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ES2653568T3 - Formulaciones de fármacos para la prevención del abuso - Google Patents

Formulaciones de fármacos para la prevención del abuso Download PDF

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Publication number
ES2653568T3
ES2653568T3 ES05759527.4T ES05759527T ES2653568T3 ES 2653568 T3 ES2653568 T3 ES 2653568T3 ES 05759527 T ES05759527 T ES 05759527T ES 2653568 T3 ES2653568 T3 ES 2653568T3
Authority
ES
Spain
Prior art keywords
microparticles
fatty acids
drug
oxycodone
active agent
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
ES05759527.4T
Other languages
English (en)
Inventor
Jane Hirsh
Alison B. Fleming
Roman V. Rariy
Alexander M. Klibanov
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Collegium Pharmaceutical Inc
Original Assignee
Collegium Pharmaceutical Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34972336&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2653568(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Collegium Pharmaceutical Inc filed Critical Collegium Pharmaceutical Inc
Application granted granted Critical
Publication of ES2653568T3 publication Critical patent/ES2653568T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Neurology (AREA)

Abstract

Una composición farmacéutica disuasoria del abuso, administrable por vía oral y que comprende micropartículas, en la que las micropartículas comprenden: (a) una cantidad terapéuticamente eficaz de un agente farmacéuticamente activo; (b) uno o más ácidos grasos seleccionados del grupo que consiste en ácidos grasos monovalentes de C5 a C30, ácidos grasos divalentes de C8 a C40 y mezclas de los mismos; y (c) un vehículo farmacéuticamente aceptable que es una sustancia de cera, en donde: el agente farmacéuticamente activo (a) comprende una sal orgánica de ácido graso de oxicodona; y el uno o más ácidos grasos (b) están presentes en una cantidad que varía de dos a quince veces la cantidad molar de oxicodona.

Description

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enlaces de hidrógeno), con las moléculas de ácido.
Otras sales que pueden aumentar la lipofilicidad y, por lo tanto, la solubilidad de los lípidos en relación con el compuesto farmacéutico precursor incluyen, pero sin limitación, sales de pectinato, tanato, fitato, salicilato, 5 sacarinato, acesulfamato, galato y tereftalato.
Tal como se describe en el presente documento, un fármaco puede modificarse covalentemente para aumentar su lipofilia. Por ejemplo, un compuesto lipófilo puede unirse covalentemente a una molécula de fármaco a través de un enlace éster o amida. Dichos derivados de fármacos se escinden in vivo, liberando así el compuesto original.
C. Micropartículas que contienen fármaco
En realizaciones preferentes, los fármacos se formulan con un material vehículo para formar micropartículas. Tal como se usa en el presente documento, el término "micropartícula" se refiere a una composición que comprende un
15 fármaco disperso dentro de un material vehículo y "micropartícula recubierta" se refiere a una composición que comprende una micropartícula que contiene fármaco o una partícula de fármaco recubierta con una o más capas de recubrimiento de material. Las micropartículas y micropartículas recubiertas tienen un intervalo de tamaño de 10 a 3000 micrómetros de diámetro.
Dentro de las micropartículas, el fármaco se dispersa, preferentemente, de forma homogénea en forma de partículas finas dentro del material vehículo. Más preferentemente, el fármaco se solubiliza parcialmente en material vehículo fundido o se disuelve parcialmente con el material vehículo en un disolvente mutuo durante la formulación de las micropartículas. De manera más preferente, el fármaco se solubiliza completamente en el material vehículo o se disuelve completamente con el material vehículo en un codisolvente durante la formulación de las micropartículas.
25 Esto se logra mediante la selección de materiales y la manera en que se procesan.
Los materiales vehículo apropiados para la fabricación de micropartículas que contienen fármaco son lentamente solubles en agua o insolubles en agua, pero capaces de degradarse dentro del tracto GI por medios, incluyendo degradación enzimática, la acción de tensioactivo de los ácidos biliares y la erosión mecánica. Tal como se usa en el presente documento, la expresión "lentamente soluble en agua" se refiere a materiales que no se disuelven en agua en un período de 30 minutos. En la presente invención, el vehículo farmacéuticamente aceptable se selecciona de entre ceras, sustancias de tipo cera y mezclas de las mismas. Tal como se describe en el presente documento, los materiales vehículo también pueden incluir grasas, sustancias grasas y mezclas de los mismos. Las grasas y sustancias grasas adecuadas incluyen alcoholes grasos (tales como alcohol laurílico, miristílico, estearílico, cetílico o 35 cetoestearílico), ácidos grasos y derivados, incluyendo, sin limitaciones, ésteres de ácidos grasos, glicéridos de ácidos grasos (mono-, di-y triglicéridos) y grasas hidrogenadas. Ejemplos específicos incluyen, pero sin limitaciones, aceite de ricino, aceite de cártamo, aceite de oliva, aceite de canola, aceite de girasol, aceite vegetal, aceite de maíz, aceite vegetal hidrogenado, aceite de semilla de algodón hidrogenado, aceite de ricino hidrogenado, aceites hidrogenados disponibles bajo el nombre comercial Sterotex®, ácido esteárico, manteca de cacao y alcohol estearílico. Los aceites y aceites hidrogenados mezclados entre sí también pueden usarse como materiales vehículo. Las ceras y los materiales similares a cera adecuados incluyen ceras naturales o sintéticas, hidrocarburos y ceras normales. Ejemplos específicos de ceras incluyen cera de abeja, glicocera, cera de ricino, cera de carnauba, parafinas y cera de candelilla. Tal como se usa en el presente documento, un material similar a la cera se define como cualquier material que es normalmente sólido a temperatura ambiente y tiene un punto de fusión de
45 aproximadamente 30 a aproximadamente 300 ºC. En una realización preferente, el vehículo es cera de abejas, cera de carnauba o una mezcla de los mismos.
En algunos casos, puede ser deseable alterar la velocidad de penetración del agua en las micropartículas que contienen el fármaco hidrófobo. Con este fin, los agentes que controlan la velocidad (capilaridad) pueden formularse junto con las grasas o ceras enumeradas anteriormente. Ejemplos de materiales que controlan la velocidad incluyen ciertos derivados de almidón (por ejemplo, maltodextrina cérea y almidón de maíz secado en tambor), derivados de celulosa (por ejemplo, hidroxipropilmetilcelulosa, hidroxipropilcelulosa, metilcelulosa y carboximetilcelulosa), ácido algínico, lactosa y talco. Además, se puede añadir un tensioactivo farmacéuticamente aceptable (por ejemplo, lecitina) para facilitar la degradación de tales micropartículas.
55 Las proteínas que son insolubles en agua, tal como la zeína, son materiales vehículo preferidos para la formación de micropartículas que contienen fármaco. Además, proteínas, se pueden formular polisacáridos y combinaciones de los mismos que son solubles en agua con fármacos en micropartículas y pueden reticularse posteriormente para formar una red insoluble. Por ejemplo, las ciclodextrinas pueden formar complejos con moléculas de fármaco individuales y, posteriormente, reticularse.
Ciertos polímeros también pueden usarse como materiales vehículo en la formulación de micropartículas que contienen fármaco. Los polímeros adecuados incluyen etilcelulosa y otros derivados de celulosa naturales o sintéticos. Los polímeros que son lentamente solubles y forman un gel en un entorno acuoso, tales como
65 hidroxipropil metilcelulosa u óxido de polietileno, también pueden ser adecuados como materiales vehículo para micropartículas que contienen fármaco.
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