CA2982425C - Ribociclib tablet - Google Patents
Ribociclib tablet Download PDFInfo
- Publication number
- CA2982425C CA2982425C CA2982425A CA2982425A CA2982425C CA 2982425 C CA2982425 C CA 2982425C CA 2982425 A CA2982425 A CA 2982425A CA 2982425 A CA2982425 A CA 2982425A CA 2982425 C CA2982425 C CA 2982425C
- Authority
- CA
- Canada
- Prior art keywords
- ribociclib
- tablet
- coating
- core
- coated
- 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.)
- Active
Links
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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562148240P | 2015-04-16 | 2015-04-16 | |
| US62/148,240 | 2015-04-16 | ||
| PCT/IB2016/052136 WO2016166703A1 (en) | 2015-04-16 | 2016-04-14 | Ribociclib tablet |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2982425A1 CA2982425A1 (en) | 2016-10-20 |
| CA2982425C true CA2982425C (en) | 2023-10-31 |
Family
ID=55806565
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2982425A Active CA2982425C (en) | 2015-04-16 | 2016-04-14 | Ribociclib tablet |
Country Status (29)
| Country | Link |
|---|---|
| US (6) | US10799506B2 (OSRAM) |
| EP (3) | EP4197530B1 (OSRAM) |
| JP (1) | JP2018514523A (OSRAM) |
| KR (2) | KR102750931B1 (OSRAM) |
| CN (2) | CN107530292B (OSRAM) |
| AR (1) | AR104257A1 (OSRAM) |
| AU (5) | AU2016248017A1 (OSRAM) |
| BR (1) | BR112017021283A2 (OSRAM) |
| CA (1) | CA2982425C (OSRAM) |
| CL (1) | CL2017002593A1 (OSRAM) |
| CO (1) | CO2017010510A2 (OSRAM) |
| DK (1) | DK3283058T3 (OSRAM) |
| EA (1) | EA201792290A1 (OSRAM) |
| EC (1) | ECSP17075052A (OSRAM) |
| ES (1) | ES2938261T3 (OSRAM) |
| FI (1) | FI3283058T3 (OSRAM) |
| HR (1) | HRP20230053T1 (OSRAM) |
| HU (1) | HUE061213T2 (OSRAM) |
| IL (1) | IL254818A0 (OSRAM) |
| MX (1) | MX2017013350A (OSRAM) |
| PE (1) | PE20180035A1 (OSRAM) |
| PH (1) | PH12017501820A1 (OSRAM) |
| PL (1) | PL3283058T3 (OSRAM) |
| PT (1) | PT3283058T (OSRAM) |
| SG (1) | SG11201708084PA (OSRAM) |
| SI (1) | SI3283058T1 (OSRAM) |
| TN (1) | TN2017000422A1 (OSRAM) |
| TW (1) | TW201642864A (OSRAM) |
| WO (1) | WO2016166703A1 (OSRAM) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FI3283058T3 (fi) * | 2015-04-16 | 2023-03-01 | Novartis Ag | Ribosiklibitabletti |
| CA3048036A1 (en) | 2018-07-02 | 2020-01-02 | Apotex Inc | Novel crystalline form of ribociclib succinate |
| CN114667147B (zh) | 2019-08-26 | 2024-09-06 | 阿尔维纳斯运营股份有限公司 | 用四氢萘衍生物作为雌激素受体降解剂的治疗乳腺癌的方法 |
| JP7681599B2 (ja) | 2019-12-16 | 2025-05-22 | ルネラ・バイオテック・インコーポレーテッド | 選択的ｃｄｋ４／６阻害剤のがん治療薬 |
| KR20220113986A (ko) | 2019-12-16 | 2022-08-17 | 루넬라 바이오테크 인코포레이티드 | 선택적 cdk 4/6 억제제 암 치료제 |
| WO2022029798A1 (en) * | 2020-08-03 | 2022-02-10 | Natco Pharma Limited | Pharmaceutical compositions comprising ribociclib |
| US20230355578A1 (en) * | 2020-09-29 | 2023-11-09 | Laboratorios Silanes S.A. De C.V. | Pharmaceutical combinations of statins and fibrates for the treatment and prevention of hyperlipidemias and cardiovascular disease |
| WO2022162122A1 (en) | 2021-01-29 | 2022-08-04 | Biotx.Ai Gmbh | Genetically verified netosis inhibitor for use in the treatment of a sars-cov2 infection |
| CN117396208A (zh) | 2021-07-16 | 2024-01-12 | 达纳－法伯癌症研究所公司 | 细胞周期蛋白依赖性激酶4/6(cdk4/6)和ikzf2(helios)的小分子降解剂及其使用方法 |
| TWI848533B (zh) | 2022-01-25 | 2024-07-11 | 瑞士商諾華公司 | 瑞博西尼藥物組成物 |
| EP4580631A1 (en) | 2022-08-31 | 2025-07-09 | Arvinas Operations, Inc. | Dosage regimens of estrogen receptor degraders |
| WO2024115680A1 (en) | 2022-12-01 | 2024-06-06 | Krka, D.D., Novo Mesto | Ribociclib salts and formulations thereof |
| AU2024244511A1 (en) | 2023-03-27 | 2025-09-25 | Novartis Ag | Method of treating early breast cancer with ribociclib in combination with an aromatase inhibitor |
| WO2025219830A1 (en) | 2024-04-15 | 2025-10-23 | Novartis Ag | Pharmaceutical compositions of ribociclib |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5428812A (en) * | 1977-08-09 | 1979-03-03 | Yoshitomi Pharmaceut Ind Ltd | Preparation of coated tablet |
| GB9414045D0 (en) | 1994-07-12 | 1994-08-31 | Berwind Pharma Service | Moisture barrier film coating composition, method, and coated form |
| JP3672314B2 (ja) * | 1994-07-12 | 2005-07-20 | バーウィンド・ファーマスーティカル・サーヴィスィーズ・インコーポレーテッド | 防湿性フィルム被覆材組成物、方法および被覆成形物 |
| US6448323B1 (en) * | 1999-07-09 | 2002-09-10 | Bpsi Holdings, Inc. | Film coatings and film coating compositions based on polyvinyl alcohol |
| US8685980B2 (en) | 2008-08-22 | 2014-04-01 | Novartis Ag | Pyrrolopyrimidine compounds and their uses |
| US20110070301A1 (en) * | 2009-09-24 | 2011-03-24 | Luber Joseph R | Orally transformable tablets |
| US20120115878A1 (en) | 2010-11-10 | 2012-05-10 | John Vincent Calienni | Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7h-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof |
| SG192666A1 (en) * | 2011-02-11 | 2013-09-30 | Wista Lab Ltd | Phenothiazine diaminium salts and their use |
| JP6226978B2 (ja) * | 2012-07-13 | 2017-11-08 | ジーティーエックス・インコーポレイテッド | 選択的アンドロゲン受容体モジュレーター（ｓａｒｍ）によりアンドロゲン受容体（ａｒ）陽性乳癌を処置する方法 |
| EP2742940B1 (en) * | 2012-12-13 | 2017-07-26 | IP Gesellschaft für Management mbH | Fumarate salt of (R)-3-(6-(4-methylphenyl)-pyridin-3-yloxy)-l-aza-bicyclo-[2.2.2]octane for adminstration once daily, twice daily or thrice daily |
| EP2934515B1 (en) * | 2012-12-20 | 2018-04-04 | Novartis AG | A pharmaceutical combination comprising binimetinib |
| UA118846C2 (uk) * | 2013-03-21 | 2019-03-25 | Новартіс Аг | Комбінована терапія |
| EP2810644A1 (en) * | 2013-06-06 | 2014-12-10 | Ferrer Internacional, S.A. | Oral formulation for the treatment of cardiovascular diseases |
| FI3283058T3 (fi) * | 2015-04-16 | 2023-03-01 | Novartis Ag | Ribosiklibitabletti |
| CN109953966A (zh) * | 2017-12-26 | 2019-07-02 | 天津耀辰实业发展有限公司 | 一种含有瑞博西尼的药物组合物及其制备方法 |
| JP7347388B2 (ja) | 2020-09-25 | 2023-09-20 | 信越化学工業株式会社 | 紫外線硬化型有機変性シリコーン組成物および硬化物 |
-
2016
- 2016-04-14 FI FIEP16718020.7T patent/FI3283058T3/fi active
- 2016-04-14 EP EP22203730.1A patent/EP4197530B1/en active Active
- 2016-04-14 ES ES16718020T patent/ES2938261T3/es active Active
- 2016-04-14 US US15/564,534 patent/US10799506B2/en active Active
- 2016-04-14 WO PCT/IB2016/052136 patent/WO2016166703A1/en not_active Ceased
- 2016-04-14 DK DK16718020.7T patent/DK3283058T3/da active
- 2016-04-14 MX MX2017013350A patent/MX2017013350A/es unknown
- 2016-04-14 EA EA201792290A patent/EA201792290A1/ru unknown
- 2016-04-14 EP EP25194967.3A patent/EP4620458A3/en active Pending
- 2016-04-14 PL PL16718020.7T patent/PL3283058T3/pl unknown
- 2016-04-14 SI SI201631661T patent/SI3283058T1/sl unknown
- 2016-04-14 CN CN201680022122.8A patent/CN107530292B/zh active Active
- 2016-04-14 AU AU2016248017A patent/AU2016248017A1/en not_active Abandoned
- 2016-04-14 JP JP2017553915A patent/JP2018514523A/ja active Pending
- 2016-04-14 HR HRP20230053TT patent/HRP20230053T1/hr unknown
- 2016-04-14 CN CN202211237232.XA patent/CN115554257A/zh active Pending
- 2016-04-14 KR KR1020177029433A patent/KR102750931B1/ko active Active
- 2016-04-14 SG SG11201708084PA patent/SG11201708084PA/en unknown
- 2016-04-14 AR ARP160101012A patent/AR104257A1/es unknown
- 2016-04-14 BR BR112017021283A patent/BR112017021283A2/pt not_active Application Discontinuation
- 2016-04-14 PT PT167180207T patent/PT3283058T/pt unknown
- 2016-04-14 EP EP16718020.7A patent/EP3283058B1/en active Active
- 2016-04-14 KR KR1020257000051A patent/KR20250009572A/ko active Pending
- 2016-04-14 HU HUE16718020A patent/HUE061213T2/hu unknown
- 2016-04-14 CA CA2982425A patent/CA2982425C/en active Active
- 2016-04-14 TN TNP/2017/000422A patent/TN2017000422A1/en unknown
- 2016-04-14 PE PE2017002096A patent/PE20180035A1/es unknown
- 2016-04-15 TW TW105111921A patent/TW201642864A/zh unknown
-
2017
- 2017-10-01 IL IL254818A patent/IL254818A0/en unknown
- 2017-10-04 PH PH12017501820A patent/PH12017501820A1/en unknown
- 2017-10-13 CL CL2017002593A patent/CL2017002593A1/es unknown
- 2017-10-13 CO CONC2017/0010510A patent/CO2017010510A2/es unknown
- 2017-11-10 EC ECIEPI201775052A patent/ECSP17075052A/es unknown
-
2019
- 2019-03-20 AU AU2019201929A patent/AU2019201929B2/en active Active
-
2020
- 2020-08-26 US US17/003,771 patent/US20200390771A1/en not_active Abandoned
- 2020-10-06 AU AU2020250190A patent/AU2020250190A1/en not_active Abandoned
-
2022
- 2022-06-08 US US17/805,956 patent/US12064434B2/en active Active
- 2022-08-08 AU AU2022215155A patent/AU2022215155B2/en active Active
-
2024
- 2024-02-27 US US18/588,259 patent/US20250090531A1/en active Pending
- 2024-10-31 AU AU2024227794A patent/AU2024227794A1/en active Pending
- 2024-12-11 US US18/977,228 patent/US12419894B2/en active Active
- 2024-12-11 US US18/977,210 patent/US20250134893A1/en active Pending
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20210413 |
|
| EEER | Examination request |
Effective date: 20210413 |
|
| EEER | Examination request |
Effective date: 20210413 |
|
| EEER | Examination request |
Effective date: 20210413 |
|
| EEER | Examination request |
Effective date: 20210413 |
|
| EEER | Examination request |
Effective date: 20210413 |
|
| EEER | Examination request |
Effective date: 20210413 |
|
| EEER | Examination request |
Effective date: 20210413 |