RU2019110912A - Стабилизированные небелковые композиции клостридиального токсина - Google Patents
Стабилизированные небелковые композиции клостридиального токсина Download PDFInfo
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- RU2019110912A RU2019110912A RU2019110912A RU2019110912A RU2019110912A RU 2019110912 A RU2019110912 A RU 2019110912A RU 2019110912 A RU2019110912 A RU 2019110912A RU 2019110912 A RU2019110912 A RU 2019110912A RU 2019110912 A RU2019110912 A RU 2019110912A
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- Russia
- Prior art keywords
- composition according
- trehalose
- paragraphs
- acetylcysteine
- polysorbate
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims 21
- 231100001102 clostridial toxin Toxicity 0.000 title claims 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 14
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 14
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 14
- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 claims 10
- 229960004308 acetylcysteine Drugs 0.000 claims 10
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 9
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 8
- 229920001213 Polysorbate 20 Polymers 0.000 claims 8
- 229930182817 methionine Natural products 0.000 claims 8
- 229920001993 poloxamer 188 Polymers 0.000 claims 8
- 229940044519 poloxamer 188 Drugs 0.000 claims 8
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 8
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 8
- 229940068977 polysorbate 20 Drugs 0.000 claims 8
- 108030001720 Bontoxilysin Proteins 0.000 claims 6
- 229940053031 botulinum toxin Drugs 0.000 claims 6
- 229940074410 trehalose Drugs 0.000 claims 6
- 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 3
- 239000003963 antioxidant agent Substances 0.000 claims 3
- 230000003078 antioxidant effect Effects 0.000 claims 3
- 229960004452 methionine Drugs 0.000 claims 2
- 239000008247 solid mixture Substances 0.000 claims 2
- 239000004480 active ingredient Substances 0.000 claims 1
- 235000021120 animal protein Nutrition 0.000 claims 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 239000012669 liquid formulation Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 229920001983 poloxamer Polymers 0.000 claims 1
- 229960000502 poloxamer Drugs 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- UEUXEKPTXMALOB-UHFFFAOYSA-J tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O UEUXEKPTXMALOB-UHFFFAOYSA-J 0.000 claims 1
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- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
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- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/164—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
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- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
- A61K38/4893—Botulinum neurotoxin (3.4.24.69)
-
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- 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
- A61K47/02—Inorganic compounds
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- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- 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
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- 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
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Neurology (AREA)
- Pain & Pain Management (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Psychiatry (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Urology & Nephrology (AREA)
- Physical Education & Sports Medicine (AREA)
- Rheumatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (30)
1. Фармацевтическая композиция, содержащая
(i) активный ингредиент в виде клостридиального токсина;
(ii) регулятор тоничности;
(iii) полоксамер и/или полисорбат; и
(iv) антиоксидант, причем
антиоксидант содержит один или более из метионина и N-ацетилцистеина, и при этом
антиоксидант дополнительно содержит натриевую соль этилендиаминтетрауксусной кислоты (ЭДТА) или аналог ЭДТА.
2. Композиция по п. 1, содержащая ботулотоксин.
3. Композиция по п. 1 или 2, содержащая трегалозу.
4. Композиция по любому одному из пп. 1-3, содержащая полоксамер 188 и/или полисорбат 20.
5. Композиция по любому одному из пп. 1-4, содержащая ботулотоксин, трегалозу, один из полоксамера 188 или полисорбата 20 и один из метионина или N-ацетилцистеина.
6. Композиция по любому одному из пп. 1-5, содержащая ботулотоксин, трегалозу, полоксамер 188 и метионин.
7. Композиция по п. 6, в которой относительные весовые количества (%, масс.) трегалозы, полоксамера 188 и метионина находятся в следующих диапазонах:
8. Композиция по любому одному из пп. 1-5, содержащая ботулотоксин, трегалозу, полисорбат 20 и метионин.
9. Композиция по п. 8, в которой относительные весовые количества (%, масс.) трегалозы, полисорбата 20 и метионина находятся в следующих диапазонах:
10. Композиция по любому одному из пп. 1-5, содержащая ботулотоксин, трегалозу, полоксамер 188 и N-ацетилцистеин.
11. Композиция по п. 10, в которой относительные весовые количества (%, масс.) трегалозы, полоксамера 188 и N-ацетилцистеина находятся в следующих диапазонах:
12. Композиция по любому одному из пп. 1-5, содержащая ботулотоксин, трегалозу, полисорбат 20 и N-ацетилцистеин.
13. Композиция по п. 12, в которой относительные весовые количества (%, масс.) трегалозы, полисорбата 20 и N-ацетилцистеина находятся в следующих диапазонах:
14. Композиция по любому одному из пп. 1-13, содержащая гистидин.
15. Композиция по любому одному из пп. 1-14, не содержащая животного белка.
16. Композиция по любому одному из пп. 1-15, в которой относительное весовое количество (%, масс.) ЭДТА находится в диапазоне от около 0,01 до 0,10.
17. Композиция по любому одному из пп. 1-16, которая представляет собой твердый состав.
18. Композиция по любому одному из пп. 11, 13 и 16, которая представляет собой твердый состав, а относительное весовое количество (%, масс.) N-ацетилцистеина составляет 0,01-0,05.
19. Композиция по любому одному из пп. 1-16, которая представляет собой жидкий состав и имеет рН 5-7.
20. Композиция по любому одному из пп. 10-13 и 16, которая представляет собой жидкий состав и имеет рН 5-7, причем относительное весовое количество N-ацетилцистеина составляет 0,1-0,5.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201662394009P | 2016-09-13 | 2016-09-13 | |
US62/394,009 | 2016-09-13 | ||
PCT/US2017/051394 WO2018053021A1 (en) | 2016-09-13 | 2017-09-13 | Stabilized non-protein clostridial toxin compositions |
Publications (3)
Publication Number | Publication Date |
---|---|
RU2019110912A true RU2019110912A (ru) | 2020-10-15 |
RU2019110912A3 RU2019110912A3 (ru) | 2020-11-30 |
RU2762607C2 RU2762607C2 (ru) | 2021-12-21 |
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Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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RU2019110875A RU2019110875A (ru) | 2016-09-13 | 2017-09-13 | Небелковые композиции клостридиального токсина |
RU2019110912A RU2762607C2 (ru) | 2016-09-13 | 2017-09-13 | Стабилизированные небелковые композиции клостридиального токсина |
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RU2019110875A RU2019110875A (ru) | 2016-09-13 | 2017-09-13 | Небелковые композиции клостридиального токсина |
Country Status (27)
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US (8) | US20190247476A1 (ru) |
EP (4) | EP3436054B2 (ru) |
JP (3) | JP7217700B2 (ru) |
KR (5) | KR102635959B1 (ru) |
CN (3) | CN109803673A (ru) |
AU (3) | AU2017326253B2 (ru) |
BR (2) | BR112019004935A2 (ru) |
CA (2) | CA3036095A1 (ru) |
CL (1) | CL2019000586A1 (ru) |
CO (1) | CO2019003630A2 (ru) |
CY (2) | CY1122263T1 (ru) |
DK (2) | DK3436054T4 (ru) |
ES (2) | ES2755816T5 (ru) |
HR (1) | HRP20191966T4 (ru) |
HU (2) | HUE046290T2 (ru) |
IL (2) | IL265109B2 (ru) |
LT (1) | LT3436054T (ru) |
MX (2) | MX2019002835A (ru) |
PH (1) | PH12019500501A1 (ru) |
PL (2) | PL3432916T3 (ru) |
PT (2) | PT3432916T (ru) |
RS (1) | RS59600B2 (ru) |
RU (2) | RU2019110875A (ru) |
SA (1) | SA519401298B1 (ru) |
SI (2) | SI3432916T1 (ru) |
TW (2) | TW202247855A (ru) |
WO (2) | WO2018053021A1 (ru) |
Families Citing this family (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8168206B1 (en) * | 2005-10-06 | 2012-05-01 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
HRP20191966T4 (hr) * | 2016-09-13 | 2022-09-16 | Allergan, Inc. | Stabilizirani neproteinski klostridijalni pripravci toksina |
KR102646145B1 (ko) | 2018-05-31 | 2024-03-11 | 주식회사 엑소코바이오 | 줄기세포 유래의 엑소좀을 유효성분으로 포함하는 모공 축소용 조성물 |
JP7079984B2 (ja) | 2018-07-28 | 2022-06-03 | エクソコバイオ インコーポレイテッド | エキソソームの凍結乾燥方法 |
KR102163806B1 (ko) | 2018-07-30 | 2020-10-07 | 주식회사 엑소코바이오 | 줄기세포 유래의 엑소좀을 유효성분으로 포함하는 피지분비 감소용 조성물 |
JP2022500426A (ja) * | 2018-09-13 | 2022-01-04 | アラーガン、インコーポレイテッドAllergan, Incorporated | クロストリジウム毒素−ヒアルロン酸組成物 |
KR102259423B1 (ko) * | 2018-11-30 | 2021-06-02 | 주식회사 휴온스바이오파마 | 보툴리눔 독소의 안정화 액상 조성물 |
US20240024220A1 (en) * | 2019-05-11 | 2024-01-25 | Youngsuk Yi | Neurotoxin compositions and methods |
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