CA2889785C - Reconstituted hdl formulation - Google Patents

Reconstituted hdl formulation Download PDF

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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
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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
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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
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Filing date
Publication date
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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
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    • 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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (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)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Dermatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Nutrition Science (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (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
EP13153903.3 2013-02-04
EP13153903 2013-02-04
US13/803,863 US9125943B2 (en) 2012-11-02 2013-03-14 Reconstituted HDL formulation
US13/803,863 2013-03-14
AU2013205684 2013-04-10
AU2013205684A AU2013205684B2 (en) 2012-11-02 2013-04-10 Reconstituted hdl formulation
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) EP3502131A1 (enExample)
JP (1) JP6340372B2 (enExample)
KR (1) KR102263810B1 (enExample)
CN (2) CN108057023B (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
ES2617977T3 (es) 2010-06-30 2017-06-20 Csl Limited Una formulación de lipoproteína de alta densidad reconstituida y método de producción de la misma
US9125943B2 (en) * 2012-11-02 2015-09-08 Csl Limited Reconstituted HDL formulation
NZ631116A (en) * 2013-06-05 2018-07-27 Csl Ltd Process for preparing apolipoprotein a-i (apo a-i)
CA2920391C (en) 2013-08-08 2023-03-28 Csl Limited Contaminant removal method
BR112019001459A2 (pt) 2016-07-27 2019-05-07 Hartis-Pharma Sa combinação, composição farmacêutica, e, método de prevenção e/ou de tratamento de uma doença ou de um distúrbio.
KR20240044543A (ko) * 2016-11-10 2024-04-04 시에스엘 리미티드 심근경색의 재구성된 고밀도 지질단백질 치료
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
PL372925A1 (en) 2001-09-28 2005-08-08 Esperion Therapeutics Inc. Prevention and treatment of restenosis by local administration of drug
MXPA04011312A (es) 2002-05-17 2005-02-14 Esperion Therapeutics Inc Metodo para el tratamiento de desordenes dislipidemicos.
BR0310100A (pt) 2002-05-17 2007-04-27 Esperion Therapeutics Inc métodos para tratar, prevenir ou reduzir a lesão de reperfusão isquêmica em um tecido ou órgão, e para prevenir ou tratar de uma condição associada com a privação de oxigênio, seguida por suprimento de oxigênio aumentado a um tecido ou órgão em necessidade disto
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
NZ582170A (en) 2007-08-17 2012-02-24 Csl Behring Gmbh Methods for purification of alpha-1-antitrypsin and apolipoprotein a-i
US8734853B2 (en) 2008-11-17 2014-05-27 University Of North Texas Health Science Center At Fort Worth HDL particles for delivery of nucleic acids
ES2617977T3 (es) 2010-06-30 2017-06-20 Csl Limited Una formulación de lipoproteína de alta densidad reconstituida y método de producción de la misma
RS58275B1 (sr) 2011-02-07 2019-03-29 Cerenis Therapeutics Holding Sa Lipoproteinski kompleksi i njihova proizvodnja i upotrebe
US9125943B2 (en) * 2012-11-02 2015-09-08 Csl Limited Reconstituted HDL formulation

Also Published As

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

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Effective date: 20181016

EEER Examination request

Effective date: 20181016