ECSP055961A - Formulaciones parenterales de péptidos para el tratamiento de lupus eritematoso sistémico - Google Patents

Formulaciones parenterales de péptidos para el tratamiento de lupus eritematoso sistémico

Info

Publication number
ECSP055961A
ECSP055961A EC2005005961A ECSP055961A ECSP055961A EC SP055961 A ECSP055961 A EC SP055961A EC 2005005961 A EC2005005961 A EC 2005005961A EC SP055961 A ECSP055961 A EC SP055961A EC SP055961 A ECSP055961 A EC SP055961A
Authority
EC
Ecuador
Prior art keywords
ala
glu
seq
lys
ser
Prior art date
Application number
EC2005005961A
Other languages
English (en)
Inventor
Cohen Vered Sharon
Naftali Esmira
Weinstein Vera
Gilbert Adrian
Klinger Ety
Original Assignee
Teva Pharma
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 Teva Pharma filed Critical Teva Pharma
Publication of ECSP055961A publication Critical patent/ECSP055961A/es

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10—Peptides having 12 to 20 amino acids
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04—Linear peptides containing only normal peptide links
    • C07K7/06—Linear peptides containing only normal peptide links having 5 to 11 amino acids
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K9/14—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
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • C07K14/4713—Autoimmune diseases, e.g. Insulin-dependent diabetes mellitus, multiple sclerosis, rheumathoid arthritis, systemic lupus erythematosus; Autoantigens
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04—Linear peptides containing only normal peptide links
    • C07K7/08—Linear peptides containing only normal peptide links having 12 to 20 amino acids
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Rheumatology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Dermatology (AREA)
  • Rehabilitation Therapy (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Toxicology (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Abstract

SUMARIO DE LA INVENCIÓN La presente invención provee una composición farmacéutica que comprende: Un vehículo acuoso de 0.1 mg/ml a 20 mg/ml de la composición de una sal farmacéuticamente aceptable de: a) un péptido que comprende por lo menos de 12 y a lo mucho 30 aminoácidos consecutivos que tiene una secuencia correspondiente a: i) una secuencia de aminoácidos encontrada dentro de una región determinante de complementariedad (CDR) de una cadena ligera o pesada de un anticuerpo 16/6 Id de un anti-ADN monoclonal humano,o ii) una secuencia de aminoácidos encontrada dentro de una región determinante de complementariedad (CDR) de una cadena ligera o pesada de un anticuerpo monoclonal anti-ADN patogénico que induce una respuesta en ratones de enfermedad similar a lupus sistémico eritematoso (SLE), o b) un péptido que comprende aminoácidos consecutivos que tienen la secuencia de: (i) TGYYX1X2X3X4X5QSPEKSLEWIG (SEC ID NO: 11) en donde X1 es Met, Ala o Val; X2 es Gln, Asp, Glu o Arg; X3 es Trp or Ala; X4 es Val o Ser; y X5 es Lys, Glu o Ala; (ii) EINPSTGGX6X7X8X9X10X11X12KAKAT (SEC ID NO:12) en donde X6 y X7 son cada Thr, Val o Ala; X8 es Tyr o Phe; X9 es Asn o Asp¸ X10 es Gln o Glu; X11 es Lys o Glu, y X12 es Phe o Tyr; (iii) YYCARX13X14X15X16X17X18YWGQGS (SEC ID NO : 13) en donde X13 es Phe, Thr o Gly; X14 es Leu, Ala o Ser; X15 es Trp o Ala; X16 es Glu o Lys; X17 es Met o Ala, y X18 es Asp, Lys o Ser; (iv) GYNX19X20X21X22X23X24X25X26LEWIG (SEC ID NO: 14)en donde X19 es Met o Ala; X20 es Asn, Asp o Arg; X21 es Trp o Ala; X22 es Val o Ser; X23 es Lys o Glu; X24 es Gln o Ala; X25 es Lys o Glu, y X26 es Ser o Ala; (v) YYCARX27X28X29YGX30X31X32GQTL (SEC ID NO: 15) en donde X27 es Ser o Phe; X28 es Gly o Ala; X29 es Arg, Ala o Glu; X30 es Asn o Asp; X31 es Tyr o Phe¸y X32 es Trp, His o Ala; (vi) X33YYWSWIX134QX35PX36X37GX38EWIG (SEC ID NO: 16) en donde X33 es Gly o Thr Gly; X34 es Arg o Lys; X35 es Pro o Ser; X36 es Gly o Glu; X37 es Lys o Asp; y X38 es Glu, Leu o Ser; (vii) YYCARX39LLX40X41X42X43X44DVDYX45GX46DV (SEC ID NO: 17) en donde X39 es Gly o Phe; X40 es Arg o Ala; X41 es Gly o Ala; X42 es Gly o Ala; X43 es Trp o Ala; X44 es Asn o Ala; X45 es Tyr o Trp; X46 es Met o Gln; (viii) FSGYYWS (SEC ID NO: 8); (ix) EINHSGSTNYKTSLKS (SEC ID NO: 9); o (x) GLLRGGWNDVDYYYGMDV (SEC ID NO: 10), o c) un péptido que comprende aminoácidos consecutivos que tienen una secuencia de cualquiera de a) y b), o por lo menos dos de las secuencias en (a) (i), (a) (ii) y (b) (i) hasta (b) (x), o d) un péptido que comprende aminoácidos consecutivos que tienen una secuencia que comprenpor lo menos de dos secuencias idénticas incluidas en (a) (i), (a) (ii) y (b) (i) hasta (b) (x); y un incrementador de solubilidad seleccionado del grupo que consiste de dimetil-acetamida, polietilenglicol, aceite de castos polioxilado, N-metil-2-pirrolidinona, 1-etenil-2-pirrolidinona, esteres de sorbitán de polioxietileno, y una ß-ciclodextrina substituida, en donde tanto el péptido como el incrementador de solubilidad se disuelven en un vehículo acuoso; y en donde la composición tiene un pH entre 4 y 9. La presente invención también provee un método para aliviar los síntomas del lupus sistémico eritematoso (SLE) en un sujeto humano que comprende administrar al sujeto humano cualquiera de las composiciones farmacéuticas de la invención en una cantidad efectiva para aliviar los síntomas de SLE en el sujeto humano.
EC2005005961A 2003-01-14 2005-08-11 Formulaciones parenterales de péptidos para el tratamiento de lupus eritematoso sistémico ECSP055961A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US43991803P 2003-01-14 2003-01-14

Publications (1)

Publication Number Publication Date
ECSP055961A true ECSP055961A (es) 2006-04-19

Family

ID=32771757

Family Applications (1)

Application Number Title Priority Date Filing Date
EC2005005961A ECSP055961A (es) 2003-01-14 2005-08-11 Formulaciones parenterales de péptidos para el tratamiento de lupus eritematoso sistémico

Country Status (21)

Country Link
US (3) US20050008634A1 (es)
EP (1) EP1594434B1 (es)
JP (2) JP4817068B2 (es)
KR (1) KR20050100617A (es)
CN (1) CN1774259B (es)
AU (1) AU2004206842A1 (es)
BR (1) BRPI0406745A (es)
CA (1) CA2513320C (es)
CO (1) CO5640143A2 (es)
CR (1) CR7938A (es)
DK (1) DK1594434T3 (es)
EA (1) EA009123B1 (es)
EC (1) ECSP055961A (es)
ES (1) ES2606464T3 (es)
IL (1) IL169574A (es)
IS (1) IS7972A (es)
MX (1) MXPA05007549A (es)
NO (1) NO20053773L (es)
NZ (1) NZ541658A (es)
WO (1) WO2004064787A2 (es)
ZA (1) ZA200506206B (es)

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IL141647A0 (en) 2001-02-26 2002-03-10 Yeda Res & Dev Synthetic human peptides and pharmaceutical compositions comprising them for the treatment of systemic lupus erythematosus
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NZ541658A (en) * 2003-01-14 2008-04-30 Teva Pharma Parenteral formulations of peptides for the treatment of systemic lupus erythematosus
US7635773B2 (en) 2008-04-28 2009-12-22 Cydex Pharmaceuticals, Inc. Sulfoalkyl ether cyclodextrin compositions
EP2358395A4 (en) * 2008-11-17 2013-11-20 Hoffmann La Roche METHOD AND FORMULATION FOR REDUCING THE AGGREGATION OF A MACROMOLECULUM UNDER PHYSIOLOGICAL CONDITIONS
DK2814849T3 (da) 2012-02-15 2020-03-09 Cydex Pharmaceuticals Inc Fremgangsmåde til fremstilling af cyclodextrin-derivater
SG11201500123XA (en) * 2012-07-12 2015-02-27 Sanofi Sa Anti-tumoral composition comprising the compound 1-(6-{[6-(4-fluorophenyl)[1,2,4]triazolo[4,3-b]pyridazin-3-yl]sulfanyl}-1,3-benzothiazol-2-yl)-3-(2-morpholin-4-ylethyl)urea
CA2888822C (en) 2012-10-22 2021-01-26 Cydex Pharmaceuticals, Inc. Alkylated cyclodextrin compositions and processes for preparing and using the same
WO2014193611A1 (en) * 2013-05-29 2014-12-04 Oklahoma Medical Research Foundation Bright/arid3a function/expression as a marker for systemic lupus erythematosus severity and intensity
WO2015013669A1 (en) 2013-07-26 2015-01-29 The Regents Of The University Of California Mps peptides and use thereof
WO2015095789A2 (en) 2013-12-20 2015-06-25 The Regents Of The University Of California Suppression of allergic lung inflammation and hyperreactivity
JP6914188B2 (ja) 2014-08-22 2021-08-04 サイデックス・ファーマシューティカルズ・インコーポレイテッド 分画アルキル化シクロデキストリン組成物ならびにその調製方法および使用方法
CA3007419A1 (en) 2015-12-30 2017-07-06 Genentech, Inc. Formulations with reduced degradation of polysorbate
TWI797073B (zh) 2016-01-25 2023-04-01 德商安美基研究（慕尼黑）公司 包含雙特異性抗體建構物之醫藥組合物
JP7242059B2 (ja) * 2017-01-05 2023-03-20 イエダ リサーチ アンド ディベロプメント カンパニー リミテッド シェーグレン症候群の治療用ペプチド
CN110476031A (zh) * 2017-04-04 2019-11-19 日东电工株式会社 冷冻干燥体的制造方法及其制造装置
US10975121B2 (en) 2017-06-24 2021-04-13 Cytogel Pharma, Llc Analgesic mu-opioid receptor binding peptide pharmaceutical formulations and uses thereof
ES2969958T3 (es) * 2017-11-30 2024-05-23 Cytogel Pharma Llc Formulaciones farmacéuticas analgésicas novedosas y usos de las mismas
CN112143707A (zh) * 2020-09-29 2020-12-29 广东先康达生物科技有限公司 一种治疗自身免疫细胞的免疫细胞及其应用

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Also Published As

Publication number Publication date
CN1774259B (zh) 2011-12-28
CR7938A (es) 2006-05-31
CA2513320A1 (en) 2004-08-05
EA200501131A1 (ru) 2006-04-28
US20050008634A1 (en) 2005-01-13
ZA200506206B (en) 2006-12-27
ES2606464T3 (es) 2017-03-24
MXPA05007549A (es) 2006-05-19
DK1594434T3 (da) 2017-01-02
JP2011173888A (ja) 2011-09-08
NO20053773D0 (no) 2005-08-08
EA009123B1 (ru) 2007-10-26
EP1594434B1 (en) 2016-09-07
WO2004064787A3 (en) 2005-12-15
IL169574A (en) 2015-08-31
EP1594434A4 (en) 2008-09-10
US20130023485A1 (en) 2013-01-24
CA2513320C (en) 2018-03-27
NZ541658A (en) 2008-04-30
NO20053773L (no) 2005-10-12
IS7972A (is) 2006-07-15
KR20050100617A (ko) 2005-10-19
EP1594434A2 (en) 2005-11-16
JP4817068B2 (ja) 2011-11-16
JP2006517540A (ja) 2006-07-27
CN1774259A (zh) 2006-05-17
BRPI0406745A (pt) 2005-12-20
US20090169559A1 (en) 2009-07-02
WO2004064787A2 (en) 2004-08-05
AU2004206842A1 (en) 2004-08-05
IL169574A0 (en) 2007-07-04
CO5640143A2 (es) 2006-05-31

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