HRP20220309T1 - Nove oralne formulacije belinostata - Google Patents
Nove oralne formulacije belinostata Download PDFInfo
- Publication number
- HRP20220309T1 HRP20220309T1 HRP20220309TT HRP20220309T HRP20220309T1 HR P20220309 T1 HRP20220309 T1 HR P20220309T1 HR P20220309T T HRP20220309T T HR P20220309TT HR P20220309 T HRP20220309 T HR P20220309T HR P20220309 T1 HRP20220309 T1 HR P20220309T1
- Authority
- HR
- Croatia
- Prior art keywords
- belinostat
- amorphous solid
- solid dispersion
- pvp
- polyvinyl
- Prior art date
Links
- NCNRHFGMJRPRSK-MDZDMXLPSA-N belinostat Chemical compound ONC(=O)\C=C\C1=CC=CC(S(=O)(=O)NC=2C=CC=CC=2)=C1 NCNRHFGMJRPRSK-MDZDMXLPSA-N 0.000 title claims 19
- 229960003094 belinostat Drugs 0.000 title claims 17
- 239000000203 mixture Substances 0.000 title claims 3
- 238000009472 formulation Methods 0.000 title 1
- 239000007962 solid dispersion Substances 0.000 claims 13
- 229920002554 vinyl polymer Polymers 0.000 claims 9
- 150000003951 lactams Chemical class 0.000 claims 8
- 229920000642 polymer Polymers 0.000 claims 8
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 5
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 4
- 239000000654 additive Substances 0.000 claims 3
- 230000000996 additive effect Effects 0.000 claims 3
- ALGZPROJSRYPIG-MDZDMXLPSA-N (e)-3-[3-(phenylsulfamoyl)phenyl]prop-2-enoic acid Chemical compound OC(=O)\C=C\C1=CC=CC(S(=O)(=O)NC=2C=CC=CC=2)=C1 ALGZPROJSRYPIG-MDZDMXLPSA-N 0.000 claims 2
- 239000002904 solvent Substances 0.000 claims 2
- 229920003083 Kollidon® VA64 Polymers 0.000 claims 1
- 206010025323 Lymphomas Diseases 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 229920003080 Povidone K 25 Polymers 0.000 claims 1
- 229920003081 Povidone K 30 Polymers 0.000 claims 1
- 229920003082 Povidone K 90 Polymers 0.000 claims 1
- -1 acetate- polyethylene Chemical group 0.000 claims 1
- 239000003963 antioxidant agent Substances 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 229920001577 copolymer Polymers 0.000 claims 1
- 229920001531 copovidone Polymers 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 239000002270 dispersing agent Substances 0.000 claims 1
- 239000006185 dispersion Substances 0.000 claims 1
- 150000002148 esters Chemical class 0.000 claims 1
- 229920000578 graft copolymer Polymers 0.000 claims 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 1
- 125000000487 histidyl group Chemical group [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C([H])=N1 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000003002 pH adjusting agent Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 229920002689 polyvinyl acetate Polymers 0.000 claims 1
- 239000011118 polyvinyl acetate Substances 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 229940069328 povidone Drugs 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000012453 solvate Substances 0.000 claims 1
- 238000001694 spray drying Methods 0.000 claims 1
- 239000003381 stabilizer Substances 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 150000003953 γ-lactams Chemical class 0.000 claims 1
- 150000003954 δ-lactams Chemical class 0.000 claims 1
- 150000003955 ε-lactams Chemical class 0.000 claims 1
Classifications
-
- 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
- A61K9/1635—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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/18—Sulfonamides
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4172—Imidazole-alkanecarboxylic acids, e.g. histidine
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Nutrition Science (AREA)
- Inorganic Chemistry (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (13)
1. Amorfna kruta disperzija belinostata koja sadrži:
a) Belinostat ili njegovu farmaceutski prihvatljivu sol, solvat ili ester;
b) Najmanje jedan polivinil laktam polimer; i
c) po izboru, najmanje jedan aditiv.
2. Amorfna kruta disperzija belinostata prema zahtjevu 1, naznačena time što se navedeni polivinil laktam polimer bira od lančanih polimera i kopolimera koji sadrže slijedeću podjedinicu:
[image]
u kojoj m predstavlja cijeli broj odabran od 1, 2, 3 ili 4 (β-, γ-, δ- ili ε-laktam), a n predstavlja broj ponavljajućih jedinica laktama u navedenoj podjedinici.
3. Amorfna kruta disperzija belinostata prema zahtjevu 1 ili 2, naznačena time što je navedeni polivinil laktam polimer topiv u vodi.
4. Amorfna kruta disperzija belinostata prema bilo kojem od zahtjeva 1 do 3, naznačena time što je navedeni polivinil laktam polimer odabran iz skupine koju čine polivinilpirolidon (PVP "povidon"), PVP-polivinil acetat (kopovidon) i polivinil kaprolaktam-polivinil acetat-polietilen glikol cijepljeni kopolimer (PCL-PVAc-PEG).
5. Amorfna kruta disperzija belinostata prema bilo kojem od prethodnih zahtjeva, naznačena time što je navedeni polivinil laktam polimer odabran od PVP K30, PVP K12, PVP K25, PVP K90, PVP VA64 i njihovih smjesa.
6. Amorfna kruta disperzija belinostata prema bilo kojem od prethodnih zahtjeva, naznačena time što sadrži:
a) oko 5 do 80% belinostata (maseni postotak); i
b) oko 20 do 95% navedenog polivinil laktam polimera (maseni postotak).
7. Amorfna kruta disperzija belinostata prema bilo kojem od prethodnih zahtjeva, naznačena time što je navedeni aditiv odabran iz skupine koju čine: pH modifikatori, antioksidansi, sredstva za dispergiranje, otapala, stabilizatori, dezintegranti ili bilo koja njihova smjesa.
8. Amorfna kruta disperzija belinostata prema bilo kojem od prethodnih zahtjeva, naznačena time što je navedeni aditiv histidin.
9. Amorfna kruta disperzija belinostata prema bilo kojem od prethodnih zahtjeva, naznačena time što navedena disperzija sadrži:
- manje od 0.2% belinostatne kiseline i/ili belinostatnog dimera, poslije ispitivanja oslobađanja; i/ili
- manje od 2% belinostatne kiseline i/ili belinostatnog dimera poslije skladištenja tijekom najmanje 18 mjeseci.
10. Postupak pripreme amorfne čvrste disperzije belinostata prema bilo kojem od prethodnih zahtjeva koji sadrži faze:
- pripremanje otopine belinostata sa navedenim polivinil laktam polimerom u otapalu;
- sušenje raspršivanjem navedene otopine.
11. Farmaceutski pripravak koji sadrži amorfnu čvrstu disperziju belinostata prema bilo kojem od prethodnih zahtjeva, i jednu ili više farmaceutski prihvatljivih pomoćnih tvari.
12. Amorfna kruta disperzija belinostata prema bilo kojem od zahtjeva 1 do 9 za upotrebu u liječenju i/ili sprječavanju raka oralnim davanjem.
13. Amorfna kruta disperzija belinostata za upotrebu prema zahtjevu 12 za liječenje limfoma.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762527684P | 2017-06-30 | 2017-06-30 | |
| EP17305853 | 2017-07-03 | ||
| EP18737225.5A EP3644970B8 (en) | 2017-06-30 | 2018-06-29 | New oral formulations of belinostat |
| PCT/EP2018/067717 WO2019002614A1 (en) | 2017-06-30 | 2018-06-29 | NEW ORAL FORMULATIONS OF BELINOSTAT |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20220309T1 true HRP20220309T1 (hr) | 2022-05-13 |
Family
ID=62816549
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20220309TT HRP20220309T1 (hr) | 2017-06-30 | 2018-06-29 | Nove oralne formulacije belinostata |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US11266614B2 (hr) |
| EP (1) | EP3644970B8 (hr) |
| JP (1) | JP7247122B2 (hr) |
| CN (1) | CN110996913A (hr) |
| AU (1) | AU2018294561B2 (hr) |
| BR (1) | BR112019028088A8 (hr) |
| CA (1) | CA3067723A1 (hr) |
| CL (1) | CL2019003801A1 (hr) |
| CO (1) | CO2019014831A2 (hr) |
| CY (1) | CY1125762T1 (hr) |
| DK (1) | DK3644970T3 (hr) |
| EC (1) | ECSP19091293A (hr) |
| ES (1) | ES2909583T3 (hr) |
| HR (1) | HRP20220309T1 (hr) |
| HU (1) | HUE057999T2 (hr) |
| IL (1) | IL271658B2 (hr) |
| LT (1) | LT3644970T (hr) |
| MX (1) | MX2019015869A (hr) |
| PL (1) | PL3644970T3 (hr) |
| RS (1) | RS63046B1 (hr) |
| SI (1) | SI3644970T1 (hr) |
| ZA (1) | ZA201908532B (hr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11708463B2 (en) * | 2018-04-06 | 2023-07-25 | Capsugel Belgium Nv | Spray drying process for low aspect ratio particles comprising poly[(methyl methacrylate)-co-(methacrylic acid)] |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1469829B1 (en) * | 2002-02-01 | 2016-01-27 | Bend Research, Inc | Immediate release dosage forms containing solid drug dispersions |
| NZ563236A (en) * | 2005-05-13 | 2010-12-24 | Topotarget Uk Ltd | Pharmaceutical formulations of N-hydroxy-3-(3-phenylsulfamoyl-phenyl)-acrylamide, aka PXD-101, and arginine |
| AU2012213940B2 (en) * | 2005-05-13 | 2015-03-26 | Topotarget Uk Limited | Pharmaceutical formulations of HDAC inhibitors |
| JP2007045788A (ja) | 2005-08-12 | 2007-02-22 | Kenjiro Koga | グリチルリチン酸高濃度水溶液の調製法 |
| US8828392B2 (en) | 2005-11-10 | 2014-09-09 | Topotarget Uk Limited | Histone deacetylase (HDAC) inhibitors (PXD101) for the treatment of cancer alone or in combination with chemotherapeutic agent |
| WO2011064663A1 (en) | 2009-11-25 | 2011-06-03 | Festuccia, Claudio | Combination treatment employing belinostat and bicalutamide |
| EP2572731A1 (en) | 2011-09-26 | 2013-03-27 | Abbott GmbH & Co. KG | Formulations based on solid dispersions |
| US20130172375A1 (en) | 2011-12-13 | 2013-07-04 | Hoffmann-La Roche Inc. | Pharmaceutical composition |
| GB201217439D0 (en) * | 2012-09-28 | 2012-11-14 | Topotarget As | Combination therapy |
| US9114170B2 (en) | 2012-11-08 | 2015-08-25 | Isp Investments Inc. | Highly loaded amorphous efavirenz composition and process for preparing the same |
| US20170095484A1 (en) | 2014-05-02 | 2017-04-06 | Oncoethix Gmbh | Method of treating resistant non-hodgkin lymphoma, medulloblastoma, and/or alk+non-small cell lung cancer using thienotriazolodiazepine compounds |
| MX2017001671A (es) | 2014-08-07 | 2017-07-04 | Pharmacyclics Llc | Formulaciones novedosas de un inhibidor de la tirosina cinasa de bruton. |
| AU2016277929B2 (en) | 2015-06-16 | 2020-09-10 | Acrotech Biopharma Inc. | Combination therapy using belinostat and pralatrexate to treat lymphoma |
| JP2017095428A (ja) | 2015-11-27 | 2017-06-01 | 国立大学法人神戸大学 | 脂質代謝改善剤 |
| WO2018029699A1 (en) * | 2016-08-11 | 2018-02-15 | Msn Research & Development Center | Solid state forms of (2e)-n-hydroxy-3-[3-(phenylsulfamoyl)phenyl]prop-2-enamide and process for preparation thereof |
-
2018
- 2018-06-29 SI SI201830618T patent/SI3644970T1/sl unknown
- 2018-06-29 RS RS20220285A patent/RS63046B1/sr unknown
- 2018-06-29 DK DK18737225.5T patent/DK3644970T3/da active
- 2018-06-29 MX MX2019015869A patent/MX2019015869A/es unknown
- 2018-06-29 US US16/627,643 patent/US11266614B2/en active Active
- 2018-06-29 AU AU2018294561A patent/AU2018294561B2/en active Active
- 2018-06-29 BR BR112019028088A patent/BR112019028088A8/pt unknown
- 2018-06-29 IL IL271658A patent/IL271658B2/en unknown
- 2018-06-29 CN CN201880043993.7A patent/CN110996913A/zh active Pending
- 2018-06-29 PL PL18737225T patent/PL3644970T3/pl unknown
- 2018-06-29 JP JP2019572383A patent/JP7247122B2/ja active Active
- 2018-06-29 CA CA3067723A patent/CA3067723A1/en active Pending
- 2018-06-29 LT LTEPPCT/EP2018/067717T patent/LT3644970T/lt unknown
- 2018-06-29 EP EP18737225.5A patent/EP3644970B8/en active Active
- 2018-06-29 ES ES18737225T patent/ES2909583T3/es active Active
- 2018-06-29 HU HUE18737225A patent/HUE057999T2/hu unknown
- 2018-06-29 HR HRP20220309TT patent/HRP20220309T1/hr unknown
-
2019
- 2019-12-20 CL CL2019003801A patent/CL2019003801A1/es unknown
- 2019-12-20 ZA ZA2019/08532A patent/ZA201908532B/en unknown
- 2019-12-26 EC ECSENADI201991293A patent/ECSP19091293A/es unknown
- 2019-12-27 CO CONC2019/0014831A patent/CO2019014831A2/es unknown
-
2022
- 2022-04-06 CY CY20221100259T patent/CY1125762T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| US11266614B2 (en) | 2022-03-08 |
| EP3644970A1 (en) | 2020-05-06 |
| EP3644970B1 (en) | 2022-02-09 |
| CO2019014831A2 (es) | 2020-04-24 |
| BR112019028088A8 (pt) | 2022-11-08 |
| JP7247122B2 (ja) | 2023-03-28 |
| SI3644970T1 (sl) | 2022-05-31 |
| ZA201908532B (en) | 2022-07-27 |
| MX2019015869A (es) | 2020-08-06 |
| EP3644970B8 (en) | 2022-03-16 |
| RS63046B1 (sr) | 2022-04-29 |
| AU2018294561B2 (en) | 2023-12-07 |
| AU2018294561A1 (en) | 2020-01-16 |
| CN110996913A (zh) | 2020-04-10 |
| IL271658B1 (en) | 2023-05-01 |
| ES2909583T3 (es) | 2022-05-09 |
| LT3644970T (lt) | 2022-04-25 |
| HUE057999T2 (hu) | 2022-06-28 |
| CL2019003801A1 (es) | 2020-09-11 |
| CY1125762T1 (el) | 2024-02-16 |
| US20200155485A1 (en) | 2020-05-21 |
| PL3644970T3 (pl) | 2022-04-25 |
| IL271658A (en) | 2020-02-27 |
| BR112019028088A2 (pt) | 2020-07-28 |
| IL271658B2 (en) | 2023-09-01 |
| DK3644970T3 (da) | 2022-03-14 |
| ECSP19091293A (es) | 2020-05-29 |
| JP2020525499A (ja) | 2020-08-27 |
| CA3067723A1 (en) | 2019-01-03 |
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