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AR096203A1 - Dosificaciones y métodos para administrar moléculas de ácido nucleico formuladas en lípidos - Google Patents

Dosificaciones y métodos para administrar moléculas de ácido nucleico formuladas en lípidos

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Publication number
AR096203A1
AR096203A1 ARP140101844A ARP140101844A AR096203A1 AR 096203 A1 AR096203 A1 AR 096203A1 AR P140101844 A ARP140101844 A AR P140101844A AR P140101844 A ARP140101844 A AR P140101844A AR 096203 A1 AR096203 A1 AR 096203A1
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AR
Argentina
Prior art keywords
dose
composition
administered
nucleic acid
subject
Prior art date
Application number
ARP140101844A
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English (en)
Inventor
Kasperkovitz Pia
Gollob Jared
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Alnylam Pharmaceuticals Inc
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Application filed by Alnylam Pharmaceuticals Inc filed Critical Alnylam Pharmaceuticals Inc
Publication of AR096203A1 publication Critical patent/AR096203A1/es

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    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/11DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/543Lipids, e.g. triglycerides; Polyamines, e.g. spermine or spermidine
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    • A61K47/59Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
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    • A61K9/1271Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers
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    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
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Abstract

Métodos, conjuntos de elementos y dispositivos de dosificación de un sujeto para reducir una respuesta de hipersensibilidad a una molécula de ácido nucleico (por ejemplo, ARN) formulada en lípidos. Reivindicación 1: Un método para reducir una respuesta relacionada con la infusión (IRR) y/o una reacción de hipersensibilidad, en un sujeto, a una composición que comprende una formulación de lípidos y una molécula de ácido nucleico, donde dicho método comprende administrar a un sujeto: una primera dosis de dicha composición; una segunda dosis de dicha composición; y en donde se cumple uno, dos, tres, cuatro o todas las siguientes condiciones de a) - e): a) la cantidad de dicha composición administrada en dicha primera dosis no es mas que 1/X, en donde X es 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40 ó 50, de la cantidad de dicha composición administrada en dicha segunda dosis; b) la cantidad de dicha composición administrada en dicha primera dosis no es mas que 1/X, en donde X es 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40 ó 50, de la cantidad total de dicha composición administrada; c) la primera dosis se administra sobre un período de tiempo que no es mayor que 1/X, en donde X es 2, 3, 4, 5, 6, 7, 8, 9 ó 10, del período de tiempo sobre el cual se administra la segunda dosis; d) la frecuencia de administración, por ejemplo, en mg/min o ml/min, de dicha primera dosis no es mayor que 1/X, en donde X es 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40 ó 50, de la frecuencia de administración de dicha segunda dosis; o e) las dosificaciones y los períodos de administración de dichas primera y segunda dosis se seleccionan de manera tal que no hay una IRR y/o una reacción de hipersensibilidad sustancial en dicho sujeto.
ARP140101844A 2013-05-06 2014-05-06 Dosificaciones y métodos para administrar moléculas de ácido nucleico formuladas en lípidos AR096203A1 (es)

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US201361820036P 2013-05-06 2013-05-06

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AR096203A1 true AR096203A1 (es) 2015-12-16

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ARP140101844A AR096203A1 (es) 2013-05-06 2014-05-06 Dosificaciones y métodos para administrar moléculas de ácido nucleico formuladas en lípidos
ARP200100401A AR118087A2 (es) 2013-05-06 2020-02-14 Dosificaciones y métodos para administrar moléculas de ácido nucleico formuladas en lípidos

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US (4) US10246708B2 (es)
EP (1) EP2994167B1 (es)
AR (2) AR096203A1 (es)
TW (1) TW201515650A (es)
WO (1) WO2014182661A2 (es)

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