AU2016398029B2 - 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
AU2016398029B2
AU2016398029B2 AU2016398029A AU2016398029A AU2016398029B2 AU 2016398029 B2 AU2016398029 B2 AU 2016398029B2 AU 2016398029 A AU2016398029 A AU 2016398029A AU 2016398029 A AU2016398029 A AU 2016398029A AU 2016398029 B2 AU2016398029 B2 AU 2016398029B2
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AU
Australia
Prior art keywords
pharmaceutical composition
total weight
taste
sodium phenylbutyrate
less
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AU2016398029A
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English (en)
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AU2016398029A1 (en
Inventor
Leah E. Appel
D. Christopher SCHELLING
Joshoua R. Shockey
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Acer Therapeutics Inc
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Acer Therapeutics Inc
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Publication of AU2016398029A1 publication Critical patent/AU2016398029A1/en
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    • 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
    • A61K9/5005—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
    • 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

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)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Psychology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (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)
AU2016398029A 2016-03-15 2016-10-17 Palatable compositions including sodium phenylbutyrate and uses thereof Active AU2016398029B2 (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 (2)

Publication Number Publication Date
AU2016398029A1 AU2016398029A1 (en) 2018-10-11
AU2016398029B2 true AU2016398029B2 (en) 2023-03-02

Family

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AU2016398029A Active AU2016398029B2 (en) 2016-03-15 2016-10-17 Palatable compositions including sodium phenylbutyrate and uses thereof

Country Status (22)

Country Link
US (6) US20170266115A1 (https=)
EP (2) EP4104822A1 (https=)
JP (4) JP7136763B2 (https=)
KR (3) KR20250150154A (https=)
AU (1) AU2016398029B2 (https=)
BR (1) BR112018068665B1 (https=)
CY (1) CY1125450T1 (https=)
DK (1) DK3429559T3 (https=)
ES (1) ES2922749T3 (https=)
HR (1) HRP20220856T1 (https=)
HU (1) HUE059630T2 (https=)
IL (3) IL296490B2 (https=)
LT (1) LT3429559T (https=)
MX (2) MX391305B (https=)
PL (1) PL3429559T3 (https=)
PT (1) PT3429559T (https=)
RS (1) RS63383B1 (https=)
SA (1) SA518400020B1 (https=)
SG (1) SG11201807979SA (https=)
SI (1) SI3429559T1 (https=)
SM (1) SMT202200386T1 (https=)
WO (1) WO2017160345A1 (https=)

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KR20250150154A (ko) 2016-03-15 2025-10-17 에이서 테라퓨틱스 인크. 소듐 페닐부티레이트를 포함하는 맛우수한 조성물 및 그의 용도
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
JP2023553274A (ja) * 2020-11-18 2023-12-21 エフビー－エイチアールエス リミテッド ライアビリティ カンパニー ドフェチリド及びメキシレチンを含有する組成物並びにその使用
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
IL315049A (en) * 2024-08-15 2026-03-01 Prilenia Neurotherapeutics Ltd Taste-masking compounds containing pridopidine, their use and method for their preparation

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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
FR2959129A1 (fr) * 2010-04-21 2011-10-28 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
US20140227351A1 (en) * 2011-08-12 2014-08-14 Boehringer Ingelheim Vetmedica Gmbh Taste masked pharmaceutical composition

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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
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
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WO2012175714A1 (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
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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
KR20250150154A (ko) 2016-03-15 2025-10-17 에이서 테라퓨틱스 인크. 소듐 페닐부티레이트를 포함하는 맛우수한 조성물 및 그의 용도

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
FR2959129A1 (fr) * 2010-04-21 2011-10-28 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
US20140227351A1 (en) * 2011-08-12 2014-08-14 Boehringer Ingelheim Vetmedica Gmbh Taste masked pharmaceutical composition

Also Published As

Publication number Publication date
EP3429559A4 (en) 2019-11-06
KR102690703B1 (ko) 2024-08-02
MX2022003969A (es) 2022-04-25
SG11201807979SA (en) 2018-10-30
MX2018011229A (es) 2019-05-30
IL296490B1 (en) 2025-09-01
AU2016398029A1 (en) 2018-10-11
HRP20220856T1 (hr) 2022-10-14
KR102865751B1 (ko) 2025-09-29
US20210220304A1 (en) 2021-07-22
JP7136763B2 (ja) 2022-09-13
LT3429559T (lt) 2022-08-10
CY1125450T1 (el) 2025-05-09
EP3429559B1 (en) 2022-04-13
RS63383B1 (sr) 2022-08-31
BR112018068665A2 (pt) 2019-02-05
US20230133629A1 (en) 2023-05-04
PT3429559T (pt) 2022-07-20
ES2922749T3 (es) 2022-09-20
IL296490B2 (en) 2026-01-01
SMT202200386T1 (it) 2022-11-18
JP2026027401A (ja) 2026-02-18
BR112018068665B1 (pt) 2023-12-26
EP4104822A1 (en) 2022-12-21
MX391305B (es) 2025-03-21
US20170266115A1 (en) 2017-09-21
JP2024081748A (ja) 2024-06-18
JP2019509345A (ja) 2019-04-04
US11433041B2 (en) 2022-09-06
IL322955A (en) 2025-10-01
KR20190008840A (ko) 2019-01-25
CA3017573A1 (en) 2017-09-21
US11202767B2 (en) 2021-12-21
EP3429559A1 (en) 2019-01-23
WO2017160345A8 (en) 2018-02-22
IL261777A (en) 2018-10-31
SI3429559T1 (sl) 2022-11-30
US11154521B2 (en) 2021-10-26
KR20240119184A (ko) 2024-08-06
US20200261385A1 (en) 2020-08-20
IL261777B2 (en) 2023-02-01
SA518400020B1 (ar) 2022-12-21
HUE059630T2 (hu) 2022-11-28
JP2022106927A (ja) 2022-07-20
DK3429559T3 (da) 2022-07-11
US20210186908A1 (en) 2021-06-24
IL296490A (en) 2022-11-01
PL3429559T3 (pl) 2022-11-07
KR20250150154A (ko) 2025-10-17
US20260076927A1 (en) 2026-03-19
IL261777B (en) 2022-10-01
WO2017160345A1 (en) 2017-09-21

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