ES2655622T3 - Una formulación de fármaco de liberación retardada - Google Patents

Una formulación de fármaco de liberación retardada Download PDF

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Publication number
ES2655622T3
ES2655622T3 ES12166110.2T ES12166110T ES2655622T3 ES 2655622 T3 ES2655622 T3 ES 2655622T3 ES 12166110 T ES12166110 T ES 12166110T ES 2655622 T3 ES2655622 T3 ES 2655622T3
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polymeric material
core
neutralized
eudragit
release drug
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Roberto Carlos Bravo Gonzàles
Thomas Buser
Frédéric Jean-Claude Goutte
Abdul Waseh Basit
Felipe José Oliveira VARUM
Ana Cristina Freire
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Tillotts Pharma AG
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Tillotts Pharma AG
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Abstract

Una formulación de fármaco de liberación retardada para administración oral con el fin de administrar un fármaco al colon de un sujeto, comprendiendo dicha formulación un núcleo y un recubrimiento para el núcleo, comprendiendo el núcleo un fármaco y comprendiendo el recubrimiento una capa externa y una capa interna, en la que la capa externa comprende una mezcla de un primer material polimérico que es susceptible al ataque de las bacterias del colon y un segundo material polimérico que tiene un umbral de pH a pH 6,5 o superior, y en la que la capa interna comprende un tercer material polimérico que es soluble en fluido intestinal, siendo dicho tercer material polimérico un polímero de ácido policarboxilico que está al menos parcialmente neutralizado, y en la que al menos el 10 % de los grupos de ácido carboxílico del polímero de ácido policarboxílico están en forma de aniones de carboxilato.

Description

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En realizaciones preferidas, el segundo y tercer materiales poliméricos se basan en el mismo polímero de ácido policarboxílico, teniendo el tercer material polimérico un mayor grado de neutralización que el segundo material polimérico. Por ejemplo, para un polímero de ácido policarboxílico particular, el segundo material polimérico puede
5 estar en forma no neutralizada con el tercer material polimérico en forma parcial o totalmente neutralizada. Como alternativa, el segundo material polimérico puede estar en forma parcialmente neutralizada, con el tercer material polimérico también en forma parcialmente neutralizada (aunque parcialmente neutralizada en mayor medida), o en forma completamente neutralizada.
10 Los ejemplos de polímeros de ácido policarboxílico adecuados incluyen acetato ftalato de celulosa (CAP), acetato ftalato de polivinilo (PVAP), ftalato de hidroxipropilmetilcelulosa (HPMCP), acetato succinato de hidroxipropilmetilcelulosa (HPMC-AS), acetato trimelitato de celulosa (CAT), goma de xantano , alginatos y goma laca. Sin embargo, el polímero de ácido policarboxílico se selecciona preferiblemente de copolímeros de un ácido (met)acrílico y un alquilo de ácido (met)acrílico, por ejemplo, éster alquílico C1-4, y es particularmente adecuado un
15 copolímero de ácido metacrílico y éster metílico del ácido metacrílico. Tal polímero se conoce como un copolímero de poli(ácido metacrílico/metacrilato de metilo) o un "polimetacrilato". La relación entre los grupos de ácido carboxílicos y los grupos de éster metílico (la relación "ácido:éster") en estos copolimeros determina el pH al que el copolimero es soluble. La relación ácido:éster puede ser de aproximadamente 2:1 a aproximadamente 1:3, por ejemplo, aproximadamente 1:1 o, preferiblemente, aproximadamente 1:2. El peso molecular ("PM") de los
20 copolimeros aniónicos preferidos es habitualmente de aproximadamente 120.000 a 150,000 g/mol, preferiblemente aproximadamente 135.000. Los copolímeros preferidos incluyen Eudragit® L; Eudragit® S; Eudragit® FS; y Eudragit® L100-55.
Los polímeros ilustrativos se pueden usar como el tercer material polimérico en forma no neutralizada (siempre que
25 el umbral de pH del polímero sea menor que el umbral de pH del segundo material polimérico - véase más arriba) o se puede usar al menos parcialmente, más preferiblemente completamente, de forma neutralizada.
Los polímeros parcialmente neutralizados adecuados para su uso como el tercer material polimérico, y sus métodos de producción, son conocidos en la técnica, por ejemplo, a partir de los documentos US 2008/0200482 A y WO
30 2008/135090 A. Estos polímeros pueden ser completamente neutralizados por la adición de más base a las soluciones de recubrimiento.
En las realizaciones preferidas, el tercer material polimérico es un copolímero al menos parcialmente, preferiblemente completamente, neutralizado de ácido (met)acrílico y un éster alquílico C1-4 de ácido (met)acrílico.
35 En realizaciones particularmente preferidas, el tercer material polimérico es un copolímero completamente neutralizado de ácido (met)acrílico y éster metílico del ácido (met)acrílico, particularmente Eudragit® S.
Los inventores han observado que Eudragit® S completamente neutralizado es capaz de formar una película y es fácil y completamente soluble en agua independientemente de al menos el intervalo de pH encontrado en el
40 intestino, por ejemplo, pH de aproximadamente 5 a pH de aproximadamente 8. Eudragit® S completamente neutralizado es particularmente preferido para su uso como el tercer material polimérico en la presente invención.
Se pueden usar mezclas de materiales de polímeros de formación de película según sea apropiado. Los componentes poliméricos en dichas mezclas pueden ser polímeros aniónicos o una mezcla de polímeros aniónicos y
45 no iónicos. Un ejemplo de una mezcla adecuada incluirá una mezcla, por ejemplo, una mezcla 1:1, de Eudragit® L y Eudragit® S, y una mezcla, por ejemplo, una mezcla 1:1, de Eudragit® S y HPMC. Sin embargo, se prefiere el uso de un material polimérico de formación de película particular en solitario, por ejemplo, un copolímero de poli(ácido metacrílico/metacrilato de metilo) y Eudragit® S en particular.
50 Base
En realizaciones preferidas, la capa interna comprende al menos una base. El objetivo de la base es proporcionar un entorno alcalino en la parte inferior de la capa externa una vez que el fluido intestinal comienza a penetrar en la capa externa. Sin quedar ligando a ninguna teoría particular, los inventores creen que el entorno alcalino facilita la
55 desintegración de la capa externa ya que el pH del entorno alcalino está por encima del umbral de pH del segundo material polimérico, acelerando de este modo la liberación del fármaco de la formulación una vez el recubrimiento externo se disuelve y/o se desintegra.
En principio, se puede usar cualquier base farmacológicamente aceptable. Las bases adecuadas incluyen bases
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Claims (1)

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ES12166110.2T 2012-04-30 2012-04-30 Una formulación de fármaco de liberación retardada Active ES2655622T3 (es)

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EP12166110.2A EP2659881B1 (en) 2012-04-30 2012-04-30 A delayed release drug formulation

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ES2655622T3 true ES2655622T3 (es) 2018-02-20

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