CA2889785C - Reconstituted hdl formulation - Google Patents

Reconstituted hdl formulation Download PDF

Info

Publication number
CA2889785C
CA2889785C CA2889785A CA2889785A CA2889785C CA 2889785 C CA2889785 C CA 2889785C CA 2889785 A CA2889785 A CA 2889785A CA 2889785 A CA2889785 A CA 2889785A CA 2889785 C CA2889785 C CA 2889785C
Authority
CA
Canada
Prior art keywords
apolipoprotein
rhdl
sucrose
lipid
formulation according
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
CA2889785A
Other languages
English (en)
French (fr)
Other versions
CA2889785A1 (en
Inventor
Yvonne VUCICA
Gary Lee WARREN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CSL Ltd
Original Assignee
CSL Ltd
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 CSL Ltd filed Critical CSL Ltd
Publication of CA2889785A1 publication Critical patent/CA2889785A1/en
Application granted granted Critical
Publication of CA2889785C publication Critical patent/CA2889785C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • 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
    • A61K38/1703Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • 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
    • 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
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/775Apolipopeptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Dermatology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nutrition Science (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA2889785A 2012-11-02 2013-10-31 Reconstituted hdl formulation Active CA2889785C (en)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201261721771P 2012-11-02 2012-11-02
US61/721,771 2012-11-02
EP13153903 2013-02-04
EP13153903.3 2013-02-04
US13/803,863 2013-03-14
US13/803,863 US9125943B2 (en) 2012-11-02 2013-03-14 Reconstituted HDL formulation
AU2013205684A AU2013205684B2 (en) 2012-11-02 2013-04-10 Reconstituted hdl formulation
AU2013205684 2013-04-10
PCT/AU2013/001260 WO2014066943A1 (en) 2012-11-02 2013-10-31 Reconstituted hdl formulation

Publications (2)

Publication Number Publication Date
CA2889785A1 CA2889785A1 (en) 2014-05-08
CA2889785C true CA2889785C (en) 2022-07-19

Family

ID=47665977

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2889785A Active CA2889785C (en) 2012-11-02 2013-10-31 Reconstituted hdl formulation

Country Status (15)

Country Link
US (6) US9125943B2 (enExample)
EP (2) EP2916857B1 (enExample)
JP (1) JP6340372B2 (enExample)
KR (1) KR102263810B1 (enExample)
CN (2) CN104755096B (enExample)
AU (1) AU2013205684B2 (enExample)
BR (1) BR112015009748B1 (enExample)
CA (1) CA2889785C (enExample)
IL (1) IL238504B (enExample)
MX (1) MX364587B (enExample)
NZ (1) NZ631131A (enExample)
PL (1) PL2916857T3 (enExample)
RU (1) RU2669568C2 (enExample)
SG (1) SG11201503083UA (enExample)
WO (1) WO2014066943A1 (enExample)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK3178481T3 (en) 2010-06-30 2019-04-08 Csl Ltd FORMULATION WITH RECONSTITUTED HIGH DENSITY LIPOPROTEIN AND PROCEDURE FOR PREPARING THEREOF
US9125943B2 (en) * 2012-11-02 2015-09-08 Csl Limited Reconstituted HDL formulation
DK3004160T3 (da) 2013-06-05 2023-01-23 Csl Ltd Fremgangsmåde til fremstilling af apolipoprotein a-i (apo a-i)
AU2014305646C1 (en) 2013-08-08 2019-01-17 Csl Limited Contaminant removal method
WO2018019911A1 (en) 2016-07-27 2018-02-01 Hartis-Pharma Sarl Therapeutic combinations to treat red blood cell disorders
IL266428B2 (en) * 2016-11-10 2024-12-01 Csl Ltd High-density lipoprotein (HDL) is restored to treat myocardial infarction
CN112546201A (zh) * 2019-09-26 2021-03-26 中国科学院生物物理研究所 人工脂蛋白颗粒apoA-Ⅳ脂肪体在治疗和/或预防糖尿病中的应用
WO2025185021A1 (zh) * 2024-03-05 2025-09-12 维康平生(北京)生物科技有限公司 一种脂肪体的冷冻干燥方法

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA1335077C (en) * 1988-02-08 1995-04-04 Henri Isliker Process for the manufacture of apolipoproteins from human blood plasma or serum
US5652339A (en) 1993-12-31 1997-07-29 Rotkreuzstiftung Zentrallaboratorium Method of producing reconstituted lipoproteins
MXPA04002848A (es) 2001-09-28 2005-06-06 Esperion Therapeutics Inc Prevencion y tratamiento de restenosis por administracion local de medicamento.
US20040067873A1 (en) 2002-05-17 2004-04-08 Dasseux Jean-Louis H. Method of treating dyslipidemic disorders
NZ537006A (en) 2002-05-17 2008-01-31 Esperion Therapeutics Inc The use of apolipoprotein A-I Milano, for the manufacture ofa composition for treating preventing or reducing ischemic reperfusion injury in a tissue or organ
PE20050438A1 (es) 2003-10-20 2005-06-14 Esperion Therapeutics Inc Formulas farmaceuticas, metodos y regimenes de dosificacion para el tratamiento y la prevencion de sindromes coronarios agudos
US20070254832A1 (en) * 2006-02-17 2007-11-01 Pressler Milton L Methods for the treatment of macular degeneration and related eye conditions
KR100992488B1 (ko) 2006-12-29 2010-11-05 주식회사 녹십자 ApoA-I의 정제방법 및 정제된ApoA-I을 이용한재구축 HDL의 생산 방법
WO2009025754A2 (en) 2007-08-17 2009-02-26 Csl Behring Gmbh Methods for purification of alpha-1-antitrypsin and apolipoprotein a-i
WO2010057203A2 (en) 2008-11-17 2010-05-20 The Board Of Regents Of The University Of Texas System Hdl particles for delivery of nucleic acids
DK3178481T3 (en) * 2010-06-30 2019-04-08 Csl Ltd FORMULATION WITH RECONSTITUTED HIGH DENSITY LIPOPROTEIN AND PROCEDURE FOR PREPARING THEREOF
PT2673296T (pt) * 2011-02-07 2019-01-31 Cerenis Therapeutics Holding Sa Complexos de lipoproteínas e sua fabricação e utilização
US9125943B2 (en) 2012-11-02 2015-09-08 Csl Limited Reconstituted HDL formulation

Also Published As

Publication number Publication date
KR102263810B1 (ko) 2021-06-15
IL238504A0 (en) 2015-06-30
WO2014066943A1 (en) 2014-05-08
US11957731B2 (en) 2024-04-16
US9925236B2 (en) 2018-03-27
EP3502131A1 (en) 2019-06-26
BR112015009748B1 (pt) 2021-04-27
US20150306176A1 (en) 2015-10-29
BR112015009748A2 (pt) 2017-07-11
US20200397859A1 (en) 2020-12-24
JP6340372B2 (ja) 2018-06-06
CN104755096B (zh) 2017-10-13
US20190015476A1 (en) 2019-01-17
US10603355B2 (en) 2020-03-31
MX2015004546A (es) 2015-07-14
CN108057023A (zh) 2018-05-22
CA2889785A1 (en) 2014-05-08
PL2916857T3 (pl) 2019-06-28
EP2916857A1 (en) 2015-09-16
CN104755096A (zh) 2015-07-01
US20230142696A1 (en) 2023-05-11
SG11201503083UA (en) 2015-05-28
AU2013205684B2 (en) 2015-08-20
IL238504B (en) 2018-02-28
AU2013205684A1 (en) 2014-05-22
MX364587B (es) 2019-05-02
EP2916857A4 (en) 2016-05-25
RU2669568C2 (ru) 2018-10-12
US9125943B2 (en) 2015-09-08
CN108057023B (zh) 2022-02-08
NZ631131A (en) 2015-12-24
RU2015120808A (ru) 2016-12-20
EP2916857B1 (en) 2019-01-16
US11464828B2 (en) 2022-10-11
US20140221272A1 (en) 2014-08-07
JP2015535263A (ja) 2015-12-10
KR20150079947A (ko) 2015-07-08
HK1212599A1 (en) 2016-06-17
US20250099537A1 (en) 2025-03-27

Similar Documents

Publication Publication Date Title
US11957731B2 (en) Reconstituted HDL formulation
AU2011274238B2 (en) A reconstituted high density lipoprotein formulation and production method thereof
US20240216467A1 (en) Dosage regime for apolipoprotein formulations
DK2916857T3 (en) RECONSTITUTED HDL FORMULATION
HK40010383A (en) Reconstituted hdl formulation
HK1212599B (en) Reconstituted hdl formulation
RU2776110C2 (ru) Схема дозирования для составов аполипопротеина
HK1199813B (en) Dosage regime for apolipoprotein formulations

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20181016

MPN Maintenance fee for patent paid

Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 12TH ANNIV.) - STANDARD

Year of fee payment: 12

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250909

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250909