ES2639833T3 - Composiciones C1-INH para uso en la prevención y tratamiento del angioedema hereditario (AEH) - Google Patents

Composiciones C1-INH para uso en la prevención y tratamiento del angioedema hereditario (AEH) Download PDF

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ES2639833T3
ES2639833T3 ES14762343.3T ES14762343T ES2639833T3 ES 2639833 T3 ES2639833 T3 ES 2639833T3 ES 14762343 T ES14762343 T ES 14762343T ES 2639833 T3 ES2639833 T3 ES 2639833T3
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inh
hae
prevention
treatment
compositions
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Cynthia GALLAGHER
Stephen Ruddy
Mark Cornell MANNING
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Viropharma Biologics LLC
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Shire Viropharma LLC
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    • 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
    • A61K38/55—Protease inhibitors
    • A61K38/57—Protease inhibitors from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A61K35/16—Blood plasma; Blood serum
    • 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
    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/55—Protease inhibitors
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/0012—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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/81—Protease inhibitors

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
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  • Cell Biology (AREA)
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  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Molecular Biology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Una composición que comprende al menos un inhibidor de la esterasa C1, donde el al menos un inhibidor de la esterasa C1 está presente en 400 U/ml o más para su uso en el tratamiento, inhibición, o prevención del angioedema hereditario (AEH) y en el que dicha composición se administra por vía subcutánea.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
imagen6
En particular, a pH 6,9, las formulaciones de citrato tenían valores de viscosidad más bajos que para el fosfato, mientras que a pH 7,9, el tampón de fosfato produce viscosidades más bajas que el tampón de tris. Viscosidades más altas significarán que se requerirá una mayor fuerza para suministrar un volumen especificado de la droga dentro de un cierto marco de tiempo.
5
La pureza por RP HPLC fue inicialmente de aproximadamente 86 al 87% para las formulaciones a pH 6,9 y más (Tabla 3). Los niveles iniciales fueron inferiores a pH 5,9, lo que sugiere que alguna degradación ya había ocurrido sólo en el proceso de preparación de las muestras. Tras el almacenamiento durante una semana a 40°C, las muestras de pH 5,9 se gelificaron, haciendo imposible el análisis por RP HPLC. Para todas las otras muestras, el
10 porcentaje de pureza era esencialmente sin cambios, lo que indica que poca, o ninguna degradación química se produce para el almacenamiento en estas condiciones.
Tabla 3: Porcentaje de pureza por RP HPLC tras el almacenamiento a 25°C (T2) o 40°C (T1).
15
20
25
30
35
40
pH
[C1 INH] Tampón t0 t1 t2
5,9
400 fosfato 82,87 6 0,75 gel 81,10 ± 2,11
500
84,74 ± 1,24 gel 83,61 ± 1,02
400
histidina 84,11 ± 1,53 gel 85,34 ± 1,55
500
86,36 ± 0,76 gel 82,99 ± 0,64
6.9
400 fosfato 87,14 ± 0,67 88,59 ± 0,29 85,19 ± 2,00
500
86,44 ± 1,49 85,65 ± 1,32 84,07 ± 1,24
400
citrato 86,67 ± 1,36 82,92 ± 1,48 86,03 ± 0,87
500
86,89 ± 1,24 86,74 ± 0,88 84,42 ± 1,19
7.9
400 fosfato 86,09 ± 1,14 85,29 ± 0,84 85,98 ± 0,90
500
86,47 ± 1,15 83,57 ± 1,33 84,00 ± 0,97
400
tris 87,14 ± 0,98 81,74 ± 7,89 86,14 ± 0,81
500
88,74 ± 0,82 87,24 ± 1,47 87,30 ± 0,95
Para las muestras almacenadas durante dos semanas a 25°C, había pequeñas pérdidas, comparables a lo que se vio en t1. Juntos, los datos de RP HPLC indican que hay pequeñas pérdidas debido a la degradación química. pH más alto parece disminuir la velocidad de degradación y puede haber cierta sensibilidad a composición
45 de tampón.
Mientras que la estabilidad química de C1 INH parece estar sin cambios durante el almacenamiento, hay cierta inestabilidad física observada como se indica por SEC (Tabla 4). Hay otras proteínas presentes en la mezcla de C1 INH, conduciendo a un 'puridad' general de aproximadamente ~ 67% en t0. Tras el almacenamiento a 40°C
50 durante una semana (t1), el contenido total de monómeros de las muestras se redujo a 54-56% para las muestras con pH 6,9 y superior. Hubo poca diferencia entre las dos condiciones de pH diferentes, los diferentes tampones y las dos concentraciones de proteína. Cuando se almacenan durante dos semanas a 25°C (t2), las muestras de pH 5,9 no se gelificaron, como lo hicieron en la temperatura de almacenamiento superior. Sin embargo, hubo apreciablemente mayor degradación, especialmente con tampón de histidina. A pH 6,9 o 7,9, la pérdida medida por
55 SEC fue de aproximadamente 2% o menos, en comparación con la pérdida de 10-12% en la temperatura más alta durante la mitad del tiempo.
8

Claims (1)

  1. imagen1
ES14762343.3T 2013-03-15 2014-03-17 Composiciones C1-INH para uso en la prevención y tratamiento del angioedema hereditario (AEH) Active ES2639833T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361791399P 2013-03-15 2013-03-15
US201361791399P 2013-03-15
PCT/US2014/030309 WO2014145519A2 (en) 2013-03-15 2014-03-17 C1-inh compositions and methods for the prevention and treatment of disorders associated with c1 esterase inhibitor deficency

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ES2639833T3 true ES2639833T3 (es) 2017-10-30

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ES17177676T Active ES2713004T3 (es) 2013-03-15 2014-03-17 Composiciones de C1-INH y métodos para la prevención y el tratamiento de trastornos asociados con la deficiencia del inhibidor de C1 esterasa
ES14762343.3T Active ES2639833T3 (es) 2013-03-15 2014-03-17 Composiciones C1-INH para uso en la prevención y tratamiento del angioedema hereditario (AEH)

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ES17177676T Active ES2713004T3 (es) 2013-03-15 2014-03-17 Composiciones de C1-INH y métodos para la prevención y el tratamiento de trastornos asociados con la deficiencia del inhibidor de C1 esterasa

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US (9) US9616111B2 (es)
EP (3) EP3508213A1 (es)
JP (9) JP6184581B2 (es)
KR (4) KR20150135242A (es)
CN (2) CN105517559A (es)
AU (3) AU2014232912A1 (es)
BR (1) BR112015023207A8 (es)
CA (2) CA3054718A1 (es)
CY (2) CY1119419T1 (es)
DE (1) DE202014011208U1 (es)
DK (2) DK2968434T3 (es)
EA (1) EA201591278A1 (es)
ES (2) ES2713004T3 (es)
GB (1) GB2530921B (es)
HK (2) HK1220403A1 (es)
HR (2) HRP20171269T1 (es)
HU (2) HUE041837T2 (es)
IL (2) IL241549B (es)
LT (2) LT2968434T (es)
ME (2) ME02865B (es)
MX (3) MX2015011281A (es)
NZ (2) NZ751555A (es)
PL (2) PL3290046T3 (es)
PT (2) PT2968434T (es)
RS (2) RS58351B1 (es)
SG (2) SG10201707598QA (es)
SI (2) SI3290046T1 (es)
TR (1) TR201900319T4 (es)
WO (1) WO2014145519A2 (es)
ZA (3) ZA201507604B (es)

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