JPWO2021155254A5 - - Google Patents
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- JPWO2021155254A5 JPWO2021155254A5 JP2022546499A JP2022546499A JPWO2021155254A5 JP WO2021155254 A5 JPWO2021155254 A5 JP WO2021155254A5 JP 2022546499 A JP2022546499 A JP 2022546499A JP 2022546499 A JP2022546499 A JP 2022546499A JP WO2021155254 A5 JPWO2021155254 A5 JP WO2021155254A5
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- nilotinib
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- 239000008194 pharmaceutical composition Substances 0.000 claims 35
- HHZIURLSWUIHRB-UHFFFAOYSA-N nilotinib Chemical compound C1=NC(C)=CN1C1=CC(NC(=O)C=2C=C(NC=3N=C(C=CN=3)C=3C=NC=CC=3)C(C)=CC=2)=CC(C(F)(F)F)=C1 HHZIURLSWUIHRB-UHFFFAOYSA-N 0.000 claims 26
- 239000005536 L01XE08 - Nilotinib Substances 0.000 claims 21
- 229960001346 nilotinib Drugs 0.000 claims 21
- 229920000642 polymer Polymers 0.000 claims 12
- 239000000203 mixture Substances 0.000 claims 8
- 239000007962 solid dispersion Substances 0.000 claims 7
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 6
- 239000013078 crystal Substances 0.000 claims 5
- 229920000639 hydroxypropylmethylcellulose acetate succinate Polymers 0.000 claims 3
- YCBPQSYLYYBPDW-UHFFFAOYSA-N 4-methyl-n-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide;hydrate;hydrochloride Chemical compound O.Cl.C1=NC(C)=CN1C1=CC(NC(=O)C=2C=C(NC=3N=C(C=CN=3)C=3C=NC=CC=3)C(C)=CC=2)=CC(C(F)(F)F)=C1 YCBPQSYLYYBPDW-UHFFFAOYSA-N 0.000 claims 2
- 208000032791 BCR-ABL1 positive chronic myelogenous leukemia Diseases 0.000 claims 2
- 208000010833 Chronic myeloid leukaemia Diseases 0.000 claims 2
- 208000033761 Myelogenous Chronic BCR-ABL Positive Leukemia Diseases 0.000 claims 2
- 239000004480 active ingredient Substances 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 230000002062 proliferating effect Effects 0.000 claims 2
- 238000006467 substitution reaction Methods 0.000 claims 2
- 125000004080 3-carboxypropanoyl group Chemical group O=C([*])C([H])([H])C([H])([H])C(O[H])=O 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 125000002777 acetyl group Chemical group [H]C([H])([H])C(*)=O 0.000 claims 1
- 239000000654 additive Substances 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 210000000349 chromosome Anatomy 0.000 claims 1
- 230000001684 chronic effect Effects 0.000 claims 1
- 230000001419 dependent effect Effects 0.000 claims 1
- 235000012631 food intake Nutrition 0.000 claims 1
- 210000004214 philadelphia chromosome Anatomy 0.000 claims 1
- 239000007909 solid dosage form Substances 0.000 claims 1
- 229940121358 tyrosine kinase inhibitor Drugs 0.000 claims 1
- 239000005483 tyrosine kinase inhibitor Substances 0.000 claims 1
- 150000004917 tyrosine kinase inhibitor derivatives Chemical class 0.000 claims 1
Claims (18)
１種以上のポリマーが、ｐＨ依存的な溶解性を示す、ヒドロキシプロピルメチルセルロースアセテートスクシネートポリマーを含み、
ニロチニブ遊離塩基及び１種以上のポリマーが、３５：６５～８０：２０(ニロチニブ：ポリマー)のｗ／ｗ比で非晶質固体分散体中に存在する、前記医薬組成物。 A pharmaceutical composition comprising an amorphous solid dispersion, the amorphous solid dispersion comprising nilotinib free base and one or more polymers;
the one or more polymers include a hydroxypropyl methylcellulose acetate succinate polymer that exhibits pH-dependent solubility;
Said pharmaceutical composition, wherein nilotinib free base and one or more polymers are present in the amorphous solid dispersion in a w/w ratio of 35:65 to 80:20 (nilotinib:polymer).
参照組成物が、ニロチニブ一塩酸塩一水和物結晶を含む従来のニロチニブ結晶の即時放出性組成物であり、the reference composition is a conventional nilotinib crystal immediate release composition comprising nilotinib monohydrochloride monohydrate crystals;
医薬組成物中のニロチニブの用量が、前記ニロチニブ結晶の即時放出性製剤の投与量と比較して、８０％減であり、the dose of nilotinib in the pharmaceutical composition is reduced by 80% compared to the dose of the immediate release formulation of crystalline nilotinib;
生物学的同等性基準が、ＣThe bioequivalence standard is C maxmax 、Ｔ, T maxmax 、及びＡＵＣから選択される、請求項１～５のいずれか１項に記載の医薬組成物。, and AUC.
参照組成物が、ニロチニブ一塩酸塩一水和物結晶を含む従来のニロチニブ結晶の即時放出性組成物であり、the reference composition is a conventional nilotinib crystal immediate release composition comprising nilotinib monohydrochloride monohydrate crystals;
医薬組成物中のニロチニブの用量が、前記ニロチニブ結晶の即時放出性製剤の投与量と比較して、８０％減であり、the dose of nilotinib in the pharmaceutical composition is reduced by 80% compared to the dose of the immediate release formulation of crystalline nilotinib;
生物学的同等性基準が、ＣThe bioequivalence standard is C maxmax 、Ｔ, T maxmax 、及びＡＵＣから選択される、請求項１～５のいずれか１項に記載の医薬組成物。, and AUC.
（ｉｉ）医薬組成物が、患者が絶食状態か若しくは摂食状態かに関係なく投与される、請求項１０に記載の使用のための医薬組成物。 (i) the pharmaceutical composition is administered without regard to food consumption , or
11. A pharmaceutical composition for use according to claim 10, wherein (ii) the pharmaceutical composition is administered regardless of whether the patient is in a fasted or fed state .
（ｂ）食事を患者に与える工程とを含み、
工程（ａ）及び工程（ｂ）が、互いに２時間未満以内に発生する方法で投与される、請求項１０又は１１に記載の使用のための医薬組成物。 (a) administering to a patient a therapeutically effective amount of the pharmaceutical composition according to any one of claims 1 to 9 ;
(b) feeding the patient with food;
12. A pharmaceutical composition for use according to claim 10 or 11, wherein step (a) and step (b) are administered in such a way that they occur within less than 2 hours of each other.
（ｉｉ）摂食状態における対象への医薬組成物の投与が、絶食状態における対象への医薬組成物の投与により得られるニロチニブの血漿ＡＵＣの３０％以内の、好ましくは、１５％以内のニロチニブの血漿ＡＵＣをもたらすか、
（ｉｉｉ）摂食状態における対象への医薬組成物の投与が、医薬組成物の２倍量～４倍量のニロチニブを有するニロチニブ結晶即時放出性製剤の絶食状態における投与により得られるニロチニブの血漿Ｃ max の２５％以内の、ニロチニブの血漿Ｃ max をもたらすか、又は
（ｉｖ）摂食状態における対象への医薬組成物の投与が、医薬組成物の２倍量～４倍量のニロチニブを有するニロチニブ結晶即時放出性製剤の絶食状態における投与により得られたニロチニブの血漿ＡＵＣの２５％以内の、ニロチニブの血漿ＡＵＣをもたらす、請求項１３に記載の医薬組成物。 (i) administration of the pharmaceutical composition to the subject in the fed state provides nilotinib within 30%, preferably within 25% of the plasma C max of nilotinib obtained by administering the pharmaceutical composition to the subject in the fasted state; resulting in a plasma C max of
(ii) administration of the pharmaceutical composition to the subject in the fed state results in a plasma AUC of nilotinib within 30%, preferably within 15% of the plasma AUC of nilotinib obtained by administration of the pharmaceutical composition to the subject in the fasted state; resulting in plasma AUC,
(iii) administration of the pharmaceutical composition to the subject in the fed state is obtained by administration in the fasted state of a nilotinib crystalline immediate release formulation having 2 to 4 times the amount of nilotinib in the pharmaceutical composition; produce a plasma Cmax of nilotinib within 25% of the max , or
(iv) administration of the pharmaceutical composition to the subject in the fed state is plasma of nilotinib obtained by administration in the fasted state of a nilotinib crystal immediate release formulation having 2 to 4 times the amount of nilotinib in the pharmaceutical composition; 14. The pharmaceutical composition of claim 13 , which provides a plasma AUC of nilotinib within 25% of the AUC .
添付文書が、医薬組成物を食物と一緒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 any one of claims 1 to 9 and a package insert,
Said kit, wherein the package insert informs the user that the pharmaceutical composition can be administered with food.
添付文書が、食物の有無にかかわらず医薬組成物を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 any one of claims 1 to 9 and a package insert,
Said kit, wherein the package insert informs the user that the pharmaceutical composition can be administered with or without food.
添付文書が、医薬組成物が食物と一緒に投与すべきではないとの警告を含まない、前記キット。 A kit for sale to users, comprising the pharmaceutical composition according to any one of claims 1 to 9 and a package insert,
Said kit, wherein the package insert does not include a warning that the pharmaceutical composition should not be administered with food.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202062968749P | 2020-01-31 | 2020-01-31 | |
| US62/968,749 | 2020-01-31 | ||
| PCT/US2021/015864 WO2021155254A1 (en) | 2020-01-31 | 2021-01-29 | Amorphous nilotinib microparticles and uses thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2023513045A JP2023513045A (en) | 2023-03-30 |
| JPWO2021155254A5 true JPWO2021155254A5 (en) | 2024-02-06 |
Family
ID=74759481
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022546499A Pending JP2023513045A (en) | 2020-01-31 | 2021-01-29 | Amorphous nilotinib microparticles and uses thereof |
Country Status (7)
| Country | Link |
|---|---|
| US (5) | US11389450B2 (en) |
| EP (1) | EP4096791A1 (en) |
| JP (1) | JP2023513045A (en) |
| AU (1) | AU2021212258A1 (en) |
| CA (1) | CA3168680A1 (en) |
| IL (1) | IL295007A (en) |
| WO (1) | WO2021155254A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112294971B (en) * | 2020-02-20 | 2022-02-01 | 深圳市泰力生物医药有限公司 | Nilotinib compositions having improved solubility |
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2021
- 2021-01-29 WO PCT/US2021/015864 patent/WO2021155254A1/en unknown
- 2021-01-29 AU AU2021212258A patent/AU2021212258A1/en active Pending
- 2021-01-29 IL IL295007A patent/IL295007A/en unknown
- 2021-01-29 EP EP21708444.1A patent/EP4096791A1/en active Pending
- 2021-01-29 CA CA3168680A patent/CA3168680A1/en active Pending
- 2021-01-29 JP JP2022546499A patent/JP2023513045A/en active Pending
- 2021-04-23 US US17/238,869 patent/US11389450B2/en active Active
-
2022
- 2022-07-18 US US17/866,939 patent/US20220362246A1/en active Pending
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- 2022-12-29 US US18/090,582 patent/US20230158026A1/en active Pending
-
2023
- 2023-01-06 US US18/094,050 patent/US20230181585A1/en active Pending
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