JP2020536089A5 - - Google Patents
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- Publication number
- JP2020536089A5 JP2020536089A5 JP2020518795A JP2020518795A JP2020536089A5 JP 2020536089 A5 JP2020536089 A5 JP 2020536089A5 JP 2020518795 A JP2020518795 A JP 2020518795A JP 2020518795 A JP2020518795 A JP 2020518795A JP 2020536089 A5 JP2020536089 A5 JP 2020536089A5
- Authority
- JP
- Japan
- Prior art keywords
- unit dosage
- dosage form
- liquid unit
- pharmaceutical composition
- gabapentinoid
- 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
- 239000002552 dosage form Substances 0.000 claims description 152
- 239000007788 liquid Substances 0.000 claims description 139
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims description 98
- 239000008194 pharmaceutical composition Substances 0.000 claims description 87
- 238000000034 method Methods 0.000 claims description 56
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 54
- 229960005489 paracetamol Drugs 0.000 claims description 49
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 36
- 239000002253 acid Substances 0.000 claims description 36
- 239000003002 pH adjusting agent Substances 0.000 claims description 30
- 229960001233 pregabalin Drugs 0.000 claims description 30
- AYXYPKUFHZROOJ-ZETCQYMHSA-N pregabalin Chemical compound CC(C)C[C@H](CN)CC(O)=O AYXYPKUFHZROOJ-ZETCQYMHSA-N 0.000 claims description 30
- 150000003839 salts Chemical class 0.000 claims description 25
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 23
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 21
- 238000004519 manufacturing process Methods 0.000 claims description 20
- 239000012535 impurity Substances 0.000 claims description 18
- 239000011780 sodium chloride Substances 0.000 claims description 18
- 239000007857 degradation product Substances 0.000 claims description 16
- 239000000203 mixture Substances 0.000 claims description 16
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims description 12
- UGJMXCAKCUNAIE-UHFFFAOYSA-N Gabapentin Chemical compound OC(=O)CC1(CN)CCCCC1 UGJMXCAKCUNAIE-UHFFFAOYSA-N 0.000 claims description 12
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical group Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 12
- 238000004587 chromatography analysis Methods 0.000 claims description 12
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 12
- 229920000642 polymer Polymers 0.000 claims description 12
- 239000000411 inducer Substances 0.000 claims description 11
- PLIKAWJENQZMHA-UHFFFAOYSA-N 4-aminophenol Chemical compound NC1=CC=C(O)C=C1 PLIKAWJENQZMHA-UHFFFAOYSA-N 0.000 claims description 8
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 8
- 239000004743 Polypropylene Substances 0.000 claims description 8
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 8
- 229910052782 aluminium Inorganic materials 0.000 claims description 8
- 239000011521 glass Substances 0.000 claims description 8
- -1 polypropylene Polymers 0.000 claims description 8
- 229920001155 polypropylene Polymers 0.000 claims description 8
- 208000002193 Pain Diseases 0.000 claims description 6
- 229960002870 gabapentin Drugs 0.000 claims description 6
- 238000004806 packaging method and process Methods 0.000 claims description 6
- 238000001356 surgical procedure Methods 0.000 claims description 6
- GUGXRXLTTHFKHC-UHFFFAOYSA-N 4-(2-methylpropyl)pyrrolidin-2-one Chemical compound CC(C)CC1CNC(=O)C1 GUGXRXLTTHFKHC-UHFFFAOYSA-N 0.000 claims description 4
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 4
- YASYEJJMZJALEJ-UHFFFAOYSA-N Citric acid monohydrate Chemical compound O.OC(=O)CC(O)(C(O)=O)CC(O)=O YASYEJJMZJALEJ-UHFFFAOYSA-N 0.000 claims description 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 4
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims description 4
- 229930195725 Mannitol Natural products 0.000 claims description 4
- 229940123973 Oxygen scavenger Drugs 0.000 claims description 4
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 4
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims description 4
- 229960004106 citric acid Drugs 0.000 claims description 4
- 229960002303 citric acid monohydrate Drugs 0.000 claims description 4
- 238000000354 decomposition reaction Methods 0.000 claims description 4
- 239000000594 mannitol Substances 0.000 claims description 4
- 235000010355 mannitol Nutrition 0.000 claims description 4
- 229910000402 monopotassium phosphate Inorganic materials 0.000 claims description 4
- 235000019796 monopotassium phosphate Nutrition 0.000 claims description 4
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims description 4
- 235000019799 monosodium phosphate Nutrition 0.000 claims description 4
- 239000001301 oxygen Substances 0.000 claims description 4
- 229910052760 oxygen Inorganic materials 0.000 claims description 4
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 claims description 4
- 229940071643 prefilled syringe Drugs 0.000 claims description 4
- 239000000047 product Substances 0.000 claims description 4
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims description 4
- 238000002211 ultraviolet spectrum Methods 0.000 claims description 4
- 230000005526 G1 to G0 transition Effects 0.000 claims description 2
- 208000004550 Postoperative Pain Diseases 0.000 claims description 2
- 230000000274 adsorptive effect Effects 0.000 claims description 2
- 238000004128 high performance liquid chromatography Methods 0.000 claims description 2
- 229960002885 histidine Drugs 0.000 claims description 2
- 238000007918 intramuscular administration Methods 0.000 claims description 2
- 238000001990 intravenous administration Methods 0.000 claims description 2
- 230000014759 maintenance of location Effects 0.000 claims description 2
- 238000013508 migration Methods 0.000 claims description 2
- 230000005012 migration Effects 0.000 claims description 2
- 229910052757 nitrogen Inorganic materials 0.000 claims description 2
- 239000002245 particle Substances 0.000 claims description 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 2
- 229940127557 pharmaceutical product Drugs 0.000 claims description 2
- 238000007920 subcutaneous administration Methods 0.000 claims description 2
- 239000012530 fluid Substances 0.000 claims 11
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 230000001939 inductive effect Effects 0.000 claims 1
- 125000000959 isobutyl group Chemical group [H]C([H])([H])C([H])(C([H])([H])[H])C([H])([H])* 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762567384P | 2017-10-03 | 2017-10-03 | |
| US62/567,384 | 2017-10-03 | ||
| PCT/US2018/053864 WO2019070641A1 (en) | 2017-10-03 | 2018-10-02 | COMBINATIONS OF ACETAMINOPHENE-PRÉGABALINE AND METHODS OF TREATING PAIN |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020536089A JP2020536089A (ja) | 2020-12-10 |
| JP2020536089A5 true JP2020536089A5 (https=) | 2021-11-04 |
| JP7249670B2 JP7249670B2 (ja) | 2023-03-31 |
Family
ID=65995245
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020518795A Active JP7249670B2 (ja) | 2017-10-03 | 2018-10-02 | アセトアミノフェン－プレガバリン組み合わせ及び疼痛を処置する方法 |
Country Status (6)
| Country | Link |
|---|---|
| US (2) | US11547686B2 (https=) |
| EP (1) | EP3691748A4 (https=) |
| JP (1) | JP7249670B2 (https=) |
| CN (1) | CN111432882A (https=) |
| CA (1) | CA3075414A1 (https=) |
| WO (1) | WO2019070641A1 (https=) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022178018A1 (en) * | 2021-02-19 | 2022-08-25 | Nevakar Injectables Inc. | Liquid unit dosage forms for treatment of pain |
| WO2022256545A1 (en) * | 2021-06-04 | 2022-12-08 | Nevakar Injectables Inc. | Injectable pregabalin formulations |
| CN115475162B (zh) * | 2022-10-18 | 2023-06-02 | 浙江震元制药有限公司 | 4-异丁基-2-吡咯烷酮在制备镇痛药物中的应用、一种镇痛药物 |
| GR1011104B (el) * | 2024-12-18 | 2026-01-16 | Ιουλια Τσετη | Προγεμισμενη συριγγα υδατικου διαλυματος παρακεταμολης καταλληλη για ενεσιμη χορηγηση |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2121435C (en) * | 1993-04-16 | 2002-01-22 | Sheila M. Ratnaraj | Aqueous pharmaceutical suspension and process for preparation thereof |
| WO1999008670A1 (en) | 1997-08-20 | 1999-02-25 | Guglietta, Antonio | Gaba analogs to prevent and treat gastrointestinal damage |
| US6451857B1 (en) | 1999-03-10 | 2002-09-17 | Warner-Lambert Company | Analgesic compositions comprising anti-epileptic compounds and methods of using same |
| US20050004219A1 (en) | 2003-07-01 | 2005-01-06 | Medtronic, Inc. | Pump systems including injectable gabapentin compositions |
| GB2416122A (en) * | 2004-07-12 | 2006-01-18 | Ipsen Ltd | Botulinum neurotoxin composition |
| US7488846B2 (en) * | 2005-04-11 | 2009-02-10 | Teva Pharmaceuical Industries Ltd. | Pregabalin free of lactam and a process for preparation thereof |
| MX2007006091A (es) | 2007-05-21 | 2009-02-25 | World Trade Imp Export Wtie Ag | Composicion farmaceutica que comprende la combinacion de un agente antiinflamatorio no esteroideo y un agente anticonvulsionante. |
| WO2009046801A1 (en) | 2007-10-09 | 2009-04-16 | Merck Patent Gmbh | Pharmaceutical compositions containing benfotiamine and one or one more pharmaceutically active agents for the treatment of pain conditions of neuropathic origin |
| US20120245230A1 (en) * | 2009-12-10 | 2012-09-27 | Tecnimede-Sociedade Tecnico- Medicinal, S.A. | Method and composition for preparing stable liquid formulations of paracetamol |
| EP2923694B1 (en) * | 2014-03-27 | 2018-11-14 | Sanovel Ilac Sanayi ve Ticaret A.S. | Oral liquid pharmaceutical solution of gabapentin |
| EP2946767B1 (en) * | 2014-05-23 | 2016-10-05 | Ares Trading S.A. | Liquid pharmaceutical composition |
| US20190029979A1 (en) * | 2016-02-05 | 2019-01-31 | Innopharma, Inc. | Process of Manufacturing a Stable, Ready to Use Infusion Bag for an Oxidation Sensitive Formulation |
| WO2017177160A1 (en) | 2016-04-07 | 2017-10-12 | Nevakar Llc | Formulation for use in a method of treatment of pain |
-
2018
- 2018-10-02 JP JP2020518795A patent/JP7249670B2/ja active Active
- 2018-10-02 CN CN201880078361.4A patent/CN111432882A/zh active Pending
- 2018-10-02 CA CA3075414A patent/CA3075414A1/en active Pending
- 2018-10-02 EP EP18864043.7A patent/EP3691748A4/en not_active Withdrawn
- 2018-10-02 WO PCT/US2018/053864 patent/WO2019070641A1/en not_active Ceased
- 2018-10-02 US US16/753,042 patent/US11547686B2/en active Active
-
2022
- 2022-12-06 US US18/076,264 patent/US20230106270A1/en not_active Abandoned
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