BR112021014581A2 - Formulações farmacêuticas líquidas de conjugados de pth - Google Patents
Formulações farmacêuticas líquidas de conjugados de pthInfo
- Publication number
- BR112021014581A2 BR112021014581A2 BR112021014581A BR112021014581A BR112021014581A2 BR 112021014581 A2 BR112021014581 A2 BR 112021014581A2 BR 112021014581 A BR112021014581 A BR 112021014581A BR 112021014581 A BR112021014581 A BR 112021014581A BR 112021014581 A2 BR112021014581 A2 BR 112021014581A2
- Authority
- BR
- Brazil
- Prior art keywords
- pth
- liquid pharmaceutical
- pharmaceutical formulations
- conjugates
- pth conjugates
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 4
- 239000007788 liquid Substances 0.000 title abstract 3
- 239000003963 antioxidant agent Substances 0.000 abstract 1
- 230000003078 antioxidant effect Effects 0.000 abstract 1
- 239000006172 buffering agent Substances 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 239000003755 preservative agent Substances 0.000 abstract 1
- 230000002335 preservative effect Effects 0.000 abstract 1
Classifications
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/06—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
- 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
- A61K47/16—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
-
- 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
- A61K47/20—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
- 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
- A61K47/26—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
-
- 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
- A61K47/54—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 compound
- A61K47/545—Heterocyclic compounds
-
- 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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- 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)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
Abstract
formulações farmacêuticas líquidas de conjugados de pth. a presente invenção refere-se a uma formulação farmacêutica líquida, em que a formulação farmacêutica compreende um conjuga-do de pth, um agente tampão, um agente isotonizante, um conservante e, opcionalmente, um antioxidante e no qual o conjugado de pth compreende uma porção de pth que é conjugada covalentemente e reversivelmente a uma porção de veículo solúvel em água.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP19156485 | 2019-02-11 | ||
EP19168857 | 2019-04-12 | ||
PCT/EP2020/053316 WO2020165087A1 (en) | 2019-02-11 | 2020-02-10 | Liquid pharmaceutical formulations of pth conjugates |
Publications (1)
Publication Number | Publication Date |
---|---|
BR112021014581A2 true BR112021014581A2 (pt) | 2021-12-14 |
Family
ID=69400577
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112021014581A BR112021014581A2 (pt) | 2019-02-11 | 2020-02-10 | Formulações farmacêuticas líquidas de conjugados de pth |
Country Status (12)
Country | Link |
---|---|
US (1) | US20220088149A1 (pt) |
EP (1) | EP3923905A1 (pt) |
JP (1) | JP2022520189A (pt) |
KR (1) | KR20210130751A (pt) |
CN (1) | CN113423383A (pt) |
AU (1) | AU2020221491A1 (pt) |
BR (1) | BR112021014581A2 (pt) |
CA (1) | CA3129357A1 (pt) |
IL (1) | IL285141A (pt) |
MX (1) | MX2021009370A (pt) |
SG (1) | SG11202107722VA (pt) |
WO (1) | WO2020165087A1 (pt) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20230015517A (ko) | 2016-03-01 | 2023-01-31 | 아센디스 파마 본 디지즈 에이/에스 | Pth 프로드럭 |
SI3518960T1 (sl) | 2016-09-29 | 2023-11-30 | Ascendis Pharma Bone Diseases A/S, | Odmerni režim za PTH spojino z nadzorovanim sproščanjem |
CA3037447A1 (en) | 2016-09-29 | 2018-04-05 | Ascendis Pharma Bone Diseases A/S | Pth compounds with low peak-to-trough ratios |
Family Cites Families (44)
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ZA9811127B (en) * | 1997-12-09 | 2000-07-11 | Lilly Co Eli | Stabilized teriparatide solutions. |
US6624142B2 (en) | 1997-12-30 | 2003-09-23 | Enzon, Inc. | Trimethyl lock based tetrapartate prodrugs |
JPWO2003064462A1 (ja) * | 2002-02-01 | 2005-05-26 | 中外製薬株式会社 | Peg結合pth又はpeg結合pth誘導体 |
US7332164B2 (en) | 2003-03-21 | 2008-02-19 | Enzon Pharmaceuticals, Inc. | Heterobifunctional polymeric bioconjugates |
DK1620118T3 (da) | 2003-04-08 | 2014-09-29 | Yeda Res & Dev | Reversible pegylerede lægemidler |
US7690003B2 (en) | 2003-08-29 | 2010-03-30 | Fuller Jeffrey C | System and method for increasing data throughput using thread scheduling |
EP1670515A2 (en) | 2003-09-19 | 2006-06-21 | Novo Nordisk A/S | Albumin-binding derivatives of therapeutic peptides |
EP2087910B1 (en) | 2004-03-23 | 2022-05-04 | Ascendis Pharma GmbH | Polymeric prodrugs |
RU2006143544A (ru) * | 2004-05-10 | 2008-06-20 | Нэстек Фармасьютикал Кампани Инк. (Us) | Композиции и способ для облегченной чресслизистой доставки паратиреоидного гормона |
US20060069021A1 (en) * | 2004-08-13 | 2006-03-30 | Nastech Pharmaceutical Company Inc. | Compositions and methods for intranasal administration of inactive analogs of PTH or inactivated preparations of PTH or PTH analogs |
KR100700869B1 (ko) * | 2005-06-03 | 2007-03-29 | 재단법인 목암생명공학연구소 | Pth, 완충제 및 안정제를 포함하는 안정한 pth조성물 |
GB2427360A (en) | 2005-06-22 | 2006-12-27 | Complex Biosystems Gmbh | Aliphatic prodrug linker |
US8450269B2 (en) | 2006-02-03 | 2013-05-28 | Prolor Biotech Ltd. | Long-acting growth hormone and methods of producing same |
JP2010503707A (ja) | 2006-09-15 | 2010-02-04 | エンゾン ファーマスーティカルズ インコーポレイテッド | オリゴヌクレオチドの送達を目的としたヒンダードエステル系生体分解性リンカー |
SI2173890T1 (sl) | 2007-06-21 | 2011-06-30 | Univ Muenchen Tech | Biološko aktivni proteini, ki imajo povečano in vivo in/ali in vitro stabilnost |
WO2009009712A1 (en) | 2007-07-11 | 2009-01-15 | Enzon Pharmaceuticals, Inc. | Polymeric drug delivery system containing a multi-substituted aromatic moiety |
EP2052736A1 (en) * | 2007-10-26 | 2009-04-29 | Nycomed Danmark ApS | Parathyroid hormone formulations und uses thereof |
CA2712224C (en) | 2008-02-01 | 2016-03-08 | Ascendis Pharma As | Prodrug comprising a drug linker conjugate |
WO2009143412A2 (en) | 2008-05-23 | 2009-11-26 | Enzon Pharmaceuticals, Inc. | Polymeric systems containing intracellular releasable disulfide linker for the delivery of oligonucleotides |
BR122021021381B1 (pt) | 2009-02-03 | 2023-05-16 | Amunix Pharmaceuticals, Inc | Método de aprimoramento de uma propriedade de uma proteína biologicamente ativa |
EP2459227B1 (en) | 2009-07-31 | 2021-03-17 | Ascendis Pharma A/S | Prodrugs containing an aromatic amine connected by an amide bond to a carrier |
WO2011082368A2 (en) | 2009-12-31 | 2011-07-07 | Enzon Pharmaceuticals, Inc | Polymeric conjugates of aromatic amine containing compounds including releasable urea linker |
EP2525830B1 (en) | 2010-01-22 | 2016-05-11 | Ascendis Pharma A/S | Dipeptide-based prodrug linkers for aliphatic amine-containing drugs |
EP2525831B1 (en) | 2010-01-22 | 2019-05-15 | Ascendis Pharma A/S | Carrier-linked carbamate prodrug linkers |
EP2525829A1 (en) | 2010-01-22 | 2012-11-28 | Ascendis Pharma A/S | Dipeptide-based prodrug linkers for aromatic amine-containing drugs |
WO2011123813A2 (en) | 2010-04-02 | 2011-10-06 | Amunix Operating Inc. | Binding fusion proteins, binding fusion protein-drug conjugates, xten-drug conjugates and methods of making and using same |
EP2566334B1 (en) | 2010-05-05 | 2018-04-18 | Prolynx, LLC | Controlled drug release from solid supports |
WO2011140393A1 (en) | 2010-05-05 | 2011-11-10 | Prolynx Llc | Controlled release from macromolecular conjugates |
CN105477641B (zh) | 2010-05-21 | 2021-03-23 | Xl-蛋白有限责任公司 | 生物合成的脯氨酸/丙氨酸无规卷曲多肽及其用途 |
US8989456B2 (en) | 2010-06-30 | 2015-03-24 | Nec Solution Innovators, Ltd. | Attribute determining method, attribute determining apparatus, program, recording medium, and attribute determining system |
US20140249093A1 (en) | 2011-08-12 | 2014-09-04 | Ascendis Pharma A/S | Carrier-Linked Prodrugs Having Reversible Carboxylic Ester Linkages |
AU2012296950B2 (en) | 2011-08-12 | 2016-09-22 | Ascendis Pharma A/S | Polymeric hyperbranched carrier-linked prodrugs |
EP2741781A1 (en) | 2011-08-12 | 2014-06-18 | Ascendis Pharma A/S | Carrier-linked treprostinil prodrugs |
AU2012296951B2 (en) | 2011-08-12 | 2016-09-15 | Ascendis Pharma A/S | Protein carrier-linked prodrugs |
WO2013036857A1 (en) | 2011-09-07 | 2013-03-14 | Prolynx Llc | Sulfone linkers |
JP2015504087A (ja) * | 2012-01-20 | 2015-02-05 | ルピン・リミテッドLupin Limited | 安定化pth製剤 |
EP2841109A1 (en) | 2012-04-25 | 2015-03-04 | Ascendis Pharma A/S | Prodrugs of hydroxyl-comprising drugs |
US9718868B2 (en) * | 2012-08-28 | 2017-08-01 | The Governors Of The University Of Alberta | Parathyroid hormone, insulin, and related peptides conjugated to bone targeting moieties and methods and making and using thereof |
US20150250882A1 (en) | 2012-10-17 | 2015-09-10 | Novo Nordisk Health Care Ag | Fatty Acid Acylated Amino Acids for Growth Hormone Delivery |
US11633487B2 (en) | 2014-08-06 | 2023-04-25 | Ascendis Pharma A/S | Prodrugs comprising an aminoalkyl glycine linker |
KR20230015517A (ko) * | 2016-03-01 | 2023-01-31 | 아센디스 파마 본 디지즈 에이/에스 | Pth 프로드럭 |
AU2017336250C1 (en) | 2016-09-29 | 2023-08-03 | Ascendis Pharma Bone Diseases A/S | Incremental dose finding in controlled-release PTH compounds |
SI3518960T1 (sl) | 2016-09-29 | 2023-11-30 | Ascendis Pharma Bone Diseases A/S, | Odmerni režim za PTH spojino z nadzorovanim sproščanjem |
CA3037447A1 (en) | 2016-09-29 | 2018-04-05 | Ascendis Pharma Bone Diseases A/S | Pth compounds with low peak-to-trough ratios |
-
2020
- 2020-02-10 AU AU2020221491A patent/AU2020221491A1/en active Pending
- 2020-02-10 MX MX2021009370A patent/MX2021009370A/es unknown
- 2020-02-10 JP JP2021546680A patent/JP2022520189A/ja active Pending
- 2020-02-10 EP EP20702852.3A patent/EP3923905A1/en active Pending
- 2020-02-10 US US17/428,608 patent/US20220088149A1/en active Pending
- 2020-02-10 WO PCT/EP2020/053316 patent/WO2020165087A1/en unknown
- 2020-02-10 CN CN202080013461.6A patent/CN113423383A/zh active Pending
- 2020-02-10 BR BR112021014581A patent/BR112021014581A2/pt unknown
- 2020-02-10 KR KR1020217029275A patent/KR20210130751A/ko unknown
- 2020-02-10 CA CA3129357A patent/CA3129357A1/en active Pending
- 2020-02-10 SG SG11202107722VA patent/SG11202107722VA/en unknown
-
2021
- 2021-07-26 IL IL285141A patent/IL285141A/en unknown
Also Published As
Publication number | Publication date |
---|---|
KR20210130751A (ko) | 2021-11-01 |
WO2020165087A1 (en) | 2020-08-20 |
CA3129357A1 (en) | 2020-08-20 |
SG11202107722VA (en) | 2021-08-30 |
EP3923905A1 (en) | 2021-12-22 |
US20220088149A1 (en) | 2022-03-24 |
AU2020221491A1 (en) | 2021-08-05 |
MX2021009370A (es) | 2021-09-10 |
CN113423383A (zh) | 2021-09-21 |
JP2022520189A (ja) | 2022-03-29 |
IL285141A (en) | 2021-09-30 |
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