RU2018142943A - Композиции для лечения нарушений кислотно-основного равновесия - Google Patents
Композиции для лечения нарушений кислотно-основного равновесия Download PDFInfo
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- 239000000203 mixture Substances 0.000 title claims 19
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 8
- 238000000034 method Methods 0.000 claims 7
- 229920000642 polymer Polymers 0.000 claims 6
- 150000001412 amines Chemical class 0.000 claims 5
- 239000000872 buffer Substances 0.000 claims 4
- 239000011780 sodium chloride Substances 0.000 claims 4
- 208000010444 Acidosis Diseases 0.000 claims 3
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims 3
- 206010027417 Metabolic acidosis Diseases 0.000 claims 3
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 3
- 210000002966 serum Anatomy 0.000 claims 3
- 210000000813 small intestine Anatomy 0.000 claims 3
- SXGZJKUKBWWHRA-UHFFFAOYSA-N 2-(N-morpholiniumyl)ethanesulfonate Chemical compound [O-]S(=O)(=O)CC[NH+]1CCOCC1 SXGZJKUKBWWHRA-UHFFFAOYSA-N 0.000 claims 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 2
- 229910019142 PO4 Inorganic materials 0.000 claims 2
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims 2
- ATUOYWHBWRKTHZ-UHFFFAOYSA-N Propane Chemical compound CCC ATUOYWHBWRKTHZ-UHFFFAOYSA-N 0.000 claims 2
- 239000002552 dosage form Substances 0.000 claims 2
- 210000004051 gastric juice Anatomy 0.000 claims 2
- 239000010452 phosphate Substances 0.000 claims 2
- 229910052700 potassium Inorganic materials 0.000 claims 2
- 239000011591 potassium Substances 0.000 claims 2
- 229910052708 sodium Inorganic materials 0.000 claims 2
- 239000011734 sodium Substances 0.000 claims 2
- WSLDOOZREJYCGB-UHFFFAOYSA-N 1,2-Dichloroethane Chemical compound ClCCCl WSLDOOZREJYCGB-UHFFFAOYSA-N 0.000 claims 1
- 125000006325 2-propenyl amino group Chemical group [H]C([H])=C([H])C([H])([H])N([H])* 0.000 claims 1
- VVJKKWFAADXIJK-UHFFFAOYSA-N Allylamine Chemical compound NCC=C VVJKKWFAADXIJK-UHFFFAOYSA-N 0.000 claims 1
- 239000012062 aqueous buffer Substances 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000008367 deionised water Substances 0.000 claims 1
- 229910021641 deionized water Inorganic materials 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 229940085991 phosphate ion Drugs 0.000 claims 1
- 239000001294 propane Substances 0.000 claims 1
- 238000010526 radical polymerization reaction Methods 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 230000008961 swelling Effects 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
- A61K31/13—Amines
-
- 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
- A61K31/74—Synthetic polymeric materials
- A61K31/785—Polymers containing nitrogen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
-
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F8/00—Chemical modification by after-treatment
- C08F8/02—Alkylation
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F226/00—Copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen
- C08F226/02—Copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen by a single or double bond to nitrogen
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F226/00—Copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen
- C08F226/02—Copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen by a single or double bond to nitrogen
- C08F226/04—Diallylamine
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
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- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Polymers & Plastics (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Obesity (AREA)
- Inorganic Chemistry (AREA)
- Urology & Nephrology (AREA)
- Dispersion Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Addition Polymer Or Copolymer, Post-Treatments, Or Chemical Modifications (AREA)
Claims (69)
1. Композиция для лечения метаболического ацидоза у взрослого пациента-человека,
где указанная композиция является невсасывающейся композицией, обладающей способностью удалять протоны из пациента,
где невсасывающаяся композиция представляет собой фармацевтическую композицию, содержащую связывающий протоны сшитый полимер амина,
где указанный сшитый полимер амина получают радикальной полимеризацией 2-пропен-1-иламина и 1,3-бис(аллиламино)пропана или их солей, и
указанный сшитый полимер амина сшит с 1,2-дихлорэтаном,
где указанный сшитый полимер амина имеет
(i) способность связывать протон, составляющую по меньшей мере 10 ммоль/г, и способность связывать хлорид-ион, составляющую по меньшей мере 10 ммоль/г, в водном буфере искусственного желудочного сока («SGF»), содержащем 35 мМ NaCl и 63 мМ HCl, при pH 1,2 и 37°C,
(ii) равновесный коэффициент набухания в деионизированной воде, равный примерно 2 или менее,
(iii) способность связывать хлорид-ион, составляющую по меньшей мере 3,5 мэкв./г по данным анализа с помощью искусственного неорганического буфера тонкого кишечника («SIB»), содержащего 36 мМ NaCl, 20 мМ NaH2PO4 и 50 мМ 2-(N-морфолино)этансульфоновой кислоты (MES), забуференном до pH 5,5, и
(iv) молярное отношение связывания хлорид-ионов к фосфат-ионам, составляющее по меньшей мере 2:1, соответственно, в водном искусственном неорганическом буфере тонкого кишечника («SIB»), содержащем 36 мМ NaCl, 20 мМ NaH2PO4 и 50 мМ 2-(N-морфолино)этансульфоновой кислоты (MES), забуференном до pH 5,5 и при 37°C.
2. Композиция по п. 1, где отношение количества связанного хлорида к количеству связанного фосфата по данным анализа SIB составляет не менее 4:1, соответственно.
3. Композиция по п. 1, где отношение количества связанного хлорида к количеству связанного фосфата по данным анализа SIB составляет
(a) по меньшей мере 2,25:1, соответственно,
(b) по меньшей мере 2,5:1, соответственно,
(c) по меньшей мере 2,75:1, соответственно,
(d) по меньшей мере 3:1, соответственно, или
(e) по меньшей мере 5:1, соответственно.
4. Композиция по любому из пп. 1-3, где метаболический ацидоз характеризуется исходным содержанием бикарбоната в сыворотке, равным
(a) менее 21 мэкв./л,
(b) менее 20 мэкв./л,
(c) менее 19 мэкв./л,
(d) менее 18 мэкв./л,
(e) менее 17 мэкв./л,
(f) менее 16 мэкв./л,
(g) менее 15 мэкв./л,
(h) менее 14 мэкв./л,
(i) менее 13 мэкв./л,
(j) менее 12 мэкв./л,
(k) менее 11 мэкв./л,
(l) менее 10 мэкв./л, или
(m) менее 9 мэкв./л.
5. Композиция по любому из пп. 1-4, где способность связывать хлорид-ионы по данным анализа с помощью искусственного неорганического буфера тонкого кишечника ("SIB") составляет
(a) по меньшей мере 4 мэкв./г,
(b) по меньшей мере 4,5 мэкв./г, или
(c) по меньшей мере 5 мэкв./г.
6. Композиция по любому из пп. 1-5, где сшитый полимер амина имеет:
(i) равновесную способность связывать протоны, составляющую по меньшей мере 12 ммоль/г, и способность связывать хлорид-ионы, составляющую по меньшей мере 12 ммоль/г, или
(ii) равновесную способность связывать протоны, составляющую по меньшей мере 14 ммоль/г, и способность связывать хлорид-ионы, составляющую по меньшей мере 14 ммоль/г,
в водном буфере искусственного желудочного сока («SGF»), содержащем 35 мМ NaCl и 63 мМ HCl при pH 1,2 и 37°C.
7. Композиция по любому из пп. 1-6, где композиция представляет собой единичную дозированную форму.
8. Композиция по п. 7, где единичная дозированная форма представляет собой капсулу, таблетку или саше.
9. Композиция по любому из пп. 1-8, где композиция содержит фармацевтически приемлемый носитель, эксципиент или разбавитель.
10. Способ лечения метаболического ацидоза у взрослого пациента-человека, включающий введение композиции по любому из пп. 1-9 для увеличения содержания бикарбоната в сыворотке этого пациента не менее, чем на 3 мэкв./л за 15 дней лечения.
11. Способ по п. 10, где увеличение содержания бикарбоната в сыворотке составляет
(a) не менее 3,5 мэкв./л,
(b) не менее 4 мэкв./л,
(c) не менее 4,5 мэкв./л,
(d) не менее 5 мэкв./л.
12. Способ по п. 10 или 11, где увеличение наблюдается в течение
(a) 14 дней,
(b) 13 дней,
(c) 12 дней,
(d) 11 дней, или
(e) 10 дней лечения.
13. Способ по любому из пп. 10-12, где при указанном лечении:
(a) 0,1-12 г,
(b) 1-11 г,
(c) 2-10 г, или
(d) 3-9 г указанного полимера вводят в указанной композиции указанному пациенту в сутки.
14. Способ по п. 13, где композицию вводят:
(a) один раз в сутки,
(b) два раза в сутки
(c) три раза в сутки для обеспечения полной заданной суточной дозы.
15. Способ по любому из пп. 10-14, где указанную композицию вводят перорально.
16. Способ по п. 15, где
(a) менее 1 г,
(b) менее 0,5 г,
(c) менее 0,1 г натрия или калия вводят в сутки, или
(d) натрий или калий не вводят.
Applications Claiming Priority (9)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662333059P | 2016-05-06 | 2016-05-06 | |
| US62/333,059 | 2016-05-06 | ||
| US201662350686P | 2016-06-15 | 2016-06-15 | |
| US62/350,686 | 2016-06-15 | ||
| US201662408885P | 2016-10-17 | 2016-10-17 | |
| US62/408,885 | 2016-10-17 | ||
| US201662414966P | 2016-10-31 | 2016-10-31 | |
| US62/414,966 | 2016-10-31 | ||
| PCT/US2017/031378 WO2017193050A1 (en) | 2016-05-06 | 2017-05-05 | Compositions for treating acid-base disorders |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2018142943A true RU2018142943A (ru) | 2020-06-08 |
| RU2018142943A3 RU2018142943A3 (ru) | 2020-08-10 |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2018142943A RU2018142943A (ru) | 2016-05-06 | 2017-05-05 | Композиции для лечения нарушений кислотно-основного равновесия |
Country Status (15)
| Country | Link |
|---|---|
| US (5) | US20190209607A1 (ru) |
| EP (3) | EP3452057A1 (ru) |
| JP (2) | JP7071284B2 (ru) |
| KR (1) | KR102655774B1 (ru) |
| CN (2) | CN109414453B (ru) |
| AU (2) | AU2017261337A1 (ru) |
| BR (1) | BR112018072714A2 (ru) |
| CA (1) | CA3023264A1 (ru) |
| IL (2) | IL262660B2 (ru) |
| MA (3) | MA44875A (ru) |
| MX (1) | MX2018013476A (ru) |
| MY (1) | MY197091A (ru) |
| RU (1) | RU2018142943A (ru) |
| SG (1) | SG11201809605PA (ru) |
| WO (3) | WO2017193050A1 (ru) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK3287133T3 (da) | 2013-06-05 | 2019-07-01 | Tricida Inc | Proton-bindende polymerer til oral indgivelse |
| CN113855703A (zh) | 2014-12-10 | 2021-12-31 | 特里赛达公司 | 用于口服施用的质子结合聚合物 |
| MA44875A (fr) | 2016-05-06 | 2019-03-13 | Tricida Inc | Compositions pour le traitement de troubles acido-basiques |
| US10934380B1 (en) | 2017-09-25 | 2021-03-02 | Tricida, Inc. | Crosslinked poly(allylamine) polymer pharmaceutical compositions |
| CN111246857A (zh) * | 2017-10-16 | 2020-06-05 | 富士胶片株式会社 | 高磷血症治疗剂及粒子 |
| CA3080651A1 (en) | 2017-11-03 | 2019-05-09 | Tricida, Inc. | Compositions for and method of treating acid-base disorders |
| SG11202003453QA (en) * | 2017-11-03 | 2020-05-28 | Tricida Inc | Method of treating acid-base disorders |
| WO2019236639A1 (en) * | 2018-06-04 | 2019-12-12 | Tricida, Inc. | Method of treating acid-base disorders |
| MA51628A (fr) * | 2018-06-04 | 2021-03-17 | Tricida Inc | Méthode de traitement de troubles de l'équilibre acido-basique |
| EP4053179A1 (en) | 2021-03-01 | 2022-09-07 | Tricida Inc. | Crosslinked poly(allylamine) polymer pharmaceutical compositions |
| WO2023109826A1 (zh) * | 2021-12-14 | 2023-06-22 | 上海石趣医药科技有限公司 | 碳酸银在制备药物中的用途 |
| WO2023109825A1 (zh) * | 2021-12-14 | 2023-06-22 | 上海石趣医药科技有限公司 | 氧化银和/或其水合物在制备药物中的用途 |
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