AR116035A2 - Formulación farmacéutica - 514 - Google Patents
Formulación farmacéutica - 514Info
- Publication number
- AR116035A2 AR116035A2 ARP190102461A ARP190102461A AR116035A2 AR 116035 A2 AR116035 A2 AR 116035A2 AR P190102461 A ARP190102461 A AR P190102461A AR P190102461 A ARP190102461 A AR P190102461A AR 116035 A2 AR116035 A2 AR 116035A2
- Authority
- AR
- Argentina
- Prior art keywords
- matrix polymer
- phthalazin
- cyclopropanecarbonyl
- fluorobenzyl
- piperazine
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 239000011159 matrix material Substances 0.000 abstract 8
- 229920000642 polymer Polymers 0.000 abstract 7
- FDLYAMZZIXQODN-UHFFFAOYSA-N olaparib Chemical compound FC1=CC=C(CC=2C3=CC=CC=C3C(=O)NN=2)C=C1C(=O)N(CC1)CCN1C(=O)C1CC1 FDLYAMZZIXQODN-UHFFFAOYSA-N 0.000 abstract 5
- 239000003814 drug Substances 0.000 abstract 3
- 229940079593 drug Drugs 0.000 abstract 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 3
- 239000007962 solid dispersion Substances 0.000 abstract 3
- 229920000623 Cellulose acetate phthalate Polymers 0.000 abstract 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 abstract 2
- DCQLZTSRKLWEAB-UHFFFAOYSA-N ac1ndudu Chemical compound O1C(C(C2OCC(C)O)OCC(C)O)C(COCC(C)O)OC2OC(C(C2OCC(C)O)OCC(C)O)C(COCC(C)O)OC2OC(C(C2OCC(C)O)OCC(C)O)C(COCC(C)O)OC2OC(C(C2OCC(C)O)OCC(C)O)C(COCC(C)O)OC2OC(C(OCC(C)O)C2OCC(C)O)C(COCC(O)C)OC2OC(C(C2OCC(C)O)OCC(C)O)C(COCC(C)O)OC2OC2C(OCC(C)O)C(OCC(C)O)C1OC2COCC(C)O DCQLZTSRKLWEAB-UHFFFAOYSA-N 0.000 abstract 2
- 229940081734 cellulose acetate phthalate Drugs 0.000 abstract 2
- 229920001531 copovidone Polymers 0.000 abstract 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 abstract 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 abstract 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 abstract 2
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 abstract 2
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 abstract 2
- 239000000155 melt Substances 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- IJAPPYDYQCXOEF-UHFFFAOYSA-N phthalazin-1(2H)-one Chemical compound C1=CC=C2C(=O)NN=CC2=C1 IJAPPYDYQCXOEF-UHFFFAOYSA-N 0.000 abstract 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 abstract 2
- 150000003839 salts Chemical class 0.000 abstract 2
- 239000012453 solvate Substances 0.000 abstract 2
- 229920000858 Cyclodextrin Polymers 0.000 abstract 1
- IYKJEILNJZQJPU-UHFFFAOYSA-N acetic acid;butanedioic acid Chemical compound CC(O)=O.OC(=O)CCC(O)=O IYKJEILNJZQJPU-UHFFFAOYSA-N 0.000 abstract 1
- 239000006185 dispersion Substances 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 229920000193 polymethacrylate Polymers 0.000 abstract 1
- 239000007787 solid Substances 0.000 abstract 1
- 239000012265 solid product 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
- 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
- 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
- A61K31/50—Pyridazines; Hydrogenated pyridazines
- A61K31/502—Pyridazines; Hydrogenated pyridazines ortho- or peri-condensed with carbocyclic ring systems, e.g. cinnoline, phthalazine
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic 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
- 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
- A61K9/2095—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
La presente se refiere a una formulación farmacéutica que contiene el fármaco 4-[3-(4-ciclopropanocarbonil-piperazina-1-carbonil)-4-fluorobencil]-2H-ftalazin-1-ona en una dispersión sólida con un polímero de matriz que tiene baja higroscopicidad y elevada temperatura de ablandamiento, como copovidona. La presente también se refiere a una dosis farmacéutica diaria del fármaco provisto por dicha formulación. Además, la presente se refiere al uso de un polímero de matriz que tiene baja higroscopicidad y elevada temperatura de ablandamiento en una dispersión sólida con 4-[3-(4-ciclopropanocarbonil-piperazina-1-carbonil)-4-fluorobencil]-2H-ftalazin-1-ona para aumentar la biodisponibilidad del fármaco. Reivindicación 1: Una composición farmacéutica caracterizada porque comprende un principio activo en dispersión sólida con un polímero de matriz, en la que el principio activo es 4-[3-(4-ciclopropanocarbonil-piperazina-1-carbonil)-4-fluorobencil]-2H-ftalazin-1-ona o una de sus sales o solvatos, y el polímero de matriz tiene baja higroscopicidad y elevada temperatura de ablandamiento, en donde el polímero de matriz se selecciona entre: copovidona, ftalato de hidroxipropilmetilcelulosa (HPMCP), acetato succinato de hidroxipropilmetilcelulosa (HPMCAS), 2-hidroxipropil-b-ciclodextrina (HPBCD), hidroxipropilmetilcelulosa (Hidromelosa, HPMC), polimetacrilatos, hidroxipropilcelulosa (HPC) y acetato ftalato de celulosa (CAP), y en donde la relación en peso principio activo:polímero de matriz es entre 1:³2 y 1:10. Reivindicación 12: Un método para producir una dispersión sólida amorfa de 4-[3-(4-ciclopropanocarbonil-piperazina-1-carbonil)-4-fluorobencil]-2H-ftalazin-1-ona de acuerdo con cualquiera de las reivindicaciones 1 a 9, caracterizado porque comprende: (i) mezclar una cantidad adecuada de 4-[3-(4-ciclopropanocarbonil-piperazina-1-carbonil)-4-fluorobencil]-2H-ftalazin-1-ona o de una de sus sales o solvatos farmacéuticamente aceptables con una cantidad deseada de al menos un polímero de matriz, donde el polímero de matriz tiene baja higroscopicidad y elevada temperatura de ablandamiento; (ii) aumentar la temperatura de la mezcla para producir una masa fundida; y (iii) extruir la masa fundida para producir un producto sólido.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10334708P | 2008-10-07 | 2008-10-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR116035A2 true AR116035A2 (es) | 2021-03-25 |
Family
ID=41396997
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP090103865A AR073792A1 (es) | 2008-10-07 | 2009-10-07 | Formulacion farmaceutica. metodo. uso |
| ARP190102461A AR116035A2 (es) | 2008-10-07 | 2019-08-29 | Formulación farmacéutica - 514 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP090103865A AR073792A1 (es) | 2008-10-07 | 2009-10-07 | Formulacion farmaceutica. metodo. uso |
Country Status (43)
Families Citing this family (45)
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| RS55157B2 (sr) * | 2008-10-07 | 2023-10-31 | Kudos Pharm Ltd | Farmaceutska formulacija 514 |
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| KR20180059560A (ko) * | 2010-10-29 | 2018-06-04 | 애브비 인코포레이티드 | 아폽토시스―유도제를 포함하는 고체 분산체 |
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| TW201618783A (zh) | 2014-08-07 | 2016-06-01 | 艾森塔製藥公司 | 以布魯頓(Bruton)氏酪胺酸激酶(BTK)佔據和BTK再合成速率為基礎之治療癌症、免疫和自體免疫疾病及發炎性疾病之方法 |
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| CN105777651A (zh) * | 2015-01-13 | 2016-07-20 | 江苏豪森药业集团有限公司 | 聚腺苷酸二磷酸核糖转移酶抑制剂的晶型及其制备方法和医药用途 |
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| CN113350349B (zh) * | 2020-03-04 | 2022-11-11 | 中国科学院上海药物研究所 | 奥拉帕尼溶出增强组合物 |
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