JP2016512210A5 - - Google Patents
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- Publication number
- JP2016512210A5 JP2016512210A5 JP2015562121A JP2015562121A JP2016512210A5 JP 2016512210 A5 JP2016512210 A5 JP 2016512210A5 JP 2015562121 A JP2015562121 A JP 2015562121A JP 2015562121 A JP2015562121 A JP 2015562121A JP 2016512210 A5 JP2016512210 A5 JP 2016512210A5
- Authority
- JP
- Japan
- Prior art keywords
- formulation
- buffer
- hydrate
- amount
- morphine sulfate
- 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
- 239000000203 mixture Substances 0.000 claims 17
- 238000009472 formulation Methods 0.000 claims 16
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 9
- GRVOTVYEFDAHCL-RTSZDRIGSA-N morphine sulfate pentahydrate Chemical compound O.O.O.O.O.OS(O)(=O)=O.O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O.O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O GRVOTVYEFDAHCL-RTSZDRIGSA-N 0.000 claims 7
- 239000000872 buffer Substances 0.000 claims 6
- 239000006172 buffering agent Substances 0.000 claims 6
- 235000002639 sodium chloride Nutrition 0.000 claims 6
- 229960004715 morphine sulfate Drugs 0.000 claims 5
- 239000011780 sodium chloride Substances 0.000 claims 5
- 239000002738 chelating agent Substances 0.000 claims 4
- 239000007951 isotonicity adjuster Substances 0.000 claims 4
- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 3
- 229940123973 Oxygen scavenger Drugs 0.000 claims 3
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims 3
- 229910052760 oxygen Inorganic materials 0.000 claims 3
- 239000001301 oxygen Substances 0.000 claims 3
- 230000035699 permeability Effects 0.000 claims 3
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 2
- 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 2
- OVBJJZOQPCKUOR-UHFFFAOYSA-L EDTA disodium salt dihydrate Chemical compound O.O.[Na+].[Na+].[O-]C(=O)C[NH+](CC([O-])=O)CC[NH+](CC([O-])=O)CC([O-])=O OVBJJZOQPCKUOR-UHFFFAOYSA-L 0.000 claims 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 2
- 239000007853 buffer solution Substances 0.000 claims 2
- 239000001110 calcium chloride Substances 0.000 claims 2
- 229960002713 calcium chloride Drugs 0.000 claims 2
- 229910001628 calcium chloride Inorganic materials 0.000 claims 2
- 235000011148 calcium chloride Nutrition 0.000 claims 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 2
- 229960002303 citric acid monohydrate Drugs 0.000 claims 2
- 230000000295 complement effect Effects 0.000 claims 2
- 239000011521 glass Substances 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- 229960005181 morphine Drugs 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 2
- 229960000999 sodium citrate dihydrate Drugs 0.000 claims 2
- 239000000243 solution Substances 0.000 claims 2
- -1 Only containing Substances 0.000 claims 1
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 229920002307 Dextran Polymers 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims 1
- 229960004543 anhydrous citric acid Drugs 0.000 claims 1
- 230000003078 antioxidant effect Effects 0.000 claims 1
- LLSDKQJKOVVTOJ-UHFFFAOYSA-L calcium chloride dihydrate Chemical compound O.O.[Cl-].[Cl-].[Ca+2] LLSDKQJKOVVTOJ-UHFFFAOYSA-L 0.000 claims 1
- 229940052299 calcium chloride dihydrate Drugs 0.000 claims 1
- 239000008121 dextrose Substances 0.000 claims 1
- 229940124274 edetate disodium Drugs 0.000 claims 1
- 239000012537 formulation buffer Substances 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 150000004677 hydrates Chemical class 0.000 claims 1
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- GRPSNTXTTSBKGW-BVGHQBMWSA-J magnesium;potassium;sodium;(3r,4s,5s,6r)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol;triacetate;chloride Chemical compound [Na+].[Mg+2].[Cl-].[K+].CC([O-])=O.CC([O-])=O.CC([O-])=O.OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O GRPSNTXTTSBKGW-BVGHQBMWSA-J 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 238000004806 packaging method and process Methods 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000001103 potassium chloride Substances 0.000 claims 1
- 235000011164 potassium chloride Nutrition 0.000 claims 1
- 229960002816 potassium chloride Drugs 0.000 claims 1
- 229940071643 prefilled syringe Drugs 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 229960002668 sodium chloride Drugs 0.000 claims 1
- 239000001540 sodium lactate Substances 0.000 claims 1
- 235000011088 sodium lactate Nutrition 0.000 claims 1
- 229940005581 sodium lactate Drugs 0.000 claims 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361785218P | 2013-03-14 | 2013-03-14 | |
| US61/785,218 | 2013-03-14 | ||
| PCT/EP2014/054831 WO2014140095A1 (en) | 2013-03-14 | 2014-03-12 | Injectable morphine formulations |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016512210A JP2016512210A (ja) | 2016-04-25 |
| JP2016512210A5 true JP2016512210A5 (enExample) | 2017-06-01 |
| JP6215970B2 JP6215970B2 (ja) | 2017-10-18 |
Family
ID=50288050
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015562121A Active JP6215970B2 (ja) | 2013-03-14 | 2014-03-12 | 注射可能なモルヒネ製剤 |
Country Status (8)
| Country | Link |
|---|---|
| US (7) | US9072781B2 (enExample) |
| EP (2) | EP2968132B1 (enExample) |
| JP (1) | JP6215970B2 (enExample) |
| CN (2) | CN104042565A (enExample) |
| AU (1) | AU2014230834B9 (enExample) |
| BR (1) | BR112015021586B1 (enExample) |
| CA (1) | CA2902343C (enExample) |
| WO (1) | WO2014140095A1 (enExample) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2695158T3 (es) | 2013-03-14 | 2019-01-02 | Fresenius Kabi Deutschland Gmbh | Sistema de envasado para fármacos sensibles al oxígeno |
| WO2014140095A1 (en) * | 2013-03-14 | 2014-09-18 | Becton Dickinson France S.A.S. | Injectable morphine formulations |
| HUE052280T2 (hu) * | 2014-12-03 | 2021-04-28 | Csl Behring Ag | Immunoglobulinokat tartalmazó megnövelt stabilitású gyógyszerészeti termék |
| US9119876B1 (en) | 2015-03-13 | 2015-09-01 | Par Pharmaceutical, Inc. | Epinephrine formulations |
| US20170189352A1 (en) | 2015-03-13 | 2017-07-06 | Par Pharmaceutical, Inc. | Epinephrine formulations |
| US20180104366A1 (en) * | 2015-05-25 | 2018-04-19 | Isotherapeutics Group, Llc | Dotmp kit formulations for radioisotopes |
| US11369700B2 (en) | 2015-05-25 | 2022-06-28 | IGL Pharma Inc. | DOTMP kit formulations for radioisotopes |
| EP3290025B1 (en) * | 2016-09-02 | 2020-02-12 | Sun Pharmaceutical Industries Ltd | Stable infusion dosage form of morphine |
| EP3515412B1 (en) * | 2016-09-23 | 2025-04-23 | Grünenthal GmbH | Stable formulation for parenteral administration of tapentadol |
| US10653646B2 (en) | 2018-03-23 | 2020-05-19 | Nevakar Inc. | Epinephrine compositions and containers |
| CN114207101B (zh) | 2019-07-31 | 2024-05-31 | 埃科莱布美国股份有限公司 | 免用个人防护设备的脱灰剂组合物 |
| US11806320B2 (en) | 2020-02-19 | 2023-11-07 | Endo Ventures Limited | Isoproterenol compositions and methods |
| WO2022131117A1 (ja) * | 2020-12-18 | 2022-06-23 | 富士フイルム富山化学株式会社 | 医薬組成物 |
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| WO2014140095A1 (en) | 2013-03-14 | 2014-09-18 | Becton Dickinson France S.A.S. | Injectable morphine formulations |
| ES2695158T3 (es) | 2013-03-14 | 2019-01-02 | Fresenius Kabi Deutschland Gmbh | Sistema de envasado para fármacos sensibles al oxígeno |
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2014
- 2014-03-12 WO PCT/EP2014/054831 patent/WO2014140095A1/en not_active Ceased
- 2014-03-12 JP JP2015562121A patent/JP6215970B2/ja active Active
- 2014-03-12 EP EP14710529.0A patent/EP2968132B1/en not_active Not-in-force
- 2014-03-12 EP EP16188526.4A patent/EP3143988A1/en not_active Withdrawn
- 2014-03-12 AU AU2014230834A patent/AU2014230834B9/en active Active
- 2014-03-12 BR BR112015021586-6A patent/BR112015021586B1/pt active IP Right Grant
- 2014-03-12 US US14/207,245 patent/US9072781B2/en active Active
- 2014-03-12 CA CA2902343A patent/CA2902343C/en active Active
- 2014-03-14 CN CN201410097764.7A patent/CN104042565A/zh active Pending
- 2014-03-14 CN CN201811072429.6A patent/CN109125254A/zh active Pending
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2015
- 2015-05-18 US US14/715,277 patent/US9192608B2/en active Active
- 2015-10-20 US US14/887,803 patent/US10213424B2/en active Active
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2019
- 2019-02-11 US US16/272,108 patent/US20190167665A1/en not_active Abandoned
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2020
- 2020-03-18 US US16/823,073 patent/US20200345720A1/en not_active Abandoned
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2023
- 2023-04-28 US US18/309,069 patent/US20230414604A1/en not_active Abandoned
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2024
- 2024-10-28 US US18/928,917 patent/US20250228846A1/en active Pending