MX2021009370A - Formulaciones farmaceuticas liquidas de conjugados de hormona paratiroidea. - Google Patents

Formulaciones farmaceuticas liquidas de conjugados de hormona paratiroidea.

Info

Publication number
MX2021009370A
MX2021009370A MX2021009370A MX2021009370A MX2021009370A MX 2021009370 A MX2021009370 A MX 2021009370A MX 2021009370 A MX2021009370 A MX 2021009370A MX 2021009370 A MX2021009370 A MX 2021009370A MX 2021009370 A MX2021009370 A MX 2021009370A
Authority
MX
Mexico
Prior art keywords
pth
liquid pharmaceutical
pharmaceutical formulations
conjugates
pth conjugates
Prior art date
Application number
MX2021009370A
Other languages
English (en)
Inventor
Felix Cleemann
Kennett Sprogøe
Sørensen Michael Duelund
Anja R H Skands
Julia Baron
Eric Hoffmann
Original Assignee
Ascendis Pharma Bone Diseases As
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ascendis Pharma Bone Diseases As filed Critical Ascendis Pharma Bone Diseases As
Publication of MX2021009370A publication Critical patent/MX2021009370A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/29Parathyroid hormone (parathormone); Parathyroid hormone-related peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/54Medicinal 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
    • A61K47/545Heterocyclic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/56Medicinal 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
    • A61K47/59Medicinal 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
    • A61K47/60Medicinal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones

Abstract

Una formulación farmacéutica líquida, en la que la formulación farmacéutica comprende un conjugado de PTH, un agente amortiguador, un agente que proporciona isotonicidad, un conservador y opcionalmente un antioxidante y en donde el conjugado de PTH comprende una porción de PTH que se conjuga covalente y reversiblemente con una porción portadora soluble en agua.
MX2021009370A 2019-02-11 2020-02-10 Formulaciones farmaceuticas liquidas de conjugados de hormona paratiroidea. MX2021009370A (es)

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
MX2021009370A true MX2021009370A (es) 2021-09-10

Family

ID=69400577

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021009370A MX2021009370A (es) 2019-02-11 2020-02-10 Formulaciones farmaceuticas liquidas de conjugados de hormona paratiroidea.

Country Status (12)

Country Link
US (1) US20220088149A1 (es)
EP (1) EP3923905A1 (es)
JP (1) JP2022520189A (es)
KR (1) KR20210130751A (es)
CN (1) CN113423383A (es)
AU (1) AU2020221491A1 (es)
BR (1) BR112021014581A2 (es)
CA (1) CA3129357A1 (es)
IL (1) IL285141A (es)
MX (1) MX2021009370A (es)
SG (1) SG11202107722VA (es)
WO (1) WO2020165087A1 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MA45809A (fr) * 2016-03-01 2019-01-09 Ascendis Pharma Bone Diseases As Promédicaments de pth
ES2943720T3 (es) 2016-09-29 2023-06-15 Ascendis Pharma Bone Diseases As Compuestos de PTH con bajas relaciones de pico a valle
BR112019005533A2 (pt) 2016-09-29 2019-06-18 Ascendis Pharma Bone Diseases As regime de dosagem para um composto de pth de liberação controlada

Family Cites Families (44)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY120063A (en) * 1997-12-09 2005-08-30 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
JP4698579B2 (ja) 2003-04-08 2011-06-08 イエダ リサーチ アンド デベロップメント カンパニー リミテッド 可逆的peg化薬物
US7690003B2 (en) 2003-08-29 2010-03-30 Fuller Jeffrey C System and method for increasing data throughput using thread scheduling
CA2539253A1 (en) 2003-09-19 2005-03-31 Novo Nordisk A/S Albumin-binding derivatives of therapeutic peptides
EP2087910B1 (en) 2004-03-23 2022-05-04 Ascendis Pharma GmbH Polymeric prodrugs
US7244709B2 (en) * 2004-05-10 2007-07-17 Nastech Pharamecutical Company Inc. Compositions and methods for enhanced mucosal delivery of parathyroid hormone
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
KR20090055623A (ko) 2006-09-15 2009-06-02 엔존 파마슈티컬즈, 인코포레이티드 올리고뉴클레오티드 전달을 위한 방해된 에스테르 기재 생분해성 링커
DK2173890T3 (da) 2007-06-21 2011-06-27 Univ Muenchen Tech Biologisk aktive proteiner med forhøjet stabilitet in vivo og/eller in vitro
EP2175878A4 (en) 2007-07-11 2014-12-03 Belrose Pharma Inc POLYMER DRUG DISPENSING SYSTEM WITH A MULTIPLE SUBSTITUTED AROMATIC PART
EP2052736A1 (en) * 2007-10-26 2009-04-29 Nycomed Danmark ApS Parathyroid hormone formulations und uses thereof
PL2237799T3 (pl) 2008-02-01 2019-09-30 Ascendis Pharma A/S Prolek zawierający samorozszczepiający się łącznik
CA2723263A1 (en) 2008-05-23 2009-11-26 Enzon Pharmaceuticals, Inc. Polymeric systems containing intracellular releasable disulfide linker for the delivery of oligonucleotides
NZ628987A (en) 2009-02-03 2015-11-27 Amunix Operating Inc Extended recombinant polypeptides and compositions comprising same
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
EP2519228A4 (en) 2009-12-31 2013-06-19 Enzon Pharmaceuticals Inc POLYMER CONJUGATES FROM AN AROMATIC AMINE WITH COMPOUNDS WITH A CLEANER UREA CONTAINER
US9062094B2 (en) 2010-01-22 2015-06-23 Ascendis Pharma As 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
WO2011140392A1 (en) 2010-05-05 2011-11-10 Prolynx Llc Controlled drug release from solid supports
JP5977229B2 (ja) 2010-05-05 2016-08-24 プロリンクス リミテッド ライアビリティ カンパニー 巨大分子共役体からの徐放
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
JP5594791B2 (ja) 2010-06-30 2014-09-24 Necソリューションイノベータ株式会社 属性判定方法、属性判定装置、プログラム、記録媒体および属性判定システム
WO2013024053A1 (en) 2011-08-12 2013-02-21 Ascendis Pharma A/S Carrier-linked prodrugs having reversible carboxylic ester linkages
CN103857413A (zh) 2011-08-12 2014-06-11 阿森迪斯药物股份有限公司 载体连接的曲罗尼尔前药
US20140323402A1 (en) 2011-08-12 2014-10-30 Ascendis Phama A/S Protein Carrier-Linked Prodrugs
EP2741778A1 (en) 2011-08-12 2014-06-18 Ascendis Pharma A/S Polymeric hyperbranched carrier-linked prodrugs
WO2013036857A1 (en) 2011-09-07 2013-03-14 Prolynx Llc Sulfone linkers
RU2014133818A (ru) * 2012-01-20 2016-03-20 Люпин Лимитед Стабилизированный состав pth
CA2868925C (en) 2012-04-25 2020-01-21 Ascendis Pharma A/S Prodrugs of hydroxyl-comprising drugs
CA2883707A1 (en) * 2012-08-28 2014-03-06 The Governors Of The University Of Alberta Parathyroid hormone, insulin, and related peptides conjugated to bone targeting moieties and methods of making and using thereof
JP2015536314A (ja) 2012-10-17 2015-12-21 ノヴォ・ノルディスク・ヘルス・ケア・アーゲー 成長ホルモン送達のための脂肪酸アシル化アミノ酸
AU2015299055C1 (en) 2014-08-06 2021-05-06 Ascendis Pharma A/S Prodrugs comprising an aminoalkyl glycine linker
MA45809A (fr) * 2016-03-01 2019-01-09 Ascendis Pharma Bone Diseases As Promédicaments de pth
WO2018060311A1 (en) 2016-09-29 2018-04-05 Ascendis Pharma Bone Diseases A/S Incremental dose finding in controlled-release pth compounds
BR112019005533A2 (pt) 2016-09-29 2019-06-18 Ascendis Pharma Bone Diseases As regime de dosagem para um composto de pth de liberação controlada
ES2943720T3 (es) 2016-09-29 2023-06-15 Ascendis Pharma Bone Diseases As Compuestos de PTH con bajas relaciones de pico a valle

Also Published As

Publication number Publication date
SG11202107722VA (en) 2021-08-30
CA3129357A1 (en) 2020-08-20
CN113423383A (zh) 2021-09-21
BR112021014581A2 (pt) 2021-12-14
AU2020221491A1 (en) 2021-08-05
US20220088149A1 (en) 2022-03-24
EP3923905A1 (en) 2021-12-22
IL285141A (en) 2021-09-30
KR20210130751A (ko) 2021-11-01
JP2022520189A (ja) 2022-03-29
WO2020165087A1 (en) 2020-08-20

Similar Documents

Publication Publication Date Title
MX2021009370A (es) Formulaciones farmaceuticas liquidas de conjugados de hormona paratiroidea.
MX2021008708A (es) Formulaciones farmaceuticas secas de conjugados de peptido natriuretico tipo c (cnp).
MX2020000333A (es) Formulaciones de conjugado anticuerpo anti-egfr-farmaco.
WO2017062271A3 (en) Antibody drug conjugate for anti-inflammatory applications
PH12018500693A1 (en) Pyrrolobenzodiazepine antibody drug conjugates and methods of use
EP3949969A3 (en) Benzazepine compounds, conjugates, and uses thereof
WO2020126609A3 (en) Antibody drug conjugates (adc) containing saponin
PH12020500675A1 (en) Cross-linked pyrrolobenzodiazepine dimer (pbd) derivative and its conjugates
WO2016127081A8 (en) Antibody drug conjugates
PE20161211A1 (es) Anticuerpos y conjugados de anticuerpo y farmaco anti-egfr
WO2017089890A8 (en) Conjugates comprising self-immolative groups and methods related thereto
CA2910494C (en) Insulin-oligomer conjugates, formulations and uses thereof
WO2020236825A8 (en) Mcl-1 inhibitor antibody-drug conjugates and methods of use
WO2015151079A3 (en) Auristatin analogues and their conjugates with cell-binding molecules
PH12020500672A1 (en) Splicing modulators antibody-drug conjugates
NZ724892A (en) Self-stabilizing linker conjugates
NZ743487A (en) Controlled-release cnp agonists with increased nep stability
WO2017180789A8 (en) Methods of treatment using chlorotoxin conjugates
WO2020236841A3 (en) Antibody drug conjugates having linkers comprising hydrophilic groups
ZA202006377B (en) Boronic acid derivatives and therapeutic uses thereof
SG11201903084UA (en) Cysteine modified antibody-drug conjugate and preparation method thereof
EP3936501A4 (en) SITE-SPECIFIC ANTIBODY CONJUGATION AND ANTIBODY-DRUG CONJUGATE SERVING AS A SPECIFIC EXAMPLE THEREOF
EP4253421A3 (en) Anti-her2 biparatopic antibody-drug conjugates and methods of use
MX2019008773A (es) Derivados de caliqueamicina y conjugados anticuerpo-farmaco de los mismos.
WO2019121687A3 (en) Immunotoxin conjugates for use in therapy