RU2019112919A - Птг соединения с низкими соотношениями пика и минимума - Google Patents
Птг соединения с низкими соотношениями пика и минимума Download PDFInfo
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- RU2019112919A RU2019112919A RU2019112919A RU2019112919A RU2019112919A RU 2019112919 A RU2019112919 A RU 2019112919A RU 2019112919 A RU2019112919 A RU 2019112919A RU 2019112919 A RU2019112919 A RU 2019112919A RU 2019112919 A RU2019112919 A RU 2019112919A
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- Prior art keywords
- pharmaceutical composition
- pth
- moiety
- compound
- water
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- 239000008194 pharmaceutical composition Substances 0.000 claims 20
- 150000001875 compounds Chemical class 0.000 claims 10
- 238000013270 controlled release Methods 0.000 claims 4
- 238000007920 subcutaneous administration Methods 0.000 claims 4
- 125000006850 spacer group Chemical group 0.000 claims 3
- 238000010254 subcutaneous injection Methods 0.000 claims 3
- 239000007929 subcutaneous injection Substances 0.000 claims 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- 102000009027 Albumins Human genes 0.000 claims 1
- 108010088751 Albumins Proteins 0.000 claims 1
- 241000282553 Macaca Species 0.000 claims 1
- 125000000524 functional group Chemical group 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 125000005647 linker group Chemical group 0.000 claims 1
- 239000000651 prodrug Substances 0.000 claims 1
- 229940002612 prodrug Drugs 0.000 claims 1
- 230000002441 reversible effect Effects 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 229920003169 water-soluble polymer Polymers 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
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
-
- 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
- A61K47/30—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
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
- A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
- A61K47/643—Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]
-
- 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
-
- 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
- A61K9/0012—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
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
- A61P5/20—Drugs for disorders of the endocrine system of the parathyroid hormones for decreasing, blocking or antagonising the activity of PTH
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Zoology (AREA)
- General Chemical & Material Sciences (AREA)
- Diabetes (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
- Reverberation, Karaoke And Other Acoustics (AREA)
- Bipolar Transistors (AREA)
Claims (25)
1. Фармацевтическая композиция, содержащая ПТГ соединение, где после подкожного введения фармакокинетический профиль ПТГ соединения проявляет соотношение пика и минимума менее 4 в течение одного интервала инъекции.
2. Фармацевтическая композиция по п. 1, где период времени между двумя последовательными подкожными введениями составляет по меньшей мере 24 часа.
3. Фармацевтическая композиция по п. 1, где период времени между двумя последовательными подкожными введениями составляет 24 часа.
4. Фармацевтическая композиция по п. 1, где период времени между двумя последовательными подкожными введениями составляет одну неделю.
5. Фармацевтическая композиция по п. 1, где подкожное введение осуществляю посредством подкожной инъекции.
6. Фармацевтическая композиция по п. 1, где подкожное введение осуществляют посредством шприца-ручки.
7. Фармацевтическая композиция по п. 1, где соотношение пика и минимума составляет менее 3.
8. Фармацевтическая композиция по п. 1, где введение осуществляют отличному от человека примату.
9. Фармацевтическая композиция по п. 8, где отличный от человека примат представляет собой яванскую макаку.
10. Фармацевтическая композиция по п. 1, где ПТГ соединение представляет собой стабильное ПТГ соединение.
11. Фармацевтическая композиция по п. 10, где ПТГ составляющая либо напрямую, либо через спейсерную составляющую ковалентно конъюгирована через стабильную связь с растворимой в воде полимерной составляющей.
12. Фармацевтическая композиция по п. 1, где ПТГ составляющая либо напрямую, либо через спейсерную составляющую ковалентно конъюгирована через стабильную связь с альбумин-связывающей составляющей.
13. Фармацевтическая композиция по п. 1, где ПТГ соединение представляет собой ПТГ соединение контролируемого высвобождения.
14. Фармацевтическая композиция по п. 13, где ПТГ соединение контролируемого высвобождения является нерастворимым в воде.
15. Фармацевтическая композиция по п. 13, где ПТГ соединение контролируемого высвобождения является растворимым в воде.
16. Фармацевтическая композиция по п. 15, где растворимое в воде ПТГ соединение контролируемого высвобождения представляет собой соединение формулы (Ia) или (Ib) или его фармацевтически приемлемую соль
где D - представляет собой ПТГ составляющую;
L1 - представляет собой обратимую линкерную составляющую пролекарства, соединенную с ПТГ составляющей -D через функциональную группу ПТГ;
L2 - представляет собой простую химическую связь или спейсерную составляющую;
Z - представляет собой растворимую в воде составляющую носителя;
x - представляет собой целое число, выбранное из группы, состоящей из 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 или 16; и
y - представляет собой целое число, выбранное из группы, состоящей из 1, 2, 3, 4 и 5.
17. Фармацевтическая композиция по п. 1, где фармацевтическая композиция имеет значение pH в интервале и включая pH 3 - pH 8.
18. Фармацевтическая композиция по любому из пп. 1-17, где фармацевтическая композиция имеет значение pH в интервале и включая pH 4 - pH 5.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16191454 | 2016-09-29 | ||
EP16191454.4 | 2016-09-29 | ||
EP17155846 | 2017-02-13 | ||
EP17155846.3 | 2017-02-13 | ||
PCT/EP2017/074594 WO2018060312A1 (en) | 2016-09-29 | 2017-09-28 | Pth compounds with low peak-to-trough ratios |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
RU2022102002A Division RU2022102002A (ru) | 2016-09-29 | 2017-09-28 | Птг-соединения с низкими соотношениями пика и минимума |
Publications (3)
Publication Number | Publication Date |
---|---|
RU2019112919A true RU2019112919A (ru) | 2020-10-30 |
RU2019112919A3 RU2019112919A3 (ru) | 2021-01-19 |
RU2766959C2 RU2766959C2 (ru) | 2022-03-16 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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RU2019112919A RU2766959C2 (ru) | 2016-09-29 | 2017-09-28 | Птг-соединения с низкими соотношениями пика и минимума |
Country Status (25)
Country | Link |
---|---|
US (4) | US11759504B2 (ru) |
EP (2) | EP3518961B1 (ru) |
JP (2) | JP7085535B2 (ru) |
KR (2) | KR102611820B1 (ru) |
CN (2) | CN117257922A (ru) |
AU (1) | AU2017336251B2 (ru) |
BR (1) | BR112019005793A2 (ru) |
CA (1) | CA3037447A1 (ru) |
DK (1) | DK3518961T3 (ru) |
ES (1) | ES2943720T3 (ru) |
FI (1) | FI3518961T3 (ru) |
HR (1) | HRP20230383T1 (ru) |
HU (1) | HUE062009T2 (ru) |
IL (1) | IL265601A (ru) |
LT (1) | LT3518961T (ru) |
MA (1) | MA46345A (ru) |
MX (1) | MX2019003182A (ru) |
NZ (1) | NZ751745A (ru) |
PL (1) | PL3518961T3 (ru) |
RS (1) | RS64177B1 (ru) |
RU (1) | RU2766959C2 (ru) |
SG (1) | SG11201901558VA (ru) |
SI (1) | SI3518961T1 (ru) |
WO (1) | WO2018060312A1 (ru) |
ZA (1) | ZA201901813B (ru) |
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BR112019005793A2 (pt) | 2016-09-29 | 2019-06-18 | Ascendis Pharma Bone Diseases As | compostos de pth com baixas proporções de pico-para-vale |
SI3518960T1 (sl) | 2016-09-29 | 2023-11-30 | Ascendis Pharma Bone Diseases A/S, | Odmerni režim za PTH spojino z nadzorovanim sproščanjem |
JP2021516222A (ja) * | 2018-03-16 | 2021-07-01 | ザ ジェネラル ホスピタル コーポレイション | 副甲状腺ホルモンポリペプチドコンジュゲートおよびその使用方法 |
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MX2022007371A (es) | 2020-01-13 | 2022-07-12 | Ascendis Pharma Bone Diseases As | Tratamiento del hipoparatiroidismo. |
EP4217004A1 (en) | 2020-09-28 | 2023-08-02 | Ascendis Pharma Bone Diseases A/S | Improvement of physical and mental well-being of patients with hypoparathyroidism |
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WO2024094673A1 (en) * | 2022-11-02 | 2024-05-10 | Ascendis Pharma Bone Diseases A/S | Pth treatment regimen comprising two pth compounds |
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