JPWO2019224323A5 - - Google Patents
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- JPWO2019224323A5 JPWO2019224323A5 JP2020565473A JP2020565473A JPWO2019224323A5 JP WO2019224323 A5 JPWO2019224323 A5 JP WO2019224323A5 JP 2020565473 A JP2020565473 A JP 2020565473A JP 2020565473 A JP2020565473 A JP 2020565473A JP WO2019224323 A5 JPWO2019224323 A5 JP WO2019224323A5
- Authority
- JP
- Japan
- Prior art keywords
- film
- weight
- alginate
- api
- film according
- 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
- 235000010443 alginic acid Nutrition 0.000 claims 14
- 229920000615 alginic acid Polymers 0.000 claims 14
- 229940072056 alginate Drugs 0.000 claims 12
- 239000003963 antioxidant agent Substances 0.000 claims 10
- 235000006708 antioxidants Nutrition 0.000 claims 10
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 9
- 239000000243 solution Substances 0.000 claims 9
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims 8
- -1 cation alginate Chemical class 0.000 claims 7
- 230000003078 antioxidant effect Effects 0.000 claims 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 6
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims 5
- 229910052739 hydrogen Inorganic materials 0.000 claims 5
- 239000001257 hydrogen Substances 0.000 claims 5
- 150000003839 salts Chemical class 0.000 claims 5
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 claims 5
- 229940001584 sodium metabisulfite Drugs 0.000 claims 5
- 235000010262 sodium metabisulphite Nutrition 0.000 claims 5
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims 4
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims 4
- UCTWMZQNUQWSLP-UHFFFAOYSA-N adrenaline Chemical compound CNCC(O)C1=CC=C(O)C(O)=C1 UCTWMZQNUQWSLP-UHFFFAOYSA-N 0.000 claims 4
- 239000003513 alkali Substances 0.000 claims 4
- 235000010323 ascorbic acid Nutrition 0.000 claims 4
- 239000011668 ascorbic acid Substances 0.000 claims 4
- 229960005070 ascorbic acid Drugs 0.000 claims 4
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 3
- DWAQJAXMDSEUJJ-UHFFFAOYSA-M Sodium bisulfite Chemical compound [Na+].OS([O-])=O DWAQJAXMDSEUJJ-UHFFFAOYSA-M 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 claims 3
- 239000000600 sorbitol Substances 0.000 claims 3
- KWGRBVOPPLSCSI-WPRPVWTQSA-N (-)-ephedrine Chemical compound CN[C@@H](C)[C@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WPRPVWTQSA-N 0.000 claims 2
- YLXIPWWIOISBDD-NDAAPVSOSA-N (2r,3r)-2,3-dihydroxybutanedioic acid;4-[(1r)-1-hydroxy-2-(methylamino)ethyl]benzene-1,2-diol Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O.CNC[C@H](O)C1=CC=C(O)C(O)=C1 YLXIPWWIOISBDD-NDAAPVSOSA-N 0.000 claims 2
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical group CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims 2
- 206010002198 Anaphylactic reaction Diseases 0.000 claims 2
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 claims 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 2
- 239000002253 acid Substances 0.000 claims 2
- 230000036783 anaphylactic response Effects 0.000 claims 2
- 208000003455 anaphylaxis Diseases 0.000 claims 2
- 239000011260 aqueous acid Substances 0.000 claims 2
- 239000002585 base Substances 0.000 claims 2
- 230000015572 biosynthetic process Effects 0.000 claims 2
- 150000001768 cations Chemical class 0.000 claims 2
- 229960004106 citric acid Drugs 0.000 claims 2
- 235000015165 citric acid Nutrition 0.000 claims 2
- 150000001875 compounds Chemical class 0.000 claims 2
- KWGRBVOPPLSCSI-UHFFFAOYSA-N d-ephedrine Natural products CNC(C)C(O)C1=CC=CC=C1 KWGRBVOPPLSCSI-UHFFFAOYSA-N 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 210000000214 mouth Anatomy 0.000 claims 2
- 235000010413 sodium alginate Nutrition 0.000 claims 2
- 239000000661 sodium alginate Substances 0.000 claims 2
- 229940005550 sodium alginate Drugs 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- JWZZKOKVBUJMES-UHFFFAOYSA-N (+-)-Isoprenaline Chemical compound CC(C)NCC(O)C1=CC=C(O)C(O)=C1 JWZZKOKVBUJMES-UHFFFAOYSA-N 0.000 claims 1
- XWTYSIMOBUGWOL-UHFFFAOYSA-N (+-)-Terbutaline Chemical compound CC(C)(C)NCC(O)C1=CC(O)=CC(O)=C1 XWTYSIMOBUGWOL-UHFFFAOYSA-N 0.000 claims 1
- SFLSHLFXELFNJZ-QMMMGPOBSA-N (-)-norepinephrine Chemical compound NC[C@H](O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-QMMMGPOBSA-N 0.000 claims 1
- AEMOLEFTQBMNLQ-SYJWYVCOSA-N (2s,3s,4s,5s,6r)-3,4,5,6-tetrahydroxyoxane-2-carboxylic acid Chemical compound O[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@@H]1O AEMOLEFTQBMNLQ-SYJWYVCOSA-N 0.000 claims 1
- UCTWMZQNUQWSLP-VIFPVBQESA-N (R)-adrenaline Chemical compound CNC[C@H](O)C1=CC=C(O)C(O)=C1 UCTWMZQNUQWSLP-VIFPVBQESA-N 0.000 claims 1
- 229930182837 (R)-adrenaline Natural products 0.000 claims 1
- KWTSXDURSIMDCE-QMMMGPOBSA-N (S)-amphetamine Chemical compound C[C@H](N)CC1=CC=CC=C1 KWTSXDURSIMDCE-QMMMGPOBSA-N 0.000 claims 1
- 208000010496 Heart Arrest Diseases 0.000 claims 1
- DZGWFCGJZKJUFP-UHFFFAOYSA-N Tyramine Natural products NCCC1=CC=C(O)C=C1 DZGWFCGJZKJUFP-UHFFFAOYSA-N 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- 239000013543 active substance Substances 0.000 claims 1
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 claims 1
- 125000000217 alkyl group Chemical group 0.000 claims 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims 1
- 229910052782 aluminium Inorganic materials 0.000 claims 1
- 239000000728 ammonium alginate Substances 0.000 claims 1
- 235000010407 ammonium alginate Nutrition 0.000 claims 1
- KPGABFJTMYCRHJ-YZOKENDUSA-N ammonium alginate Chemical compound [NH4+].[NH4+].O1[C@@H](C([O-])=O)[C@@H](OC)[C@H](O)[C@H](O)[C@@H]1O[C@@H]1[C@@H](C([O-])=O)O[C@@H](O)[C@@H](O)[C@H]1O KPGABFJTMYCRHJ-YZOKENDUSA-N 0.000 claims 1
- 229940025084 amphetamine Drugs 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 230000000740 bleeding effect Effects 0.000 claims 1
- 125000002091 cationic group Chemical group 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 238000007872 degassing Methods 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 229960002179 ephedrine Drugs 0.000 claims 1
- 229960005139 epinephrine Drugs 0.000 claims 1
- 150000002431 hydrogen Chemical class 0.000 claims 1
- 229960001317 isoprenaline Drugs 0.000 claims 1
- 238000002372 labelling Methods 0.000 claims 1
- LMOINURANNBYCM-UHFFFAOYSA-N metaproterenol Chemical compound CC(C)NCC(O)C1=CC(O)=CC(O)=C1 LMOINURANNBYCM-UHFFFAOYSA-N 0.000 claims 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims 1
- 229960002748 norepinephrine Drugs 0.000 claims 1
- SFLSHLFXELFNJZ-UHFFFAOYSA-N norepinephrine Natural products NCC(O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-UHFFFAOYSA-N 0.000 claims 1
- 229960002657 orciprenaline Drugs 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000004014 plasticizer Substances 0.000 claims 1
- 235000010408 potassium alginate Nutrition 0.000 claims 1
- 239000000737 potassium alginate Substances 0.000 claims 1
- MZYRDLHIWXQJCQ-YZOKENDUSA-L potassium alginate Chemical compound [K+].[K+].O1[C@@H](C([O-])=O)[C@@H](OC)[C@H](O)[C@H](O)[C@@H]1O[C@@H]1[C@@H](C([O-])=O)O[C@@H](O)[C@@H](O)[C@H]1O MZYRDLHIWXQJCQ-YZOKENDUSA-L 0.000 claims 1
- KWGRBVOPPLSCSI-WCBMZHEXSA-N pseudoephedrine Chemical compound CN[C@@H](C)[C@@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WCBMZHEXSA-N 0.000 claims 1
- 229960003908 pseudoephedrine Drugs 0.000 claims 1
- 229960002052 salbutamol Drugs 0.000 claims 1
- 238000007789 sealing Methods 0.000 claims 1
- 229940001607 sodium bisulfite Drugs 0.000 claims 1
- 229960000195 terbutaline Drugs 0.000 claims 1
- 229960003732 tyramine Drugs 0.000 claims 1
- DZGWFCGJZKJUFP-UHFFFAOYSA-O tyraminium Chemical compound [NH3+]CCC1=CC=C(O)C=C1 DZGWFCGJZKJUFP-UHFFFAOYSA-O 0.000 claims 1
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2024002052A JP2024050598A (ja) | 2018-05-23 | 2024-01-10 | 医薬製剤 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB1808462.4 | 2018-05-23 | ||
| GBGB1808462.4A GB201808462D0 (en) | 2018-05-23 | 2018-05-23 | Pharmaceutical formulation |
| PCT/EP2019/063376 WO2019224323A1 (en) | 2018-05-23 | 2019-05-23 | Pharmaceutical formulation |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2024002052A Division JP2024050598A (ja) | 2018-05-23 | 2024-01-10 | 医薬製剤 |
Publications (4)
| Publication Number | Publication Date |
|---|---|
| JP2021526519A JP2021526519A (ja) | 2021-10-07 |
| JPWO2019224323A5 true JPWO2019224323A5 (https=) | 2022-05-26 |
| JP2021526519A5 JP2021526519A5 (https=) | 2022-05-26 |
| JP7419263B2 JP7419263B2 (ja) | 2024-01-22 |
Family
ID=62812324
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020565473A Active JP7419263B2 (ja) | 2018-05-23 | 2019-05-23 | 医薬製剤 |
| JP2024002052A Pending JP2024050598A (ja) | 2018-05-23 | 2024-01-10 | 医薬製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2024002052A Pending JP2024050598A (ja) | 2018-05-23 | 2024-01-10 | 医薬製剤 |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US12005140B2 (https=) |
| EP (1) | EP3796896B1 (https=) |
| JP (2) | JP7419263B2 (https=) |
| KR (1) | KR20210031857A (https=) |
| CN (1) | CN112236133B (https=) |
| AU (1) | AU2019274772B2 (https=) |
| BR (1) | BR112020023741A2 (https=) |
| CA (1) | CA3098112A1 (https=) |
| DK (1) | DK3796896T3 (https=) |
| FI (1) | FI3796896T3 (https=) |
| GB (1) | GB201808462D0 (https=) |
| IL (1) | IL278927B2 (https=) |
| MA (1) | MA52704A (https=) |
| MX (1) | MX2020012336A (https=) |
| WO (1) | WO2019224323A1 (https=) |
Families Citing this family (8)
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| MX389336B (es) | 2016-11-15 | 2025-03-20 | Klaria Pharma Holding Ab | Formulacion farmaceutica. |
| GB201709141D0 (en) | 2017-06-08 | 2017-07-26 | Klaria Pharma Holding Ab | Pharmaceutical formulation |
| SE544672C2 (en) | 2020-05-07 | 2022-10-11 | Liw Innovation Ab | New compositions for oral or nasal use |
| US12414916B2 (en) | 2021-06-10 | 2025-09-16 | Belhaven BioPharma Inc. | Dry powder formulations of epinephrine and associated methods |
| EP4302750A1 (en) * | 2022-07-07 | 2024-01-10 | LTS Lohmann Therapie-Systeme AG | Oral thin films comprising adrenaline |
| EP4302751A1 (en) * | 2022-07-07 | 2024-01-10 | LTS Lohmann Therapie-Systeme AG | Oral thin films with low water activity |
| CN115950999B (zh) * | 2022-12-21 | 2024-08-30 | 武汉嘉诺康医药技术有限公司 | 一种同时检测重酒石酸去甲肾上腺素中api游离碱与配对有机酸的hplc检测方法 |
| US20260108686A1 (en) | 2024-10-21 | 2026-04-23 | Belhaven BioPharma Inc. | Compositions, devices, and methods for intranasal delivery of dry powder epinephrine |
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-
2018
- 2018-05-23 GB GBGB1808462.4A patent/GB201808462D0/en not_active Ceased
-
2019
- 2019-05-23 CN CN201980034455.6A patent/CN112236133B/zh active Active
- 2019-05-23 DK DK19726391.6T patent/DK3796896T3/da active
- 2019-05-23 CA CA3098112A patent/CA3098112A1/en active Pending
- 2019-05-23 JP JP2020565473A patent/JP7419263B2/ja active Active
- 2019-05-23 EP EP19726391.6A patent/EP3796896B1/en active Active
- 2019-05-23 MA MA052704A patent/MA52704A/fr unknown
- 2019-05-23 KR KR1020207035183A patent/KR20210031857A/ko not_active Ceased
- 2019-05-23 US US17/054,945 patent/US12005140B2/en active Active
- 2019-05-23 AU AU2019274772A patent/AU2019274772B2/en not_active Expired - Fee Related
- 2019-05-23 FI FIEP19726391.6T patent/FI3796896T3/fi active
- 2019-05-23 IL IL278927A patent/IL278927B2/en unknown
- 2019-05-23 WO PCT/EP2019/063376 patent/WO2019224323A1/en not_active Ceased
- 2019-05-23 BR BR112020023741-8A patent/BR112020023741A2/pt unknown
- 2019-05-23 MX MX2020012336A patent/MX2020012336A/es unknown
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2024
- 2024-01-10 JP JP2024002052A patent/JP2024050598A/ja active Pending
- 2024-05-03 US US18/654,460 patent/US20250099374A1/en active Pending
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