SG10201908916UA - Stable MIA/CD-RAP formulations - Google Patents

Stable MIA/CD-RAP formulations

Info

Publication number
SG10201908916UA
SG10201908916UA SG10201908916UA SG10201908916UA SG 10201908916U A SG10201908916U A SG 10201908916UA SG 10201908916U A SG10201908916U A SG 10201908916UA SG 10201908916U A SG10201908916U A SG 10201908916UA
Authority
SG
Singapore
Prior art keywords
rap
formulations
stable
mia
formulation
Prior art date
Application number
Inventor
Klaus Hellerbrand
Rainer Sigl
Original Assignee
Scil Tech Gmbh
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 Scil Tech Gmbh filed Critical Scil Tech Gmbh
Publication of SG10201908916UA publication Critical patent/SG10201908916UA/en

Links

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
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • 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
    • 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/24—Organic 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
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • C07K14/4701—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals not used
    • C07K14/4702—Regulators; Modulating activity
    • C07K14/4703—Inhibitors; Suppressors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/78—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing 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
    • A61K9/0012—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
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue

Abstract

STABLE MIA/CD-RAP FORMULATIONS The present invention relates to stable aqueous formulations comprising at least 5 mg/mL CD- RAP and a charged amino acid, said amino acid preferably having a net charge at a pH between 5 about 6 and 8. The ingredients of the formulation preferably provide stability over repeated freeze-thaw cycles. In a preferred aspect, the formulation is for use in therapy, preferably for use in the treatment of inflammatory disorders, preferably osteoarthritis. Furthermore, a kit comprising the formulation of the invention is provided. (Fig 1) 10
SG10201908916U 2010-04-27 2011-04-27 Stable MIA/CD-RAP formulations SG10201908916UA (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP10161160 2010-04-27

Publications (1)

Publication Number Publication Date
SG10201908916UA true SG10201908916UA (en) 2019-11-28

Family

ID=43806879

Family Applications (3)

Application Number Title Priority Date Filing Date
SG10201908916U SG10201908916UA (en) 2010-04-27 2011-04-27 Stable MIA/CD-RAP formulations
SG10201502398RA SG10201502398RA (en) 2010-04-27 2011-04-27 Stable MIA/CD-RAP formulations
SG2012064804A SG183561A1 (en) 2010-04-27 2011-04-27 Stable aqueous mia/cd-rap formulations

Family Applications After (2)

Application Number Title Priority Date Filing Date
SG10201502398RA SG10201502398RA (en) 2010-04-27 2011-04-27 Stable MIA/CD-RAP formulations
SG2012064804A SG183561A1 (en) 2010-04-27 2011-04-27 Stable aqueous mia/cd-rap formulations

Country Status (20)

Country Link
US (2) US9511116B2 (en)
EP (1) EP2563809B1 (en)
JP (2) JP2013525406A (en)
KR (1) KR101880905B1 (en)
CN (1) CN102869679B (en)
AU (1) AU2011247659B2 (en)
BR (1) BR112012027361A2 (en)
CA (1) CA2792965A1 (en)
CL (1) CL2012002948A1 (en)
CO (1) CO6592098A2 (en)
HK (1) HK1179273A1 (en)
IL (1) IL222712B (en)
MA (1) MA34225B1 (en)
MX (1) MX344732B (en)
MY (1) MY160916A (en)
NZ (1) NZ601927A (en)
RU (2) RU2588658C2 (en)
SG (3) SG10201908916UA (en)
WO (1) WO2011134979A2 (en)
ZA (1) ZA201206235B (en)

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* Cited by examiner, † Cited by third party
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SG10201908916UA (en) * 2010-04-27 2019-11-28 Scil Tech Gmbh Stable MIA/CD-RAP formulations
WO2014098232A1 (en) * 2012-12-21 2014-06-26 Yamashita Chikamasa Pharmaceutical composition comprising pi3 kinase inhibitor, pharmaceutical composition comprising compound which acts on vitamin d receptor, freeze-dried composition, method for producing freeze-dried composition, and pharmaceutical composition for transpulmonary administration
US10206878B2 (en) * 2014-05-28 2019-02-19 Nono Inc. Lyophilized formulation of TAT-NR2B9C with acetylation scavenger
WO2017046314A2 (en) * 2015-09-18 2017-03-23 Sanofi Improvement of expression and folding in the manufacturing process of cd-rap by using a cd-rap precursor protein
US10279048B2 (en) * 2016-07-13 2019-05-07 Reform Biologics, Llc Stabilizing excipients for therapeutic protein formulations
WO2018101358A1 (en) * 2016-11-29 2018-06-07 Ｓｐｉｂｅｒ株式会社 Protein composition, method for producing same and method for improving heat stability
JP7179717B2 (en) * 2017-03-31 2022-11-29 Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 Aqueous formulation, aqueous formulation containing syringe, antibody protein disaggregation agent, and antibody protein disaggregation method
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CN112386575B (en) * 2019-08-19 2023-03-21 鲁南制药集团股份有限公司 Freeze-dried preparation of metabolism regulation fusion protein
KR102427935B1 (en) 2022-05-23 2022-08-03 주식회사 동우이엔티 Wet electrostatic precipitation system capable of simultaneous treatment of complex gas mixed with particulate and gaseous pollutants including wet scrubber

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Also Published As

Publication number Publication date
KR20130086531A (en) 2013-08-02
JP2013525406A (en) 2013-06-20
MX344732B (en) 2017-01-04
MX2012012115A (en) 2013-01-29
CN102869679A (en) 2013-01-09
US20130137639A1 (en) 2013-05-30
WO2011134979A9 (en) 2012-08-16
BR112012027361A2 (en) 2021-04-27
IL222712A0 (en) 2012-12-31
EP2563809B1 (en) 2020-04-01
US20170042971A1 (en) 2017-02-16
RU2016118646A3 (en) 2019-06-20
CA2792965A1 (en) 2011-11-03
WO2011134979A3 (en) 2012-06-14
RU2016118646A (en) 2018-11-02
CO6592098A2 (en) 2013-01-02
AU2011247659A1 (en) 2012-09-06
SG10201502398RA (en) 2015-05-28
RU2739078C2 (en) 2020-12-21
CL2012002948A1 (en) 2013-02-15
RU2012144771A (en) 2014-06-10
NZ601927A (en) 2013-07-26
RU2588658C2 (en) 2016-07-10
SG183561A1 (en) 2012-09-27
AU2011247659B2 (en) 2014-07-24
MY160916A (en) 2017-03-31
EP2563809A2 (en) 2013-03-06
ZA201206235B (en) 2021-04-28
WO2011134979A2 (en) 2011-11-03
JP2016034958A (en) 2016-03-17
MA34225B1 (en) 2013-05-02
JP6078129B2 (en) 2017-02-08
US9907829B2 (en) 2018-03-06
US9511116B2 (en) 2016-12-06
IL222712B (en) 2018-02-28
KR101880905B1 (en) 2018-07-23
HK1179273A1 (en) 2013-09-27
CN102869679B (en) 2015-11-25

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