JP2020526538A5 - - Google Patents
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- Publication number
- JP2020526538A5 JP2020526538A5 JP2020501137A JP2020501137A JP2020526538A5 JP 2020526538 A5 JP2020526538 A5 JP 2020526538A5 JP 2020501137 A JP2020501137 A JP 2020501137A JP 2020501137 A JP2020501137 A JP 2020501137A JP 2020526538 A5 JP2020526538 A5 JP 2020526538A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- bedaquiline
- months
- composition according
- pharmaceutically acceptable
- 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
Links
- 239000008194 pharmaceutical composition Substances 0.000 claims description 21
- 150000003839 salts Chemical class 0.000 claims description 20
- QUIJNHUBAXPXFS-XLJNKUFUSA-N bedaquiline Chemical compound C1([C@H](C2=CC3=CC(Br)=CC=C3N=C2OC)[C@@](O)(CCN(C)C)C=2C3=CC=CC=C3C=CC=2)=CC=CC=C1 QUIJNHUBAXPXFS-XLJNKUFUSA-N 0.000 claims description 17
- 229960000508 bedaquiline Drugs 0.000 claims description 17
- 239000000203 mixture Substances 0.000 claims description 15
- 239000011859 microparticle Substances 0.000 claims description 10
- 239000002105 nanoparticle Substances 0.000 claims description 10
- 239000003607 modifier Substances 0.000 claims description 6
- 239000002245 particle Substances 0.000 claims description 6
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims description 4
- 229920001983 poloxamer Polymers 0.000 claims description 4
- 238000010254 subcutaneous injection Methods 0.000 claims description 4
- 239000007929 subcutaneous injection Substances 0.000 claims description 4
- 239000000725 suspension Substances 0.000 claims description 4
- 206010062207 Mycobacterial infection Diseases 0.000 claims description 3
- 241000186362 Mycobacterium leprae Species 0.000 claims description 3
- 241000187479 Mycobacterium tuberculosis Species 0.000 claims description 3
- 238000010255 intramuscular injection Methods 0.000 claims description 3
- 239000007927 intramuscular injection Substances 0.000 claims description 3
- 208000027531 mycobacterial infectious disease Diseases 0.000 claims description 3
- 230000001717 pathogenic effect Effects 0.000 claims description 3
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical group OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims description 2
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims description 2
- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- 229920001214 Polysorbate 60 Polymers 0.000 claims description 2
- 229930003427 Vitamin E Natural products 0.000 claims description 2
- 239000008365 aqueous carrier Substances 0.000 claims description 2
- 239000000872 buffer Substances 0.000 claims description 2
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 2
- 229940079593 drug Drugs 0.000 claims description 2
- 239000003814 drug Substances 0.000 claims description 2
- 229930195729 fatty acid Natural products 0.000 claims description 2
- 239000000194 fatty acid Substances 0.000 claims description 2
- -1 fatty acid ester Chemical class 0.000 claims description 2
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims description 2
- 239000007951 isotonicity adjuster Substances 0.000 claims description 2
- 150000002632 lipids Chemical class 0.000 claims description 2
- 239000007788 liquid Substances 0.000 claims description 2
- 238000000034 method Methods 0.000 claims description 2
- 238000003801 milling Methods 0.000 claims description 2
- 229960000502 poloxamer Drugs 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 229920000136 polysorbate Polymers 0.000 claims description 2
- 239000003755 preservative agent Substances 0.000 claims description 2
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims description 2
- 229940046009 vitamin E Drugs 0.000 claims description 2
- 235000019165 vitamin E Nutrition 0.000 claims description 2
- 239000011709 vitamin E Substances 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 2
- 239000008215 water for injection Substances 0.000 claims description 2
- 239000000080 wetting agent Substances 0.000 claims description 2
- 238000012153 long-term therapy Methods 0.000 claims 1
- 210000003205 muscle Anatomy 0.000 claims 1
- 230000002335 preservative effect Effects 0.000 claims 1
- 206010065048 Latent tuberculosis Diseases 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 208000033353 latent tuberculosis infection Diseases 0.000 description 3
- 238000010172 mouse model Methods 0.000 description 2
- WDZCUPBHRAEYDL-GZAUEHORSA-N rifapentine Chemical compound O([C@](C1=O)(C)O/C=C/[C@@H]([C@H]([C@@H](OC(C)=O)[C@H](C)[C@H](O)[C@H](C)[C@@H](O)[C@@H](C)\C=C\C=C(C)/C(=O)NC=2C(O)=C3C(O)=C4C)C)OC)C4=C1C3=C(O)C=2\C=N\N(CC1)CCN1C1CCCC1 WDZCUPBHRAEYDL-GZAUEHORSA-N 0.000 description 2
- 229960002599 rifapentine Drugs 0.000 description 2
- 241000699670 Mus sp. Species 0.000 description 1
- 238000002512 chemotherapy Methods 0.000 description 1
- 238000011866 long-term treatment Methods 0.000 description 1
- 201000009671 multidrug-resistant tuberculosis Diseases 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
- 201000008827 tuberculosis Diseases 0.000 description 1
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2022108846A JP7441276B2 (ja) | 2017-07-14 | 2022-07-06 | 長時間作用型配合物 |
| JP2023216574A JP7620692B2 (ja) | 2017-07-14 | 2023-12-22 | 長時間作用型配合物 |
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17181354 | 2017-07-14 | ||
| EP17181354.6 | 2017-07-14 | ||
| EP18167463.1 | 2018-04-16 | ||
| EP18167463 | 2018-04-16 | ||
| PCT/EP2018/069066 WO2019012100A1 (en) | 2017-07-14 | 2018-07-13 | EXTENDED ACTION FORMULATIONS |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022108846A Division JP7441276B2 (ja) | 2017-07-14 | 2022-07-06 | 長時間作用型配合物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020526538A JP2020526538A (ja) | 2020-08-31 |
| JP2020526538A5 true JP2020526538A5 (enExample) | 2021-08-19 |
| JP7102500B2 JP7102500B2 (ja) | 2022-07-19 |
Family
ID=62874924
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020501137A Active JP7102500B2 (ja) | 2017-07-14 | 2018-07-13 | 長時間作用型配合物 |
| JP2022108846A Active JP7441276B2 (ja) | 2017-07-14 | 2022-07-06 | 長時間作用型配合物 |
| JP2023216574A Active JP7620692B2 (ja) | 2017-07-14 | 2023-12-22 | 長時間作用型配合物 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022108846A Active JP7441276B2 (ja) | 2017-07-14 | 2022-07-06 | 長時間作用型配合物 |
| JP2023216574A Active JP7620692B2 (ja) | 2017-07-14 | 2023-12-22 | 長時間作用型配合物 |
Country Status (28)
| Country | Link |
|---|---|
| US (2) | US11141384B2 (enExample) |
| EP (3) | EP4356968A3 (enExample) |
| JP (3) | JP7102500B2 (enExample) |
| KR (2) | KR102679979B1 (enExample) |
| CN (2) | CN115252548A (enExample) |
| AU (1) | AU2018298855B2 (enExample) |
| BR (1) | BR112020000687A2 (enExample) |
| CO (1) | CO2020000328A2 (enExample) |
| CY (1) | CY1124782T1 (enExample) |
| DK (2) | DK3943070T3 (enExample) |
| ES (2) | ES2970801T3 (enExample) |
| FI (1) | FI3943070T3 (enExample) |
| HR (2) | HRP20240058T1 (enExample) |
| HU (2) | HUE064651T2 (enExample) |
| JO (1) | JOP20200004B1 (enExample) |
| LT (2) | LT3943070T (enExample) |
| MD (1) | MD3651736T2 (enExample) |
| MX (1) | MX393782B (enExample) |
| PE (1) | PE20200336A1 (enExample) |
| PH (1) | PH12020500076A1 (enExample) |
| PL (2) | PL3651736T3 (enExample) |
| RS (2) | RS65207B1 (enExample) |
| SA (1) | SA520410975B1 (enExample) |
| SI (2) | SI3651736T1 (enExample) |
| SM (2) | SMT202100557T1 (enExample) |
| UA (1) | UA126403C2 (enExample) |
| WO (1) | WO2019012100A1 (enExample) |
| ZA (1) | ZA202000215B (enExample) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2018298855B2 (en) | 2017-07-14 | 2024-07-18 | Janssen Pharmaceutica Nv | Long-acting formulations |
| US20220023282A1 (en) * | 2018-12-13 | 2022-01-27 | Mannkind Corporation | Compositions of Bedaquiline, Combinations Comprising Them, Processes for Their Preparation, Uses and Methods of Treatment Comprising Them |
| JP2023533014A (ja) | 2020-07-09 | 2023-08-01 | ヤンセン ファーマシューティカ エヌ．ベー． | 長時間作用型配合物 |
| CA3184868A1 (en) * | 2020-07-09 | 2022-01-13 | Rene Holm | Long-acting formulations |
| CA3182854A1 (en) | 2020-07-09 | 2022-01-13 | Rene Holm | Long-acting formulations |
| TW202233168A (zh) * | 2020-11-12 | 2022-09-01 | 比利時商健生藥品公司 | 治療非結核分枝桿菌疾病的藥物組分之組合 |
| US11793808B2 (en) | 2021-02-22 | 2023-10-24 | Mannkind Corp. | Compositions of clofazimine, combinations comprising them, processes for their preparation, uses and methods comprising them |
| WO2024068693A1 (en) | 2022-09-28 | 2024-04-04 | Janssen Pharmaceutica Nv | Long-acting formulations |
| TW202423427A (zh) | 2022-09-28 | 2024-06-16 | 比利時商健生藥品公司 | 長效配方 |
Family Cites Families (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5145684A (en) | 1991-01-25 | 1992-09-08 | Sterling Drug Inc. | Surface modified drug nanoparticles |
| US5346702A (en) | 1992-12-04 | 1994-09-13 | Sterling Winthrop Inc. | Use of non-ionic cloud point modifiers to minimize nanoparticle aggregation during sterilization |
| US5352459A (en) | 1992-12-16 | 1994-10-04 | Sterling Winthrop Inc. | Use of purified surface modifiers to prevent particle aggregation during sterilization |
| US6495534B2 (en) | 2000-05-15 | 2002-12-17 | Pharmacia & Upjohn Spa | Stabilized aqueous suspensions for parenteral use |
| SI1527050T1 (sl) | 2002-07-25 | 2010-08-31 | Janssen Pharmaceutica Nv | Kinolinski derivati in njihova uporaba kot mikobakterijski inhibitorji |
| EE05394B1 (et) | 2004-12-24 | 2011-04-15 | Janssen Pharmaceutica N.V. | Kinoliinihendid kasutamiseks latentse tuberkuloosi ravis |
| SG162724A1 (en) | 2005-05-25 | 2010-07-29 | Janssen Pharmaceutica Nv | Process for preparing <alpha s, beta r>-6-bromo-alpha-[2-<dimethylamino>ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol |
| PT3366278T (pt) * | 2006-06-23 | 2024-10-21 | Janssen Sciences Ireland Unlimited Co | Suspensões aquosas de tmc278 |
| UA97813C2 (uk) | 2006-12-05 | 2012-03-26 | Янссен Фармацевтика Н.В. | Фумаратна сіль (альфа s, бета r)-6-бром-альфа-[2-(диметиламіно)етил]-2-метоксі-альфа-1-нафталеніл-бета-феніл-3-хінолінетанолу |
| TW201023912A (en) | 2008-12-05 | 2010-07-01 | Alcon Res Ltd | Pharmaceutical suspension |
| US9421194B2 (en) | 2010-04-05 | 2016-08-23 | Rutgers, The State University Of New Jersey | Lung targeting dual drug delivery system |
| TWI577377B (zh) | 2010-09-16 | 2017-04-11 | Ｖｉｉｖ醫療保健公司 | 醫藥組合物 |
| HRP20201241T1 (hr) | 2011-04-15 | 2020-11-27 | Janssen Pharmaceutica N.V. | Nanosuspenzije lijeka osušene zamrzavanjem |
| MX2017001656A (es) | 2014-08-08 | 2017-07-24 | Pharmacyclics Llc | Combinaciones de inhibidor de tirosina cinasa de bruton y usos de estas. |
| KR102631986B1 (ko) | 2015-01-27 | 2024-01-30 | 얀센 파마슈티카 엔브이 | 분산성 조성물 |
| WO2016179231A1 (en) * | 2015-05-04 | 2016-11-10 | Board Of Trustees Of Michigan State University | Compositions and methods for inhibiting bacterial growth |
| AU2016338637A1 (en) | 2015-10-14 | 2018-04-26 | The Global Alliance For Tb Drug Development, Inc. | Combination antibacterial composition and short-course antibacterial regimen |
| KR102106318B1 (ko) * | 2015-10-20 | 2020-05-06 | 쯔지앙 하이썬 파머슈티컬 컴퍼니, 리미티드 | 베다퀼린 푸마레이트의 결정형 및 그의 제조방법 |
| US20200179273A1 (en) | 2017-06-06 | 2020-06-11 | Merck Sharp & DohmeCorp | Long-action implant for treatment of infectious diseases |
| AU2018298855B2 (en) | 2017-07-14 | 2024-07-18 | Janssen Pharmaceutica Nv | Long-acting formulations |
| CA3184868A1 (en) | 2020-07-09 | 2022-01-13 | Rene Holm | Long-acting formulations |
| CA3182854A1 (en) | 2020-07-09 | 2022-01-13 | Rene Holm | Long-acting formulations |
| JP2023533014A (ja) | 2020-07-09 | 2023-08-01 | ヤンセン ファーマシューティカ エヌ．ベー． | 長時間作用型配合物 |
-
2018
- 2018-07-13 AU AU2018298855A patent/AU2018298855B2/en active Active
- 2018-07-13 MD MDE20200530T patent/MD3651736T2/ro not_active IP Right Cessation
- 2018-07-13 ES ES21178526T patent/ES2970801T3/es active Active
- 2018-07-13 JP JP2020501137A patent/JP7102500B2/ja active Active
- 2018-07-13 ES ES18739856T patent/ES2891976T3/es active Active
- 2018-07-13 PE PE2020000033A patent/PE20200336A1/es unknown
- 2018-07-13 KR KR1020207003364A patent/KR102679979B1/ko active Active
- 2018-07-13 HR HRP20240058TT patent/HRP20240058T1/hr unknown
- 2018-07-13 EP EP23206129.1A patent/EP4356968A3/en active Pending
- 2018-07-13 PL PL18739856T patent/PL3651736T3/pl unknown
- 2018-07-13 LT LTEP21178526.6T patent/LT3943070T/lt unknown
- 2018-07-13 BR BR112020000687-4A patent/BR112020000687A2/pt unknown
- 2018-07-13 DK DK21178526.6T patent/DK3943070T3/da active
- 2018-07-13 WO PCT/EP2018/069066 patent/WO2019012100A1/en not_active Ceased
- 2018-07-13 SM SM20210557T patent/SMT202100557T1/it unknown
- 2018-07-13 HU HUE21178526A patent/HUE064651T2/hu unknown
- 2018-07-13 EP EP21178526.6A patent/EP3943070B1/en active Active
- 2018-07-13 RS RS20240102A patent/RS65207B1/sr unknown
- 2018-07-13 US US16/630,676 patent/US11141384B2/en active Active
- 2018-07-13 UA UAA202000901A patent/UA126403C2/uk unknown
- 2018-07-13 RS RS20211178A patent/RS62362B1/sr unknown
- 2018-07-13 HU HUE18739856A patent/HUE055762T2/hu unknown
- 2018-07-13 SM SM20240033T patent/SMT202400033T1/it unknown
- 2018-07-13 SI SI201830409T patent/SI3651736T1/sl unknown
- 2018-07-13 DK DK18739856.5T patent/DK3651736T3/da active
- 2018-07-13 EP EP18739856.5A patent/EP3651736B1/en active Active
- 2018-07-13 CN CN202210671005.1A patent/CN115252548A/zh active Pending
- 2018-07-13 CN CN201880046696.8A patent/CN110869004B/zh active Active
- 2018-07-13 MX MX2020000461A patent/MX393782B/es unknown
- 2018-07-13 FI FIEP21178526.6T patent/FI3943070T3/fi active
- 2018-07-13 PL PL21178526.6T patent/PL3943070T3/pl unknown
- 2018-07-13 JO JOP/2020/0004A patent/JOP20200004B1/ar active
- 2018-07-13 HR HRP20211450TT patent/HRP20211450T1/hr unknown
- 2018-07-13 LT LTEPPCT/EP2018/069066T patent/LT3651736T/lt unknown
- 2018-07-13 KR KR1020247021329A patent/KR20240108542A/ko active Pending
- 2018-07-13 SI SI201930692T patent/SI3943070T1/sl unknown
-
2020
- 2020-01-06 SA SA520410975A patent/SA520410975B1/ar unknown
- 2020-01-09 PH PH12020500076A patent/PH12020500076A1/en unknown
- 2020-01-13 ZA ZA2020/00215A patent/ZA202000215B/en unknown
- 2020-01-14 CO CONC2020/0000328A patent/CO2020000328A2/es unknown
-
2021
- 2021-09-08 US US17/469,021 patent/US12171887B2/en active Active
- 2021-09-23 CY CY20211100837T patent/CY1124782T1/el unknown
-
2022
- 2022-07-06 JP JP2022108846A patent/JP7441276B2/ja active Active
-
2023
- 2023-12-22 JP JP2023216574A patent/JP7620692B2/ja active Active
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