HRP20211446T1 - Formulacije inhibitora pi3k/mtor za intravensko davanje - Google Patents
Formulacije inhibitora pi3k/mtor za intravensko davanje Download PDFInfo
- Publication number
- HRP20211446T1 HRP20211446T1 HRP20211446TT HRP20211446T HRP20211446T1 HR P20211446 T1 HRP20211446 T1 HR P20211446T1 HR P20211446T T HRP20211446T T HR P20211446TT HR P20211446 T HRP20211446 T HR P20211446T HR P20211446 T1 HRP20211446 T1 HR P20211446T1
- Authority
- HR
- Croatia
- Prior art keywords
- phenyl
- triazin
- piperidin
- dimethylamino
- carbonyl
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 5
- 238000009472 formulation Methods 0.000 title claims 4
- 238000001990 intravenous administration Methods 0.000 title claims 2
- 239000012823 PI3K/mTOR inhibitor Substances 0.000 title 1
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims 36
- 239000000243 solution Substances 0.000 claims 31
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims 28
- DWZAEMINVBZMHQ-UHFFFAOYSA-N 1-[4-[4-(dimethylamino)piperidine-1-carbonyl]phenyl]-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea Chemical compound C1CC(N(C)C)CCN1C(=O)C(C=C1)=CC=C1NC(=O)NC1=CC=C(C=2N=C(N=C(N=2)N2CCOCC2)N2CCOCC2)C=C1 DWZAEMINVBZMHQ-UHFFFAOYSA-N 0.000 claims 25
- 239000008194 pharmaceutical composition Substances 0.000 claims 23
- 239000012931 lyophilized formulation Substances 0.000 claims 21
- 229960000448 lactic acid Drugs 0.000 claims 18
- 239000007864 aqueous solution Substances 0.000 claims 17
- 239000004310 lactic acid Substances 0.000 claims 16
- 235000014655 lactic acid Nutrition 0.000 claims 16
- 235000011007 phosphoric acid Nutrition 0.000 claims 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 13
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 claims 5
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 claims 4
- 239000004202 carbamide Substances 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- 150000003013 phosphoric acid derivatives Chemical class 0.000 claims 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 2
- JVTAAEKCZFNVCJ-REOHCLBHSA-N L-lactic acid Chemical compound C[C@H](O)C(O)=O JVTAAEKCZFNVCJ-REOHCLBHSA-N 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 239000000945 filler Substances 0.000 claims 2
- 150000003893 lactate salts Chemical class 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- 239000008181 tonicity modifier Substances 0.000 claims 2
- NSJFQBFLPMIGFZ-UHFFFAOYSA-N 2-hydroxypropanoic acid;urea Chemical compound NC(N)=O.CC(O)C(O)=O NSJFQBFLPMIGFZ-UHFFFAOYSA-N 0.000 claims 1
- 229930182843 D-Lactic acid Natural products 0.000 claims 1
- JVTAAEKCZFNVCJ-UWTATZPHSA-N D-lactic acid Chemical compound C[C@@H](O)C(O)=O JVTAAEKCZFNVCJ-UWTATZPHSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 239000013011 aqueous formulation Substances 0.000 claims 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical group OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 229940022769 d- lactic acid Drugs 0.000 claims 1
- 239000008121 dextrose Substances 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 238000007911 parenteral administration Methods 0.000 claims 1
- 239000005720 sucrose Substances 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K31/17—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
-
- 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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5355—Non-condensed oxazines and containing further heterocyclic rings
-
- 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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
- C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
- C07D401/12—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings linked by a chain containing hetero atoms as chain links
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Plural Heterocyclic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462093060P | 2014-12-17 | 2014-12-17 | |
| US201562250633P | 2015-11-04 | 2015-11-04 | |
| PCT/IB2015/059515 WO2016097949A1 (en) | 2014-12-17 | 2015-12-10 | Formulations of a pi3k/mtor-inhibitor for intravenous administration |
| EP15813578.0A EP3233054B1 (en) | 2014-12-17 | 2015-12-10 | Formulations of a pi3k/mtor-inhibitor for intravenous administration |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20211446T1 true HRP20211446T1 (hr) | 2021-12-24 |
Family
ID=54937330
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20211446TT HRP20211446T1 (hr) | 2014-12-17 | 2015-12-10 | Formulacije inhibitora pi3k/mtor za intravensko davanje |
Country Status (25)
| Country | Link |
|---|---|
| US (2) | US10172942B2 (https=) |
| EP (1) | EP3233054B1 (https=) |
| JP (1) | JP6420753B2 (https=) |
| KR (1) | KR102016822B1 (https=) |
| CN (1) | CN107205923B (https=) |
| AU (1) | AU2015365497B2 (https=) |
| CA (1) | CA2915199C (https=) |
| CY (1) | CY1124527T1 (https=) |
| DK (1) | DK3233054T3 (https=) |
| ES (1) | ES2881214T3 (https=) |
| HR (1) | HRP20211446T1 (https=) |
| HU (1) | HUE055928T2 (https=) |
| IL (1) | IL252158B (https=) |
| LT (1) | LT3233054T (https=) |
| MX (1) | MX380172B (https=) |
| NZ (1) | NZ731518A (https=) |
| PL (1) | PL3233054T3 (https=) |
| PT (1) | PT3233054T (https=) |
| RS (1) | RS62337B1 (https=) |
| RU (1) | RU2672875C1 (https=) |
| SG (1) | SG11201703826TA (https=) |
| SI (1) | SI3233054T1 (https=) |
| TW (1) | TWI660729B (https=) |
| WO (1) | WO2016097949A1 (https=) |
| ZA (1) | ZA201703764B (https=) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RS62663B1 (sr) | 2017-08-25 | 2021-12-31 | Pfizer | Farmaceutska vodena formulacija koja sadrži 1-(4-{[4-(dimetilamino)piperidin-1-il]karbonil}fenil)-3-[4-(4,6-dimorfolin-4-il-1,3,5-triazin-2-il)fenil]ureu |
| MX2020013238A (es) * | 2018-06-07 | 2021-02-22 | Pfizer | Formulacion acuosa que comprende 1-(4-{[4-(dimetilamino)piperidin- 1-il]carbonil}fenil)-3-[4-(4,6-dimorfolin-4-il-1,3,5-triazin-2-il )fenil]urea. |
| WO2023009438A1 (en) | 2021-07-26 | 2023-02-02 | Celcuity Inc. | 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea (gedatolisib) and its combinations for use in the treatment of cancer |
| WO2025128712A1 (en) | 2023-12-12 | 2025-06-19 | Celcuity Inc. | Treatment of ocular diseases using 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl)phenyl)-3-[4-(4,6- dimorpholin-4- yl-1,3,5-triazin-2-yl)phenyl]urea |
| US20260053814A1 (en) | 2024-08-21 | 2026-02-26 | Celcuity Inc. | Treatment regimens for gedatolisib in hormonally-driven disorders |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0852951A1 (de) * | 1996-11-19 | 1998-07-15 | Roche Diagnostics GmbH | Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern |
| KR20080018908A (ko) * | 2005-05-27 | 2008-02-28 | 바이엘 헬스케어 아게 | 암 치료용 디아릴 우레아 화합물 및 ｐｉ３, ａｋｔ 키나제또는 ｍｔｏｒ 억제제 (라파마이신)를 포함하는 병용요법 |
| US20080234262A1 (en) * | 2007-03-21 | 2008-09-25 | Wyeth | Pyrazolopyrimidine analogs and their use as mtor kinase and pi3 kinase inhibitors |
| DE202008001253U1 (de) * | 2008-01-28 | 2008-04-10 | Mirror Image Ag | Bildanzeigegerät |
| AP2775A (en) | 2008-05-23 | 2013-09-30 | Wyeth Llc | Triazine compounds as P13 kinase and MTOR inhibitors |
| JP2011521968A (ja) * | 2008-05-30 | 2011-07-28 | ジェネンテック， インコーポレイテッド | プリンｐｉ３ｋ阻害剤化合物および使用方法 |
| WO2010096619A1 (en) * | 2009-02-23 | 2010-08-26 | Wyeth Llc | Process, purification and crystallization of 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea |
| WO2014078522A1 (en) * | 2012-11-14 | 2014-05-22 | Ohio State Innovation Foundation | Materials and methods useful for treating glioblastoma |
| EP2968191B1 (en) * | 2013-03-14 | 2021-06-16 | Abraxis BioScience, LLC | Methods of treating bladder cancer |
| MA39734B1 (fr) * | 2014-03-14 | 2019-07-31 | Pfizer | Nanoparticules thérapeutiques comportant un agent thérapeutique, et leurs procédés de fabrication et d'utilisation |
-
2015
- 2015-12-10 HR HRP20211446TT patent/HRP20211446T1/hr unknown
- 2015-12-10 DK DK15813578.0T patent/DK3233054T3/da active
- 2015-12-10 PT PT158135780T patent/PT3233054T/pt unknown
- 2015-12-10 SG SG11201703826TA patent/SG11201703826TA/en unknown
- 2015-12-10 US US15/534,999 patent/US10172942B2/en active Active
- 2015-12-10 LT LTEPPCT/IB2015/059515T patent/LT3233054T/lt unknown
- 2015-12-10 KR KR1020177016417A patent/KR102016822B1/ko active Active
- 2015-12-10 AU AU2015365497A patent/AU2015365497B2/en active Active
- 2015-12-10 PL PL15813578T patent/PL3233054T3/pl unknown
- 2015-12-10 ES ES15813578T patent/ES2881214T3/es active Active
- 2015-12-10 HU HUE15813578A patent/HUE055928T2/hu unknown
- 2015-12-10 MX MX2017008072A patent/MX380172B/es unknown
- 2015-12-10 EP EP15813578.0A patent/EP3233054B1/en active Active
- 2015-12-10 CN CN201580068063.3A patent/CN107205923B/zh active Active
- 2015-12-10 NZ NZ731518A patent/NZ731518A/en unknown
- 2015-12-10 WO PCT/IB2015/059515 patent/WO2016097949A1/en not_active Ceased
- 2015-12-10 RU RU2017119282A patent/RU2672875C1/ru active
- 2015-12-10 SI SI201531687T patent/SI3233054T1/sl unknown
- 2015-12-10 RS RS20211128A patent/RS62337B1/sr unknown
- 2015-12-14 CA CA2915199A patent/CA2915199C/en active Active
- 2015-12-14 TW TW104141933A patent/TWI660729B/zh active
- 2015-12-15 JP JP2015243831A patent/JP6420753B2/ja active Active
-
2017
- 2017-05-08 IL IL252158A patent/IL252158B/en active IP Right Grant
- 2017-06-01 ZA ZA201703764A patent/ZA201703764B/en unknown
-
2018
- 2018-11-13 US US16/189,009 patent/US10660959B2/en active Active
-
2021
- 2021-09-28 CY CY20211100851T patent/CY1124527T1/el unknown
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