JPWO2021150981A5 - - Google Patents
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- JPWO2021150981A5 JPWO2021150981A5 JP2022545075A JP2022545075A JPWO2021150981A5 JP WO2021150981 A5 JPWO2021150981 A5 JP WO2021150981A5 JP 2022545075 A JP2022545075 A JP 2022545075A JP 2022545075 A JP2022545075 A JP 2022545075A JP WO2021150981 A5 JPWO2021150981 A5 JP WO2021150981A5
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- Prior art keywords
- pharmaceutical composition
- patient
- solid dispersion
- amorphous solid
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- 239000008194 pharmaceutical composition Substances 0.000 claims 28
- 239000007962 solid dispersion Substances 0.000 claims 15
- 229920000642 polymer Polymers 0.000 claims 12
- ZBNZXTGUTAYRHI-UHFFFAOYSA-N Dasatinib Chemical compound C=1C(N2CCN(CCO)CC2)=NC(C)=NC=1NC(S1)=NC=C1C(=O)NC1=C(C)C=CC=C1Cl ZBNZXTGUTAYRHI-UHFFFAOYSA-N 0.000 claims 9
- 239000002067 L01XE06 - Dasatinib Substances 0.000 claims 9
- 229960002448 dasatinib Drugs 0.000 claims 9
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 7
- 230000002062 proliferating effect Effects 0.000 claims 7
- SOGAXMICEFXMKE-UHFFFAOYSA-N Butylmethacrylate Chemical compound CCCCOC(=O)C(C)=C SOGAXMICEFXMKE-UHFFFAOYSA-N 0.000 claims 6
- 230000001419 dependent effect Effects 0.000 claims 6
- 239000003638 chemical reducing agent Substances 0.000 claims 4
- 210000004211 gastric acid Anatomy 0.000 claims 4
- JIGUQPWFLRLWPJ-UHFFFAOYSA-N Ethyl acrylate Chemical compound CCOC(=O)C=C JIGUQPWFLRLWPJ-UHFFFAOYSA-N 0.000 claims 3
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 claims 3
- 229920001577 copolymer Polymers 0.000 claims 3
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims 3
- PNJWIWWMYCMZRO-UHFFFAOYSA-N pent‐4‐en‐2‐one Natural products CC(=O)CC=C PNJWIWWMYCMZRO-UHFFFAOYSA-N 0.000 claims 3
- JKNCOURZONDCGV-UHFFFAOYSA-N 2-(dimethylamino)ethyl 2-methylprop-2-enoate Chemical compound CN(C)CCOC(=O)C(C)=C JKNCOURZONDCGV-UHFFFAOYSA-N 0.000 claims 2
- 208000002310 Achlorhydria Diseases 0.000 claims 2
- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 claims 2
- 239000003963 antioxidant agent Substances 0.000 claims 2
- 239000012736 aqueous medium Substances 0.000 claims 2
- 230000002496 gastric effect Effects 0.000 claims 2
- 210000004214 philadelphia chromosome Anatomy 0.000 claims 2
- 239000000612 proton pump inhibitor Substances 0.000 claims 2
- 229940126409 proton pump inhibitor Drugs 0.000 claims 2
- 210000002784 stomach Anatomy 0.000 claims 2
- 238000011269 treatment regimen Methods 0.000 claims 2
- YFVKHKCZBSGZPE-UHFFFAOYSA-N 1-(1,3-benzodioxol-5-yl)-2-(propylamino)propan-1-one Chemical compound CCCNC(C)C(=O)C1=CC=C2OCOC2=C1 YFVKHKCZBSGZPE-UHFFFAOYSA-N 0.000 claims 1
- 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims 1
- 208000014697 Acute lymphocytic leukaemia Diseases 0.000 claims 1
- 208000032791 BCR-ABL1 positive chronic myelogenous leukemia Diseases 0.000 claims 1
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 1
- 208000010833 Chronic myeloid leukaemia Diseases 0.000 claims 1
- 206010019375 Helicobacter infections Diseases 0.000 claims 1
- 208000033761 Myelogenous Chronic BCR-ABL Positive Leukemia Diseases 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 1
- 229940069428 antacid Drugs 0.000 claims 1
- 239000003159 antacid agent Substances 0.000 claims 1
- 239000005557 antagonist Substances 0.000 claims 1
- 230000001458 anti-acid effect Effects 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- OWMBTIRJFMGPAC-UHFFFAOYSA-N dimethylamino 2-methylprop-2-enoate Chemical compound CN(C)OC(=O)C(C)=C OWMBTIRJFMGPAC-UHFFFAOYSA-N 0.000 claims 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 claims 1
- 239000003485 histamine H2 receptor antagonist Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000000473 propyl gallate Substances 0.000 claims 1
- 229940075579 propyl gallate Drugs 0.000 claims 1
- 235000010388 propyl gallate Nutrition 0.000 claims 1
Claims (19)
１種以上のポリマーが、ｐＨ依存的な溶解性を示すポリマーを含み、the one or more polymers include a polymer that exhibits pH-dependent solubility;
ダサチニブ及び１種以上のポリマーが、３０：７０～９５：５(ダサチニブ：ポリマー)のｗ／ｗ比で前記非晶質固体分散体中に存在する、前記非晶質固体分散体。The amorphous solid dispersion, wherein dasatinib and one or more polymers are present in the amorphous solid dispersion in a w/w ratio of 30:70 to 95:5 (dasatinib:polymer).
患者が胃酸減少剤を併用しているか否かに関係なく前記患者に投与される、前記医薬組成物。 11. A pharmaceutical composition according to claim 9 or 10 for use in treating a proliferative disorder in a patient in need thereof,
The pharmaceutical composition is administered to a patient regardless of whether the patient is also taking a gastric acid reducing agent.
胃酸減少剤と一緒に患者に投与される、前記医薬組成物。 11. A pharmaceutical composition according to claim 9 or 10 for use in treating a proliferative disorder in a patient in need thereof,
The above pharmaceutical composition is administered to a patient together with a gastric acid reducing agent.
非晶質固体分散体が、患者の胃のｐＨが上昇しているか否かに関係なく投与されるか、又は患者の胃のｐＨが、上昇している、前記医薬組成物。 11. A pharmaceutical composition according to claim 9 or 10 for use in treating a proliferative disorder in a patient in need thereof,
Said pharmaceutical composition, wherein the amorphous solid dispersion is administered regardless of whether or not the patient's stomach pH is elevated , or the patient's stomach pH is elevated .
（ａ）患者の胃のｐＨが慢性的に上昇していることにより、状態を特定することと、
（ｂ)治療上有効量の前記医薬組成物を患者に投与することとを含み、
治療上有効量が、２０ｍｇ～１４０ｍｇのダサチニブを含む、前記医薬組成物。 11. A pharmaceutical composition according to claim 9 or 10 for use in treating a proliferative disorder in a patient in need thereof, said use comprising:
(a) identifying the condition by chronically elevated gastric pH in the patient;
(b) administering to a patient a therapeutically effective amount of said pharmaceutical composition;
Said pharmaceutical composition , wherein the therapeutically effective amount comprises from 20 mg to 140 mg of dasatinib.
前記計画が、
（ａ）標準投与量のプロトンポンプ阻害薬又はＨ2拮抗薬を含む第１用量を患者に投与する工程と、
（ｂ）第１用量後の２０時間以内に、治療上有効量の前記医薬組成物を含む第２用量を患者に投与する工程とを含み、
治療上有効量が、２０ｍｇ～１４０ｍｇのダサチニブを含む、前記医薬組成物。 11. A pharmaceutical composition according to claim 9 or 10 for use in a treatment regimen for treating a proliferative disorder in a patient in need thereof, comprising:
The plan is
(a) administering to the patient a first dose comprising a standard dose of a proton pump inhibitor or H2 antagonist;
(b) administering to the patient a second dose comprising a therapeutically effective amount of the pharmaceutical composition within 20 hours after the first dose;
Said pharmaceutical composition , wherein the therapeutically effective amount comprises from 20 mg to 140 mg of dasatinib.
前記計画が、
（ａ）標準投与量の制酸薬を含む第１用量を患者に投与する工程と、
（ｂ）第１用量前の２時間以内に又は第１用量後の２時間以内に、前記医薬組成物を含む第２用量を患者に投与する工程とを含み、
第２用量の投与が、治療上の妥当な曝露量のダサチニブを患者に提供する、前記医薬組成物。 11. A pharmaceutical composition according to claim 9 or 10 for use in a treatment regimen for treating a proliferative disorder in a patient in need thereof, comprising:
The plan is
(a) administering to the patient a first dose comprising a standard dose of an antacid;
(b) administering to the patient a second dose comprising said pharmaceutical composition within two hours before the first dose or within two hours after the first dose;
Said pharmaceutical composition , wherein administration of the second dose provides a therapeutically relevant exposure of dasatinib to the patient.
添付文書が、
医薬組成物と胃酸減少剤とを併用できることをユーザーに知らせるか、或いは
医薬組成物がＨ 2 拮抗薬又はプロトンポンプ阻害薬と併用すべきではないとの警告を含まないか、或いは
ユーザーの胃のｐＨが慢性的に上昇している場合、医薬組成物を適切に投与することができることをユーザーに知らせるか、或いは
ユーザーが無酸症若しくは低酸症と診断された場合、又はユーザーが無酸症若しくは低酸症に苦しんでいる場合、医薬組成物を適切に投与することができることをユーザーに知らせるか、或いは
ユーザーがヘリコバクター・ピロリ感染症と診断された場合、又はユーザーがヘリコバクター・ピロリ感染症に苦しんでいる場合、医薬組成物を適切に投与することができることをユーザーに知らせる、前記キット。 A kit for sale to users, comprising the pharmaceutical composition according to claim 9 or 10 and a package insert,
The attached document is
Inform the user that the pharmaceutical composition can be used in combination with the gastric acid reducing agent , or
does not contain a warning that the pharmaceutical composition should not be used in combination with H2 antagonists or proton pump inhibitors, or
Informing the user that the pharmaceutical composition can be appropriately administered if the user's gastric pH is chronically elevated; or
informing the user that the pharmaceutical composition can be appropriately administered if the user has been diagnosed with achlorhydria or hypochlorhydria, or if the user is suffering from achlorhydria or hypochlorhydria; or
Said kit informing the user that the pharmaceutical composition can be appropriately administered if the user is diagnosed with or suffering from a Helicobacter pylori infection.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202062965650P | 2020-01-24 | 2020-01-24 | |
| US62/965,650 | 2020-01-24 | ||
| US202063018182P | 2020-04-30 | 2020-04-30 | |
| US63/018,182 | 2020-04-30 | ||
| PCT/US2021/014742 WO2021150981A1 (en) | 2020-01-24 | 2021-01-22 | Amorphous solid dispersions of dasatinib and uses thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2023513444A JP2023513444A (en) | 2023-03-31 |
| JPWO2021150981A5 true JPWO2021150981A5 (en) | 2024-01-30 |
Family
ID=74673317
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022545075A Pending JP2023513444A (en) | 2020-01-24 | 2021-01-22 | Solid amorphous dispersion of dasatinib and uses thereof |
Country Status (7)
| Country | Link |
|---|---|
| US (10) | US11202778B2 (en) |
| EP (1) | EP4093379A1 (en) |
| JP (1) | JP2023513444A (en) |
| AU (1) | AU2021210974A1 (en) |
| CA (1) | CA3168667A1 (en) |
| IL (1) | IL294928A (en) |
| WO (1) | WO2021150981A1 (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021150981A1 (en) | 2020-01-24 | 2021-07-29 | Nanocopoeia, Llc | Amorphous solid dispersions of dasatinib and uses thereof |
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| US11529351B2 (en) * | 2021-01-21 | 2022-12-20 | Xspray Pharma Ab | Fast dissolving pharmaceutical compositions |
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-
2021
- 2021-01-22 WO PCT/US2021/014742 patent/WO2021150981A1/en unknown
- 2021-01-22 JP JP2022545075A patent/JP2023513444A/en active Pending
- 2021-01-22 IL IL294928A patent/IL294928A/en unknown
- 2021-01-22 AU AU2021210974A patent/AU2021210974A1/en active Pending
- 2021-01-22 CA CA3168667A patent/CA3168667A1/en active Pending
- 2021-01-22 EP EP21707445.9A patent/EP4093379A1/en active Pending
- 2021-03-19 US US17/206,823 patent/US11202778B2/en active Active
- 2021-12-08 US US17/545,370 patent/US11324745B2/en active Active
- 2021-12-08 US US17/545,324 patent/US11298356B1/en active Active
- 2021-12-13 US US17/549,104 patent/US11413290B2/en active Active
- 2021-12-15 US US17/551,512 patent/US20220105035A1/en not_active Abandoned
-
2022
- 2022-05-05 US US17/737,399 patent/US20220273657A1/en active Pending
- 2022-05-05 US US17/737,409 patent/US20220280512A1/en active Pending
- 2022-05-05 US US17/737,375 patent/US20220273656A1/en active Pending
- 2022-08-15 US US17/888,060 patent/US11633398B2/en active Active
-
2023
- 2023-04-21 US US18/137,722 patent/US20230355620A1/en active Pending
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