AU2016398029B2 - Palatable compositions including sodium phenylbutyrate and uses thereof - Google Patents
Palatable compositions including sodium phenylbutyrate and uses thereof Download PDFInfo
- 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
- Authority
- AU
- Australia
- Prior art keywords
- pharmaceutical composition
- total weight
- taste
- sodium phenylbutyrate
- less
- 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.)
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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
- 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
- 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
- A61K9/5084—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)
- 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)
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
ID=59847918
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2016398029A Active AU2016398029B2 (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) | KR102690703B1 (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) |
Families Citing this family (7)
| 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 |
| WO2022011061A1 (en) * | 2020-07-07 | 2022-01-13 | Acer Therapeutics Inc. | 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 |
Citations (4)
| 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 |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| 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 |
| CA2687192C (en) * | 2007-06-04 | 2015-11-24 | Egalet A/S | 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 |
| PT2456304E (pt) | 2009-07-24 | 2015-10-12 | Baylor College Medicine | Métodos de modulação de ácidos de cadeia ramificada e utilização dos mesmos |
| WO2012077038A1 (en) | 2010-12-06 | 2012-06-14 | Degama Berrier Ltd. | Composition and method for improving stability and extending shelf life of probiotic bacteria and food products thereof |
| US8897280B2 (en) * | 2011-03-29 | 2014-11-25 | Qualcomm Incorporated | System and method for clear channel assessment that supports simultaneous transmission by multiple wireless protocols |
| WO2012156997A2 (en) * | 2011-05-16 | 2012-11-22 | Sun Pharma Advanced Research Company Ltd | Multi-particulate pharmaceutical composition |
| 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 |
| AU2012265842A1 (en) | 2011-06-07 | 2014-01-23 | SPAI Group Ltd. | Compositions and methods for improving stability and extending shelf life of sensitive food additives and food products thereof |
| RU2014100048A (ru) * | 2011-06-22 | 2015-07-27 | Гмп-Орфан | Соль 4-фенилбитурата, предназначенная для лечения болезни моторных нейронов или метаболического заболевания при ректальном введении |
| 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 |
| IL296490B1 (en) | 2016-03-15 | 2025-09-01 | Acer Therapeutics Inc | Tasty compositions containing sodium phenylbutyrate and their uses |
-
2016
- 2016-10-17 IL IL296490A patent/IL296490B1/en unknown
- 2016-10-17 HR HRP20220856TT patent/HRP20220856T1/hr unknown
- 2016-10-17 PL PL16894786.9T patent/PL3429559T3/pl unknown
- 2016-10-17 HU HUE16894786A patent/HUE059630T2/hu unknown
- 2016-10-17 LT LTEPPCT/US2016/057415T patent/LT3429559T/lt unknown
- 2016-10-17 SI SI201631567T patent/SI3429559T1/sl unknown
- 2016-10-17 EP EP16894786.9A patent/EP3429559B1/en active Active
- 2016-10-17 SG SG11201807979SA patent/SG11201807979SA/en unknown
- 2016-10-17 JP JP2019500212A patent/JP7136763B2/ja active Active
- 2016-10-17 DK DK16894786.9T patent/DK3429559T3/da active
- 2016-10-17 EP EP22167705.7A patent/EP4104822A1/en active Pending
- 2016-10-17 CA CA3017573A patent/CA3017573A1/en active Pending
- 2016-10-17 BR BR112018068665-4A patent/BR112018068665B1/pt active IP Right Grant
- 2016-10-17 ES ES16894786T patent/ES2922749T3/es active Active
- 2016-10-17 RS RS20220651A patent/RS63383B1/sr unknown
- 2016-10-17 KR KR1020187029452A patent/KR102690703B1/ko active Active
- 2016-10-17 PT PT168947869T patent/PT3429559T/pt unknown
- 2016-10-17 IL IL322955A patent/IL322955A/en unknown
- 2016-10-17 KR KR1020247025507A patent/KR102865751B1/ko active Active
- 2016-10-17 SM SM20220386T patent/SMT202200386T1/it unknown
- 2016-10-17 MX MX2018011229A patent/MX391305B/es unknown
- 2016-10-17 KR KR1020257031993A patent/KR20250150154A/ko active Pending
- 2016-10-17 AU AU2016398029A patent/AU2016398029B2/en active Active
- 2016-10-17 WO PCT/US2016/057415 patent/WO2017160345A1/en not_active Ceased
- 2016-10-17 US US15/295,881 patent/US20170266115A1/en not_active Abandoned
-
2018
- 2018-09-13 SA SA518400020A patent/SA518400020B1/ar unknown
- 2018-09-13 IL IL261777A patent/IL261777B2/en unknown
- 2018-09-14 MX MX2022003969A patent/MX2022003969A/es unknown
-
2020
- 2020-01-17 US US16/746,186 patent/US11433041B2/en active Active
-
2021
- 2021-03-09 US US17/196,416 patent/US11154521B2/en active Active
- 2021-03-09 US US17/196,599 patent/US11202767B2/en active Active
-
2022
- 2022-05-09 JP JP2022076939A patent/JP2022106927A/ja not_active Withdrawn
- 2022-07-12 CY CY20221100475T patent/CY1125450T1/el unknown
- 2022-09-02 US US17/902,358 patent/US20230133629A1/en not_active Abandoned
-
2024
- 2024-03-29 JP JP2024055290A patent/JP2024081748A/ja active Pending
Patent Citations (4)
| 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 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FGA | Letters patent sealed or granted (standard patent) |