HRP20210044T1 - Farmaceutski prihvatljive soli beta-gvanidinopropionske kiseline sa poboljšanim svojstvima i njihova upotreba - Google Patents
Farmaceutski prihvatljive soli beta-gvanidinopropionske kiseline sa poboljšanim svojstvima i njihova upotreba Download PDFInfo
- Publication number
- HRP20210044T1 HRP20210044T1 HRP20210044TT HRP20210044T HRP20210044T1 HR P20210044 T1 HRP20210044 T1 HR P20210044T1 HR P20210044T T HRP20210044T T HR P20210044TT HR P20210044 T HRP20210044 T HR P20210044T HR P20210044 T1 HRP20210044 T1 HR P20210044T1
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- Croatia
- Prior art keywords
- pharmaceutically acceptable
- acceptable salt
- cancer
- salt according
- salt
- Prior art date
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- 150000003839 salts Chemical class 0.000 title claims 23
- KMXXSJLYVJEBHI-UHFFFAOYSA-N 3-guanidinopropanoic acid Chemical class NC(=[NH2+])NCCC([O-])=O KMXXSJLYVJEBHI-UHFFFAOYSA-N 0.000 title claims 3
- 206010028980 Neoplasm Diseases 0.000 claims 5
- 201000011510 cancer Diseases 0.000 claims 5
- 239000000546 pharmaceutical excipient Substances 0.000 claims 4
- 208000037819 metastatic cancer Diseases 0.000 claims 3
- 208000011575 metastatic malignant neoplasm Diseases 0.000 claims 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- 206010017993 Gastrointestinal neoplasms Diseases 0.000 claims 2
- 150000001875 compounds Chemical class 0.000 claims 2
- 230000001394 metastastic effect Effects 0.000 claims 2
- 206010061289 metastatic neoplasm Diseases 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 238000000634 powder X-ray diffraction Methods 0.000 claims 2
- 150000003890 succinate salts Chemical class 0.000 claims 2
- 238000002411 thermogravimetry Methods 0.000 claims 2
- 230000004580 weight loss Effects 0.000 claims 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical class OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims 1
- OFOBLEOULBTSOW-UHFFFAOYSA-N Malonic acid Chemical compound OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 claims 1
- 239000013078 crystal Substances 0.000 claims 1
- 238000000113 differential scanning calorimetry Methods 0.000 claims 1
- 238000001802 infusion Methods 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 150000003891 oxalate salts Chemical class 0.000 claims 1
Classifications
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- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C277/00—Preparation of guanidine or its derivatives, i.e. compounds containing the group, the singly-bound nitrogen atoms not being part of nitro or nitroso groups
- C07C277/08—Preparation of guanidine or its derivatives, i.e. compounds containing the group, the singly-bound nitrogen atoms not being part of nitro or nitroso groups of substituted guanidines
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C279/00—Derivatives of guanidine, i.e. compounds containing the group, the singly-bound nitrogen atoms not being part of nitro or nitroso groups
- C07C279/04—Derivatives of guanidine, i.e. compounds containing the group, the singly-bound nitrogen atoms not being part of nitro or nitroso groups having nitrogen atoms of guanidine groups bound to acyclic carbon atoms of a carbon skeleton
- C07C279/14—Derivatives of guanidine, i.e. compounds containing the group, the singly-bound nitrogen atoms not being part of nitro or nitroso groups having nitrogen atoms of guanidine groups bound to acyclic carbon atoms of a carbon skeleton being further substituted by carboxyl groups
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
- C07C51/41—Preparation of salts of carboxylic acids
- C07C51/412—Preparation of salts of carboxylic acids by conversion of the acids, their salts, esters or anhydrides with the same carboxylic acid part
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
- C07C51/42—Separation; Purification; Stabilisation; Use of additives
- C07C51/43—Separation; Purification; Stabilisation; Use of additives by change of the physical state, e.g. crystallisation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C57/00—Unsaturated compounds having carboxyl groups bound to acyclic carbon atoms
- C07C57/02—Unsaturated compounds having carboxyl groups bound to acyclic carbon atoms with only carbon-to-carbon double bonds as unsaturation
- C07C57/13—Dicarboxylic acids
- C07C57/15—Fumaric acid
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- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Oncology (AREA)
- Crystallography & Structural Chemistry (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Claims (15)
1. Farmaceutski prihvatljiva sol β-gvanidinopropionske kiseline naznačena time da ima Carr-ov indeks manji od 20 i/ili Hausner-ov odnos manji od 1.25, pri čemu navedena farmaceutski prihvatljiva sol predstavlja sol β-gvanidinopropionske kiseline i dikarboksilne kiseline.
2. Farmaceutski prihvatljiva sol prema patentnom zahtjevu 1, naznačena time da je navedena farmaceutski prihvatljiva sol 1:1 fumaratna sol, 2:1 sukcinatna sol ili 1:1 oksalatna sol.
3. Farmaceutski prihvatljiva sol prema patentnom zahtjevu 2, naznačena time da je navedena farmaceutski prihvatljiva sol 2:1 sukcinatna sol.
4. Farmaceutski prihvatljiva sol prema patentnom zahtjevu 3, naznačena time da je navedena sol kristalna, a po mogućnosti da ova sol sadrži manje od 40 tež. % amorfnog spoja.
5. Farmaceutski prihvatljiva sol prema patentnom zahtjevu 3, naznačena time da navedena sol ima endotermne pikove na oko 130, 175 i 232 °C, a egzotermne pikove ima na oko 179 °C na profilu diferencijalne skenirajuće kalorimetrije (DCS).
6. Farmaceutski prihvatljiva sol prema bilo kojem od patentnih zahtjeva od 1 do 5, naznačena time da ima najmanje jedan pik kod kuta difrakcije 2Ө (°) od 27±0.5, mjereno rendgenskom difrakcijom praha, pri čemu ova sol, po mogućnosti ima najmanje jedan pik kod kuta difrakcije 2Ө (°) od 19.99, 20.62 i/ili 27.26, mjereno rendgenskom difrakcijom praha.
7. Farmaceutski prihvatljiva sol prema patentnim zahtjevima od 4 do 6 naznačen time da je u obliku štapićastih kristala.
8. Farmaceutski prihvatljiva sol prema bilo kojem od patentnih zahtjeva od 3 do 7, naznačena time da od 31°C do 135°C ima gubitak težine od oko 0.4%, mjereno termo-gravimetrijskom analizom.
9. Farmaceutski prihvatljiva sol prema bilo kojem od patentnih zahtjeva od 3 do 8, naznačena time da od 135 °C do 215 °C ima gubitak težine od oko 13%, mjereno termo-gravimetrijskom analizom.
10. Pripravak koji sadrži farmaceutski prihvatljivu sol prema bilo kojem od patentnih zahtjeva od 1 do 9, naznačen time da sadrži manje od 10 tež.% amorfnog spoja i farmaceutski prihvatljiv ekscipijent.
11. Farmaceutski pripravak u obliku jedinične doze, naznačen time da sadrži farmaceutski prihvatljivu sol prema bilo kojem od patentnih zahtjeva 1 do 9 i farmaceutski prihvatljiv ekscipijent.
12. Farmaceutski pripravak naznačen time da sadrži farmaceutski prihvatljivu sol prema bilo kojem od patentnih zahtjeva od 1 do 9 i farmaceutski prihvatljiv ekscipijent, pri čemu je navedeni farmaceutski pripravak formuliran za intravensku infuziju.
13. Farmaceutski prihvatljiva sol prema bilo kojem od patentnih zahtjeva od 1 do 9 ili kompozicija prema bilo kojem od patentnih zahtjeva od 10 do 12 naznačena time da je za upotrebu u liječenju karcinoma, po mogućnosti gdje je:
(a) spomenuti karcinom je metastatski karcinom;
(b) spomenuta efikasna količina sadrži količinu efikasnu za suzbijanje metastatske kolonizacije spomenutog karcinoma;
(c) spomenuti karcinom je gastrointestinalni karcinom.
14. Vodeni pripravak, naznačen time da sadrži farmaceutski prihvatljivu sol prema bilo kojem od patentnih zahtjeva od 1 do 9 i farmaceutski prihvatljiv ekscipijens u količini koja je efikasna za suzbijanje metastatske kolonizacije navedenog karcinoma za upotrebu u liječenju metastatskog karcinoma.
15. Vodena kompozicija za upotrebu prema patentnom zahtjevu 14, naznačena time da spomenuti metastatski karcinom je gastrointestinalni karcinom.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562209624P | 2015-08-25 | 2015-08-25 | |
| PCT/US2016/048643 WO2017035331A1 (en) | 2015-08-25 | 2016-08-25 | PHARMACEUTICALLY ACCEPTABLE SALTS OF β-GUANIDINOPROPIONIC ACID WITH IMPROVED PROPERTIES AND USES THEREOF |
| EP16840104.0A EP3340973B1 (en) | 2015-08-25 | 2016-08-25 | Pharmaceutically acceptable salts of beta-guanidinopropionic acid with improved properties and uses thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20210044T1 true HRP20210044T1 (hr) | 2021-04-30 |
Family
ID=58100994
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20210044TT HRP20210044T1 (hr) | 2015-08-25 | 2021-01-12 | Farmaceutski prihvatljive soli beta-gvanidinopropionske kiseline sa poboljšanim svojstvima i njihova upotreba |
Country Status (17)
| Country | Link |
|---|---|
| US (4) | US20170056352A1 (hr) |
| EP (1) | EP3340973B1 (hr) |
| JP (2) | JP6880023B2 (hr) |
| KR (1) | KR102707964B1 (hr) |
| CN (2) | CN108472269B (hr) |
| AU (1) | AU2016311368B2 (hr) |
| CA (1) | CA2996520A1 (hr) |
| DK (1) | DK3340973T3 (hr) |
| ES (1) | ES2843561T3 (hr) |
| HK (1) | HK1257822A1 (hr) |
| HR (1) | HRP20210044T1 (hr) |
| HU (1) | HUE053963T2 (hr) |
| PL (1) | PL3340973T3 (hr) |
| PT (1) | PT3340973T (hr) |
| RS (1) | RS61804B1 (hr) |
| SI (1) | SI3340973T1 (hr) |
| WO (1) | WO2017035331A1 (hr) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2885451T3 (es) | 2014-04-30 | 2021-12-13 | Inspirna Inc | Inhibidores del transporte de creatina y usos de los mismos |
| WO2016100619A2 (en) * | 2014-12-17 | 2016-06-23 | Rgenix, Inc. | Treatment and diagnosis of cancer |
| US20170056352A1 (en) * | 2015-08-25 | 2017-03-02 | Rgenix, Inc. | PHARMACEUTICALLY ACCEPTABLE SALTS OF beta-GUANIDINOPROPIONIC ACID WITH IMPROVED PROPERTIES AND USES THEREOF |
| TWI794171B (zh) | 2016-05-11 | 2023-03-01 | 美商滬亞生物國際有限公司 | Ｈｄａｃ抑制劑與ｐｄ-ｌ１抑制劑之組合治療 |
| TWI808055B (zh) | 2016-05-11 | 2023-07-11 | 美商滬亞生物國際有限公司 | Hdac 抑制劑與 pd-1 抑制劑之組合治療 |
| WO2018160178A1 (en) * | 2017-03-01 | 2018-09-07 | Rgenix, Inc. | Pharmaceutically acceptable salts of b-guanidinopropionic acid with improved properties and uses thereof |
| AU2018373028A1 (en) | 2017-11-21 | 2020-04-30 | Inspirna, Inc. | Polymorphs and uses thereof |
| CA3161341A1 (en) | 2019-12-11 | 2021-06-17 | Masoud Fakhr Tavazoie | Methods of treating cancer |
| PL4073025T3 (pl) | 2019-12-13 | 2024-09-16 | Inspirna, Inc. | Sole metali i ich zastosowania |
| KR102615692B1 (ko) | 2021-10-13 | 2023-12-19 | 주식회사 휴엔켐 | 베타-구아니디노프로피온산을 포함하는 간섬유화 예방 또는 치료용 조성물 |
| KR20240067636A (ko) | 2022-11-09 | 2024-05-17 | 충남대학교산학협력단 | 베타-구아니디노프로피온산을 포함하는 장내 미생물 개선용 조성물 |
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-
2016
- 2016-08-24 US US15/245,750 patent/US20170056352A1/en not_active Abandoned
- 2016-08-25 SI SI201631048T patent/SI3340973T1/sl unknown
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- 2016-08-25 PL PL16840104T patent/PL3340973T3/pl unknown
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- 2016-08-25 RS RS20210023A patent/RS61804B1/sr unknown
- 2016-08-25 PT PT168401040T patent/PT3340973T/pt unknown
- 2016-08-25 EP EP16840104.0A patent/EP3340973B1/en active Active
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- 2016-08-25 KR KR1020187008144A patent/KR102707964B1/ko active IP Right Grant
- 2016-08-25 CN CN202111189796.6A patent/CN114057611A/zh active Pending
- 2016-08-25 AU AU2016311368A patent/AU2016311368B2/en active Active
- 2016-08-25 HU HUE16840104A patent/HUE053963T2/hu unknown
- 2016-08-25 DK DK16840104.0T patent/DK3340973T3/da active
- 2016-08-25 ES ES16840104T patent/ES2843561T3/es active Active
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- 2016-09-30 US US15/281,329 patent/US9827217B2/en active Active
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2017
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2019
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- 2019-11-06 US US16/675,669 patent/US20200138759A1/en not_active Abandoned
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2021
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- 2021-04-30 JP JP2021077099A patent/JP7134294B2/ja active Active
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| JP2021121597A (ja) | 2021-08-26 |
| ES2843561T3 (es) | 2021-07-19 |
| HK1257822A1 (zh) | 2019-11-01 |
| WO2017035331A1 (en) | 2017-03-02 |
| JP2018531280A (ja) | 2018-10-25 |
| US20170056353A1 (en) | 2017-03-02 |
| JP7134294B2 (ja) | 2022-09-09 |
| US20180243248A1 (en) | 2018-08-30 |
| PT3340973T (pt) | 2021-01-19 |
| EP3340973B1 (en) | 2020-10-14 |
| EP3340973A1 (en) | 2018-07-04 |
| JP6880023B2 (ja) | 2021-06-02 |
| DK3340973T3 (da) | 2021-01-11 |
| HUE053963T2 (hu) | 2021-07-28 |
| RS61804B1 (sr) | 2021-06-30 |
| US9827217B2 (en) | 2017-11-28 |
| US10512623B2 (en) | 2019-12-24 |
| KR20180059446A (ko) | 2018-06-04 |
| SI3340973T1 (sl) | 2021-07-30 |
| US20200138759A1 (en) | 2020-05-07 |
| CN114057611A (zh) | 2022-02-18 |
| AU2016311368B2 (en) | 2020-10-08 |
| EP3340973A4 (en) | 2019-04-03 |
| KR102707964B1 (ko) | 2024-09-20 |
| PL3340973T3 (pl) | 2021-06-14 |
| CA2996520A1 (en) | 2017-03-02 |
| AU2016311368A1 (en) | 2018-03-29 |
| US20170056352A1 (en) | 2017-03-02 |
| CN108472269A (zh) | 2018-08-31 |
| CN108472269B (zh) | 2021-11-02 |
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