JP2016512210A5 - - Google Patents
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- 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
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- 239000000203 mixture Substances 0.000 claims 18
- 238000009472 formulation Methods 0.000 claims 15
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 9
- UIIMBOGNXHQVGW-UHFFFAOYSA-M buffer Substances [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 8
- 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
- 239000006172 buffering agent Substances 0.000 claims 6
- MYMOFIZGZYHOMD-UHFFFAOYSA-N oxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 claims 6
- 229910052760 oxygen Inorganic materials 0.000 claims 6
- 239000001301 oxygen Substances 0.000 claims 6
- 239000011780 sodium chloride Substances 0.000 claims 6
- 235000002639 sodium chloride Nutrition 0.000 claims 6
- 229960004715 Morphine Sulfate Drugs 0.000 claims 5
- 239000002738 chelating agent Substances 0.000 claims 4
- 239000007951 isotonicity adjuster Substances 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- UXVMQQNJUSDDNG-UHFFFAOYSA-L cacl2 Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 3
- 230000035699 permeability Effects 0.000 claims 3
- 239000002516 radical scavenger Substances 0.000 claims 3
- 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 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
- 229960002303 citric acid monohydrate Drugs 0.000 claims 2
- 230000000295 complement 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
- 229930014694 morphine Natural products 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims 2
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate dihydrate 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
- WQZGKKKJIJFFOK-VFUOTHLCSA-N β-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
- -1 Only containing Substances 0.000 claims 1
- 229960004543 Anhydrous Citric Acid Drugs 0.000 claims 1
- 229940052299 Calcium Chloride Dihydrate Drugs 0.000 claims 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N D-Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- FBPFZTCFMRRESA-KAZBKCHUSA-N D-Mannitol Natural products OC[C@@H](O)[C@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KAZBKCHUSA-N 0.000 claims 1
- 229920002307 Dextran Polymers 0.000 claims 1
- 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 1
- 229960001484 Edetic Acid Drugs 0.000 claims 1
- GUBGYTABKSRVRQ-UUNJERMWSA-N Lactose Natural products O([C@@H]1[C@H](O)[C@H](O)[C@H](O)O[C@@H]1CO)[C@H]1[C@@H](O)[C@@H](O)[C@H](O)[C@H](CO)O1 GUBGYTABKSRVRQ-UUNJERMWSA-N 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 229940071643 Prefilled Syringe Drugs 0.000 claims 1
- 229940005581 Sodium Lactate Drugs 0.000 claims 1
- NGSFWBMYFKHRBD-UHFFFAOYSA-M Sodium lactate Chemical compound [Na+].CC(O)C([O-])=O NGSFWBMYFKHRBD-UHFFFAOYSA-M 0.000 claims 1
- 108060008443 TPPP Proteins 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
- 230000003078 antioxidant Effects 0.000 claims 1
- 229960004106 citric acid Drugs 0.000 claims 1
- 239000008121 dextrose Substances 0.000 claims 1
- ZGTMUACCHSMWAC-UHFFFAOYSA-L disodium;2-[2-[carboxylatomethyl(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetate Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 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
- GUBGYTABKSRVRQ-XLOQQCSPSA-N 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
- 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
- 150000003839 salts Chemical class 0.000 claims 1
- 235000017557 sodium bicarbonate Nutrition 0.000 claims 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims 1
- 229960001407 sodium bicarbonate Drugs 0.000 claims 1
- 229960002668 sodium chloride Drugs 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- 239000001540 sodium lactate Substances 0.000 claims 1
- 235000011088 sodium lactate Nutrition 0.000 claims 1
- 239000011778 trisodium citrate Substances 0.000 claims 1
Claims (15)
- （ａ）約２ｍｇから約１０ｍｇまでの硫酸モルヒネあるいはその水和物；
（ｂ）塩化ナトリウム；
（ｃ）緩衝剤に対する硫酸モルヒネのモル比が約０．４から約１．３となる量で、且つ製剤に約５のｐＨを与え、緩衝剤に共役塩基を提供するのに十分な量の緩衝剤を含む緩衝系；
（ｄ）エデト酸二ナトリウムあるいはその水和物；
（ｅ）塩化カルシウムあるいはその水和物；及び
（ｆ）注射用水、
を１ｍＬにつき含むことを特徴とする、注射可能な医薬製剤。 - （ａ）約４ｍｇから１０ｍｇまでの間の硫酸モルヒネあるいはその水和物；及び
（ｃ）緩衝剤に対する硫酸モルヒネのモル比が約０．４から０．８となる量で、且つ製剤に約５のｐＨを与えるのに十分な量の緩衝剤；
を含むことを特徴とする、請求項１記載の製剤。 - 緩衝系がクエン酸一水和物とクエン酸ナトリウム二水和物を含むことを特徴とする、請
求項１記載の製剤。 - 製剤は少なくとも１４日間８０℃で安定であることを特徴とする、請求項１記載の製剤。
- （ａ）約２ｍｇから約１０ｍｇまでの硫酸モルヒネ五水和物；
（ｂ）約７ｍｇから約９ｍｇまでの塩化ナトリウム；
（ｃ）約２ｍｇから約４ｍｇまでのクエン酸ナトリウム二水和物；
（ｄ）約０．７ｍｇから約１．２ｍｇのクエン酸一水和物；
（ｅ）約０．１ｍｇから約０．１５ｍｇのエデト酸二ナトリウム二水和物；
（ｆ）約０．０４ｍｇから約０．０６ｍｇの塩化カルシウム二水和物；及び
（ｇ）注射用水、
を１ｍＬにつき含むことを特徴とする、医薬製剤。 - 製剤は酸素の透過性を低くし、脱酸素剤をさらに含む第２の包装容器に保存されている、ガラス容器に保存されることを特徴とする、請求項１記載の製剤。
- （ａ）モルヒネ、又はその塩、あるいはその水和物；
（ｂ）等張剤；
（ｃ）抗酸化特性を有する緩衝剤；
（ｄ）キレート剤；
（ｅ）キレート剤に対する相補物；及び
（ｆ）水、
を含み、等張剤は、塩化ナトリウム、塩化カルシウム、塩化カリウム、重炭酸ナトリウム、乳酸ナトリウム、リンゲル液、デキストロース、ラクトース、マンニトール、グルコース、グリセリン、デキストラン、Ｎｏｒｍｏｓｏｌ Ｒ、食塩水、ハルトマン液、およびそれらの混合物並びにそれらの組み合わせから選択されることを特徴とする、医薬製剤。 - 等張剤は塩化ナトリウムであることを特徴とする、請求項７記載の製剤。
- 緩衝剤は、緩衝剤に対するモルヒネのモル比が約０．４から約１．３となる量であることを特徴とする、請求項７記載の製剤。
- 緩衝剤は、無水クエン酸とその水和物、及び無水のクエン酸ナトリウムとその水和物を含む緩衝液を形成することを特徴とする、請求項７記載の製剤。
- 緩衝剤は、製剤に約４．５から約５．５までのｐＨを与えるのに十分な量であることを特徴とする、請求項７記載の製剤。
- （ａ）約２ｍｇから約１５ｍｇまでの硫酸モルヒネ五水和物；
（ｂ）等張剤；
（ｃ）緩衝剤に対する硫酸モルヒネのモル比が約０．４〜約１．３となる量で、且つ製剤にｐＨ５を与えるのに十分な量の緩衝剤；
（ｄ）キレート剤；
（ｅ）キレート剤に対する相補物；及び
（ｆ）水、
を１ｍＬにつき含むことを特徴とする、請求項７記載の製剤。 - 製剤は、少なくとも１４日間８０℃で安定であることを特徴とする、請求項７記載の製剤。
- 製剤は、酸素への透過性を低くし脱酸素剤をさらに含む第２の容器に保存される、ガラス又はプラスチック容器に保存されることを特徴とする、請求項７記載の製剤。
- （ａ）請求項７記載の製剤を含む、予め充填されたシリンジ；及び
（ｂ）酸素の透過性を低くし、脱酸素剤をさらに含む第２の包装容器、を含むキット。
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 (ja) | 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 (6) | US9072781B2 (ja) |
| EP (2) | EP3143988A1 (ja) |
| JP (1) | JP6215970B2 (ja) |
| CN (2) | CN104042565A (ja) |
| AU (1) | AU2014230834B9 (ja) |
| BR (1) | BR112015021586B1 (ja) |
| CA (1) | CA2902343C (ja) |
| WO (1) | WO2014140095A1 (ja) |
Families Citing this family (12)
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| US20180264111A1 (en) * | 2014-12-03 | 2018-09-20 | Csl Behring Gmbh Ag | Pharmaceutical product with increased stability comprising immunoglobulins |
| US20170189352A1 (en) | 2015-03-13 | 2017-07-06 | Par Pharmaceutical, Inc. | Epinephrine formulations |
| US9119876B1 (en) * | 2015-03-13 | 2015-09-01 | Par Pharmaceutical, Inc. | Epinephrine formulations |
| CA2987242C (en) * | 2015-05-25 | 2023-10-10 | 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 |
| MX2019003257A (es) * | 2016-09-23 | 2019-06-10 | Gruenenthal Gmbh | Formulacion estable para la administracion parenteral de tapentadol. |
| US10653646B2 (en) | 2018-03-23 | 2020-05-19 | Nevakar Inc. | Epinephrine compositions and containers |
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-
2014
- 2014-03-12 BR BR112015021586-6A patent/BR112015021586B1/pt active IP Right Grant
- 2014-03-12 EP EP16188526.4A patent/EP3143988A1/en not_active Withdrawn
- 2014-03-12 CA CA2902343A patent/CA2902343C/en active Active
- 2014-03-12 AU AU2014230834A patent/AU2014230834B9/en active Active
- 2014-03-12 WO PCT/EP2014/054831 patent/WO2014140095A1/en active Application Filing
- 2014-03-12 EP EP14710529.0A patent/EP2968132B1/en not_active Not-in-force
- 2014-03-12 US US14/207,245 patent/US9072781B2/en active Active
- 2014-03-12 JP JP2015562121A patent/JP6215970B2/ja active Active
- 2014-03-14 CN CN201410097764.7A patent/CN104042565A/zh active Pending
- 2014-03-14 CN CN201811072429.6A patent/CN109125254A/zh active Pending
-
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
-
2019
- 2019-02-11 US US16/272,108 patent/US20190167665A1/en not_active Abandoned
-
2020
- 2020-03-18 US US16/823,073 patent/US20200345720A1/en not_active Abandoned
-
2023
- 2023-04-28 US US18/309,069 patent/US20230414604A1/en active Pending
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