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AR108631A1 - Formulación de neurotoxinas - Google Patents

Formulación de neurotoxinas

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Publication number
AR108631A1
AR108631A1 ARP170101464A ARP170101464A AR108631A1 AR 108631 A1 AR108631 A1 AR 108631A1 AR P170101464 A ARP170101464 A AR P170101464A AR P170101464 A ARP170101464 A AR P170101464A AR 108631 A1 AR108631 A1 AR 108631A1
Authority
AR
Argentina
Prior art keywords
liquid composition
botulinum neurotoxin
neurotoxin
tryptophan
stable
Prior art date
Application number
ARP170101464A
Other languages
English (en)
Original Assignee
Ipsen Biopharma 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 Ipsen Biopharma Ltd filed Critical Ipsen Biopharma Ltd
Publication of AR108631A1 publication Critical patent/AR108631A1/es

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893—Botulinum neurotoxin (3.4.24.69)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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    • A61K38/164—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
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Abstract

Formulaciones de neurotoxinas líquidas estable que están libres de proteínas animales, que comprende un tensioactivo, un aminoácido seleccionado de triptófano y tirosina, un tampón que comprende iones sodio, cloruro y fosfato, que tienen un pH de entre 5,5 y 8 y que son estables durante 2 meses. Estas composiciones son apropiadas para usar en terapia y en particular para administrar a un paciente para lograr un efecto terapéutico o estético deseado. Se refiere al uso de un aminoácido seleccionado de triptófano y tirosina para proteger una neurotoxina proteinácea de la degradación en una composición líquida que está libre de proteínas derivadas de animales. Reivindicación 1: Una composición líquida que comprende una neurotoxina proteinácea, un tensioactivo, un aminoácido seleccionado de triptófano y tirosina, un tampón que comprende iones sodio, cloruro y fosfato, en donde dicha composición líquida tiene un pH de entre 5,5 y 8, en donde dicha composición esta libre de proteínas derivadas de animales y en donde dicha composición líquida es estable en el tiempo. Reivindicación 8: Una composición líquida de acuerdo con cualquiera de las reivindicación 1 a 7, en donde dicha neurotoxina proteinácea es una neurotoxina botulínica, seleccionada de una neurotoxina botulínica natural en forma compleja, una neurotoxina botulínica natural de alta pureza y una neurotoxina botulínica recombinante. Reivindicación 9: Una composición líquida de acuerdo con la reivindicación 8, en donde dicha neurotoxina botulínica es una neurotoxina botulínica recombinante seleccionada de una neurotoxina botulínica A, B, C, D, E, F o G, una neurotoxina botulínica modificada y una neurotoxina botulínica quimérica. Reivindicación 10: Una composición líquida de acuerdo con cualquiera de las reivindicación 1 a 9, en donde dicha composición líquida comprende: 4 a 10000 unidades LD50 de neurotoxina botulínica por mL, 0,001 al 15% v/v de polisorbato, 0,1 a 5 mg/mL de triptófano, 10 a 500 mM de NaCl, 1 a 50 mM de KCl, 1 a 100 mM de fosfato de sodio, tiene un pH de entre 5,5 y 8 y es estable durante 6 meses a 5ºC. Reivindicación 11: Una composición líquida de acuerdo con la reivindicación 10, en donde dicha composición líquida comprende: 10 a 2000 unidades LD50 de neurotoxina botulínica por mL, 0,05 al 0,2% v/v de polisorbato 80, 0,1 a 5 mg/mL de triptófano, 25 a 300 mM de NaCl, 1 a 10 mM de KCl, 2 a 50 mM de fosfato de sodio, tiene un pH de entre 6,0 y 7,5 y es estable durante 12 meses a 5 ºC.
ARP170101464A 2016-05-27 2017-05-29 Formulación de neurotoxinas AR108631A1 (es)

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EP2016062085 2016-05-27

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AR108631A1 true AR108631A1 (es) 2018-09-12

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US (5) US20190183988A1 (es)
EP (3) EP4026532B1 (es)
JP (1) JP7053498B2 (es)
KR (2) KR102399451B1 (es)
CN (2) CN109562148A (es)
AR (1) AR108631A1 (es)
AU (1) AU2017270359B2 (es)
BR (1) BR112018074311A2 (es)
CA (1) CA3025437A1 (es)
CY (2) CY1124237T1 (es)
DK (3) DK4026532T3 (es)
EA (1) EA038124B1 (es)
ES (2) ES2911124T3 (es)
GE (1) GEP20207139B (es)
HR (2) HRP20202070T1 (es)
HU (2) HUE057640T2 (es)
IL (2) IL285190B (es)
LT (2) LT3463432T (es)
MX (1) MX392529B (es)
PL (2) PL3679946T3 (es)
PT (2) PT3463432T (es)
RS (2) RS62832B1 (es)
RU (1) RU2741497C9 (es)
SA (1) SA518400513B1 (es)
SG (1) SG11201810561YA (es)
SI (2) SI3679946T1 (es)
SM (2) SMT202100003T1 (es)
TW (1) TWI777955B (es)
UA (1) UA123679C2 (es)
WO (1) WO2017203038A1 (es)
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AR133528A1 (es) 2023-08-10 2025-10-08 Merz Pharma Gmbh & Co Kgaa Formulación líquida de toxina botulínica y su uso

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