JPWO2022004859A5 - - Google Patents
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- Publication number
- JPWO2022004859A5 JPWO2022004859A5 JP2022529745A JP2022529745A JPWO2022004859A5 JP WO2022004859 A5 JPWO2022004859 A5 JP WO2022004859A5 JP 2022529745 A JP2022529745 A JP 2022529745A JP 2022529745 A JP2022529745 A JP 2022529745A JP WO2022004859 A5 JPWO2022004859 A5 JP WO2022004859A5
- Authority
- JP
- Japan
- Prior art keywords
- acid
- pharmaceutical composition
- composition according
- oral pharmaceutical
- inorganic
- 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.)
- Granted
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- 239000008203 oral pharmaceutical composition Substances 0.000 claims 7
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 6
- 150000007522 mineralic acids Chemical class 0.000 claims 5
- 150000007524 organic acids Chemical class 0.000 claims 5
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims 4
- 229920001477 hydrophilic polymer Polymers 0.000 claims 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 3
- 229960003943 hypromellose Drugs 0.000 claims 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims 2
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims 2
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims 2
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 2
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims 2
- 239000002253 acid Substances 0.000 claims 2
- WNLRTRBMVRJNCN-UHFFFAOYSA-N adipic acid Chemical compound OC(=O)CCCCC(O)=O WNLRTRBMVRJNCN-UHFFFAOYSA-N 0.000 claims 2
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims 2
- 235000015165 citric acid Nutrition 0.000 claims 2
- -1 copolyvidone Polymers 0.000 claims 2
- 239000004220 glutamic acid Substances 0.000 claims 2
- 235000013922 glutamic acid Nutrition 0.000 claims 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims 2
- 235000011007 phosphoric acid Nutrition 0.000 claims 2
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 2
- 239000011975 tartaric acid Substances 0.000 claims 2
- 235000002906 tartaric acid Nutrition 0.000 claims 2
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 1
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 claims 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims 1
- 235000011054 acetic acid Nutrition 0.000 claims 1
- IYKJEILNJZQJPU-UHFFFAOYSA-N acetic acid;butanedioic acid Chemical compound CC(O)=O.OC(=O)CCC(O)=O IYKJEILNJZQJPU-UHFFFAOYSA-N 0.000 claims 1
- 150000007513 acids Chemical class 0.000 claims 1
- 239000001361 adipic acid Substances 0.000 claims 1
- 235000011037 adipic acid Nutrition 0.000 claims 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims 1
- 239000011668 ascorbic acid Substances 0.000 claims 1
- 235000010323 ascorbic acid Nutrition 0.000 claims 1
- 229960005070 ascorbic acid Drugs 0.000 claims 1
- 235000003704 aspartic acid Nutrition 0.000 claims 1
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Natural products OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 claims 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 239000001530 fumaric acid Substances 0.000 claims 1
- 235000011087 fumaric acid Nutrition 0.000 claims 1
- 229920000578 graft copolymer Polymers 0.000 claims 1
- 235000011167 hydrochloric acid Nutrition 0.000 claims 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 1
- 239000004310 lactic acid Substances 0.000 claims 1
- 235000014655 lactic acid Nutrition 0.000 claims 1
- 239000001630 malic acid Substances 0.000 claims 1
- 235000011090 malic acid Nutrition 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- 229940068984 polyvinyl alcohol Drugs 0.000 claims 1
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229940069328 povidone Drugs 0.000 claims 1
- 239000006188 syrup Substances 0.000 claims 1
- 235000020357 syrup Nutrition 0.000 claims 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims 1
Claims (8)
- ＡＲＴ－００１（セラベリシブ）と、無機又は有機の酸と、親水性ポリマーとを含み、ここで無機又は有機の酸が、リン酸、塩酸、クエン酸、リンゴ酸、酒石酸、アスコルビン酸、フマル酸、コハク酸、アスパラギン酸、乳酸、酢酸、グルタミン酸、及びアジピン酸から選択される１種又は２種以上の酸である、経口用医薬組成物。
- 無機又は有機の酸として、少なくともリン酸、クエン酸、酒石酸、及びグルタミン酸から選択される酸を含む、請求項１に記載の経口用医薬組成物。
- 親水性ポリマーが、ポリビニルアルコール、ポビドン、ヒプロメロース、コポリビドン、ヒドロキシプロピルセルロース、ポリビニルアルコール・ポリエチレングリコール・グラフトコポリマー、ヒプロメロースフタル酸エステル、及びヒプロメロース酢酸エステルコハク酸エステルから選択される１種又は２種以上のポリマーである、請求項１又は２に記載の経口用医薬組成物。
- ＡＲＴ－００１（セラベリシブ）の含有率が２～４０質量％の範囲である、請求項１～３の何れか一項に記載の経口用医薬組成物。
- ＡＲＴ－００１（セラベリシブ）１質量部に対する無機又は有機の酸の含有割合が０．１～１０質量部の範囲である、請求項１～４の何れか一項に記載の経口用医薬組成物。
- ＡＲＴ－００１（セラベリシブ）１質量部に対する親水性ポリマーの含有割合が０．０２～５質量部の範囲である、請求項１～５の何れか一項に記載の経口用医薬組成物。
- ドライシロップ剤である、請求項１～６の何れか一項に記載の経口用医薬組成物。
- 請求項１～７の何れか一項に記載の経口用医薬組成物を製造する方法であって、ＡＲＴ－００１（セラベリシブ）、無機又は有機の酸、及び親水性ポリマーを含む混合物を湿式造粒し、乾燥することを含む方法。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2022152235A JP2022174317A (ja) | 2020-07-02 | 2022-09-26 | 経口用医薬組成物及びその製造方法 |
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2020114978 | 2020-07-02 | ||
| JP2020114978 | 2020-07-02 | ||
| JP2021011901 | 2021-01-28 | ||
| JP2021011901 | 2021-01-28 | ||
| PCT/JP2021/025019 WO2022004859A1 (ja) | 2020-07-02 | 2021-07-01 | 経口用医薬組成物及びその製造方法 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022152235A Division JP2022174317A (ja) | 2020-07-02 | 2022-09-26 | 経口用医薬組成物及びその製造方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JPWO2022004859A1 JPWO2022004859A1 (ja) | 2022-01-06 |
| JPWO2022004859A5 true JPWO2022004859A5 (ja) | 2022-07-21 |
| JP7149449B2 JP7149449B2 (ja) | 2022-10-06 |
Family
ID=79316406
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022529745A Active JP7149449B2 (ja) | 2020-07-02 | 2021-07-01 | 経口用医薬組成物及びその製造方法 |
| JP2022152235A Pending JP2022174317A (ja) | 2020-07-02 | 2022-09-26 | 経口用医薬組成物及びその製造方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022152235A Pending JP2022174317A (ja) | 2020-07-02 | 2022-09-26 | 経口用医薬組成物及びその製造方法 |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US20230364063A1 (ja) |
| EP (1) | EP4176902A1 (ja) |
| JP (2) | JP7149449B2 (ja) |
| KR (1) | KR20230034207A (ja) |
| CN (1) | CN115989022A (ja) |
| AU (1) | AU2021299348A1 (ja) |
| CA (1) | CA3182166A1 (ja) |
| TW (1) | TW202216117A (ja) |
| WO (1) | WO2022004859A1 (ja) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023239337A1 (en) * | 2022-06-08 | 2023-12-14 | Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi | A pharmaceutical composition comprising palbociclib |
| JP2024086701A (ja) * | 2022-12-16 | 2024-06-27 | ＡＲＴｈａｍ Ｔｈｅｒａｐｅｕｔｉｃｓ株式会社 | 脈管奇形用医薬組成物及び脈管奇形の治療方法 |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6287599B1 (en) * | 2000-12-20 | 2001-09-11 | Shire Laboratories, Inc. | Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles |
| GB0517205D0 (en) | 2005-08-22 | 2005-09-28 | Novartis Ag | Organic compounds |
| BRPI0614870A2 (pt) * | 2005-08-22 | 2011-04-19 | Novartis Ag | composições farmacêuticas |
| CN107530342A (zh) | 2015-04-28 | 2018-01-02 | 安斯泰来制药有限公司 | 口服给药用医药组合物 |
| KR102068423B1 (ko) | 2015-06-04 | 2020-01-20 | 화이자 인코포레이티드 | 팔보시클립의 고체 투여 형태 |
| CN109078006B (zh) | 2016-03-29 | 2021-04-20 | 深圳市药欣生物科技有限公司 | 一种帕布昔利布的药物制剂及其制备方法 |
-
2021
- 2021-07-01 US US18/013,616 patent/US20230364063A1/en active Pending
- 2021-07-01 CN CN202180044261.1A patent/CN115989022A/zh active Pending
- 2021-07-01 CA CA3182166A patent/CA3182166A1/en active Pending
- 2021-07-01 WO PCT/JP2021/025019 patent/WO2022004859A1/ja active Application Filing
- 2021-07-01 KR KR1020227041888A patent/KR20230034207A/ko active Search and Examination
- 2021-07-01 EP EP21834289.7A patent/EP4176902A1/en active Pending
- 2021-07-01 JP JP2022529745A patent/JP7149449B2/ja active Active
- 2021-07-01 TW TW110124197A patent/TW202216117A/zh unknown
- 2021-07-01 AU AU2021299348A patent/AU2021299348A1/en active Pending
-
2022
- 2022-09-26 JP JP2022152235A patent/JP2022174317A/ja active Pending
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