PE20121084A1 - Forma de dosificacion farmaceutica para administracion oral de un inhibidor de la familia bcl-2 - Google Patents
Forma de dosificacion farmaceutica para administracion oral de un inhibidor de la familia bcl-2Info
- Publication number
- PE20121084A1 PE20121084A1 PE2011002058A PE2011002058A PE20121084A1 PE 20121084 A1 PE20121084 A1 PE 20121084A1 PE 2011002058 A PE2011002058 A PE 2011002058A PE 2011002058 A PE2011002058 A PE 2011002058A PE 20121084 A1 PE20121084 A1 PE 20121084A1
- Authority
- PE
- Peru
- Prior art keywords
- weight
- amount
- dosage form
- pharmaceutical dosage
- active ingredient
- Prior art date
Links
- 239000002552 dosage form Substances 0.000 title abstract 2
- 102000051485 Bcl-2 family Human genes 0.000 title 1
- 108700038897 Bcl-2 family Proteins 0.000 title 1
- 239000003112 inhibitor Substances 0.000 title 1
- 239000002904 solvent Substances 0.000 abstract 4
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 abstract 3
- -1 AMINO Chemical class 0.000 abstract 2
- 239000004480 active ingredient Substances 0.000 abstract 2
- JNYAEWCLZODPBN-JGWLITMVSA-N (2r,3r,4s)-2-[(1r)-1,2-dihydroxyethyl]oxolane-3,4-diol Chemical compound OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O JNYAEWCLZODPBN-JGWLITMVSA-N 0.000 abstract 1
- XZIIFPSPUDAGJM-UHFFFAOYSA-N 6-chloro-2-n,2-n-diethylpyrimidine-2,4-diamine Chemical compound CCN(CC)C1=NC(N)=CC(Cl)=N1 XZIIFPSPUDAGJM-UHFFFAOYSA-N 0.000 abstract 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 abstract 1
- XTXRWKRVRITETP-UHFFFAOYSA-N Vinyl acetate Chemical compound CC(=O)OC=C XTXRWKRVRITETP-UHFFFAOYSA-N 0.000 abstract 1
- ZAKOWWREFLAJOT-ADUHFSDSSA-N [2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-yl] acetate Chemical compound CC(=O)OC1=C(C)C(C)=C2OC(CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C ZAKOWWREFLAJOT-ADUHFSDSSA-N 0.000 abstract 1
- OCBFFGCSTGGPSQ-UHFFFAOYSA-N [CH2]CC Chemical class [CH2]CC OCBFFGCSTGGPSQ-UHFFFAOYSA-N 0.000 abstract 1
- 239000000654 additive Substances 0.000 abstract 1
- 230000000996 additive effect Effects 0.000 abstract 1
- GEAXLHPORCRESC-UHFFFAOYSA-N chlorocyclohexatriene Chemical class ClC1=CC=C=C[CH]1 GEAXLHPORCRESC-UHFFFAOYSA-N 0.000 abstract 1
- 229920001577 copolymer Polymers 0.000 abstract 1
- 238000000354 decomposition reaction Methods 0.000 abstract 1
- 239000007884 disintegrant Substances 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- 230000002062 proliferating effect Effects 0.000 abstract 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 abstract 1
- 239000007962 solid dispersion Substances 0.000 abstract 1
- 229940035044 sorbitan monolaurate Drugs 0.000 abstract 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 abstract 1
- 150000003462 sulfoxides Chemical class 0.000 abstract 1
- 239000002562 thickening agent Substances 0.000 abstract 1
Classifications
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- 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
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
- A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
-
- 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
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
- A61K9/4833—Encapsulating processes; Filling of capsules
-
- 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
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- Oncology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
REFERIDA A UNA FORMA DE DOSIFICACION FARMACEUTICA QUE COMPRENDE: A) UN PRINCIPIO ACTIVO DE N-(4-(4-((2-(4-CLOROFENIL)-5,5-DIMETIL-1-CICLOHEX-1-EN-1-IL)-METIL)PIPERAZIN-1-IL)BENZOIL)-4-(((1R)-3-(MORFOLIN-4-IL)-1-((FENILSULFANIL)FENIL)PROPIL)AMINO)-3-((TRIFLUOROMETIL)SULFONIL)BENCENOSULFAMIDA EN UNA CANTIDAD DE 0,5-40%; B) UN POLIMERO FARMACEUTICAMENTE ACEPTABLE SELECCIONADO DE COPOLIMERO N-VINIL PIRROLIDONA Y ACETATO DE VINILO EN UNA CANTIDAD DE 40-97,5% EN PESO; C) UN SOLUBILIZANTE SELECCIONADO DE SOLUBILIZANTE NO IONICO TAL COMO ALFA TOCOFERILO POLIETILENGLICOL SUCCINATO, MONOLAURATO DE SORBITAN Y POLIOXIETILEN MONOLAURATO DE SORBITAN, ENTRE OTROS; SOLUBILIZANTES TAL COMO LAURILSULFATO DE SODIO, Y COMBINACIONES DE LOS MISMOS EN UNA CANTIDAD DE 2-20%; D) UN SOLVENTE NO VOLATIL LIQUIDO A TEMPERATURA AMBIENTE PARA EL PRINCIPIO ACTIVO TAL COMO PROPILENGLICOL; E) AL MENOS UN ADITIVO SELECCIONADO DE REGULADORES DE FLUJO, DESINTEGRANTES, AGENTES ESPESANTES Y LUBRICANTES EN UNA CANTIDAD DE 0-15% EN PESO. COMPRENDE ADEMAS MENOS DE 1,5% EN PESO EN RELACION AL PESO DEL INGREDIENTE ACTIVO DE PRODUCTOS DE DESCOMPOSICION CON SULFOXIDO DEL INGREDIENTE ACTIVO. DICHA COMPOSICION ES UNA DISPERSION SOLIDA UTIL EN EL TRATAMIENTO DE TRASTORNOS PROLIFERATIVOS
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US18513009P | 2009-06-08 | 2009-06-08 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20121084A1 true PE20121084A1 (es) | 2012-09-13 |
Family
ID=43063251
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2015002532A PE20160043A1 (es) | 2009-06-08 | 2010-06-08 | Forma de dosificacion farmaceutica para administracion oral de un inhibidor de la familia bcl-2 |
| PE2011002058A PE20121084A1 (es) | 2009-06-08 | 2010-06-08 | Forma de dosificacion farmaceutica para administracion oral de un inhibidor de la familia bcl-2 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2015002532A PE20160043A1 (es) | 2009-06-08 | 2010-06-08 | Forma de dosificacion farmaceutica para administracion oral de un inhibidor de la familia bcl-2 |
Country Status (37)
| Country | Link |
|---|---|
| US (6) | US9642796B2 (es) |
| EP (3) | EP3272334B1 (es) |
| JP (2) | JP5872459B2 (es) |
| KR (2) | KR101791404B1 (es) |
| CN (2) | CN102802606A (es) |
| AR (2) | AR077021A1 (es) |
| AU (1) | AU2010258367B2 (es) |
| BR (2) | BRPI1012831B1 (es) |
| CA (1) | CA2763441C (es) |
| CL (1) | CL2011003054A1 (es) |
| CO (1) | CO6480964A2 (es) |
| CR (1) | CR20170037A (es) |
| CY (1) | CY1119663T1 (es) |
| DK (2) | DK2982366T3 (es) |
| DO (2) | DOP2011000375A (es) |
| EC (1) | ECSP12011580A (es) |
| ES (2) | ES2551860T3 (es) |
| HR (2) | HRP20151342T1 (es) |
| HU (2) | HUE035727T2 (es) |
| IL (2) | IL216494A (es) |
| LT (1) | LT2982366T (es) |
| MX (1) | MX2011013164A (es) |
| MY (1) | MY159824A (es) |
| NO (1) | NO2982366T3 (es) |
| NZ (1) | NZ597241A (es) |
| PE (2) | PE20160043A1 (es) |
| PL (2) | PL2982366T3 (es) |
| PT (2) | PT2982366T (es) |
| RU (2) | RU2711359C2 (es) |
| SG (1) | SG176264A1 (es) |
| SI (2) | SI2440177T1 (es) |
| SM (1) | SMT201500317B (es) |
| TW (2) | TWI471321B (es) |
| UA (1) | UA104471C2 (es) |
| UY (1) | UY32695A (es) |
| WO (1) | WO2010143074A2 (es) |
| ZA (1) | ZA201108853B (es) |
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| TWI471321B (zh) | 2009-06-08 | 2015-02-01 | 亞培公司 | Ｂｃｌ－２族群抑制劑之口服醫藥劑型 |
| SG2014013502A (en) | 2010-06-09 | 2014-05-29 | Abbvie Inc | Solid dispersions containing kinase inhibitors |
| TWI535712B (zh) | 2010-08-06 | 2016-06-01 | 阿斯特捷利康公司 | 化合物 |
| UA113500C2 (xx) | 2010-10-29 | 2017-02-10 | Одержані екструзією розплаву тверді дисперсії, що містять індукуючий апоптоз засіб | |
| SG10201801794WA (en) | 2010-10-29 | 2018-04-27 | Abbvie Inc | Solid dispersions containing an apoptosis-inducing agent |
| SI2642999T1 (sl) | 2010-11-23 | 2017-01-31 | Abbvie Ireland Unlimited Company | Postopki zdravljenja z uporabo selektivnih Bcl-2 inhibitorjev |
| SG190361A1 (en) | 2010-11-23 | 2013-06-28 | Abbvie Inc | Salts and crystalline forms of an apoptosis-inducing agent |
| KR102191562B1 (ko) * | 2012-11-07 | 2020-12-15 | 에스케이바이오팜 주식회사 | 난용성 약물의 고체분산체 및 이의 제조방법 |
| US20160022708A1 (en) * | 2013-03-14 | 2016-01-28 | St. Jude Children's Research Hospital | Methods and compositions for the treatment of glutamine-addicted cancers |
| US20140275082A1 (en) | 2013-03-14 | 2014-09-18 | Abbvie Inc. | Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases |
| WO2015051252A1 (en) * | 2013-10-03 | 2015-04-09 | Duke University | Compositions and methods for treating cancer with jak2 activity |
| EP3129407A2 (en) * | 2014-03-12 | 2017-02-15 | Novartis Ag | Specific sites for modifying antibodies to make immunoconjugates |
| EP3157569B1 (en) * | 2014-06-18 | 2019-07-24 | F.Hoffmann-La Roche Ag | New pharmaceutical composition comprising non-ionic surfactants |
| CN105616419A (zh) * | 2014-11-07 | 2016-06-01 | 江苏豪森药业集团有限公司 | 含有细胞周期蛋白抑制剂固体分散体的药物组合物及其制备方法 |
| CN108367005B (zh) | 2016-02-29 | 2022-01-07 | 豪夫迈·罗氏有限公司 | 包含酪氨酸蛋白激酶抑制剂的剂型组合物 |
| JOP20190191A1 (ar) | 2017-02-22 | 2019-08-08 | Astrazeneca Ab | وحدات شجرية علاجية |
| US11872237B2 (en) * | 2018-12-28 | 2024-01-16 | Ascentage Pharma (Suzhou) Co., Ltd. | Pharmaceutical composition and preparation method thereof |
| US11285159B2 (en) | 2019-11-05 | 2022-03-29 | Abbvie Inc. | Dosing regimens for use in treating myelofibrosis and MPN-related disorders with navitoclax |
| US20230295183A1 (en) * | 2020-02-24 | 2023-09-21 | Newave Pharmaceutical Inc. | Hot melt extruded solid dispersions containing a bcl2 inhibitor |
| CN114533677A (zh) * | 2020-11-25 | 2022-05-27 | 苏州亚盛药业有限公司 | 固体分散体、制剂、其制备方法及其应用 |
| EP4274562A4 (en) * | 2021-01-08 | 2024-11-20 | Syros Pharmaceuticals, Inc. | TREATMENT REGIMEN WITH FIXED DOSES OF TAMIBAROTEN |
| CN113520995B (zh) * | 2021-08-16 | 2023-03-10 | 海南鑫开源医药科技有限公司 | 一种离子敏感型眼用原位凝胶、其制备方法及应用 |
| WO2023172958A1 (en) * | 2022-03-08 | 2023-09-14 | Onkosxcel Therapeutics, Llc | Stable formulations of talabostat |
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