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ES2594867T3 - Unidad de calentamiento para usar en un dispositivo de administración de fármaco - Google Patents

Unidad de calentamiento para usar en un dispositivo de administración de fármaco Download PDF

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Publication number
ES2594867T3
ES2594867T3 ES08754883.0T ES08754883T ES2594867T3 ES 2594867 T3 ES2594867 T3 ES 2594867T3 ES 08754883 T ES08754883 T ES 08754883T ES 2594867 T3 ES2594867 T3 ES 2594867T3
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Spain
Prior art keywords
substrate
holes
drug
drug delivery
inches
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ES08754883.0T
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Martin J. Wensley
Marc Glazer
James Bresson
Ryan Timmons
Daniel J. Myers
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Alexza Pharmaceuticals Inc
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Alexza Pharmaceuticals Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/04—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised
    • A61M11/041—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters
    • A61M11/042—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters electrical
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    • A61K31/13—Amines
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    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
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    • 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
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
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    • 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
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    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
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    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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    • A61K9/0009—Galenical forms characterised by the drug release technique; Application systems commanded by energy involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis
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Abstract

Un dispositivo de administracion de farmaco en aerosol que comprende una unidad de suministro de farmaco (130) que comprende un sustrato (108), caracterizado por que el sustrato tiene una superficie que contiene una pluralidad de orificios pasantes (132) conformados, en el que el aire fluye a traves de dichos orificios, y en el que al menos una parte de la superficie esta revestida de una composicion de farmaco, en el que el sustrato tiene un espesor, y en el que los orificios son circulares y tienen un diametro de al menos un valor tan grande como el espesor del sustrato.

Description

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Se puede usar un número de materiales diferentes para construir el sustrato. Normalmente, los sustratos son termoconductores e incluyen metales o aleaciones, tales como aluminio, hierro, cobre, acero inoxidable, oro, titanio y similares, aleaciones. Los orificios del sustrato pueden estar formados por cualquier método conocido en la técnica. En una variación, el sustrato termo-conductor es una lámina de papel metalizado de acero inoxidable que presenta orificios sometidos a ataque químico o perforados por toda la lámina. En algunas realizaciones, el acero inoxidable tiene ventajas con respecto a otros materiales tales como aluminio, debido a que presenta un bajo valor de conductividad térmica, sin un aumento apreciable en masa térmica. La baja conductividad térmica es útil, ya que el calor generado por el proceso necesita permanecer en el área intermedia de interés.
Una unidad de suministro de fármaco de la invención también puede comprender sustratos tratados, que se han descrito como que proporcionan una pureza mejorada del aerosol de la composición de fármaco generado a partir de las películas aplicadas sobre la misma. Los sustratos a modo de ejemplo de este tipo se describen en Bennett et al., Publicación de Estados Unidos n.º 2005/0034723. Los sustratos metálicos divulgados en la misma tienen una superficie exterior tratada. La superficie exterior tratada está normalmente tratada con ácido, tratada con calor, o es una superficie enriquecida con óxido metálico. Los enfoques de tratamiento divulgados en la misma son aplicables a diversos metales y aleaciones, incluyendo sin limitación, acero, acero inoxidables, aluminio, cromo, cobre, hierro, titanio y similares, siendo aluminio, cobre y acero, especialmente acero inoxidables, realizaciones particularmente preferidas. En una variación, el sustrato termo-conductor es una chapa de acero inoxidable tratada con SULFINERT®.
Alternativamente, el sustrato puede comprender un material cerámico o polímero. En una variación, el sustrato termo-conductor es una lámina de película de poliimida (película de poliimida de KAPTON®, DuPont, Wilmington, DE) que comprende una pluralidad de orificios. En tal caso, la unidad de suministro de fármaco puede además comprender un elemento de dispositivo de calentamiento dispuesto sobre o dentro del sustrato polimérico. Con el fin de rebajar la masa térmica, en algunas realizaciones preferidas, se puede usar una lámina fina de película de poliimida (de 5 x 104 pulgadas a 1 x 103 pulgadas (de 12,7 micras a 25,4 micras). En algunas realizaciones, se pueden formar trazas de dispositivo de calentamiento eléctricamente conductor sobre una superficie de la lámina de película de poliimida. Aunque las trazas del dispositivo de calentamiento normalmente comprenden cobre, también se contempla en la presente memoria que las trazas se pueden formar por medio de otros materiales conductores, tales como aluminio, níquel u oro.
Normalmente, el sustrato tiene un espesor de al menos 5 x 104 pulgadas (12,7 micras). Cuando el sustrato comprende un metal (por ejemplo acero inoxidable), el sustrato normalmente tiene un espesor dentro del intervalo de aproximadamente 5 x 104 pulgadas a aproximadamente 1 x 102 pulgadas (de 12,7 micras a 254 micras). Cuando el sustrato comprende un polímero (por ejemplo, una película de poliimida), el sustrato normalmente tiene un espesor dentro del intervalo de aproximadamente 5 x 104 pulgadas a aproximadamente 5 x 103 pulgadas (de 12,7 micras a 127 micras).
Al menos una parte de la superficie del sustrato comprende una pluralidad de orificios a través de los cuales puede pasar un flujo de gas. Normalmente, el sustrato comprende al menos 10, al menos 20, al menos 30, al menos 40, al menos 50, al menos 60, al menos 70, al menos 80, al menos 90, al menos 100, al menos 250, al menos 500 o más, orificios.
Normalmente, un gas (por ejemplo, aire) fluye a través de los orificios tras inhalación por parte de un sujeto que usa el dispositivo de administración de fármaco. El gas se puede extraer al interior de un dispositivo por medio de la acción de inhalación o, por el contrario, se puede proporcionar (por ejemplo, puede almacenarse dentro del dispositivo bajo presión hasta la inhalación).
Normalmente, los orificios tienen una forma regular, tal como un círculo, una elipse, un cuadrado, un rectángulo o un polígono regular. En una realización preferida, el sustrato comprende una pluralidad de orificios pequeños, circulares, espaciados regularmente, normalmente de tamaño igual o similar. No obstante, la invención no está limitada a ello y los orificios podrían ser de forma irregular, y/o tener tamaños y/o espaciado variables. La pluralidad de los orificios puede tener diferentes formas (por ejemplo, una combinación de orificios circulares y rectangulares).
Las dimensiones de los orificios normalmente permanecen uniformes ya que se extienden a través del sustrato, pero se encuentra dentro del alcance de la invención que los orificios puedan variar en cuanto a forma y dimensión ya que se extienden a través del sustrato. Por ejemplo, los orificios podrían tener forma ahusada, cónica, ya que los orificios tienen un diámetro sobre una superficie del sustrato más grande que sobre la otra.
En el caso de una unidad de suministro de fármaco que comprende un sustrato polimérico (por ejemplo, una película de poliimida) con trazas de dispositivo de calentamiento, los orificios están preferentemente ubicados entre las trazas del dispositivo de calentamiento, como se muestra en las Figuras 2A y 2B, que muestran sustratos de película de poliimida que tienen orificios de tamaño pequeño y grande, respectivamente. El sustrato 200 mostrado en la Figura 2A tiene orificios pequeños que miden 2,8 x 103 pulgadas por 5,25 x 103 pulgadas (71,1 micras por 133,3 micras). El dispositivo de calentamiento 20 mostrado en la Figura 2B tiene orificios grandes que miden 8,8 x 103 pulgadas por 9,8 x 102 pulgadas (223,5 pulgadas por 2489,2 micras). Las películas de poliimida tienen un espesor
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rendimiento tras calentamiento de un 100 % de la película de fármaco y partículas de aerosol que tienen una pureza de fármaco de un 100 %, la relación entre dosis, espesor y área proporcionada anteriormente se correlaciona directamente con la dosis proporcionada al usuario. A medida que disminuye la pureza de partícula y/o el rendimiento en porcentaje, se pueden realizar ajustes en el área de sustrato, según sea necesario, para proporcionar la dosis deseada. De igual forma, como un experto en la técnica reconocerá, se pueden usar áreas de sustratos grandes diferentes del área calculada mínima para un espesor de película particular con el fin de proporcionar una dosis terapéuticamente eficaz del fármaco. Además, como puede apreciarse por parte del experto en la técnica, no es necesario revestir la película para completar el área superficial si dicho área superficial seleccionada supera el mínimo requerido para administrar la dosis terapéutica a partir de un espesor de película seleccionado.
Formación de Aerosoles de Condensación
También se divulga en la presente memoria un método para producir un aerosol de condensación que contiene fármaco que comprende proporcionar un sustrato que tiene un fármaco depositado sobre su superficie, en el que la superficie del sustrato tiene una pluralidad de orificios formados en la misma. El sustrato se calienta hasta una temperatura suficiente para vaporizar el fármaco al tiempo que proporciona simultáneamente un flujo de aire en dirección transversal al sustrato y a través del sustrato por medio de la pluralidad de orificios. Preferentemente, el fármaco se calienta hasta una temperatura y durante un tiempo que tiene como resultado un nivel aceptablemente bajo de descomposición. El fármaco vaporizado se mezcla de forma preferentemente rápida con el flujo de aire para enfriar y excluir la descomposición adicional del fármaco. A continuación, se permite que el fármaco vaporizado se condense para dar lugar a un aerosol que comprende partículas. Los términos "aire" y "gas" y la expresión "flujo de aire" se usan de forma intercambiable en la presente memoria, y se pretende que engloben aire ambiente así como también cualesquiera otros gases apropiados (es decir, fisiológicamente aceptables, no explosivos), incluyendo gases comprimidos. Por ejemplo, el dispositivo de la invención se puede unir a un tanque por separado de gas comprimido que insufla aire u otro gas apropiado a través de las perforaciones en el sustrato de manera concurrente con el calentamiento del sustrato.
Preferentemente, el fármaco en forma de aerosol tiene un nivel de pureza de al menos un 90 %; más preferentemente, al menos un 95 %; más preferentemente, al menos un 96 %; más preferentemente, al menos un 97 %. Según se usa en la presente memoria, el término "puro" se refiere a un fármaco en forma de aerosol que no contiene productos de degradación térmica, excipientes u otros contaminantes. Por ejemplo, un fármaco en forma de aerosol que sea al menos un 97 % puro contiene menos de un 3 % de productos de degradación térmica, excipientes u otros contaminantes. Tal y como se usa en la presente memoria, la expresión "producto de degradación térmica" significa cualquier subproducto que sea el resultado del calentamiento del fármaco.
El aerosol se caracteriza preferentemente por menos de un 10 % en peso de un producto de degradación térmica, más preferentemente, menos de un 5 %, más preferentemente, menos de un 1 %, más preferentemente, menos de un 0,5 %, más preferentemente, menos de un 0,1 %, más preferentemente, menos de un 0,03 % en peso de un producto de degradación térmica.
En determinadas realizaciones, por ejemplo, cuando el dispositivo de administración de fármaco está diseñado para un uso portátil con una fuente de energía de pila, puede resultar deseable un uso de energía eficiente: La minimización de la energía usada para liberar el fármaco del sustrato puede depender, al menos en parte, de la forma y dimensiones del sustrato, los materiales que forman el sustrato, y la colocación del sustrato dentro de las vías respiratorias. En determinadas realizaciones, el sustrato puede comprender un material eléctricamente resistivo tal como una papel metalizado. En determinadas realizaciones, el sustrato puede ser un papel metalizado de acero inoxidable y puede incluir una capa de uno o más materiales tales como una capa de oro para facilitar, por ejemplo, la formación de una conexión eléctrica y/o la modificación de las propiedades eléctricas tales como resistencia de una parte del papel metalizado. Las dimensiones apropiadas para un sustrato pueden depender al menos en parte, de la resistencia deseada, la cantidad de fármaco dispuesto sobre el sustrato, la cantidad de energía necesario para vaporizar el fármaco dispuesto sobre el sustrato y/o las consideraciones de estabilidad mecánica.
Dispositivos de Administración
Como se muestra en la Figura 1A, existe una unidad de suministro de fármaco 130 que tiene un sustrato termoconductor 108 que comprende una pluralidad de orificios 132 que se extienden a través del mismo. Un revestimiento de composición 134 es al menos una parte de la superficie superior 134.
La Figura 1B proporciona una vista en corte y perspectiva de otra realización de la unidad 140 de suministro de fármaco. La unidad de suministro de fármaco comprende un sustrato cilíndrico 142. Este sustrato puede formarse a partir de un material termo-conductor, por ejemplo. El sustrato 142 incluye una pluralidad de orificios 144 que se extienden a través del mismo. Se reviste una capa fina de un fármaco (no mostrada) sobre la superficie externa 142. Como se muestra en la parte de corte, existe un elemento de calentamiento 146 dispuesto en el sustrato 142. El sustrato 142 puede ser hueco con un elemento de calentamiento insertado en el interior del espacio hueco, o sólido con un elemento de calentamiento incorporado en el sustrato. El flujo de gas "inferior" al interior del espacio hueco
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KR102852740B1 (ko) 2018-02-02 2025-08-29 알렉스자 파마스티칼즈, 인크. 전기적 응축 에어로졸 디바이스

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US20200246559A1 (en) 2020-08-06
US20080216828A1 (en) 2008-09-11
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