HRP20191092T1 - Pripravci za oralno doziranje s odgođenim otpuštanjem koji sadrže amorfni cddo-me - Google Patents

Pripravci za oralno doziranje s odgođenim otpuštanjem koji sadrže amorfni cddo-me Download PDF

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Publication number
HRP20191092T1
HRP20191092T1 HRP20191092T HRP20191092T1 HR P20191092 T1 HRP20191092 T1 HR P20191092T1 HR P20191092 T HRP20191092 T HR P20191092T HR P20191092 T1 HRP20191092 T1 HR P20191092T1
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HR
Croatia
Prior art keywords
dosage form
solid dosage
form according
hydrophilic binder
proportion
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Application number
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English (en)
Inventor
Jiang Zhang
Colin J Meyer
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Reata Pharmaceuticals Inc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42335073&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20191092(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Reata Pharmaceuticals Inc filed Critical Reata Pharmaceuticals Inc
Publication of HRP20191092T1 publication Critical patent/HRP20191092T1/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
    • A61K31/275Nitriles; Isonitriles
    • A61K31/277Nitriles; Isonitriles having a ring, e.g. verapamil
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • 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
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • 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
    • A61K9/1635Organic 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
    • A61K9/20Pills, tablets, discs, rods
    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07JSTEROIDS
    • C07J63/00Steroids in which the cyclopenta(a)hydrophenanthrene skeleton has been modified by expansion of only one ring by one or two atoms
    • C07J63/008Expansion of ring D by one atom, e.g. D homo steroids

Claims (14)

1. Čvrsti oblik doziranja koji sadrži (A) čestice koje se sastoje od amorfnog bardoksolon metila i staklaste pomoćne tvari, gdje je oblik doziranja naznačen time što ima jednu temperaturu staklenja, u smjesi s (B) česticama najmanje jednog hidrofilnog veziva, kojeg se bira iz skupine koju čine: (1) prirodni ugljikohidratni polimeri, koje se bira između škroba i predželatiniranog škroba; (2) želatina ili modificirane želatine; (3) hitozan; (4) anionski polimeri, koje se bira između homopolimera akrilne kiseline umreženih s alilsaharozom ili alilpentaeritritolom, i (5) pomoćne tvari na bazi celuloze, koje se bira iz skupine koju čine C3-C10 alkilhidroksimetilceluloza, arilhidroksimetilceluloza, te supstituirana arilhidroksimetilceluloza.
2. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 1, naznačen time što je hidrofilno vezivo pomoćna tvar na bazi celuloze.
3. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 1, naznačen time što navedene čestice (A) su čvrsta disperzija amorfnog bardoksolon metila u staklastom matriksu.
4. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 1, naznačen time što su navedene čestice (A) rezultat postupka koji se sastoji u sušenju raspršivanjem smjese bardoksolon metila s kopolimerom metakrilne kiseline.
5. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 4, naznačen time što se navedeni postupak sastoji u sušenju raspršivanjem 4:6 smjese bardoksolon metila s kopolimerom metakrilne kiseline.
6. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 1, naznačen time što je pomoćna tvar na bazi celuloze C3-C10 alkilhidroksimetilceluloza, koju se bira iz skupine koju čine metilceluloza, etilceluloza, propilceluloza, hidroksimetilceluloza, hidroksipropilceluloza, te celulozni acetat.
7. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 1, naznačen time što je hidrofilno vezivo prirodni ugljikohidratni polimer, kojeg se bira između škroba i predželatiniranog škroba.
8. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 1, naznačen time što je hidrofilno vezivo anionski polimer, kojeg se bira između homopolimera akrilne kiseline umreženih s alilsaharozom ili alilpentaeritritolom.
9. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 1, naznačen time što je udio hidrofilnog veziva između 1% i 40% (tež./tež.) od ukupne formulacije.
10. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 9, naznačen time što je udio hidrofilnog veziva između 2% i 20% (tež./tež.) od ukupne formulacije.
11. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 9, naznačen time što je udio hidrofilnog veziva između 4% i 10% (tež./tež.) od ukupne formulacije.
12. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 9, naznačen time što je udio hidrofilnog veziva između 5% i 7,5% (tež./tež.) od ukupne formulacije.
13. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 9, naznačen time što je udio hidrofilnog veziva između 7% i 7,5% (tež./tež.) od ukupne formulacije.
14. Čvrsti oblik doziranja u skladu s patentnim zahtjevom 9, naznačen time što je udio hidrofilnog veziva 7% (tež./tež.) od ukupne formulacije.
HRP20191092 2009-02-13 2019-06-17 Pripravci za oralno doziranje s odgođenim otpuštanjem koji sadrže amorfni cddo-me HRP20191092T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15260809P 2009-02-13 2009-02-13
EP17181174.8A EP3254675B1 (en) 2009-02-13 2010-02-12 Delayed release, oral dosage compositions that contain amorphous cddo-me

Publications (1)

Publication Number Publication Date
HRP20191092T1 true HRP20191092T1 (hr) 2019-11-29

Family

ID=42335073

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20171639TT HRP20171639T1 (hr) 2009-02-13 2017-10-26 ORALNI PRIPRAVCI DOZIRANJA S ODGOĐENIM OSLOBAĐANJEM KOJI SADRŽE AMORFNI CDDO-Me
HRP20191092 HRP20191092T1 (hr) 2009-02-13 2019-06-17 Pripravci za oralno doziranje s odgođenim otpuštanjem koji sadrže amorfni cddo-me

Family Applications Before (1)

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HRP20171639TT HRP20171639T1 (hr) 2009-02-13 2017-10-26 ORALNI PRIPRAVCI DOZIRANJA S ODGOĐENIM OSLOBAĐANJEM KOJI SADRŽE AMORFNI CDDO-Me

Country Status (29)

Country Link
US (2) US8747901B2 (hr)
EP (2) EP2395979B1 (hr)
JP (1) JP5775464B2 (hr)
KR (2) KR101483203B1 (hr)
CN (2) CN102387789A (hr)
AU (1) AU2010213594B2 (hr)
BR (1) BRPI1008023B8 (hr)
CA (1) CA2752048C (hr)
CO (1) CO6361904A2 (hr)
CY (2) CY1119595T1 (hr)
DK (2) DK2395979T3 (hr)
EA (1) EA023652B1 (hr)
ES (2) ES2731601T3 (hr)
HK (1) HK1220130A1 (hr)
HR (2) HRP20171639T1 (hr)
HU (2) HUE044005T2 (hr)
IL (1) IL214258A (hr)
LT (2) LT3254675T (hr)
MX (1) MX2011008344A (hr)
MY (1) MY173715A (hr)
NO (1) NO2395979T3 (hr)
NZ (1) NZ594488A (hr)
PL (2) PL2395979T3 (hr)
PT (2) PT2395979T (hr)
SG (1) SG173601A1 (hr)
SI (2) SI2395979T1 (hr)
TR (1) TR201909743T4 (hr)
WO (1) WO2010093944A2 (hr)
ZA (1) ZA201105630B (hr)

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Publication number Publication date
BRPI1008023B8 (pt) 2023-04-11
ES2646816T3 (es) 2017-12-18
JP2012518008A (ja) 2012-08-09
EP2395979B1 (en) 2017-08-23
CO6361904A2 (es) 2012-01-20
CA2752048C (en) 2014-11-25
KR20110118721A (ko) 2011-10-31
HUE044005T2 (hu) 2019-09-30
CN105232471A (zh) 2016-01-13
BRPI1008023A2 (pt) 2016-03-15
CY1122066T1 (el) 2020-11-25
AU2010213594B2 (en) 2013-11-14
ZA201105630B (en) 2012-04-25
US20140235711A1 (en) 2014-08-21
US9155721B2 (en) 2015-10-13
HRP20171639T1 (hr) 2017-12-15
LT3254675T (lt) 2019-06-25
US8747901B2 (en) 2014-06-10
NZ594488A (en) 2013-10-25
PL3254675T3 (pl) 2019-09-30
EA023652B1 (ru) 2016-06-30
MY173715A (en) 2020-02-18
EP3254675A1 (en) 2017-12-13
TR201909743T4 (tr) 2019-07-22
SG173601A1 (en) 2011-09-29
WO2010093944A2 (en) 2010-08-19
AU2010213594A1 (en) 2011-08-18
WO2010093944A3 (en) 2011-08-11
CA2752048A1 (en) 2010-08-19
BRPI1008023B1 (pt) 2019-12-31
NO2395979T3 (hr) 2018-01-20
PT3254675T (pt) 2019-06-14
PT2395979T (pt) 2017-11-16
CY1119595T1 (el) 2018-03-07
DK3254675T3 (da) 2019-06-24
SI3254675T1 (sl) 2019-08-30
PL2395979T3 (pl) 2018-02-28
MX2011008344A (es) 2011-09-29
DK2395979T3 (da) 2017-11-27
EA201190092A1 (ru) 2012-02-28
JP5775464B2 (ja) 2015-09-09
KR101483203B1 (ko) 2015-01-15
KR20140016441A (ko) 2014-02-07
EP2395979A2 (en) 2011-12-21
HK1220130A1 (zh) 2017-04-28
ES2731601T3 (es) 2019-11-18
HUE035013T2 (en) 2018-05-02
SI2395979T1 (sl) 2017-12-29
EP3254675B1 (en) 2019-05-15
LT2395979T (lt) 2017-12-11
US20120022156A1 (en) 2012-01-26
IL214258A (en) 2017-06-29
CN102387789A (zh) 2012-03-21
IL214258A0 (en) 2011-09-27

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