (1) ES2922749T3 (pt)
HR (1) HRP20220856T1 (pt)
HU (1) HUE059630T2 (pt)
IL (2) IL296490A (pt)
LT (1) LT3429559T (pt)
MX (2) MX2018011229A (pt)
PL (1) PL3429559T3 (pt)
PT (1) PT3429559T (pt)
RS (1) RS63383B1 (pt)
SA (1) SA518400020B1 (pt)
SG (1) SG11201807979SA (pt)
SI (1) SI3429559T1 (pt)
WO (1) WO2017160345A1 (pt)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3429559B1 (en) 2016-03-15 2022-04-13 Acer Therapeutics Inc. Palatable compositions including sodium phenylbutyrate and uses thereof
CA3184989A1 (en) * 2020-07-07 2022-01-13 Christopher D. Schelling Methods of administering taste masked phenylbutyrate and compositions therefor
CN113332267A (zh) * 2021-03-31 2021-09-03 中山大学孙逸仙纪念医院 苯丁酸钠在制备预防或治疗帕金森病的药物中的应用
IT202100019613A1 (it) 2021-07-23 2023-01-23 Kolfarma S R L Formulazione farmaceutica o di integratore alimentare contenente alfa-lattoalbumina e acido butirrico o un suo sale
CN216570857U (zh) * 2021-08-11 2022-05-24 Acer治疗公司 改善药物物质适口性的剂型和多个剂型

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US5910304A (en) 1982-12-13 1999-06-08 Texas A&M University System Low-dose oral administration of interferons
CA1320905C (en) 1986-11-06 1993-08-03 Joseph M. Cummins Treatment of immuno-resistant disease
US6036949A (en) 1998-03-05 2000-03-14 Amarillo Biosciences, Inc. Treatment of fibromyalgia with low doses of interferon
AR034813A1 (es) 2001-07-20 2004-03-17 Novartis Ag Composiciones farmaceuticas y uso de las mismas
EP1291015A1 (en) 2001-09-10 2003-03-12 Lunamed AG Dosage forms having prolonged active ingredient release
US20040152784A1 (en) * 2002-07-23 2004-08-05 Special Products Limited Pharmaceutical composition and method for treatment of a urea cycle deficiency or sickle-cell anaemia
FR2850275B1 (fr) 2003-01-24 2005-04-08 Scherer Technologies Inc R P Capsules molles a macher contenant une substance active a gout masque
JP2005060310A (ja) 2003-08-13 2005-03-10 Towa Yakuhin Kk 不快な味をマスキングする経口投与用製剤
US6984403B2 (en) 2003-12-04 2006-01-10 Pfizer Inc. Azithromycin dosage forms with reduced side effects
CA2561855A1 (en) * 2004-04-12 2005-10-20 Pfizer Products Inc. Taste-masked drugs in rupturing multiparticulates
AU2008258596B2 (en) * 2007-06-04 2013-02-14 Egalet Ltd Controlled release pharmaceutical compositions for prolonged effect
ES2332687B1 (es) 2008-03-13 2011-01-10 Proyecto De Biomedicina Cima, S.L. Nuevos usos de 4pba y sus sales farmaceuticamente aceptables.
JP4706785B2 (ja) * 2008-09-30 2011-06-22 アステラス製薬株式会社 経口投与用粒子状医薬組成物
WO2011011781A1 (en) * 2009-07-24 2011-01-27 Baylor College Of Medicine Methods of modulation of branched chain acids and uses thereof
FR2959129B1 (fr) * 2010-04-21 2013-02-01 Lucane Pharma Particules comprenant du 4-phenylbutyrate de sodium, procede de preparation et utilisations
EP2389932A1 (en) * 2010-05-28 2011-11-30 Lunamed AG Compositions for use in genetic disorders comprising 4-phenyl-butyric acid and its salts
BR112013014044A2 (pt) 2010-12-06 2017-10-31 Degama Barrier Ltd composição, produto alimentício e processo para prepará-lo
JP2012240917A (ja) 2011-05-16 2012-12-10 Zensei Yakuhin Kogyo Kk 製剤化用微粒子とそれを含む製剤
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CA2840131A1 (en) * 2011-06-22 2012-12-27 Gmp-Orphan Phenylbutyrate in rectal form for the treatment of a motor neuron disease or a metabolic disease
RU2014109079A (ru) 2011-08-12 2015-09-20 Бёрингер Ингельхайм Ветмедика Гмбх Фармацевтическая композиция с маскированным вкусом
EP2599477A1 (en) * 2011-11-30 2013-06-05 Lunamed AG 4-Phenylbutyric acid sustained release formulation
US8993041B2 (en) 2012-10-15 2015-03-31 New Jersey Institute Of Technology Taste masked active pharmaceutical powder compositions and processes for making them
CN105560203A (zh) 2013-01-28 2016-05-11 万平 定位速释生物粘附剂及其制备方法和应用
JP6147711B2 (ja) 2014-05-26 2017-06-14 富士フイルム株式会社 医薬用組成物及びその製造方法、並びに口腔内崩壊錠及びその製造方法
EP3429559B1 (en) 2016-03-15 2022-04-13 Acer Therapeutics Inc. Palatable compositions including sodium phenylbutyrate and uses thereof

Also Published As

Publication number Publication date
WO2017160345A1 (en) 2017-09-21
US20210186908A1 (en) 2021-06-24
US20170266115A1 (en) 2017-09-21
AU2016398029B2 (en) 2023-03-02
CA3017573A1 (en) 2017-09-21
IL261777B (en) 2022-10-01
US11433041B2 (en) 2022-09-06
ES2922749T3 (es) 2022-09-20
RS63383B1 (sr) 2022-08-31
US11154521B2 (en) 2021-10-26
MX2018011229A (es) 2019-05-30
PT3429559T (pt) 2022-07-20
US20210220304A1 (en) 2021-07-22
IL261777B2 (en) 2023-02-01
JP2022106927A (ja) 2022-07-20
WO2017160345A8 (en) 2018-02-22
EP4104822A1 (en) 2022-12-21
EP3429559B1 (en) 2022-04-13
JP7136763B2 (ja) 2022-09-13
JP2019509345A (ja) 2019-04-04
SG11201807979SA (en) 2018-10-30
SA518400020B1 (ar) 2022-12-21
DK3429559T3 (da) 2022-07-11
LT3429559T (lt) 2022-08-10
IL296490A (en) 2022-11-01
KR20190008840A (ko) 2019-01-25
HRP20220856T1 (hr) 2022-10-14
US20230133629A1 (en) 2023-05-04
PL3429559T3 (pl) 2022-11-07
AU2016398029A1 (en) 2018-10-11
EP3429559A4 (en) 2019-11-06
EP3429559A1 (en) 2019-01-23
US20200261385A1 (en) 2020-08-20
HUE059630T2 (hu) 2022-11-28
US11202767B2 (en) 2021-12-21
MX2022003969A (es) 2022-04-25
SI3429559T1 (sl) 2022-11-30
BR112018068665B1 (pt) 2023-12-26
IL261777A (en) 2018-10-31

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