CA1184495A - Process of producing pharmaceutical composition of famotidine for injection - Google Patents
Process of producing pharmaceutical composition of famotidine for injectionInfo
- Publication number
- CA1184495A CA1184495A CA000417637A CA417637A CA1184495A CA 1184495 A CA1184495 A CA 1184495A CA 000417637 A CA000417637 A CA 000417637A CA 417637 A CA417637 A CA 417637A CA 1184495 A CA1184495 A CA 1184495A
- Authority
- CA
- Canada
- Prior art keywords
- famotidine
- acid
- injection
- aspartic acid
- aqueous solution
- 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.)
- Expired
Links
- XUFQPHANEAPEMJ-UHFFFAOYSA-N famotidine Chemical group NC(N)=NC1=NC(CSCCC(N)=NS(N)(=O)=O)=CS1 XUFQPHANEAPEMJ-UHFFFAOYSA-N 0.000 title claims abstract description 71
- 229960001596 famotidine Drugs 0.000 title claims abstract description 71
- 238000002347 injection Methods 0.000 title claims abstract description 21
- 239000007924 injection Substances 0.000 title claims abstract description 21
- 238000000034 method Methods 0.000 title claims description 11
- 239000008194 pharmaceutical composition Substances 0.000 title description 2
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims abstract description 37
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 claims abstract description 32
- 229960005261 aspartic acid Drugs 0.000 claims abstract description 32
- CKLJMWTZIZZHCS-UHFFFAOYSA-N D-OH-Asp Natural products OC(=O)C(N)CC(O)=O CKLJMWTZIZZHCS-UHFFFAOYSA-N 0.000 claims abstract description 30
- CKLJMWTZIZZHCS-UWTATZPHSA-N L-Aspartic acid Natural products OC(=O)[C@H](N)CC(O)=O CKLJMWTZIZZHCS-UWTATZPHSA-N 0.000 claims abstract description 30
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 28
- 239000007864 aqueous solution Substances 0.000 claims abstract description 26
- 239000000203 mixture Substances 0.000 claims abstract description 24
- 229960002989 glutamic acid Drugs 0.000 claims abstract description 20
- 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 abstract description 12
- 235000010355 mannitol Nutrition 0.000 claims abstract description 9
- 229930195725 Mannitol Natural products 0.000 claims abstract description 6
- 239000000594 mannitol Substances 0.000 claims abstract description 6
- 239000000243 solution Substances 0.000 claims description 22
- 239000007972 injectable composition Substances 0.000 claims description 5
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims description 3
- 239000004220 glutamic acid Substances 0.000 claims description 3
- 235000013922 glutamic acid Nutrition 0.000 claims description 3
- 229940090044 injection Drugs 0.000 claims 4
- 239000000546 pharmaceutical excipient Substances 0.000 abstract description 2
- 239000002253 acid Substances 0.000 description 22
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 12
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 description 9
- 239000002244 precipitate Substances 0.000 description 9
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 8
- OFOBLEOULBTSOW-UHFFFAOYSA-N Malonic acid Chemical compound OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 description 8
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 6
- 150000007513 acids Chemical class 0.000 description 6
- 150000001875 compounds Chemical class 0.000 description 6
- 230000003381 solubilizing effect Effects 0.000 description 6
- 238000003756 stirring Methods 0.000 description 6
- 150000003839 salts Chemical class 0.000 description 5
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 5
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 5
- 239000003814 drug Substances 0.000 description 4
- 229960000443 hydrochloric acid Drugs 0.000 description 4
- 235000011167 hydrochloric acid Nutrition 0.000 description 4
- XNGIFLGASWRNHJ-UHFFFAOYSA-N phthalic acid Chemical compound OC(=O)C1=CC=CC=C1C(O)=O XNGIFLGASWRNHJ-UHFFFAOYSA-N 0.000 description 4
- 239000000047 product Substances 0.000 description 4
- 239000001530 fumaric acid Substances 0.000 description 3
- 235000006408 oxalic acid Nutrition 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 235000003704 aspartic acid Nutrition 0.000 description 2
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Natural products OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 239000013078 crystal Substances 0.000 description 2
- 238000000354 decomposition reaction Methods 0.000 description 2
- 229910052500 inorganic mineral Inorganic materials 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 description 2
- 239000011976 maleic acid Substances 0.000 description 2
- 239000011707 mineral Substances 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 150000007524 organic acids Chemical class 0.000 description 2
- 239000001384 succinic acid Substances 0.000 description 2
- BOCMLKVGEOTAKH-UHFFFAOYSA-N 2-sulfamoylpropanimidamide Chemical compound NC(=N)C(C)S(N)(=O)=O BOCMLKVGEOTAKH-UHFFFAOYSA-N 0.000 description 1
- KDDQRKBRJSGMQE-UHFFFAOYSA-N 4-thiazolyl Chemical group [C]1=CSC=N1 KDDQRKBRJSGMQE-UHFFFAOYSA-N 0.000 description 1
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 1
- ATJFFYVFTNAWJD-UHFFFAOYSA-N Tin Chemical compound [Sn] ATJFFYVFTNAWJD-UHFFFAOYSA-N 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 150000001412 amines Chemical class 0.000 description 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- -1 diaminomethYlene Chemical class 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000027119 gastric acid secretion Effects 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 229940102223 injectable solution Drugs 0.000 description 1
- 229960004717 insulin aspart Drugs 0.000 description 1
- 238000007918 intramuscular administration Methods 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 125000000446 sulfanediyl group Chemical group *S* 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP201934/1981 | 1981-12-15 | ||
| JP56201934A JPS58103312A (ja) | 1981-12-15 | 1981-12-15 | 難溶性医薬品の注射剤用水溶液 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1184495A true CA1184495A (en) | 1985-03-26 |
Family
ID=16449204
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000417637A Expired CA1184495A (en) | 1981-12-15 | 1982-12-14 | Process of producing pharmaceutical composition of famotidine for injection |
Country Status (7)
| Country | Link |
|---|---|
| JP (1) | JPS58103312A (cs) |
| KR (1) | KR880001632B1 (cs) |
| CA (1) | CA1184495A (cs) |
| ES (1) | ES8405613A1 (cs) |
| GR (1) | GR77823B (cs) |
| MX (1) | MX7581E (cs) |
| PT (1) | PT75985B (cs) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002051411A1 (fr) * | 2000-12-22 | 2002-07-04 | Yamanouchi Pharmaceutical Co., Ltd. | Injections de famotidine |
| CN111904936A (zh) * | 2020-08-28 | 2020-11-10 | 开封康诺药业有限公司 | 一种法莫替丁冻干粉针剂 |
| CN114028342A (zh) * | 2021-12-08 | 2022-02-11 | 广东彼迪药业有限公司 | 一种法莫替丁速崩颗粒、法莫替丁片及制备方法 |
| CN114681409A (zh) * | 2021-10-20 | 2022-07-01 | 海南倍特药业有限公司 | 一种注射用法莫替丁及其制备方法 |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES550690A0 (es) * | 1985-06-28 | 1987-03-16 | Barisintex Sa | Perfeccionamientos en la patente de invencion n.544661 por: procedimiento de preparazcion de ascorbatos antagonistas h2-receptores. |
| AU2002224063A1 (en) * | 2000-11-24 | 2002-06-03 | Yamanouchi Pharmaceutical Co..Ltd. | Water-soluble liquid internal medicine |
| JP4828040B2 (ja) * | 2001-04-27 | 2011-11-30 | テルモ株式会社 | ファモチジン注射液 |
| JP4374250B2 (ja) * | 2001-12-27 | 2009-12-02 | テルモ株式会社 | ファモチジン注射液 |
| AU2003235236A1 (en) * | 2002-05-13 | 2003-11-11 | Daiichi Pharmaceutical Co., Ltd. | Lyophilization product |
-
1981
- 1981-12-15 JP JP56201934A patent/JPS58103312A/ja active Granted
-
1982
- 1982-12-14 ES ES518199A patent/ES8405613A1/es not_active Expired
- 1982-12-14 GR GR70069A patent/GR77823B/el unknown
- 1982-12-14 PT PT75985A patent/PT75985B/pt unknown
- 1982-12-14 CA CA000417637A patent/CA1184495A/en not_active Expired
- 1982-12-15 KR KR8205621A patent/KR880001632B1/ko not_active Expired
- 1982-12-15 MX MX82101115U patent/MX7581E/es unknown
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002051411A1 (fr) * | 2000-12-22 | 2002-07-04 | Yamanouchi Pharmaceutical Co., Ltd. | Injections de famotidine |
| US7094414B2 (en) | 2000-12-22 | 2006-08-22 | Astellas Pharma Inc. | Famotidine injections |
| CN111904936A (zh) * | 2020-08-28 | 2020-11-10 | 开封康诺药业有限公司 | 一种法莫替丁冻干粉针剂 |
| CN114681409A (zh) * | 2021-10-20 | 2022-07-01 | 海南倍特药业有限公司 | 一种注射用法莫替丁及其制备方法 |
| CN114028342A (zh) * | 2021-12-08 | 2022-02-11 | 广东彼迪药业有限公司 | 一种法莫替丁速崩颗粒、法莫替丁片及制备方法 |
| CN114028342B (zh) * | 2021-12-08 | 2023-04-28 | 广东彼迪药业有限公司 | 一种法莫替丁速崩颗粒、法莫替丁片及制备方法 |
Also Published As
| Publication number | Publication date |
|---|---|
| ES518199A0 (es) | 1984-06-16 |
| ES8405613A1 (es) | 1984-06-16 |
| JPS6365047B2 (cs) | 1988-12-14 |
| PT75985A (en) | 1983-01-01 |
| KR880001632B1 (en) | 1988-09-03 |
| PT75985B (en) | 1985-12-05 |
| KR840002654A (ko) | 1984-07-16 |
| MX7581E (es) | 1989-11-24 |
| GR77823B (cs) | 1984-09-25 |
| JPS58103312A (ja) | 1983-06-20 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEC | Expiry (correction) | ||
| MKEX | Expiry |