HRP20220856T1 - Pripravci ugodna okusa uključujući natrijev fenilbutirat i njihove uporabe - Google Patents

Pripravci ugodna okusa uključujući natrijev fenilbutirat i njihove uporabe Download PDF

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Publication number
HRP20220856T1
HRP20220856T1 HRP20220856TT HRP20220856T HRP20220856T1 HR P20220856 T1 HRP20220856 T1 HR P20220856T1 HR P20220856T T HRP20220856T T HR P20220856TT HR P20220856 T HRP20220856 T HR P20220856T HR P20220856 T1 HRP20220856 T1 HR P20220856T1
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HR
Croatia
Prior art keywords
pharmaceutical preparation
preparation according
total weight
taste
plasticizer
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HRP20220856TT
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English (en)
Inventor
Leah E. Appel
Joshua R. Shockey
D. Christopher SCHELLING
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Acer Therapeutics Inc.
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Application filed by Acer Therapeutics Inc. filed Critical Acer Therapeutics Inc.
Publication of HRP20220856T1 publication Critical patent/HRP20220856T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/501Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism

Claims (14)

1. Farmaceutski pripravak za oralnu primjenu natrijevog fenilbutirata, naznačen time, da sadrži: 50-65% spomenutog natrijevog fenilbutirata, prema ukupnoj masi; i 5-30% obloge za maskiranje okusa, koja sadrži polimer formiran od dimetilaminoetil metakrilata, butil metakrilata, i metil metakrilata, prema ukupnoj masi; pri čemu polimer jest Eudragit E PO; dok navedeni Eudragit E PO sadrži 50-75% po masi obloge za maskiranje okusa; gdje se farmaceutski pripravak formulira kao mnoštvo sprejom nanesenih kuglica, koje sadrže jezgru zametka, sloj lijeka koji sadrži navedeni natrijev fenilbutirat, i navedenu oblogu za maskiranje okusa.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da spomenuti sloj lijeka nadalje sadrži vezivno sredstvo od 3-10% prema ukupnoj masi, dok poželjno pritom vezivno sredstvo jest HPMC E 5.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 ili 2, naznačen time, da spomenuti sloj lijeka nadalje sadrži plastifikator od 0,1-1% prema ukupnoj masi, dok poželjno pritom navedeni plastifikator jest polietilen glikol, još poželjnije navedeni polietilen glikol jest PEG6000.
4. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da spomenuta obloga za maskiranje okusa nadalje sadrži plastifikator od 1-9% prema ukupnoj masi, dok poželjno pritom navedeni plastifikator jest polietilen glikol, još poželjnije navedeni polietilen glikol jest PEG6000.
5. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da spomenuta obloga za maskiranje okusa nadalje sadrži hidrirani magnezijev silikat od 4-15% prema ukupnoj masi, dok poželjno pritom spomenuti hidrirani magnezijev silikat jest talk.
6. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da spomenuti pripravak sadrži 1-35% prema ukupnoj masi, navedene jezgre zametka, dok poželjno pritom spomenuta jezgra zametka sadrži mikrokristalnu celulozu.
7. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da je za uporabu u postupku liječenja: prirođene pogreške u metabolizmu; prirođene pogreške u metabolizmu koja je bolest urina mirisa javorovog sirupa; ili prirođene pogreške u metabolizmu koja je poremećaj ciklusa uree.
8. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da je za uporabu u postupku liječenja: neurodegenerativnog poremećaja; ili neurodegenerativnog poremećaja koji je Parkinsonova bolest.
9. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da je za uporabu u postupku liječenja spinalne muskularne atrofije.
10. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da je za uporabu u postupku liječenja inkluzijskog miozitisa tijela.
11. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da je za uporabu u postupku liječenja distonije.
12. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 7 do 11, naznačen time, da se navedeni pripravak primjenjuje u kombinaciji s nosačem za doziranje i s tekućinom, tako da konačni viskozitet bude u rasponu od otprilike 50-1750 mPa.s (cP).
13. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 12, naznačen time, da navedena tekućina je voda.
14. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 12 ili 13, naznačen time, da nosač za doziranje je modificirani kukuruzni škrob ili kombinacija modificiranog kukuruznog škroba i maltodekstrina.
HRP20220856TT 2016-03-15 2016-10-17 Pripravci ugodna okusa uključujući natrijev fenilbutirat i njihove uporabe HRP20220856T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662308614P 2016-03-15 2016-03-15
PCT/US2016/057415 WO2017160345A1 (en) 2016-03-15 2016-10-17 Palatable compositions including sodium phenylbutyrate and uses thereof
EP16894786.9A EP3429559B1 (en) 2016-03-15 2016-10-17 Palatable compositions including sodium phenylbutyrate and uses thereof

Publications (1)

Publication Number Publication Date
HRP20220856T1 true HRP20220856T1 (hr) 2022-10-14

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HRP20220856TT HRP20220856T1 (hr) 2016-03-15 2016-10-17 Pripravci ugodna okusa uključujući natrijev fenilbutirat i njihove uporabe

Country Status (21)

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

Families Citing this family (5)

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Publication number Priority date Publication date Assignee Title
KR20190008840A (ko) 2016-03-15 2019-01-25 에이서 테라퓨틱스 인크. 소듐 페닐부티레이트를 포함하는 맛우수한 조성물 및 그의 용도
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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
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Publication number Publication date
US20170266115A1 (en) 2017-09-21
EP3429559A1 (en) 2019-01-23
JP7136763B2 (ja) 2022-09-13
MX2018011229A (es) 2019-05-30
US11202767B2 (en) 2021-12-21
AU2016398029B2 (en) 2023-03-02
IL261777B (en) 2022-10-01
RS63383B1 (sr) 2022-08-31
IL261777A (en) 2018-10-31
US20230133629A1 (en) 2023-05-04
US20210220304A1 (en) 2021-07-22
US11154521B2 (en) 2021-10-26
EP4104822A1 (en) 2022-12-21
MX2022003969A (es) 2022-04-25
ES2922749T3 (es) 2022-09-20
BR112018068665A2 (pt) 2019-02-05
US11433041B2 (en) 2022-09-06
EP3429559B1 (en) 2022-04-13
US20210186908A1 (en) 2021-06-24
PL3429559T3 (pl) 2022-11-07
PT3429559T (pt) 2022-07-20
EP3429559A4 (en) 2019-11-06
LT3429559T (lt) 2022-08-10
IL261777B2 (en) 2023-02-01
SA518400020B1 (ar) 2022-12-21
CA3017573A1 (en) 2017-09-21
BR112018068665B1 (pt) 2023-12-26
JP2022106927A (ja) 2022-07-20
WO2017160345A1 (en) 2017-09-21
JP2019509345A (ja) 2019-04-04
SG11201807979SA (en) 2018-10-30
SI3429559T1 (sl) 2022-11-30
DK3429559T3 (da) 2022-07-11
US20200261385A1 (en) 2020-08-20
HUE059630T2 (hu) 2022-11-28
AU2016398029A1 (en) 2018-10-11
WO2017160345A8 (en) 2018-02-22
KR20190008840A (ko) 2019-01-25
IL296490A (en) 2022-11-01

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