CA3017573A1 - Palatable compositions including sodium phenylbutyrate and uses thereof - Google Patents

Palatable compositions including sodium phenylbutyrate and uses thereof Download PDF

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Publication number
CA3017573A1
CA3017573A1 CA3017573A CA3017573A CA3017573A1 CA 3017573 A1 CA3017573 A1 CA 3017573A1 CA 3017573 A CA3017573 A CA 3017573A CA 3017573 A CA3017573 A CA 3017573A CA 3017573 A1 CA3017573 A1 CA 3017573A1
Authority
CA
Canada
Prior art keywords
total weight
pharmaceutical composition
composition
taste
sodium phenylbutyrate
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.)
Pending
Application number
CA3017573A
Other languages
English (en)
French (fr)
Inventor
Leah E. Appel
Joshua R. Shockey
D. Christopher SCHELLING
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.)
Zevra Therapeutics Inc
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 CA3017573A1 publication Critical patent/CA3017573A1/en
Pending legal-status Critical Current

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
    • A61K31/185—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
    • A61K47/30—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
    • 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • A61P13/00—Drugs for disorders of the urinary system
    • 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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Psychology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Urology & Nephrology (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)
CA3017573A 2016-03-15 2016-10-17 Palatable compositions including sodium phenylbutyrate and uses thereof Pending CA3017573A1 (en)

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 (1)

Publication Number Publication Date
CA3017573A1 true CA3017573A1 (en) 2017-09-21

Family

ID=59847918

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3017573A Pending CA3017573A1 (en) 2016-03-15 2016-10-17 Palatable compositions including sodium phenylbutyrate and uses thereof

Country Status (23)

Country Link
US (5) US20170266115A1 (enExample)
EP (2) EP3429559B1 (enExample)
JP (3) JP7136763B2 (enExample)
KR (3) KR20250150154A (enExample)
AU (1) AU2016398029B2 (enExample)
BR (1) BR112018068665B1 (enExample)
CA (1) CA3017573A1 (enExample)
CY (1) CY1125450T1 (enExample)
DK (1) DK3429559T3 (enExample)
ES (1) ES2922749T3 (enExample)
HR (1) HRP20220856T1 (enExample)
HU (1) HUE059630T2 (enExample)
IL (3) IL296490B1 (enExample)
LT (1) LT3429559T (enExample)
MX (2) MX391305B (enExample)
PL (1) PL3429559T3 (enExample)
PT (1) PT3429559T (enExample)
RS (1) RS63383B1 (enExample)
SA (1) SA518400020B1 (enExample)
SG (1) SG11201807979SA (enExample)
SI (1) SI3429559T1 (enExample)
SM (1) SMT202200386T1 (enExample)
WO (1) WO2017160345A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL296490B1 (en) 2016-03-15 2025-09-01 Acer Therapeutics Inc Tasty compositions containing sodium phenylbutyrate and their uses
US11583542B2 (en) * 2019-12-16 2023-02-21 Amylyx Pharmaceuticals, Inc. Compositions of bile acids and phenylbutyrate compounds
CA3184989A1 (en) * 2020-07-07 2022-01-13 Christopher D. Schelling Methods of administering taste masked phenylbutyrate and compositions therefor
CN116669715A (zh) * 2020-11-18 2023-08-29 Fb-Hrs有限责任公司 含有多非利特和美西律的组合物及其应用
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
ATE378042T1 (de) * 2004-04-12 2007-11-15 Pfizer Prod Inc Arzneiimittel mit verdecktem geschmack in aufbrechenden multipartikeln
EP2155167A2 (en) * 2007-06-04 2010-02-24 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
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US20100136110A1 (en) * 2008-09-30 2010-06-03 Astellas Pharma Inc. Granular pharmaceutical composition for oral administration
ES2546526T3 (es) * 2009-07-24 2015-09-24 Baylor College Of Medicine Métodos de modulación de ácidos de cadena ramificada y usos de los mismos
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
PT2648528T (pt) 2010-12-06 2016-10-25 Degama Berrier Ltd Composição e método para aperfeiçoar a estabilidade e prolongar a vida útil de bactérias probióticas e produtos alimentares das mesmas
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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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AU2012273976A1 (en) * 2011-06-22 2014-01-16 Gmp-Orphan Phenylbutyrate in rectal form for the treatment of a motor neuron disease or a metabolic disease
MX2014001557A (es) * 2011-08-12 2014-03-31 Boehringer Ingelheim Vetmed Inhibidores de corrientes funny (if) para utilizar en un metodo de tratamiento y prevencion de la insuficiencia cardiaca en felinos.
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
CN103070844A (zh) 2013-01-28 2013-05-01 万平 一种定位速释生物粘附剂及其应用
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
IL296490B1 (en) 2016-03-15 2025-09-01 Acer Therapeutics Inc Tasty compositions containing sodium phenylbutyrate and their uses

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Also Published As

Publication number Publication date
ES2922749T3 (es) 2022-09-20
WO2017160345A1 (en) 2017-09-21
JP7136763B2 (ja) 2022-09-13
KR20240119184A (ko) 2024-08-06
RS63383B1 (sr) 2022-08-31
EP3429559B1 (en) 2022-04-13
US11433041B2 (en) 2022-09-06
EP3429559A4 (en) 2019-11-06
BR112018068665A2 (pt) 2019-02-05
US20210186908A1 (en) 2021-06-24
HUE059630T2 (hu) 2022-11-28
WO2017160345A8 (en) 2018-02-22
SMT202200386T1 (it) 2022-11-18
KR20250150154A (ko) 2025-10-17
AU2016398029A1 (en) 2018-10-11
MX391305B (es) 2025-03-21
KR102690703B1 (ko) 2024-08-02
KR102865751B1 (ko) 2025-09-29
BR112018068665B1 (pt) 2023-12-26
IL322955A (en) 2025-10-01
US11154521B2 (en) 2021-10-26
IL296490B1 (en) 2025-09-01
HRP20220856T1 (hr) 2022-10-14
US20200261385A1 (en) 2020-08-20
SA518400020B1 (ar) 2022-12-21
DK3429559T3 (da) 2022-07-11
AU2016398029B2 (en) 2023-03-02
MX2022003969A (es) 2022-04-25
US20230133629A1 (en) 2023-05-04
JP2022106927A (ja) 2022-07-20
US11202767B2 (en) 2021-12-21
LT3429559T (lt) 2022-08-10
SI3429559T1 (sl) 2022-11-30
JP2024081748A (ja) 2024-06-18
SG11201807979SA (en) 2018-10-30
KR20190008840A (ko) 2019-01-25
JP2019509345A (ja) 2019-04-04
EP4104822A1 (en) 2022-12-21
PL3429559T3 (pl) 2022-11-07
IL261777A (en) 2018-10-31
EP3429559A1 (en) 2019-01-23
PT3429559T (pt) 2022-07-20
IL296490A (en) 2022-11-01
IL261777B (en) 2022-10-01
CY1125450T1 (el) 2025-05-09
IL261777B2 (en) 2023-02-01
US20170266115A1 (en) 2017-09-21
US20210220304A1 (en) 2021-07-22
MX2018011229A (es) 2019-05-30

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