MXPA00002983A - Composiciones bioadhesivas y metodos para la administracion topica de agentes activos - Google Patents
Composiciones bioadhesivas y metodos para la administracion topica de agentes activosInfo
- Publication number
- MXPA00002983A MXPA00002983A MXPA/A/2000/002983A MXPA00002983A MXPA00002983A MX PA00002983 A MXPA00002983 A MX PA00002983A MX PA00002983 A MXPA00002983 A MX PA00002983A MX PA00002983 A MXPA00002983 A MX PA00002983A
- Authority
- MX
- Mexico
- Prior art keywords
- bioadhesive
- composition
- composition according
- acid
- weight
- Prior art date
Links
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Abstract
Se describen composiciones bioadhesivas en una forma flexible, finita para aplicación tópica a la piel o membranas mucosas, que comprenden una composición que resulta de una mezcla de por lo menos un polímero de PVP, por lo menos un bioadhesivo, opcionalmente un solvente farmacéuticamente aceptable adecuado para usarse con un agente activo, y métodos par administrar agentes activos a un sujeto. La composición bioadhesiva puede incluir ya sea un agente activo incorporado directamente en la composición o una fuente separada de un agente activo.
Description
COMPOSICIONES BIOADHESIVAS Y M-ETODOS PARA LA ADMINISTRACIÓN TÓPICA DE AGENTES ACTIVOS
1.- Antecedentes de la Invención Esta invención se refiere generalmente a composiciones bioadhesivas y a métodos para I administración tópica de agentes activos a un mamífero. Más particularmente, esta invención se refiere a composiciones capaces de ser utilizadas en ambientes húmedos o mojados, especialmente en membranas mucosas, durante un período de tiempo prolongado. No existe ninguna limitación sobre el tipo de fármaco que pueda ser utilizado en la presente invención, siempre que este pueda ser tópicamente administrado. De esta manera, el agente activo incluye tanto fármacos que son tópicamente aplicados para efectos locales como aquellos que pueden ser administrados tópicamente para efectos sistémicos.
2. Descripción de la Técnica Relacionada Las membranas mucosas tales como la mucosa de la cavidad bucal tienen varios atributos físicos, tales como un suministro rico en sangre, que hace que este sea un sitio deseable para la administración tópica de agentes activos para el suministro sistémico. El suministro transmucosa de agentes activos además evita el metabolismo de primer paso por el hígado así como un pobre consumo o inactivación a través de la trayectoria gastrointestinal. Ejemplos de dichos agentes incluyen esteroides tales como
estrógenos, progestinas y compuestos rela-cionados; andrógenos y esteroides anabólicos; agentes anti-inflamatorios no esteroidales tales como cetoprofen; diclofenac; propranolol; hormonas de tiroides; péptidos sensibles al pH y pequeñas proteínas tales como insulina y ACT; fisostigmina; escopolamina; verapamil; y galopamil. Además, por lo general es deseable o necesario suministrar agentes farmacéuticos localmente, para aliviar el dolor en la cavidad bucal. Las composiciones de suministro bucales y/o de mucosa, dispositivos y métodos se describen en, por ejemplo, la patente de E.U.A. 3,972,995 de Tsu y otros, patente de E.U.A. 4,755,396 de Hsiao y otros, patente de E.U.A. 4,764,378 de Keit y otros, patente de E.U.A. 4,740,365 de Yukimatsu y otros, patente de E.U.A. 4,889,720 de Konishi y otros, patente de E.U.A. 5,047,244 de Sanvordeker y otros, y RE 33,093 de Schiraldi y otros. El uso de bioadhesivos en la administración de agentes activos a membranas mucosas ha sido conocido durante algún tiempo. Las composiciones bioadhesivas más comúnmente utilizadas tienen substancias que "no son finitas" (es decir, substancias de extensión que no retienen su forma) y portadores líquidos o semilíquidos tales como pastas, genes, lociones, emulsiones, cremas, aspersiones gotas o ungüentos. Recientemente se ha incrementado el uso de portadores o vehículos "finitos" (substancias que no se extienden, las cuales retienen su forma) tales como películas, vendajes y bandas o que empiezan como finitas, después se disuelven tales
como trociscos y pastillas. Dichas composiciones y dispositivos han sido menos satisfactorios para lograr la liberación controlada de dichos agentes, y para mantener la adhesión (es decir, simplemente permaneciendo en su lugar) o eficacia durante períodos prolongados. Además, por lo general tienen residuos pegajosos inaceptables después de la remoción. En la patente de E.U.A. 5,446,070 de Mantelle, se describe que las concentraciones de agentes anestésicos substancialmente disueltos y otros fármacos tanto como un 50% en peso puede lograrse en un sistema conteniendo un vehículo bioadhesivo en donde la adhesión del vehículo no está impedida. Sin embargo, existe la necesidad de incrementar la cantidad de tiempo que dichas composiciones pueden ser mantenidas en el sitio de administración con el fin de obtener una prolongación máxima de los efectos terapéuticos, tanto sistemática como localmente. Un dispositivo bioadhesivo exitoso para la administración, tópica de agentes activos durante períodos prolongados necesita satisfacer un número de características físicas. Por ejemplo, el forro de liberación debe ser fácilmente desprendible de la porción bioadhesiva, aún está última debe ser tanto suficientemente adhesiva como cohesiva para mantener cerca o un contacto íntimo con el sitio de aplicación durante períodos prolongados, típicamente de entre 1 a 2 horas, y hasta 24 horas con ciertos agentes activos. La composición bioadhesiva además de retener el agente activo a una velocidad apropiada para el suministro sostenido o controlado bajo
las condiciones que prevalecen en ambientes húmedos y mojados asociados con mucosa. Además, la composición bioadhesiva debe ser no tóxica, no ocasionar irritación química y debe ser fácilmente removible con una irritación o daño mecánico mínimo en el sitio de aplicación. A este respecto, las composiciones de acuerdo con la presente invención son capaces de adherirse durante períodos prolongados, tal como, por ejemplo, más de 1 hora, de preferencia 2 horas, preferiblemente 4 horas y muy preferiblemente más de 8 horas, hasta aún 24 horas, para humedecer el tejido tal como mucosa y de esta manera los efectos terapéuticos deseados son asegurados por el alto grado de adhesión provisto por las composiciones de esta invención.
COMPENDIO DE LA INVENCIÓN
Esta invención proporciona una composición bioadhesiva que comprende una mezcla de por lo menos dos materiales bioadhesivos, especialmente comprendiendo por lo menos un polímero de polivinilpirrolidona ("PVP") soluble, opcionalmente en mezcla con un solvente farmacéuticamente aceptable adecuado para utilizarse con un agente activo, el solvente opcionalmente incluyendo un plastificante para los bioadhesivos. Las composiciones bioadhesivas de esta adhesión tanto incluyen por lo menos un agente activo solubilizado dentro de la composición como, alternativamente, son utilizadas junto con la administración tópica de por lo menos un
agente activo en el sitio de aplicación, ta-l como los medios para adherir un depósito de fármaco al sitio de aplicación. De acuerdo con un aspecto de la invención, una composición r bioadhesiva mejorada de un tipo que es adecuado para adherencia prolongada a superficies húmedas o mojadas para la liberación controlada de un agente activo, comprende una mezcla de un polisacárido, preferiblemente una goma natural tal como goma de karaya y una PVP soluble. Opcionalmente, la composición bioadhesiva además puede comprender un adhesivo sensible a la presión, de preferencia un polímero acrílico a base de solvente. De acuerdo con otro aspecto de la invención, las composiciones bioadhesivas proporcionan la administración tópica de dos o más agentes activos de diferentes velocidades de flujo, con el fin de lograr efectos terapéuticos prolongados y/o múltiples. De acuerdo con otro aspecto más de la invención, la composición bioadhesiva también sirve como un adhesivo sensible a la presión adecuado para la adherencia prolongada ya sea a superficies húmedas/mojadas o superficies secas, tales como la piel, para la liberación controlada de un agente activo de partir de la misma. Esta invención también se refiere a métodos para administrar las composiciones anteriores. En particular, ia invención está dirigida a una composición bioadhesiva en una forma flexible, finita para la administración
tópica, que comprende: (a) una mezcla de dos o más bioadhesivos, en donde por lo menos un bioadhesivo es un polímero de PVP soluble; (b) opcionalmente un solvente farmacéuticamente aceptable adecuado para utilizarse con un agente activo, el solvente incluyendo opcionalmente un plastificante para los bioadhesivos; (c) opcionalmente un adhesivo sensible a la presión; en donde la composición está substancialmente libre de agua y substancialmente insoluble en agua; y en donde la composición ya incluye por lo menos un agente activo o, alternativamente, se utiliza junto con un agente activo. La invención además se refiere a una composición bioadhesiva en una forma flexible, finita para la administración tópica que comprende: (a) una mezcla de dos o más bioadhesivos en donde por lo menos un bioadhesivo es un polímero de PVP soluble; (b) opcionalmente un solvente farmacéuticamente aceptable adecuado para utilizarse con un agente activo, el solvente opcionalmente incluyendo un plastificante para los bioadhesivos; (c) en una mezcla con por lo menos dos agentes activos, los dos agentes activos comprendiendo: (i) combinaciones del mismo agente activo en ácido libre, base libre y formas de sal, o (¡i) una combinación de diferentes agentes activos, cada uno siendo suministrado a un sujeto a una velocidad de flujo
diferente; (d) opcionalmente un adhesivo sensible a la presión; en donde la composición está substancialmente libre de agua y es *• substancialmente insoluble en agua. Esta invención además se refiere a una composición en una forma flexible, finita para la administración tópica, que comprende:
(a) una mezcla de dos o más bioadhesivos en donde por lo menos un bioadhesivo es un polímero de PVP soluble; (b) opcionalmente un solvente farmacéuticamente aceptable adecuado para utilizarse con un agente activo, el solvente opcionalmente incluyendo plastificante para los bioadhesivos; en donde la composición está substancialmente libre de agua, es substancialmente ¡nsoluble en agua y es tanto un bioadhesivo como un adhesivo sensible a la presión; y en donde la composición tanto incluye por lo menos un agente activo como, alternativamente, se utiliza junto con un agente activo. Las composiciones bioadhesivas además comprende un material de respaldo y un forro de liberación que se conforma al tamaño y forma de una unidad de dosis individual o sistema de suministro. La invención también se refiere a un método para la administración tópica prolongada de uno o más agentes activos a un sujeto, que comprende los pasos de: (a) proveer una composición bioadhesiva en una forma finita, flexible que comprende:
i. una mezcla de dos o más -.bioadhesivos, en donde por lo menos un bioadhesivo es un polímero de PVP soluble; ii. opcionalmente un solvente farmacéuticamente aceptable adecuado para utilizarse con un agente activo, el solvente opcionalmente incluyendo un plastificante para los bioadhesivos; iii. opcionalmente, un adhesivo sensible a la presión; en donde la composición está substancialmente libre de agua y es substancialmente insoluble en agua; (b) poner en contacto un área de la piel o membrana mucosa, preferiblemente la mucosa oral, con la composición bioadhesiva para administrar uno o más agentes activos, en donde la composición incluye ya sea por lo menos un agente activo o, alternativamente, se utiliza junto con un agente activo. La invención además se refiere a un método para ia administración tópica de dos o más agentes activos a un sujeto, que comprende los pasos de: (a) proporcionar una composición bioadhesiva en una forma flexible, finita, que comprende: i. una mezcla de dos o más bioadhesivos en donde por lo menos un bioadhesivo es un polímero de PVP soluble; ii. opcionalmente, un solvente farmacéuticamente aceptable adecuado para utilizarse con un agente activo, el solvente opcionalmente incluyendo un plastificante para los bioadhesivos;
iii. en une mezcla con por -io menos dos agentes activos, por lo menos los dos agentes activos comprendiendo: (1) combinaciones del mismo agente activo en formas de ácido libre, base libre y sal, o (2) combinaciones de diferentes agentes activos, cada uno siendo administrado a un sujeto a una velocidad de flujo diferente; iv. opcionalmente, un adhesivo sensible a la presión; en donde la composición está substancialmente libre de agua y es substancialmente insoluble en agua; (b) poner en contacto un área de la piel o membrana mucosa, preferiblemente la mucosa oral, con la composición bioadhesiva para administrar los dos o más agentes activos, en donde la composición ya sea incluye por lo menos un agente activo o, alternativamente, se utiliza junto con un agente activo. La presente invención también incluye una composición bioadhesiva en una forma flexible, finita para la aplicación tópica de uno o más agentes activos que resultan de una mezcla que comprende: (a) por lo menos un polímero de polivinilpirrolidona soluble (PVP); (b) por lo menos un bioadhesivo; (c) una cantidad terapéuticamente efectiva de uno o más agentes activos; y (d) opcionalmente uno o más solventes. La invención además incluye una composición para la administración de uno o más agentes activos que comprende: (a) una fuente de uno o más agentes activos; y (b) una capa adhesiva
adaptada para adherirse al tejido dérmico o-mucosa y que resulta de una mezcla que comprende; (i) por lo menos un polímero de polivinilpirrolidona soluble (PVP); (ii) por lo menos un bioadhesivo; y (iii) opcionalmente uno o más solventes, en donde la fuente (a) es diferente que la capa adhesiva de (b). Otros objetos, aspectos y ventajas de la presente invención serán evidentes a partir de la siguiente consideración de la descripción detallada y modalidades preferidas.
DESCRIPCIÓN DE LA INVENCIÓN INCLUYENDO MODALIDADES
PREFERIDAS
Esta invención se refiere a composiciones bioadhesivas para el suministro de un agente activo que tiene acción local o sistémica, y a métodos para utilizar las mismas. La ventaja de estas composiciones bioadhesivas yace en su habilidad para mantener un contacto directo o íntimo con el sitio de aplicación durante períodos prolongados, tales como, por ejemplo, más de 1 hora, de preferencia 2 horas, preferiblemente 4 horas, muy preferiblemente más de 8 horas, y hasta 24 horas. Se cree que el uso de un polímero de PVP soluble en combinación con otro bioadhesivo, especialmente un bioadhesivo insoluble tal como una goma natural, en un solvente que incluye un plastificante para los bioadhesivos, permite que cada uno se hinche (es decir, absorba humedad) independientemente uno del otro y consecutivamente más bien al mismo tiempo, tal como cuando se
aplica la mucosa, proporcionando así una adherencia prolongada y mejorada a superficies húmedas mojadas tales como membranas mucosas y dientes, y de esta manera incrementando la penetración o absorción efectiva, y suministro sostenido del agente activo. Aunque no se pretende que esté ligado a ninguna teoría, los inventores creen que la combinación de PVP y otro bioadhesivo proporciona una adhesión superior que no se puede obtener a través de ya sea el PVP u otro bioadhesivo sólo. Se cree que la presencia de un bioadhesivo, tai como una goma de karaya, tiene el efecto de absorber preferencialmente e hincharse con líquidos, tales como solventes, plastificantes y saliva que de otra manera pueden interferir con las propiedades bioadhesivas de la PVP. De esta manera, la adición del otro bioadhesivo proporciona una acción más rápida y una duración más larga de la adhesión. Las composiciones además son provistas en una forma finita, flexible para la aplicación tópica conveniente del agente activo. Las composiciones de la presente no se degradan substancialmente durante uso y no ocasionan una irritación indebida o efectos laterales que hayan sido experimentados con otras composiciones de transmucosa de la técnica anterior. El término "bioadhesivos" o "mucoadhesivos" como se utiliza en la presente, significan materiales naturales, sintéticos o semi-sintéticos que se adhieren y de preferencia se adhieren en forma fuerte a una superficie, tal como la piel, dientes o membrana mucosa después de humedecer o hidratación. Para que un material sea
calificado como un bioadhesivo, éste debe ser capaz de mantener un contacto cerrado o íntimo con una superficie húmeda o mojada durante una cantidad de tiempo mínima. La composición bioadhesiva de la presente invención es finita y "autoadhesiva", ya que es capaz de unirse al sitio de aplicación sin la necesidad de reforzar dicha unión a través del uso de otro adhesivo aplicado sobre este mismo o a un respaldo. Un bioadhesivo frecuentemente se caracteriza como uno que absorbe cierto número de veces su peso en agua (es decir, se puede hinchar con el agua). Dependiendo del bíoadhesivo, éste puede ser tan bajo como aproximadamente 10 o tan alto como aproximadamente 1000 veces su peso de agua. Los bioadhesivos ilustrativos son gomas vegetales naturales que absorben de aproximadamente 30 a aproximadamente 50 veces su peso en agua dependiendo de la goma seleccionada. La bioadhesión por lo general es un fenómeno difícil de medir. La resistencia bioadhesiva para los propósitos de esta invención puede ser medida a través de pruebas estándares para medir fuerza, por ejemplo, en dinas por centímetro cuadrado, como se describe por Robinson en la patente de E.U.A. 4,615,697, y es un mínimo de 50 dinas por centímetro cuadrado, y muy preferiblemente de 100 a 500 dinas por centímetro cuadrado o aún 1000 dinas por centímetro cuadrado. Los materiales bioadhesivos de la presente invención incluyen polímeros, ya sea solubles en agua o insolubles en agua, con o sin
agentes de entrelazamiento, conocidos -en la literatura como bioadhesivos. Se pueden utilizar para este propósito varios bioadhesivos incluyendo, preferiblemente materiales naturales tales como gomas, carmelosa, quitosán, carragenanos, eucheuma, fucoidan, hipnea, laminaran, furcelaran, agar, agarosa, algina, amilosa, escleroglucano, arabinoglactinas, galactomanan, almidones, arginatos tales como potasio y sodio, pectinas polipéptidos tales como gelatinas, colágeno y similares; materiales de celulosa incluyendo celulosas substituidas y no substituidas tales como celulosa, etilcelulosa, metilcelulosa, nitrocelulosa, propilceiulosa, hidroxipropilcelulosa, hidroxietilcelulosa, carboximetilcelulosa, e hidroxipropilmetilcelulosa, derivados de celulosa, alquilcelulosa e hidroxialquilcelulosa como derivados, en donde el grupo alquilo es de 1 a 7 carbonos, acetato-butirato de celulosa y carboxialquilcelulosa; polímeros sintéticos y semi-sintéticos incluyendo copolímeros de carboxivinilo, glicol polietilénico, éteres de glicol polietilénico de alcoholes alifáticos (tales como cetílico, laurílico, oleílico y estearílico), metacrilatos de polihidroxialquilo, alginato de glicol propilénico, óxidos de polietileno, poliacrilamidas y ácidos poliacrílicos; polímeros de vinilo tales como alcohol polivinílico, éteres polivinílicos, acetato de polivinilo y polivinilpirrolidonas, y copolimerización y/o entrelazamiento tanto de monómeros hidrofílicos como hidrofóbicos tales como esteres hidroxialquílicos de acrílico y metacrilamida, y N-vinil-2-pirrolidona, acrilatos y metacrilatos de alquilo, acetato de vinilo, acrilonitrilo y
estireno; y generalmente, cualquier polímero fisiológicamente aceptable que muestre propiedades bioadhesivas. Los bioadhesivos particularmente adecuados incluyen polisacáridos naturales o sintéticos. El término "polisacáridos" como se utiliza en la presente, significa un carbohidrato que se puede descomponer a través de hidrólisis en dos o más moléculas de monosacáridos o sus derivados. Los polisacáridos adecuados incluyen materiales de celulosa, como se especificó anteriormente, pectina, una mezcla de sacarosa sulfatada e hidróxido de aluminio, polisacáridos de N-vinil-lactama y muy preferiblemente gomas naturales tales como karaya, guar, okra, arábiga, acacia, pectina, gati, tragacanto, xantano, algarroba, semilla de psillium, tamarindo, destria, caseína y similares. Algunos polímeros de ácido poliacrílico adecuados incluyen polímeros de ácido acrílico entrelazado con éteres polialquilénicos (genéricamente conocidos como carbómeros) o glicol divinílico (genéricamente conocidos como policarbofilos) y comercialmente disponibles de B. F. Goodrich, Cincinnati, Ohio, bajo la marca comercial de copolímeros o resinas de Carbopol®, emulsificantes poliméricos Pemulen® y policarbofilos Noveon®. Particularmente preferidos son Carbopol® 934 NF, 934P NF, 940 NF y 971P NF. Los éteres de glicol polietilénico ilustrativos de alcoholes alifáticos incluyen éter laurílico (4) de polioxietileno, éter oleílico (2) de polioxietileno y éter oleílico (10) de polioxietileno, los cuales se venden bajo las marcas comerciales de BRIJ® 30, 93 y 97 por ICI
Americas, Inc., y BRIJ® 35, 52, 56, 58, 72, 7-6, 78, 92, 96, 700 y 721. El término "polivinilpirrolidona" o "PVP" se refiere a un polímero, ya sea un homopolímero o copolímero, que contiene vinilpirrolidona (también denominada'como N-vinilpirrolidona, N-vinil-2-pirroIidona y N-vinil-2-pirrolidinona) como una unidad monomérica. Los polímeros de PVP incluyen PVPs homopoliméricas solubles e insolubles y copolímeros tales como vinilpirrolidona/acetato de vinilo y vinilpirrolidona/dimetilamino-metacrilato de etilo. El homopolímero entrelazado es insoluble y generalmente es conocido en la industria farmacéutica bajo las designaciones de polivinilpolipirrolidona, crospovidona y PVP. El copolímero de vinilpirrolidona-acetato de vinilo generalmente es conocido en la industria farmacéutica bajo las designaciones Copolyvidon(e), Copolyvidonum o VP-Vac. El término "soluble", cuando se utiliza con referencia PVP significa que el polímero es soluble en agua y generalmente no está substancialmente entrelazado, y tiene un peso molecular menor que aproximadamente 2,000,000. Ver, en general, Bühler, KOLLIDON®; POLYVINYLPRYRROLIDONE FOR TE PHARMACEUTICAL INDUSTRY, BASF Aktiengesellschaft (1992). Los polímeros de PVP solubles han sido identificados bajo la industria farmacéutica de acuerdo con una variedad de nombres, los más comúnmente utilizados incluyen Povidona, Polividon(a), Polividono, Polividono, poli (N-vinil-2-pirrolidinona, poli (N-vinilbutirolactama), poli (1 -vinil-2-pirrolidona) , poli [1-(2-oxo-1-pirrolidinil)etileno]. El término "membrana mucosa" o "mucosa" como se utiliza en la
presente, significa superficies orales, bucales, vaginales, rectales, nasales, intestinales y oftálmicas. El término "bucal" u "oral" como se utiliza en la presente, significa la boca y el área esofágica circundante incluyendo las encías, dientes, paladar, lengua, amígdalas y tejido periodontal. El término "adhesivos" como se utiliza en la presente, significa un material natural o sintético que es capaz de adherirse al sitio de aplicación o administración tópica. El término "tópico" o "tópicamente" se utiliza en la presente en su significado convencional que se refiere al contacto directo con una mancha en un mamífero, que puede ser cualquier sitio anatómico o área de superficie incluyendo la piel, membranas mucosas o tejido endurecido tal como hueso, dientes o uñas. El término "administrar" o "administración" pretende significar cualquier modo de aplicación a un tejido que de cómo resultado el contacto físico de la composición con el sitio anatómico o área de superficie. El término "sujeto" incluye todos los mamíferos de sangre caliente, preferiblemente seres humanos. Como se utiliza en la presente, el término "prolongado" o
"extendido" se refiere a un período de tiempo mayor que 30 minutos. La composición de la presente es capaz de ser mantenida en contacto con la mucosa, tal como la mucosa bucal, durante un período de hasta 24 horas, de preferencia durante períodos que varía de aproximadamente 30 minutos a aproximadamente 24 horas,
preferiblemente alrededor de 1 hora _a 16 horas y muy preferiblemente aproximadamente 1 hora a aproximadamente 12 horas. Como se utiliza en la presenté, el término "flujo" es definido como la absorción del agente activo a través de la piel o mucosa, y se describe por la primera ley de difusión de Fick: J = D (dCm/dx), en donde J es el flujo en g/cm2/seg, D es el coeficiente de difusión del fármaco a través de la piel o mucosa en cm2/seg y dCm/dx es el gradiente de concentración del agente activo a través de la piel o mucosa. La frase "forma flexible, finita" significa una forma sólida capaz de conformarse a una superficie con la cual está en contacto, y que es capaz de mantener el contacto en dicha forma sólida con ei fin de facilitar a aplicación tópica sin ninguna respuesta fisiológica adversa y sin ser apreciablemente descompuesta por el contacto acuoso durante la administración a un sujeto. Una característica importante de las modalidades de la presente invención se refiere a la naturaleza substancialmente libre de agua e insoluble en agua de la composición. Por el término "substancialmente libre de agua" significa que la composición contiene menos de aproximadamente 10% en peso de agua, y de preferencia menos de 5% y muy preferiblemente menos de 3% antes de su aplicación tópica. En general, es deseable evitar la adición de agua completamente y eliminar, en lo más posible, la presencia de
agua en los otros ingredientes de la composición. Por el término "substancialmente insoluble en agua" se quiere dar a entender que la composición permanece "finita" y generalmente no se separa del sitio de aplicación y bajo las condiciones de uso regular, destinado durante un período de por lo menos 3 horas. Las ventajas que se derivan de la naturaleza substancialmente libre de agua e insoluble en agua de las composiciones de la presente invención incluye lograr concentraciones superiores de agente activo. Otra ventaja de estas composiciones es reducir al mínimo la precipitación del agente activo, dicha precipitación afecta el procesamiento de la composición, afecta la velocidad de suministro de los agentes activos y en ciertos casos puede afectar la sensibilidad de sujeto al agente activo. Las composiciones de la presente, en una modalidad, pueden incluir el uso de dos agentes activos, los cuales pueden ser iguales o diferentes. Por ejemplo, un agente puede estar en forma de base y el otro agente puede estar en forma de ácido o sal. Además, Puede estar presente un agente que se suministre rápidamente teniendo una velocidad de flujo relativamente alta, junto con un segundo agente el cual sea suministrado durante un período prolongado y tenga una velocidad de flujo más lenta. Específicamente, la composición de la presente permite la dosificación de dos o más agentes activos simultáneamente. Por ejemplo, un primer agente puede estar presente en la composición con el fin de ser suministrado completa o substancialmente después
de un período de, por ejemplo, aproximadamente 1 a 90 minutos, en particular durante un período de 5 a 60 minutos, aproximadamente. Al mismo tiempo, otro agente activo puede estar presente en la composición, de manera que el segundo agente es suministrado durante un período más largo, por ejemplo, hasta un período de aproximadamente 24 horas, en particular durante un período que varía de aproximadamente 5 minutos a aproximadamente 16 horas. Es decir, en una modalidad de la presente invención, el primer agente puede tener una velocidad de flujo total mayor que el segundo agente dando como resultado un agotamiento temprano del primer agente de la composición bioadhesiva. Ei período para suministrar los agentes activos puede depender de muchos factores, es decir, las condiciones de dosificación, los agentes que se están suministrando, etc. Por ejemplo, de acuerdo con la presente invención, puede ser posible incluir un agente anestésico tópico el cual sea suministrado rápidamente, es decir en 20 minutos, y que también incluya un segundo agente anestésico, el cual sea igual o diferente al primer anestésico y pueda opcionaimente ser sistémico, que pueda ser suministrado durante un período extendido, es decir durante un período de hasta 8 horas aún 24 horas. Dicha disposición podría ser adecuada para múltiples aplicaciones, tales como durante procedimientos dentales. Alternativamente, dos o más agentes activos pueden ser tópicamente administrados para lograr ya sea un efecto terapéutico prolongado o efectos terapéuticos múltiples, o ambos. Por ejemplo,
un agente anti-inflamatorio no esteroidal -puede ser tópicamente administrado junto con un agente anestésico, de manera que la composición bioadhesiva proporciona una reducción en el dolor a través de tanto el efecto analgésico como la anestesia de dichos agentes, respectivamente. Los efectos pretendidos de dicha combinación de agentes, u otras combinaciones múltiples de agentes, pueden ser durante un período de hasta 24 horas para los agentes múltiples, o períodos variables sobre 24 horas. La velocidad de suministro de ios agentes activos puede ser controlada ya sea a través de la concentración y/o solubilidad de dichos agentes en la composición bioadhesiva, el pH de la composición, el espesor de la composición o el tamaño del sistema como una forma de dosis acabada, o la permeabilidad o solubilidad de toda la composición. Como se utiliza en la presente, el término "agente activo" (y sus equivalentes, "agente", "agente bioactivo", "fármaco", "medicamento", y "agente farmacéutico") pretende tener el significado más amplio e incluye por lo menos uno de cualquier substancia activa terapéutica, profiláctica, farmacológica o fisiológica, o mezcla de las mismas, la cual sea suministrada a un mamífero para producir un efecto deseado, usualmente benéfico. Más específicamente, cualquier agente activo que sea capaz de producir una respuesta farmacológica, localizada o sistémica, sin considerar si por naturaleza es terapéutico, de diagnóstico o profiláctico, está dentro de la presente invención. Se debe observar
que los agentes activos o fármacos pueden ser utilizados individualmente o como una mezcla de dos o más agentes o fármacos, y en cantidades suficientes para prevenir, curar, diagnosticar, mitigar o tratar una enfermedad o condición, según sea el caso. 1. Agonistas a-adrenérgicos tales como Adrafinil, Adrenolona, Amidafrina, Apraclonidina, Budralazina, Clonidina, Ciclopentamina, Detomidina, Dimetofrina, Dipivefrin, Efedrina, Epinefrina, Fenoxazolina, Guanabenz, Guanfacina, Hidroxaamfetamina, Ibopamina, Indanazolina, Isometepteno,
Mefentermina, Metaraminol, Clorhidrato de Metoxamina,
Metilhexanamina, Metizaleno, Midodrina, Nafazolina, Norepinefrina, Norfenefrina, Octodrina, Octopamina, Oximetazolina, Clorhidrato de Fenilefrina, Clorhidrato de Fenilpropanolamina, Fenilpropilmetilamina, Foledrina, Propilhexedrina, Pseudaefedrína, Rilmenidina, Sinefrina, Tetrahidrozolina, Tiamenidina, Tramazolina, Tuaminoheptano, Timazolina, Tiramina y Xilometazolina. 2. Agonistas ß-adrenérgicos tales como Albuterol, Banibuterol Sitolterol, Carbuterol, Clenbuterol, Clorprenalina, Denopamina, Dioxechedrina, Dopexamina, Efedrina, Epinefrina, Etafedrina, Etilnorepinefrina, Penocerol, Pormoterol, Hexoprenalina, Ibopamina, Isoetarina, Isoproterenal, Mabuterol, Metaproterenol, Metoxifenamina, Oxifedrina, Pirbuterol, Prenalterol, Procaterol, Protoquilol, Reproterol, Rimiterol, Ritodrina, Soterenol, Terbuterol y Xamoterol.
3. Bloqueadores ß-adrenérgicos tales como Amosulalol,
Arotinolol, Dapiprazol, Doxazosin, Mesilatos Ergoloides, Penspirida, lndoramin, Labetalol, Nicergolina, Prazosin, Terazosin, Tolazolina, Trimazosin y Yohimbina. 4. Bloqueadores ß-adrenérgicos tales como Acebutolol,
Alprenolol, Amomulalol, Arotinolol, Atenalol, Befunclol, Betaxolol, Bevantolol, Bisaprolol, Bopindolol, Bucumolol, Befetolol, Bufuralol, Bunitrolol, Supranclol, Clorhidrato de Butidrina, Butofilolol, Carazoloi, Carteolol, Carvedilol, Celiprolol, Cetamolol, Cloranolol, Dilevalol, Epanolol, Esmolol, Indenolol, Labetalol, Levobunolol, Mepindolol, Metipranalol, Metoprolol, Moprolol, Nadoxolol, Nifenalol, Nipradilol, Oxprenolol, Penbutolol, Pindolol, Practolol, Prontalol, Propranolol, Sotalol, Sulfinalol, Talinolol, Tertatolol, Timolol, Toliprolol y Xibenolol. 5. Disuasivos de alcohol tales como Cianamida de Calcio
Cifrada, Disulfiram, Nadida y Nitrefazol. 6. Inhibidores de aldosa-reductasa tales como Epalrestat, Ponalrestat, Sorbinil y Tolrestat. 7. Anabólicos tales como Androisoxazol, Androstendiol, Bolandiol, Bolasterona, Clostebol, Etilestrenol, Formildienolona,
4-Hidroxi-19-nortestosterona, Metandriol, Metenolona,
Metiltrienolona, Nandrolona, Decanoato de Nandrolona, p-Hexiloxifenilpropionato de Nandrolona, Fenpropionato de Nandrolona, Norboletona, Oximesterona, Pizotilina, Quinbolona, Stenbolona y Trenbolona.
8. Analgésicos (dentales) tales como Clorobutanol, Clavo y Sugenol. 9. Analgésicos (narcóticos) tales como Alfentanil, Alillprodina, Alfaprodina, Anileridina, Benzilmorfina, Bezitramida, Buprenorfina, Butorfanol, Clanitazeno, Codeína, Bromuro de Metil Codeína, Fosfato de Codeína, Sulfato de Codeína, Desomerfina, Dextromoramida, Dezocina, Diampromida, Dihidrocodeína, Enol Acetato de Dihídrocodeinona, Dihidromorfina, Dimenoxadol, Dimefeptanol, Dimetiltiambuteno, Butirato de Dioxafetilo, Dipipanona, Eptazocína, Etoheptazina, Etilmetiltiambuteno, Etilmorfina,
Etonitazeno, Pentanilo, Hidrocodona, Bitartrato de Hidrocodona,
Hidromorfona, Hidroxipetidina, Isometadona, Cetobemidona,
Levorfanol, Lofentanil, Meperidina, Meptazinol, Metazocina,
Clorhidrato de Metadona, Metopon, Morfina, Derivados de Morfina, Mirofina, Nalbufina, Narceina, Nicomorfina, Norlevorfanol, Normetadoria, Normorfina, Norpipanona, Opio, Oxicodona, Oximorfona, Papaveretum, Pentazocina, Fenadoxona, Fenazocina, Feoperidina, Piminodina, Piritramida, Proheptazina, Promedol, Properidina, Propiram, Propoxifeno, Sufentanil y Tilidina. 10. Analgésicos (no-narcóticos) tales como Acetaminofen,
Acetaminosalol, Acetanilida, Acido Acetilsalicilsalicílico, Alclofenac, Alminoproten, Aloxiprin, Aluminum Bis (acetilsalicilato),
Aminoclortenoxazin, 2-Amino-4-picolina, Aminopropilon , Aminopirina, Salicilato de Amonio, Antipirina, Salicilato de Antipirina, Antrafenina, Apazona, Aspirina, Benorilato, Benoxaprofen, Benzpiperilon,
Benzidamina, p-Bromoacetanilida, Acetato de ácido
-Bromosal?cíl?co, Bucetin, Bufexamac, Bumadizon, Butacetin, Acetilsalicilate de Calcio, Carbamazepina, Carbetidina, Carbifeno, Carsalam, Cloralantipipna, Clortenóxaz?n(a), Salicilato de Colina, Cincofen, Ciramadol, Clometacm, Cropropamida, Crotetamida, Dexoxadrol, Difenamizol, Diflunisal, Acetilsalicilato de
Dihidroxialuminio, Dipirocetilo, Dipirona, Emorfazona, Acido Enfenámico, Epipzol, Etersalato, Etenzamida, Etoxazeno, Etodolac, Felbinac, Penoprofen, Floctafenme, Acido Plufenámico, Fluoresona, Flupirtma, Fluproguazona, Flurbiprofen, Posfosal, Acido Gentisíco, Glafenina, Ibufenac, Salicilato de Imidazol, Indornetacina, Indoprofen, Isofezolac, Isoladol, Isonixm, Cetoprofen, Cetorolac, p-Lactofenetida, Lefetamina, Loxoproten, Acetilsalicilato de Lisina, Acetilsalicilato de Magnesio, Metotpmeprazina, Metofolina, Miroprofen, Morazona, Salicilato de Morfolina, Naproxen, Nefopam, Nifenazona, 5' N?tro-2' propoxiacetani da, Parsalmida, Pepsoxal, Fenacetin, Clorhidrato de Fenazopipdma, Fenocoll, Fenopirazona, Acetilsalicilato de Fenilo, Salicilato de Fenilo, Feniramidol, Pipebuzona, Pipeplona, Prodilidina, Propacetamol, Propifenazona, Proxazol, Salicilato de Quinina, Ramifenazona, Metilsulfato de Rimazclio, Salacetamida, Salicm, Salicilamida, Acido O-acético de Salicilamida, Acido Sa cilsulfúpco, Salsalto, Salvepna, Simetpda, Salicilato de Sodio, Sulfamipipna, Suprofen, Talniflumato Tenoxicam, Terofenamato, Tetradpna Tinopdma Acido Tolfenamico, Tolpronina, Tramadol, Viminol, Xenbucm and
Zomepirac. 11. Andrógenos tales como Androsterona, Boldenona, Deshidroepiandrosterona, Fluoximesterona, Mestanolona, Mesterolona, Metandrostenolona, 17-Metiltestosterona, 17a- Éter 3-Ciclopentil Enólico de Metiltestosterona, Noretandrolona,
Normetandrone, Oxandrolona, Oximesterona, Oximetolona,
Prasterona, Starilolona, Stanozolol, Testosterona, 17-Cloral Hemiacetal de testosternoa, 17ß-Cipionato de Testosterona, Enantato de Testosterona, Nicotinato de Testosterona, Fenilacetato de Testosterona, Propionato de Testosterona y Tiomesterona. 12. Anestésicos tales como Acetamidoeugenol, acetato de Alfadolona, Alfaxalona, Amucaína, Amolanona, Clorhidrato de Amilocaína, Renoxinato, Benzocaína, Betoxicaína, Bifenamina, Bupivacaína, Butacaína, Butaben, Butanilicaína, Buretamina, Sodio de Butalital, Butoxicaína, Carticaína, Clorhidrato de 2-Cloroprocaína, Cocaetileno, Cocaína, Ciclometicaína, Clorhidrato de Dibucaína, Dimetisoquin, Dimetocaína, Clorhidrato de Diperadon, Diclonina, Ecgonidína, Ecgonina, Aminobenzoato de Etilo, Cloruro de Etilo, Etidocaína, Etoxadrol, ß-Eucaína, Euprocin, Venalcomina, Pomocaína, Hexobarbítal, Clorhidrato de Hexilcaína, Sodio de Hidroxidiona, Hidroxiprocaína, Hídroxitetracaína, p-Aminobenzoato de Isobutilo, Centamina, Mesilato de Leucinocaína, Levoxadrol, Lidocaína, Mepivacaína, Clorhidrato de Meprylcaína, Clorhidrato de Metabutoxicaína, Sodio de Metohexitai, Cloruro de Metilo, Midazolam, Mirtecaína, Naepaína, Octacaína, Ortocaína, Oxetazaina,
Paretoxicaína, Clorhidrato de Fenacaína, Fenciclidina, Fenol, Piperocaína, Piridocaína, Polidocanol, Pramoxina, Prilocaína, Procaína, Propanidid, Propanocaína, Proparacaína, Propipocaína, Propofol, Clorhidrato de Propoxicaí a, Pseudococaína, Pirrocaína, Clorhidrato de Quinina Urea, Risocaína, Alcohol Salicílico, Clorhidrato de Tetracaína, Tialbarbital, Timilal, Tiobutabarbital, Sodio de Tiopental, Tolicaína, Trimecaína y Zolamina. 13. Anoréxicos tales como Aminorex, Anfeclorai, Anfetamina, Benzafetamina, Clorfentermina, Clobenzorex, Cloforex, Clortermina, Cíclexedrina, Sulfato de Destroanfetamina, Dietilpropion,
Difemetoxidina, N-Etilanfetamina, Fenbutrazato, Fenfluramina, Fenproporex, Furfurilmetilanfetamina, Levofacetoperato, Mazindol, Mefenorex, Metanfeproamona, Metanfetamina, Norpseudoefedrina, Fendimetrazina, Tartrato de Fendimetrazina, Fenmetrazina, Fenpentermina, Clorhidrato de Fenilpropanolamina y Picilorex. 14. Antihelmínticos (Cestodos) tales como Arecolina, Aspidin, Aspidinol, Diclorofen(o), Embelin, Kosin, Naftaleno, Niclosamida, Pellertierina, Tanato de Pellertierina y Quinacrina. 15. Antihelmínticos (Nemátodes) tales como Alantolactona, Amoscanato, Ascaridol, Befenio, Bitoscanato, Tetracloruro de
Carbono, Carvacrol, Ciclobendazol, Dietílearbamazina, Difenano, Yoduro de Ditiazanina, Dimantina, Violeta de Genciana, 4-Hexilresorcinol, Acido Caínico, Mebendazol, 2-Naptol, Oxantel, Papaína, Piperazina, Adipato de Piperazina, Citrato de Piperazina, Piperazin Edetato de Calcio, Tartrato de Piperazina, Pirantel,
Pamoato de Pirvinio, a-Saritonina, Y-oduro de Estilbazio, Tetracloroetileno, Tetramisol, Tiabendazol, Tymol,
N-Isoamilcarbamato de Timilo, Triclafenol Piperazina y Urea Estibamina. 16. Antihelmínticos (Onchocerca) tales como Ivermectina y
Sodio de Suramin. 17. Antihelmínticos (Schistosoma) tales como Amoscanate, Anfotalide, Tartrato de Antimonio-Potasio, Gluconato de Antimonio-Sodio, Tartrato de Antimonio-Sodio, Tioglicolato de Antimonio-Sodio, Tioglicolamida de Antimonio, Becantona, Hicantona, Clorhidrato de Lucantona, Niridazol, Oxamniquina, Praziquantel, Estibocaptato, Estibofen y Urea Estibamina. 18. Anitelmínticos (Tremátodes) tales como Antiolimina y Tetracloroetileno. 19. Fármacos Antiacné tales como Adapeleno, Acetofenida de
Aigestona, Acido Azelaico, Peróxido de Benzoilo, Cioctol, Ciproterona, Motretinida, Resorcinol, Acido Retinoico, Tetroquinona y Tretinonina. 20. Antialérgicos tales como Amlexanox, Astemizol, Azelastina, Cromolin, Penpiprano, Histamina, Ibudilast, Nedocromil, oxatomida, Pentigetida, Extracto de Venona de Hiedra, Extracto de Venono de Roble, Extracto de Venono de Zumaque, Repirinast, Tranilast, Traxanox y Urusiol. 21. Antiamibiáticos tales como Arstinol, Bialarnicol, Carbarsona, Cefaelina, Clorbetamida, Cloroquina, Clorferioxamida,
Clortetraciclina, Deshidroemetina, Dibromoµropamidina, Diloxanida, Defetarsona, Emetina, Fumagilina, Glaucarubin, Glicobíarsol, Acido 8-Hidroxi-7-yodo-5-quinolinasul fónico, yodoclorHidroxiquina, yodoquinol, Paromomicin, Fanquino'na, Sulfoxilato de Fearsona, Polibenzarsol, Propamidina, Quintamida, Secnidazol, Sulfarmida, Teclozan, Tetraciclina, Tiocarbamizina, Tiocarbarsona y Tinidazol. 22. Antiandrógenpos tales como Bifluranol, Cioctol, Ciproterona, Acetato de Delmadinona, Flutimida, Nilutamida y Oxendolona. 23. Antianginales tales como Acebutolol, Alprenolol,
Amiodarona, Amlodipina, Arotinolol, Atenolol, Bepridil, Bevantolol, Bucumolol, Bufetolol, Bufuralol, Bunitrolol, Bupranolol, Carozolol, Carteolol, Carvedilol, Celiprolol, Maleato de Cinepazet, Diltiazem, Epanalol, Pelodipina, Galopamil, Imolamina, Indenolol, Dinitrato de Isosorbida, Isradipina, Limaprost, Mepindolol, Metoprolol,
Molsidomina, Nadolol, Nicardipina, Nifedipina, Nifenalol, Nilvadipina, Nipradilol, Nisoldipina, Nitroglicerina, Oxprenolol, Oxifedrina, Ozagrel, Penbutolol, Tetranitrato de Pentaeritritol, Pindolol, Pronetalol, Propranolol, Sotalol, Terodilina, Timolol, Toliprolol y Verapamil. 24. Antiarrítmicos tales como Acebutol, Acecaína, Adenosina, Aimalina, Alprenolol, Amiodarona, Amoproxan, Aprindina, Arotinolol, Atenolol, Bevantolol, Tosilato de Bretilio, Bubumolol, Bufetolol, Bunaftina, Bunitrolol, Bupranolol, Clorhidrato de Butidpna, Butobendina, Acido Capobénico, Carazolol, Carteolol, Cifenlina,
Cloranolol, Disopyramida, Encainida, Esmolo , Flecainida, Galopamil, Hidroquinidina, Indecainida, Indenolol, Bromuro de Ipratropio, Lidocaína, Lorajmine, Lorcainida, Meobentina, Metipranolol, Mexiletina, Moricizina, Nadoxolol, NFfenalol, Oxprenolol, Penbutolol, Pindolol, Pirmenol, Practoiol, Prajmalina, Clorhidrato de Procainamido, Pronetalol, Propafenona, Propranolol, Pirinolina, Sulfato de Quinidina, Quinidina, Sotalol, Talinolol, Timolol, Tocainida, Verapamil, Viquidil y Xibenolol. 25. Antiarterioescleróticos tales como Carbamato de Piridinol. 26. Antiartríticos/Antireumáticos tales como Sodio de
Alocupreida, Auranofin, Aurotioglucosa, Aurotioglicanida,
Azatioprina, 3-Aurotio-2-propanoI-1 -sulfonato de Calcio, Celecoxib, Cloroquina, Clobuzarit, Cuproxolina, Diacerein, Glucosamina, Tiomalato de Oro-Sodio, Tiosulfato de Oro-Sodio, Hidroxicioroquina, Kebuzona, Lobenzarit, Melittin, Metotrexato, Mioral y Penicilamina. 27. Fármacos Antibacterianos (antibióticos) incluyendo: Aminoglicósidos tales como Amicacina, Apramicina, Arbecacina, Bambermicinas, Sutirosina, Dibecacina, Dihdroestreptomicina, Fortimicina(s), Gentamicina, Ispamicina, Canamicina, Micronomicina, Neomicina, Undecilenato de Neomocina, Netilmicina, Paromomicina, Ribostamicina, Sisomicina, Espectinomicina,
Estreptomicinaa, Estreptonicozida y Tobramicina; Anfenicoles tales como Azidanfenicol, Cloranfenicol, Palmitato de Cloranfenicol, Pantotenato de Cloranfenicol, Florfenicol y Tianfenicol;
Ansamicinas tales como Rifamida, Rifampina, Rifamicina y Rifaximina; ß-Lactamas, incluyendo: Carbapenemas tales como Imipenema; Cefalosporinas tales como Cefactor, Cetadroxil, Cetamandol,
Cefatrizina, Cefazedona, Cefazolin, Cefixima, Cefmenoxima, Cefodízima, Cefonicida, Cefoperazona, Ceforanida, Ceforaxima, Cefotiam, Cefpimizol, Cefpirimida, Cefpodoxima Proxetil, Cefroxadina, Cefsulodin, Ceftazidima, Cefterarn, Ceftezcle, Ceftibuten, Ceftizoxima, Ceftriaxona, Cefuroxima, Cefuzonam, Sodio de Cefacetrilo, Cefalexin, Cefaloglicina, Cefaloridina, Cefalosporina, Cefalotina, Sodio de cefapirina, Cefradina y Pivcefalexina; Cefamicinas tales como Cefbuperazona, Cefmetazol, Cefminox, Cefetan y Cefoxitina; Monobactamas tales como Aztreonam, Carumonam y
Tigemonam; Oxacefemas tales como Flomoxef y Moxolactama; Penicilinas tales como Amidinocilina, Amdinocilina Pivoxil, Amoxicilina, Ampicillan, Apalcilina, Aspoxicilina, Azidocilan, Azlocilan, Bacampicilina, Acido Benzilpenicilí'nico, Sodio de Bencilpenicilina, Carbenicilina, Sodio de Carfecilina, Carindacilina, Clometocilina, Cloxacilina, Ciclacilina, Dicloxacilina, Sodio de Difenicilina, Epicilina, Penbenicilina, Floxicilina, Hetacilina, Lenampicilina, Metampicilina, Sodio de Meticilina, Mezlocilina, Sodio de Nafeilina, Oxacilina, Penamecilina, Yodhidrato de Penetamato,
Penicilina G Benetamina, Penicilina G Benzatina, Penicilina G Benzhidrilamina, Penicilina G Calcio, Penicilina G Hidrabamina, Potasio de Penicilina G, Procaína de Penicilina G, Penicilina N, Penicilina O, Penicilina V, Penicilina V Berizatina, Penicilina V Hidrabamina, Penimepiciclina, Potasio de Feneticilina, Piperacilina, Pivapicilina, Propicilina, Quinacilina, Sulbenicilina, Talampicilina, Temocilina y Ticarcilina; Lincosamidas tales como Clindamicina y Lincomicina; Macrólidos tales como Azitromicina, Carbomicina, Claritromicina, Eritromicina, Acistrato de Eritromicina, Estolato de Eritromicina, Glucoheptonato de Eritromicina, Lactobionato de Eritromicina, Propionato de Eritromicina, Estearato de Eritromicina, Josamicina, Leucomicinas, Midecamicinas, Miocamicina,
Oleandomicina, Primicina, Rocitamicina, Rosaramicina, Roxitromicina, Espiramicina y Troleandomicina; Polipéptidos tales como Anfomicina, Bacitracina, Capreomicina, Colistina, Endura cid i na, Enviomicina, Fusafungina, Gramicidina(s), Gramicidina S, Micamicina, Polimixina, Acido Polimixina B-Metanesulfónico, Pristinamicina, Ristocetina, Teicoplanina, Tiostrepton, Tuberactinomicina, Tirocidina, Tirotricina, Vancomicina, Viomicina, Pantotenato de Viomicina, Virginiamicina y Bacitracina de Zinc; Tetracíclinas tales como Apiciclina, Clortetraciclina, Clomociclina, Demeclociclina, Doxiciclina, Guameciclina, Limeciclina, Meclociclina, Metaciclina, Minociclina, Oxitetraciclina,
Penimepiciclina, Pipaciclina, Rolitetraciciina., Sanciclina, Senociclina y Tetraciclina; y otros antibióticos tales como Cicloserina, Mupirocina y Tuberina. 28. Fármacos Antibacterianos (sintéticos), incluyendo: 2,4-Diaminopirimidines tales como Brodimoprim, Tetroxoprim y Trimetoprim; Nitrofuranos tales como Furaltadona, Cloruro de Furazolio, Nifuradeno, Nifuratel, Nituriolina, Nifurpirinol, Nifurprazina, Nifurtoinol y Nitrofurantoina; Quinolonas y análogos tales como Amifloxacin, Cinoxacin,
Ciprofloxacin, Difloxacin, Enoxacin, Pleroxacin, Flumequina,
Lomefloxacin, Miloxacin, Acido Nalidíxico, Norfloxacin, Ofloxacin, acido Oxolínico, Pefloxacin, Acido Pipemídico, Acido Piromidíco, Rosoxacin, Temafloxacin y Tosufloxacin; Sulfonamidas tales como Acetil Sulfametoxipirazina, Acetil Sulfisoxazol, Azosulfamida, Bencilsultamida, Cloramina-B,
Cloramina-T, Dicloramina-T, Formosulfatiazol, N2- Formilsulfisomidina, N2-ß-D-Glucosilsulfanilamida, Mafenida, 4'-(Metilsulfamoil) sulfanilanilida, p-Nitrosulfatiazol, Noprilsulfamida, Ftalilsulfacetamida, Ftalilsulfatiazol, Salazosulfadimidina,
Succinilsuifatiazol, Sulfabenzamida, Sulfacetamida,
Sulfaclorpiridazina, Sulfacrisoidina, Sulfacitina, Sulfadiazina, Sulfadicramida, Sulfadimetoxina, Sulfadoxina, Sulfaetídol, Sulfaguanidina, Sulfaguanol, Sulfalena, Acido Sulfalóxico,
Sulfamerazina, Sulfameter, Sulfamejazina, Sulfametizol,
Sulfametomidina, Sulfametoxazol, Sulfametoxipiridazina, Sultametrol, Sulfamidocrisoidina, Sulfamoxol, Sulfanilamida, Sal de
Trietanolamina de Acido Sulfanil midometansulfónico, Acido 4-Sulfanilamidosalicílico, N4-Sulfanililsulfanilamida, Sulfanililurea, N-Sulfanilil-3,4-xilamida, Sulfanitran, Sulfaperina, Sulfafenazol, Sulfaproxilina, Sulfapirazina, Sulfapiridine, Sulfasomizol,
Sulfasimazina, Sultatiazol, Sulfatiourea, Sulfatolamida, Sulfisomidina y Sulfisoxazol; Sulfonas tales como Acedapsona, Acediasulfona, Sodio de
Acetosulfona, Dapsona, Diatimosulfona, Sodio de Glucosulfona, Solasulfona, Succisulfona, Acido Sulfanílico, p-Sulfanililencilamina, p,p'-Sulfonildianil¡n-N-N'd¡galactosido, Sodio de Sulfoxona y Tiazolsulfona; y otros tales como Clofoctol, Hexedina, Metenamina, Citrato de
Metenamina-Anhidrometileno, Hipurato de Metenamina, Mandelato de Metenamina, Sulfosalicilato Metenamina, Nitroxclina y Xibornol. 29. Anticolinérgicos tales como Clorhidrato de Adifenina, Alverina, Bromuro de Ambutonomio, Aminopentamida, Amixetrina, Fosfato de Amprotropina, Metilbromuro de Anisotropina, Apoatropina, Atropina, N-Oxido de Atropina, Benactizina, Benaprizina, Benzetimida, Bromuro de Benzilonio, Mesilato de Denztropina, Metil Sulfato de Beironio, Biperiden, Bromuro de Butropio, Bromuro de N-Butilscopolamonio, Buzepida, Camilofina, Clorhidrato de Caramifen, Clorbenzoxamina, Clorfenoxamina, Bromuro de Cimetropio, Bromuro
de Clidinio, Ciclodrina, Yoduro de Ciclonio, Clorhidrato de Cicrimina, Deptropina, Dexetimida, Sulfato de Dibutolina, Clorhidrato de Diciclomina, Dietazina, Difemerina, Dihexiverina, Metiisulfato de Difemanil, N-(1 ,2-Difeniletil)nicotinamida, Dipiproverina, Bromuro de Diponio, Bromuro de Emepronio, Bromuro de Endobencilina, Etopropazina, Etilbenztropina, Etilbenzhidramina, Etomidolina, Bucatropina, Bromuro de Fenpiverinio, Bromuro de Fentonio, Bromuro de Flutropio, Glicopirrolato, Bromuro de Heteronio, Metil Sulfato de Hexociciio, Homatropina, Hiosciamina, Bromuro de Ipratropio, Isopropamida, Levomepato, Mecloxamina, Bromuro de Mepenzolato, Metcarafen, Bromuro de Metantelina, Metixeno, Bromuro de Met-ocopolamina, Octamilamina, Cioruro de Oxibutinina, Oxifenclimina, Bromuro de Oxifenonio, Pentapiperida, Bromuro de Pentienato, Fencarbamida, Fenglutarimida, Bromuro de Pipenzolato, Piperidolato, Piperilato, Metiisulfato de Poldina, Pridinol, Bromuro de Prifínio, Prociclidina, Bromuro de Propantelina, Propenzolato, Propiromazina, Escapolamina, N-Oxido de Escopolamina, Yoduro de estilonio, Estramonio, Sultroponio, Tihexinol, Tifenamil, Yoduro de Tiemonio, Bromuro de Timepidio, Bromuro de Tiquizio, Yoduro de Tridihexetilo, Clorhidrato de Trihexifenidilo, Tropacina, Tropenzila, Tropicamida, Cloruro de Trospio, Bromuro de Valetamato y Bromuro de Xenitropio. 30. Anticonvulsivos tales como Acetilfeneturida, Albutoina, Aloxidona, Aminoglutetimida, Acido 4-Amino-3-Hidroxibutírico, Atrolactamida, Beclamida, Buramato, Bromuro de Calcio,
Carbamazepina, Cinromida, Clometiazol, CLonazepam, Decimemida, Dietadiona, Dimetadiona, Doxenitoina, Eterobarb, Etadiona, Etosuximida, Etotoina, Fluoresona, Garbapentina, 5- Hidroxitriptofano, Lamotrigina, Lorñactil, Bromuro de Magnesio, Sulfato de Magnesio, Mefenitoina, Mefobarbital, Metarbital, Metetoina, Metauximida, 5-Metil-5-(3-fenantriI)hidantoina, 3-MetiI-5-fenilhidantoina, Narcobarbital, Nimetazepam, Nitrazepam, Parametadiona, Fenacemida, Fenetarbital, Feneturida, Fenobarbital, Sodio de Fenobarbital, Fensuximida, Acido Fenilmetilbarbitúrico, Fenitoina, Sodio de Fetenilato, Bromuro de Potasio, Pregabatina, Primidona, Progabida, Bromuro de Sodio, Valproato de Sodio, Solano, Bromuro de estroncio, Suclofenida, Sultiame, Tetrantoina, Tiagabina, Trimetadiona, Acido Valproico, Valpromida, Vigabatrina y Zonisamida. 31. Antidepresivos, incluyendo: Bicíclicos tales como Binedalina, Caroxazona, Cicalopram, Dimetazan, Indalpine, Pencamina, Maleato de Fluvoxamina, Clorhidrato de Indeloxazina, Nefopam, Nomifensina, Oxitriptan, Oxipertina, Paroxetina, Sertralina, Tiazesim, Trazociona, Venlafaxina y Zometapina; Hidrazidas/Hidrazinas tales como Benmoxina, Iproclozida, Iproniazid, Izocarboxazid, Nialamida, Octamoxin y Fenelzina; Pirrolidonas tales como Cotinina, Roliciprina y Rolipram; Tetracíclicos tales como Maprotilina, Metralindol, Mianserin y Oxaprotilina.
Tricíclicos Tales como Adiriazolam, Amitriptilina,
Amitriptilinoxido, Amoxapina, Butriptilina, Clomipramina,
Demexiptilina, Desipramina, Dibenzepin, Dimetracrina, Dotiepin, Doxepin, Fluacizina, Imipramina, N-Oxido de Imipramina, Iprindol, Lofepramina, Melitraceri, Metapramina, Nortriptilina, Noxiptilin, Opipramol, Pizotilina, Propizepina, Protriptilina, Quinupramina, Tianeptina y Trimipramina; y Otros tales como Adrafinil, Benactizina, Bupropion, Butacetin, Deanol, Deanol Aceglumate, Acetamidobenzoato de Deanol, Dioxadrol, Etoperidona, Febarbamato, Femoxetina, Fenpentadiol, Fluoxetina, Fluvoxamina, Hematoporfirina, Hipercinina,
Levofacetoperano, Medifoxamina, Minaprina, Moclobemida,
Oxaflozano, Piberalina, Prolintano, Pirisuccideanol, Cloruro de Rubidio, Sulpirida, Sultoprida, Teniloxazina, Tozalinona, Tofenacin, Toloxatona, Tranilcioromina, L-Triptofan, Viloxazina y Zimeldina. 32. Antidiabéticos, incluyendo; Biguanides tales como Buformin, Metformin and Fenformin; Hormones tales como Glucagon, Insulina, Injeccion de Insulina, Suspensión de Insulina Zinc, Suspensión de Isofano Insulina, Suspensión de Protamina Zinc Insulina y Cristales de Zinc Insulina;
Derivados de Sulfonilurea tales como Acetohexamida, 1-Butil- 3-metanililurea, Carbutamida, Clorpropamida, Glibornurido,
Gliclazida, Glipizida, Glíquidona, Glisoxepid, Gliburida, Glibutiazol(e)
Glibuzol, Glihexamida, Glimidine, Glipinamida, Fenbutamida, Tolazamida, Tolbutamida y Tolciclamida; y
Otros tales como Acarbosa, MesoxalatQ de Calcio y Miglitol. 33. Fármacos Antidiarreícos tales como Acid Acetiltánico, Tanato de Albúmina, Alcofanona, Salicilatos de Aluminio - Básicos, Catechina, Difenoxina, Difenoxila'to, Lidamidina, Loperamida, Mebiquina, Trilio y Uzarina. 34. Antidiuréticos tales como Desmopresina, Felipresina, Lipresina, Ornipresina, Oxicincofen, Terlipresina y Vasopresina Pituitaria -Posterior. 35. Antiestrógenos tales como Acetato de Delmadinana, Etamoxitrifetol, Tamoxifen y Toremifeno. 36. Fármacos antifúngicos (antibióticos), incluyendo: Polienos tales como Anfotericin-B, Candicidina, Dermostatina,
Filipina, Fungicromina, Hachimicina, Hamicina, Lucensomicina, Mepartricina, Natamicina, Nistatina, Pecilocina y Perimicina; y otros tales como Azaserina, Griseofulirina, Oligomicinas,
Undecilenato de Neomicina, Pírrolnitrina, Sicanina, Tubercidina y Viridina. 37. Fármacos antifúngicos (sintéticos), incluyendo: Alylaminas tales como Naftifina y Terbinafina; Imidazoles tales como Bifonazol, Butoconazol, Clordantoina,
Clormidazol, Cloconazol, Clotrimazol, Econazol, Enilconazol, Penticonazol, isoconazol, Cetoconazol, Miconazol, Omoconazol, Oxiconazol, Nitrato, Sulconazol y Tioconazol; Tríazoles tales como Fluconazol, itraconazol y Terconazol; y otros tales como Acrisorcina, Amorolfina, Bifenamina,
BromosalicilCloranilida, Buelosamida, Propionato de Calcio, Ciofenesina, Ciclopirox, Cloxiquina, Coparafinato, Diamtazol, Diclorhidrato, Exalamida, Flucitosina, Haletazol, Hexetidina, Loflucarban, Nifuratel, Yoduro dé Potasio, Acido Propiónico, Piritiona, Salicilanilida, Propionato de Sodio, Sulbentina, Tenonitrozol, Toiciclato, Tolindato, Tolnaftato, Tricetina, Ujotiona, Acido Undecilénico y Propionato de Zinc. 38. Fármacos antiglaucoma tales como Acetazolamida, Befunolol, Betaxolol, Bupranolol, Carteolol, Dapiprazoque, Diclorfenamida, Dipivefrina, Epinefrina, Levobunolol, Metazolamida, Metipranolol, Pilocarpina, Píndolol y Timolol. 39. Antigonadotropinaa tales como Danazol, Gestrinona y Paroxipropiono. 40. Fármacos antigota tales como Alopurinol, Carprofen, Colcicina, Probenecid and Sulfinpirazona. 41. Antihistaminas, incluyendo: Derivados de alquilamina tales como Acrivastina, Bamipina, Bromfeniramina, Clorfeniramina, Dimetindeno, Metron S, Feniramina, Pirrobutamina, Tenaldina, Tolpropamina y Triprolidina; Éteres aminoalquílicos tales como Bietanautina,
Bromodifenhidramina, Carbinoxamina, Clemastina, Difenilpiralina, Doxilamina, Embramina, Medrilamina, Mefenfidramina, p-Metildifenhidramina, Orfenadrina, Feniltoloxamina, Piprinhydrinato y Setasina; Derivados de etilenodiamina tales como Aloclamida, p-
Bromtripelenamina, Cloropiramina, Clqjoten, Histapirrodina,
Metafuriieno, Metafenileno, Metapirileno, Fenbenzamina, Pirilamina, Talastina, Tenildiamina, Clorhidrato de Tonzilarnina, Tripelenamina y Zoiamina; Piperazinas tales como Cetirizina, Clorciclizina, Cinarizina,
Clocinizina y Hidroxizina; Tricíclicos, incluyendo: Fenotiazinas tales como Ahistan, Etymemazina, Fenetazina, Cloruro de N-Hidroxietilprometazina, Isoprometazina, Mequitazina, Prometazina, Piratiazina y Metil Sulfato de Tiazinamio; y otros tales como Azatadina, Clobenzepam, Ciproheptadina, Deptropina, Isotipendilo, Loratadina y Protipendilo; y otras antihistaminas tales como Antazolina, Astemizol, Azelastina, Cetoxima, Clemizol, Clobenztropina, Difenazolina, Difenhidramina, Propionato de Fluticasona, Mebhidrolina, Fenindamina, Terfenadina y Tricoqualina. 42. Antihíperlipoproteinémicos, incluyendo: Derivados de ácido Ariloxialaanoico tales como Beclorbrato, Bazafibrato, Binifibrato, Ciprofibrato, Clinofibrato, Clotibrato, acido Clofíbrico, Ztonfibrata, Fenofibrata, Gemfibrozil, Nicotibrato, Pirifibrata, Ronifibrato, Simfibrato y Teofibrato; Agentes de secuestro de ácido biliar tales como Resina de Colestiramina, Colestipol y Polidéxido; Los inhibidores de HMG CoA reducíase tales como Fluvastatina, Lovastatina, Sodio de Fravastatina t Simvastatina;
Derivados de ácido nicotínico, Nicotinaio de Alumino, Acipimox, Niceritrol, Nicoclonato, Nicomol y Acido Oxiniacico; Hormonas de tiroides y análogos tales como Etiroxato, acido Tyropropico y Tiroxina; y otros tales como Acifran, Azacosteral, Benfluorex, ß- Benzalbutiramida, Carnitina, Sulfato de Condroitina, Clomestona, Detaxtran, Sodio de Sulfato de Dextrano, Acido 5,8,11,14,17-Eicosapentaenoico, Eritadenina, Fuzazbol, Meglutol, Melinamida, Mitatrienodiol, Ornitina, ?-Oryzanol, Pantetina, Tetraacetato de Penataeritritol, a-Fenilbutiramida, Pirozadíl, Probucol, a-Sitosterol, Acido Sultosílico, Sal de Piperazina, Tiadenol, Triparanol y Xembucina. 43. Fármacos antihipertensivos, incluyendo: Derivados de Ariletanolamina tales como Amosulalol, Buturalol, Dilevalol, Labetalol, Pronetalol, Sotalol y Sulfinalol; Derivados de Ariloxipropanolamina tales como Acebutolol, Alprenolol, Arotinolol, Atenolol, Betaxclol, Bevantolol, Bisoprolol, Bopindolol, Bunitrolol, Bupranolal, Butofilolol, Carazolol, Cartezolol, Carvedilol, Celiprolol, Cetamolol, Epanolol, Indenolal, Mepindolol, Metipranolol, Metcprolol, Moprolol, Nadolol, Nipradilol, Oxprenolol, Penbutolol, Pindoiol, Propranolol, Talinolol, Tetraclol, Timolol y Toliprolol; Derivados de Benzotiadiazina tales como Altiazida,
Bendroflumetiazida, Benztiazida, Bencilhidroclorotiazida, Butiazida, Clorotiazida, Clortalidone, Ciclopentiazida, Ciclotiazida, Diazoxido,
Epitiazida, Etiazida, Fenquizone,. Hidroclorotiazida,
Hidroflumetiazida, Meticlotiazida, Meticrane, Metolazona,
Paraflutizida, Politiazida, Tetraclormetiazida y Triclormetiazida; Derivados de N-Carboxialquiló (péptido/lactama) tales como Alacepril, Captopril, Cilazapril, Delapril, Enalapril, Enalaprilat, Fosinopril, Lisinopril, Moveltipril, Perindopril, Quinapril y Ramipril; Derivados de Dihidropiridina tales como Amlodipina, Felodipina, Isradipina, Nicardipina, Nitedipina, Nilvadipina, Nisoldipina y Nitrendipina; Derivatives de Guanidina tales como Betanidina, Debrisoquina,
Guanabenz, Guanaclina, Guanadrel, Guanazodina, Guanotidina, Guanfacina, Guanoclor, Guanoxabenz y Guanoxan; Hidrazinas y ftaiazinas tales como Budralazina, Cadralazina, Dihidralazina, Endralazina, Hidracarbazina, Hidralazina, Feniprazina, Pildralazina y Todralazina; Derivados de Imidazol tales como Clonidina, Lofexidina, Fentolamina, Mesilato de Fentolamina, Tiamenidina y Tolonidina; Compuestos de amonio cuaternario como Bromuro de Azametonio, Cloruro de Clorisondamina, Hexametonio, Bis (metiisulfato) de Pentacinio, Bromuro de Pentametonio, Tartato de Pentolinio, Cloruro de Fenactopinio y Metosulfato de Trimetidiuno; Derivados de Quinazolina tales como Alfuzasin, Bunazosin, Doxazosin, Prasosin, Terazosin y Trimazosin; Derivados de Reserpina tales como Bietaserpina, Deserpidina, Rescinamina, Reserpina y Sirosingopina;
Derivados de Sulfonamida tales como Ambusida, Clopamida, Furosemida, Indapamida, Quinetazona, Tripamida y Xipamida; y otros tales como Ajmalina, Acido ?-Aminobutírico, Bufeniode, Candesartan, Clortalidone, Cicietai?a, Cielosidomina, Tanatos de Criptenamina, Eprosartan, Fenoldopam, Flosequinan, Indoramin, Irbesartan, Cetanserin, Losarían, Metbutamafo, Mecamilamina, Meíildopa, 4-Piridil Celona Tiosemicarbarzona de Meíilo, Meíolazona, Mínoxidil, Muzolimina, Pargilina, Pempidina, Pinacidil, Piperoxan, Primaperona, Protoveratrinas, Raubasina, Rescimelol, Rilmenideno, Saralasin, Niíroprusida de Sodio, Ticrinafen, Camsilato de Trimetafan, Tyrosinasa, Urapidil y Valsarían. 44. Antihipertiroides tales como 2-Amino-4-metiltiazol, 2-Aminotiazol, Carbimazal, 3,5-Dibromo-L-tirosina, 3,5-Diyodotirosina, Hinderina, yodina, lotiouracil, Metimazol, Metiitiouracil, Propiltiouracil, Percloraío de Sodio, Tibenzazolina, Tiobarbital y 2-Tiouracil. 45. Fármacos Antihipoíensores íales como Meíil Sulfaío de Amezinio, Amida de Angiotensina, Dimetofrina, Dopamina, Etifelmina, Eíilefrina, Gepefrina, Meíaraminol, Miclocírina, Norepinefrina, Foledrinead y Sinefrina. 46. Fármacos Aníihipotiroides tales como Sodio de Levoíiroxina, Lioíironina, Tiroide, Tiroidina, Tiroxina, Tiratricol y TSH. 47. Fármacos Anti-lnf lamatoríos (no-esteroidales), incluyendo:
Derivados de Acido Aminoarilcarboxjlico tales como Acido Enfenámico, Etofenamato, Acido Flufenámico, Isonixin, Acido Meciofenámico, Acido Mefanámico, acido Niflúmico, Talniflumaío, Terofenamaío y Acido Tolfenámico; Derivados de Acido Arilacético tales como Acemetacin,
Alclofenac, Arnfenac, Bufexamac, Cinmetacin, Ciopirac, Sodio de Diclofenac, Etodolac, Felbinac, Fenclofenac, Fenclorac, Acido Fenclozico, Fentiazac, Glucametacina, Ibufenac, Indometacina, Isofezolac, Isoxepac, Lonazolac, Acido Metiazínico, Oxametacina, Proglumeíacina, Sulindac, Tiaramida, Tolmeíin y Zomepirac; Derivados de Acido Arilbuíírico íales como Bumadizon, Buíibufen, Fenbufen y Xenbucin; Ácidos Arilcarboxílicos tales como Clidanac, Cetorolac y Tinoridina; Derivados de Acido Arilpropiínico íales como Alminoprofen,
Benoxaprofen, Acido Bucloxico, Carprofen, Fenoprofen,
Flunoxaprofen, Flurbiprofen, Ibuprofen, Ibuproxam, Indoprofen, Ceíoprofen, Loxoprofen, Miroprofen, Naproxen, Oxaprozin, Piceíoprofen, Pirprofen, Pranoprofen, Acido Prolizínico, Suprofen Accido Tiaprofénico; Pirazoles íales como Difenamizol y Epirizol; Pirazolonas tales como Apazona, Benzpiperilon, Feprazona, Mofebutazona, Morazona, oxifenbutazona, Fenibuíazona,
Pipebuzona, Propifenazona, Ramifenazona, Suxibuzona y Tiazolínobutazona;
Derivados de Acido Salicílico íales_ como Aceíaminosaiol, Aspirina, Benorilato, Eromosaligenin, Acetilsalicilaíe de Calcio, Diflunisal, Etersalato, Fendosal, Acido Geníisico, Salicilaío de Glicol, Sa cylaío de Imidazol, Aceíilsalicilaío de Lisina, Mesalamina, Salicilaío de Morfolina, Salicilato 1 -Naftilo, Olsalazina, Parsalmida, Acefilsalicilato de Feniio, Salicilato de Fenilo, Salacetamida, Acido Salicilamina O-Acético, Acido Salicilsulf úrico, Salsalato y Sulfasalazina; Tiazinacarboxamidas tales como Droxicam, Inoxicam, Piroxicam y Tenoxicam; y Otros tales como Acido e-Acetamidocaproico, S- Adenosilmeíionina, Acido 3-Amino-4-Hidroxibuf írico, Amixeírina, Bendazac, Benzidamina, Bucolome, Difenpiramida, Ditazol, Emorfazona, Guaiazuleno, Nabumetona, Nimesulida, Orgotein, oxaceprol, Paranilina, Perisoxal, Pifoxime, Proquazona, Proxazol y Tenidap. 48. Fármacos Aníimalaria íales como Acedapsona, Amodiaquin, Aríeéíer, Aríemeíer, Arfemisinin, Aríesunafo, Bebeerina, Berberina, Chiraía, Clorguanida, Cloroquina, Clorproguanil, Cinchona, Cinchonidina, Cinchonina, Cicloguanil, Genfiopicrin, Halofanírina, Hidroxicloroquina, Clorhidraío de Meflocpaina, 3-Meíilarsaceíin, Pamaquma, Plasmocid, Primaquina, Pirimetamina, Quinacrina, Quinina, Bisulfato de Quinina, Carbonato de Quinina, Dibromhidrato de Quinina, Diclorhidrato de Quinina, Etilcarbonato de Quinina, Formiato de Quinina, Gluconato de Quinina, Yohidraío de
Quinina, Clorhidraío de Quinina, Salicilafo_.de Quinina, Sulfafo de Quinina, Tanaío de Quinina, Clorhidraío de Quinina Urea, Quinocida, Quinolina y Arsenaío de Sodio Diabásico. 49. Fármacos Antimigraña' tales como Alpiroprida, Dihidroergotamina, Eleíripían, Ergocornina, Ergocorninina,
Ergocripíina, Ergoí, Ergoíamina, Aceíaío de Flumedroxona, Ponazina, Lisuride, Meíisergid(e), Naratripían, Oxeíorona, Pizotilina, Rizatriptan y Sumatripían. 50. Fármacos Coníra Nauseas íales como Monoetanolamina de Acetilleucina, Alizaprida, Benzquinamida, Bieíanauíina,
Bromoprida, Buclizina, Clorpromazina, Cleboprida, Ciclizina, Dimenhydrinafe, Difeniodol, Domperidone, Graniseíron, Meclizine, Metaltral, Meíoclopramida, Meíopimazina, Nabilona, Ondansíeron, Oxipendyl, Pipamazina, Piprinhidrinafo, Proclorperazina, Escopolamina, Teírahidrocannabinoles, Tieíilperazina,
Tioproperzaina y Trimeíobenzamida. 51. Fámacos Anfineoplásíicos, incluyendo: ageníes de alquilación, incluyendo: Alquilsulfonaíos íales como Busulfan, Improsulfan y Piposulfan; Aziridinas íales como Benzodepa, Carboquone, Meíuredepa y
Uredepa; Elileniminas y meíilmelaminas íales como Alírefamina, Trieíilen-melamina, Trieíilen-fosforamida, Trietilen-tiofosforamida y Trimetilolomelamina; Mostazas de Nitrógeno tales como Clorambucil, Clornafazina,
Chclofosfamida, Estramustina, Ifosfamida, Mecloreíamina,
Clorhidraío de Oxido de Mecloreíamina, Melfalan, Novembichin, Fenesterina, Prednimustina, Trofosfamida y Mostaza de Uracilo; Nitrosoureas tales como ' Carmustina, Chlorozoíocin, Poíemusíina, bomusíina, Nimusíina y Ranimusfirl; y Oíros íales como campíoíecina, Dacarbazina, Manomusíina, Miíobronitol, Mitolacíol y Pipobroman; Antibióticoss íales como Aclacinomicinas, Actinomicina F|, Antraimicina, Azaserina, Bleomicinas, Cacfinomicina, Carubicin, Carzinofilin, Cromomicinas, Vacfinomicina, Daunorubicin,
6-Diazo-5-oxo-L-norleucina, Doxorubicin, Epirubicin, Miiomicinas, Acido Micofenólico, Nogalamicina, Olivomicinas, Peplomicina, Plicamicina, Porfiromicina, Puromicina, Estreptonigrina,
Estrepíozocina, Tubercidina, Ubenimex, Zinosfaíina y Zorubicina; Antimetabolitos, incluyendo: Análogo de Acido Fólico íales como Denopíerin, Meíoírexaía, Píeropíerin y Tpmelrexalo; Análogos de Purina íales como Fludarabina, 6-Mercaníopurina, Tiamiprina y Tioguanaina; y Análogos de Pirimidina íales como Anciíabina, Azacitidina,
6-Azauridina, Carmfur, Ciíarabina, Doxifluridina, Enociíabina, Floxuridina, Flurocuracil y Tegafur; Enzimas íales como L-Asparaginasa; y otros tales como Aceglatona, Amsacrina, Bestrabucil, Bisantrena, Briostatin 1, Carboplatin, Cisplatin, Defofamida,
Demecolcina, Diaziquona, Elforniíina, _Aceíaío de Elipíinio, Eíogiucido, Eloposido, Nilrato de Galio, Hidroxiurea, Interferon-a, inferieron- ß, Inferferon-?, iníerleucina-2, Lentinan, Letrozol, Lonidamina, Miíoguazona, Mitoxantrona, Mopidamol, Nitracrina, Pentosíaíin, Fenameí, Pirarubicin, Acido Podofilínico, 2-Eíiíidrazida, Poliniírocubanos, Procarbazina, PSK7, Razoxana, Sizofiran, Espirogermanio, Taxol, Teniposida, Acido Tenuazónico, Triaziguona, 2,2',2"Tricloroíriefilamina, Urefan, Vinblasíina, Vincrisfina, Vindesina y Vinorelbina. 52. Fármacos Aníineoplásíicos (hormonal), incluyendo: Andrógenos íales como Calusterona, Propionato de Dromosíanolona, Epiíiosíanol, Mepiíiosfano y Tesíolacíona; Aníiadrenales íales como Aminogluíetimida, Mitolano y Trilosíana; Aníiandrógenos íales como Fiutamida y Nílutamida; y Antiestrógenos tales como Tamoxifen y Toremifeno. 53. Auxiliares Antineoplásíicos incluyendo abastecedores de ácido fólico tales como Acido Frolínico. 54. Fármacos Anitiparquinsonianos lales como Amantadina, Benoerazida, Bietanautina, Biperiden, Bromocripíina, Budipina,
Cabergolina, Carbidopa, Deprenil (a/k/a L-deprenilo, L-deprenilo, L-deprenalina y selegilina), Dexeíimida, Dieíazina, Difenhidramina, Droxidopa, Eíopropazina, Ef ilbenzhidramina, Levodopa, Naxagolido, Pergolido, Piroheptino, Pramipexole, Pridinol, Prodipine, Quinpirol, Remacemida, Ropinirol, Tergurida, Tigloidina y Clorhidrato de
Trihexifenidilo. 55. Fármacos Anlifeocromocifoma fales como Meíyrosina, Fenoxibenzamina y Feníolamina. 56. Fármacos Anlipneumocysfis drugs íales como Effornifine, Peníamidine and Sulfameloxazol. 57. Fármacos de hiperírofia Aníiprosíáíica íales como Caproaíe Geslonorona, Meparíricina, Oxendolona y Proscar7. 58. Fármacos Aníiprocozoal (Leahmania) lales como Gluconafo de Aníimonio-Sodio, Eíilelibamina, Hidroxisíilbamidina, N-Mefilglucamina, Peníamidina, Esíilbamidina y urea Estibamina. 59. Fármacos Antiproíozoarios (Tricomonas) íales como Aceíarsona, Aminitrozol, Anisomicina, Azanidazol, Forminitrazol, Furazolidona, Hachimicina, Lauroguadina, Meparíricin, Meíronidazol, Nifuratel, Nifuroxima, Nimorazol, Secnidazol, Picraío de Plata, Tenonitrozol y Tinidazol. 60. Fármacos Antiproíozoarios (Tripanosma) íales como Benznídazol, Eflorniíina, Melarsoprol, Nifurfimox, Oxofenarsina, Clorhidraío, Pentamidina, Propamidina, Puromicina, Quinapiramina, Estilbamidina, Sodio de Suramin, Rojo Tripano y Triparasmida. 61. Aníipurííicos íales como Alcarfor, Ciprohepfadina,
Diclorisona, Glicina, Halomeíasona, 3-Hidroxialcanfor, Meníol, Mesulfen, Mefdilazina, Fenol, Polidocanol, Risocaína, Espíritu de alcanfor, Tenaldina, Tolpropamina y Trimeprazina. 62. Fármacos Antipsoriáticos tales como Acitretin, Salicilato de Amonio, Antralin, 6-Azauridina, Bergapten(a), Crisarobin,
Etreíinaío y Pirogalol. 63. Fármacos Anlipsicóficos, incluyendo: Bufirofenonas fales como Benperidol, Bromperidol, Droperidol, Fluanisona, Haioperidol, Melperona, moperona, Pipamperona, Sniperona, Timiperona y Trifluperidol; Fenoíiazinas íales como Aceíofenazina, Buíaperazina, Carfenazina, Ciorproelazina, Clorpromazina, Clospirazina,
Ciamemazina, Dixirazina, Flufenazina, Imiclopazina, Mepazina, Mesoridazina, Meíoxipromazina, Meíofenazaíe, Oxaflumazina, Perazina, Periciazina, Perimeíazina, Perfenazina, Piperacetazina, Pipotiazina, Prociorperazina, Promazina, Sulforidazina,
Tiopropazaío, Tioridazina, Trifluoperazina y Triflupronlazina; Tioxaníenos íales como Clorproíixeno, Clopeníixol, Flupeníixol y Tiofixeno; Oíros fricíclicos íales como Benzquinamida, Carpipramina,
Clocapramina, Clomacran, Cloíiapina, Clozapina, Opipramol, Protipendil, Tetrabenazina, y Zotepina; y oters tales como Alizapride, Amisulpride, Buramate, Fluspirilene, Molindone, Penfluridol, Pimoz¡de, Spirilene and Sulpiride. 64. Antipiréficos íales como Aceíaminofen, Acetaminosalol, Acetanilida, Aconina, Aconita, Aconitina, Alclofenac, Bis(Aceíilsalicilalo) de Aluminio, Aminocloríenoxazin, Aminopirína, Aspirina, Benorilate, Benzidamina, Berbepna, p-Bromoacetanilida, Bufexamac, Bumadizop, Acetilsalicilato de Calcio, Clortenoxazin(a) ,
Salicilato de Colina, Clidanac, Acetilsalicylato de Dihidroxialuminio, Dipirocelilo, Dipirona, Epirizcle, Etersalafo, Salicilaío de Imidazol, Indomefacin, Isofezolac, p-Lactofenetida, Aceíilsalicilaío de Lisina, Aceíilsalicilaío de Magnesio, Acido Meciofenaámico, Morazona, Salicilaío de Morfolina, Naproxen, Nifenazona, 5'-Nitro-2'-propoxiacelanilida, Fenaceíin, Fenicarbazida, Fenocoll,
Fenopirazona, Aceíilsalicilaío de Fenilo, Salicilaío de Fenilo, Pipebuzona, Propaceíamol, Propifenazona, Ramifenazona,
Salaceíamida, Salicilamida Acido O-Acálico, Salicilato de Sodio, Sulfamipirina, Tetrandrina y Tinoridina. 65. Fármacos Aníirickeísiales lales como Acido p-Aminobenzoico, Cloramfenicol, Palmiíato de Cloramfenicol, Pantotenato de Cloramfenicol y Tef raciclina. 66. Fármacos Aníiseborreicos lales como Cloroxina, Diaceíato de 3-O-lauroilpiridoxol, Piroctona, Piritiona, Resorcinol, Sulfuros de
Selenio y Tioxolona. 67. Antisépticos, incluyendo: Guanidinas tales como Alexidina, Ambazona, Clorhexidina y Picloxidina; Halógenos y compuesíos de halógeno íales como Oxido de
Yoduro de Bismuío, Yodosubgalaío de Bismulo, Tribromofenaío de Bismuto, Cloruro de Bornilo, Yodato de Calcio, Cal Clorada, Cloflucarban, Flurosalan, Acido yódico, yodina, Monoclorhidrato de yodina, Tricloruro de yodina. Yodoforma, Tetraiodino de Metenamina, Oxicloroseno, Povidona-yodina, Hipoclorito de Sodio, Yodato de
Sodio, Simcioseno, Yoduro de Timol, Triclocarban, Triclosan y Poíasio de Trocloseno; Compuesíos Mercuriales íales como Hidragafen, Sodio de Maraleina, Merbromina, Cloruro de 'Mercurio, Cloruro de Mercurio, Amoniacado, p-Fenolsulfonaío de Mercurio Sodio, Succininfida de Mercurio, Sulfuro de Mercurio, Rojo, Mercurofen, Acefaío Mercuroso, Cloruro Mercuroso, Yoduro Mercuroso, Niíromersol,
Tetrayodornercurato(II) de poíasio, Soluíión de Triyodomercuralo (II), Timerfonato de Sodio y Timerosal; Nitrofuranos tales como Furazolidona, 2-(Metoximeíil)-5-nifrofuran, Nidroxizona, Nifuroxima, Nifurzida y Nifrofurazona; Fenoles íales como Acefomerocíol, Biíionol, Salicilaío de Cadmio, Carvacrol, Cloroxilenol, Clorofeno, Cresoíe, Cresol(s), p-Cresol, Fenticlor, Hexaclorofeno, Salicilato de 1-NaftiIo, Salicilato de 2-Nafíilo, 2,4,6-Tribromo-m-cresol, y 37475-Triclorosalicilanilida;
Quinolinas fales como Aminoquinurida, Benzoxiquina,
Broxiquinolina, Cloroxina, Clorquinaldol, Cloxiquin, Etilhidrocupreina,
Euprocin, Halquinol, Hidrastina, 8-Hidroxquinolina, Sulfato de
8-Hidroxquinolina y Yodoclorhidroxiquina; y otros tales como Solución de Acétalo de Aluminio, Solución de sebacalo de Alumino, Sulfalo de Aluminio, Acido 3-Amino-4-Hidroxibutírico, Acido Bórico, Clorhexidina, Cloroazodin, Acetato de m-Cresilo, Sulfato Cúprico, Dibrornopropamidina, Ichtammol, Negato17, Noxitiolin, Ornidazol, ß-Propioiactona, a-TerpineoI. 68. Fármacos Antiespasmódicos tales como Alibendol,
Ambucetamida, Aminopromazina, Apoatropina, Metil Sulfalo de Bevonio, Bieíamiverina, Butaverina, Bromuro de Butropio, Bromuro de N-Butilescopolamonio, Caroverina, Bromuro de Cimetropio, Cinamedrina, Cleboprida, Bromhidrato de Coniina, Clorhidrato de Coniina, Yoduro de Ciclonio, Difemerina, Diisoprornina, Butiraío de Dioxafetilo, Bromuro de Diponio, Drofenina, Bromuro de Emepronio, Etaverina, Peclemina, Fenalamida, Fenoverina, Fenpiprana, Bromuro de Fenpiverinio, Bromuro de Fentonio, Flavoxato, Flopropiona, Acido Glucónico, Guaiactamina, Hidramitrazina, Himecromona, Leiopyrrol, Mebeverina, Moxaverina, Nafiverina, Octamilamina, Octaverina, Pentapiperida, Clorhidrato de Fenamacida, Floroglucinol, Bromuro de Pinaverio, Piperilato, Clorhidrato de Pipoxolan, Pramiverin, Bromuro de Prifinio, Properidina, Propivana, Propyromazina, Prozapina, Racefemina, Rociverina, Espasmolitol, Yoduro de Eslilonio, Sullroponio, Yoduro de Tiemonio, Bromuro de Tiquizio, Tircpramida, Trepibutona, Tricromil, Trifolio, Trimebutina, N.N-1 -Trimetil-3, 3-difenilpropilamina, Tropenzilo, Cloruro de Trosponio y Bromuro de Xenitropio. 69. Fármacos Antitrombóticos tales como Anagrelida, Argalroban, Cilostazol, Crisoptin, Daltroban, Defibroíida, Enoxaparin,
Fraxiparina7, Indobufen, Lamoparan, Ozagrel, Picotamida, Plafibrida, Reviparin, Tedelparin, Ticlopidina, Triflusal y Warfarin. 70. Fármacos Antitusivos tales como Allocamida, Amicibona, Benproperina, Benzonatato, Bromuro de Bibenzonio, Bromoform, Butamirata, Butetamata, Etanodisulfonaío de Caramifen,
Carbetapentano, Clofedianol, Clobutinol, DIoperastina, Codeína, Metil Bromuro de Codeína, N-Oxido Codeína, Formifate Codeína, Sulfato de Codeína, Ciclexanona, Dextrometorfan, Sodio de Dibunato, Dihidrocodeína, Enoi Acétale de Dihidrocodeinona, Dimemorfan, Dimetoxanalo, a,a-Difenil-2-piperidin-propanol,
Dropropizina, Drotebanol, Eprazinona, Dibunato de Etilo, Etilmorfina, Fominoben, Guiaiapate, Hidrocodona, Isoaminil, Levopropoxifeno, Morclofono, Narceina, Normetadona, Noscapina, Oxeladin, Oxolamina, Foleodina, Picoperina, Pipazetate, Piperidiona, Clorhidrato de Prenoxdiazina, Racemetorfan, Clorhidrato de Taziprinona, Tipepidina y Zipeprol. 71. Fármacos Anliulcerativos tales como Complejo de Aceglutamida de Aluminio, Sal de Zinc de Acido e-Acetamidocaproico, Acetoxolona, Arbaprostil, Clorhidrato de Benexato, Sol de subcitrato de bismuto (Dried), Carbenoxolona, Cetraxato, Cimetidina, Enprostil, Esaprazol, Famotidina, Ftaxilida, Gefarnato, Guaiazuleno, Irsogladina, Misoprostol, Nizatidina, Omeprazol, Ornoprostil, ?-OzyzanoI, Pifarnine, Pirenzepine, Piaunotol, Ranitidine, Rioprostil, Rosaprostol, Rotraxato, Acétalo de Roxalidina, Sofalcona, Spizofurona, Sucralfato, Teprenona, Trímoprostil, Tritiozina, Troxipido y Zolimidina. 72. Fármacos Antiurolíticos tales como Acido Acetohidroxinámico, Alopurinol, Citraío de Polasio y Succinimida. 73. Fármacos Antivenina tales como Lyovac7 Antivenina. 74. Fármacos Antivirales, incluyendo:
Purinas y pirimidinonas tales como Aciclovir, Cytarabina, Didesoxiadenosina, Didesoxicitidina, Didesoxiinosina, Edoxudina, Floxuridina, Ganciclovir, Idoxuridina, Inosina Pranobex, MADU, Penciclovir, Trifluridina, Vidrarbina y Zidovudiina; y Otros tales como Monoetanolamina de Acetilleucina,
Amantadina, Amidinomicina, Cosalano, Tiosemicarbazona de Cuminaldehído, Sodio Foscarnet, Imiquimod, Inlerferon-a, lnterferon-ß, Cetoxal, Lisozima, Metisazona, Moroxidina,
Podofilotoxina, Ribavirina, Rimantadina, Estalimicina, Estatolon, Tromantadina y Acido Xenazoico. 75. Fármacos Anxiolíticos, incluyendo: Arilpiperazinas tales como Buspirona, Gepirona, Ipsapirona y Tondospirona. Derivados Benzodiazepina tales como Alprazolam, Bromazepam, Camazeparn, Clordiazepóxido, Clobazam, Clorazepato, Chotiazepam, Cloxazolam, Díazeparn, Elil Loflazepato, Etizolam, Fluidazepam, Flutazolam, Flutoprazepam, Halazepam, Cetazolam, Lorazepam, Loxapirie, Medazepam, Metaclazepam, Mexazolam, Nordazepam, Oxazepam, Oxazolam, Pinazepam, Prazepam y Tofisopam; Carbamatos tales como Ciclarbamato, Emilcamato,
Hidroxifenamato, Meprobamato, Fenprobamato y Tibamato; y Otros tales como Alpidem, Benzoctamina, Captodiamina,
Clormezanona, Etifoxina, Piesinoxan, Fluoresona, Acido Glutámico, Hidroxizina, Lesopitron, mecloralurea, Mefenoxalona, Mirtazepina,
Oxanamida, Fenaglicodol, Suriclona y Zatosetron. 76. Antagonistas de Benzodiazepinatales como Flumazenil. 77. Broncodilatadores, incluyendo: Derivados de Efedrina tales' como Albuterol, Bambuterol, Bitolterol, Carbuterol, Clenbuterol, Clorprenalina, Dioxechedrina, Efedrina, Epinifrine, Eprozinol, Etafedrina, Etilnorepinefrina, Penoterol, Hexoprenalina, Isoetarina, Isoproterenol, Mabuterol, Metaproterenol, N-Metilefedrina, Pirbuteral, Procaterol, Protoquilol, Reproterol, Rimiterol, Salmetero!, Soterenol, Terbutalina y Tuiobuterol; Compuestos de amonio cuaternario tales como Metil Sulfato de Bevonio, Clutropium Bromuro de, Bromuro de Ipratropio y Bromuro de Oxitropio; Derivados de Xantina tales como Acefilina, Acefilina Piperazina, Anibufylina, Aminofylina, Bamifylina, Teofilinato de
Colina, Doxofílina, Difilina, Enprofilina, Etamifilina, Etofilina,
Guaitílina, Proxifilina, Teobromuro, Acido 1 -Teobrornineacético y
Teofilina; y otros tales como Fenspirida, Medibazina, montekulast, Metoxifenanima, Tretoquinol y Zafirkulast. 78. Bloqueadores del canal de calcio, incluyendo: Arilalquilaminas tales como Bepridil, Ditiazem, Pendilina,
Galopanil, Prenilamina, Terodilina y Verapamil; Derivados de Dihidropiridine derivatives tales como relodipina, Isradipina, Nicardipina, Nifedipina, Nilvadipina, Nimodipina,
Nisoldipina y Nitrendipina; Derivados de Piperazina íales como Cinarizina, Flunarisina y Lidoflazinc; y Oíers tales como Bencyclano, Etafenona yPerhexilina. 79. Reguladores de Calcio íales como Calcifediol, Calciíonin,
Calcifriol, Acido Clodrónico, Dihidrolaquisferol, Elcaíonina, Acido Elidronico, Ipriflavona, Acid Pamidrónico, Hormona Paraliroides y Acefaío de Teriparaíida. 80. Cardioíónicos íales como Acefilina, Acefildigititoxinas, 2-Amino-4-picolina, Amrinona, Hemisuccinaío de Benfurodilo,
Buclasdesina, Cerberosida, Alcanforíamida, Convallaíoxina,
Cimarina, Denopamina, Deslanosido, Diíalin, Digiíalia, Digiíoxin, Digoxin, Dobuíamina, Dopamina, Dopexamina, Enoximona, Erilrofleine, Fenalcomine, Gilalin, Giíoxin, Glicociamina, Reptaminol, Hidrastinina, Ibopamina, Lanoíodises, Mefamivam, Milrinona, Neriifolin, Oleandrin, Ouabain, Oxifedrina, Prenalíerol, Proscilaridin, Resibufogenin, Scilaren, Seilarenin, Esírofaníina, Sulmazol, Teobromuro y Xamolerol. 81. Ageníes quelaíadores tales como Deferozmina, Sodio de Ditiocarb, Edeíaío de Calcio Disódico, Edeíaío Disódico, Edeato de
Sodio, Edetaío Trisódico, Penicilamina, Peníeíaío de Calcio Trisódico, Acido Peníéctico, Succimer and Trientine; 82. Aníagonisías de Colecisíocinina íales como Proglumida. 83. Agenfes Coleliíolíficos agenís íales como Chenodiol, Eíer Melil ter-Butílico, Monooctanoina y Ursodiol.
84. Coleréficos íales como Alibendol, Aneíol Trition, Azintamida, Acido Cólico, Acido Cicroíoico, Clanobuíina, Ciclobuíirol, Ciclovalona, Cinarin(a), Acido Deshidrocólico, Acido Desoxicólico, Acido Dimecróíico, Alcohol a-ElilBéncílico, Exiproben, Feguprol, Fencibuliroi, Fenipeníol, Floraníirona, Himecromona, Menbuíona, Acido 3-(o-Meíoxifenil)-2-fenilacrílico, Meíochalcona, Moquizona, Osalmid, Exíracío biliar de buey, 4,4'-Oxidi-2-buíanol, Piprozolin, Prozapina, 4-Saliciloilmorfolina, Sincalida, Acido Taurocólico, Timonacic, Tocamfil, Trepibulona y Vaniliolida. 85. Cholinargic agenís íales como Aceclidina, Bromuro de
Acefilcolina, Cloruro de Aceíilcolida, Napadisilaío de Aclaíonio, Bromuro de Benzpirinio, Cloruro de Beíanechol, Carbachol, Cloruro de Carpronio, Bromuro de Demecario, Dexpanfenol, Díisopropil Paraoxon, Yoduro de Ecoíiofaío, Cloruro de Edrofonio, Eseridina, Furlrefonio, Isoflurofaio, Cloruro de Metacolina, Muscarina, Neostigmina, Yoduro de Oxapropanio lodide, Fisosíigmina y Bromuro de Piridosfigmina. 86. Inhibidores de Colinasterasa tales como Cloruro de Ambenonio, Bromuro de Distigmina y Galaníamína. 87. Reacíivadores de Colinesíerasa íales como <cloruro de
Obidoximina y Cloruro de Pralidoxima. 88. Esíimulaníes y ageníes del sisíema nervioso cenfral íales como Aminaptina, Amfetimina, Anfeíaminil, Bemegrida, Benzfefamina, Brucina, Cafeína, Clorfentermina, Clofenciclan, Clortermina, Coca, Fosfato de Demanilo, Dexoxadrol, Sulfato de Dextroamfetamina,
Dieílpropion, N-Eíilanfefamina, Etamivan,_ Etifelmin, Efripfamína, Fencamfamina, Feneíilina, Fenosolona, Flurolilo, Galaníamina, Hexaciclonafo de Sodio, Elomocamfin, Mazindol, Megexamida, Meíanfeíamina, Meíilfenidafo, ' Nicefamida, Pemolina, Peníileníeírazol, Fenidimef razina, Fenmetrazina, Fentermina, Picrotoxin, Pipradrol, Prolintano y Pirovalerona. 89. Descongesíionantes tales como Amidafrina, Cafaminol, Ciclopentamina, Efedrina, Epinefrina, Renoxazolirie, Indanazolina, Meíizolina, Nafazolina, Clorhidrafo de Nordefrin, Ocíodrina, Oximelazolina, Clorhidraío de Fenilefrina, Clorhidraío de Fenilpropanolamina, Fenilpropilmeíilamina, Propilhexedrina,
Pseudoefedrina, Telrahidrozolina, Timazolina y Xilomelazalina. 90. Ageníes denfales, incluyendo: Bisfosfonales (enfermedad aníi-periodoníal y reabsorción de huesos) lales como Alendronaío, Clodronato, Etidroriato, Pamidronato y Tiludronato; Profilácticos de caries tales como Arginina y Fluoruro de Sodio; Agentes de Desensibilización tales como Nitrato de Potasio y Citrato Oxalato. 91. Despigmentadores tales como Hidroquinina, Hidroquinona y Monobenzona. 92. Diuréticos, incluyendo: Organomercurios tales como Clormerodrina, Meralurida, Mercamfamida, Sodio de Mercaptomerina, Acido Mercumalílico, Sodio de Mercumatilina, Cloruro Mercuroso y Mersalilo;
Pteridinas tales como Furtereno y Triarntereno; Purinas tales como Acefylina, 7-Morfolinometil-teofilina, Pamabrom, Proteobromuro y Teobromuro; Esteroides tales como ' Canrenona, Oleandrina y Espironolactona; Derivados de suifonamida tales como Acetazolmida, Ambusida, Azosemida, Bumetanida, Butazolamida, Cloraminofenamida,
Clofenamida, Clopamida, Clorexoleno, Difenilmetan-4,4'-disulfonamida, Disulfamida, Etoxzolamida, Furosemida, Indapamida, Mefrueida, Metazolamida, Piretanida, Quinetazona, Torasemida, Tripamida y Xipamida; Uracilos tales como Aminometradina y Amisometradina; Otros tales como Amanozina, Amilorida, Arbutin, Clorazanil, Acido Etacrínico, Etozolin, Hidracarbazina, Isosorbida, Manitol, Metocalcona, Muzolimina, Perhexilina, Ticrinafen y Urea. 93. Agonisías de recepíor de dopamina íales como Bromocripíina, Dopexamina, Fenoldopam, Ibopamina, Lisurida, Naxagolida y Pergolida. 94. Ecíoparasilicidas íales como Amilraz, Benzoalo de Bencilo, Carbaril, Croíamííon, DDT, Dixaníogen, Tiocianoaceíalo de isobornilo - Técnicol, Solución azufrada de cal, Lindano, Malafiona, Oleaío de Mercurio, Mesulfen y Azufre - Farmacéuíical. 95. Enzimas, incluyendo: Enzimas digestivas tales como a-Amylasa (Páncreas de cochino), Lipasa, Pancrelipasa, Pepsina y Renina;
Enzimas Mucolíticas tales como Lísozima; Enzimas de inacíivación de penicilina lales como Penicilinasa;
Enzimas proleolíticas tales como Colagenase, Quimiomopapaína, quimiomotripsinas, Papaína y Tripsina. 96. Inductores de enzima (hepática) tales como Flumecinol. 97. Estrógenos, incluyendo: Estrógenos no esteroidales tales como Benzestrol, Broparoestrol, Clorotrianiseno, Dieneslrol, D ieti Isti Ibestrol , Diproprionato de Dietilstilbestrol, Dimestrol, Fosfestrol, Hexestrol, Metalenestril y Metentrol; y Estrógenos esteroidales tales como Colpormon, Hormonas
Estrogénicas Conjugadas, Equilenin, Equilin, Estradiol, Benzoato de
Estradiol, 17ß-Cipionato de Estradiol, Estriol, Estrona, Etinil Estradiol, Mestranol, Moxestrol, Mitatrienodiol, Quinestradiol y
Quinestrol. 98. Inhibidores de secresión gástrica tales como Enterogastrona y Octreotida. 99. - G.lucocorticoides tales como' 21 -Acetoxiprefnenolona, Aalclometasona, Algestona, Amicinonida, Beclometasona,
Betametasona, Budesonida, Clorprednisona, Clobetasol,
Blovetasona, Clacartolona, Cloprednol, Corticosterona, Cortisona, Cortivazol, Deflazacort, Desonida, Desoximetasona, Dexametasona, Diflorasona, Diflucortolona, Difluprednato, Enoxolona, Fluazacort, Flucloronída, Flumehtasona, Flunisolida, Acetonida de Fluocinolona,
Fluocinonida, Fluocortin Bufil, Fluocoríolona, Fiuoromelolona, Acéfalo de Fluperolona, Aceíato de Fluprednideno, Fluprednisolona, Fluranclrenolida, Formocortal, Halcinonida, Halometasona, Acetato de Halopredona, Hidrocortamato, ' Hidrocorlisona, Aceíaío de Hidrocoríisona, Fosfaío de Ydrocorlisona, 21-Sodio Succinaío de Hidrocortisona, Tebutafo de Hidrocortisona, Mazipredona, Medrisona, Meprednisona, Meíiolprednisoiona, Puroaío de Momeíasona, Parametasona, Prednicarbato, Prednisolona, 21-Dietilaminoacetaío de Prednisolona, Sodio Fosfaío de Prednisona, Sodio Succinaío de Prednisolona, Sodio 21 -m-Sulfobenzoaío de Prednisolona, 21 -Esíearoilglicolafo de Prednisolona, Tebuíato de Prednisolona, 21 -Trimetilaceíafo de Prednisolona, Prednisona, Prednival, Prednilideno, 21 -Dieíilaminoacefaío de Prednilideno, Tixocoríal, Triamcinolona, Triamcinolona Acetonida, Triamcinolona Benetonide y Triamcinolona Rexacetonida. 100. Principios de eslimulación de gónadas íales como Buserelina, Clomifeno, Ciclofenil, Epimesfrol, FSH, HCG y LH-RH. 101. Hormonas gonadoírópicas fales como LH y PMSG. 102. Inhibidores, de hormona de- crecimienío- lales como Ocíreotida y Somatostatina. 103. Factores de liberación de hormona de crecimiento tales como Semorelina. 104. Estimulantes de crecimiento tales como Somatotropina. 105. Agentes hemolíticos tales como Fenilhidrazina y Clorhidrato de Fenilhidrazina.
106. Antagonisías de Heparina íales como Bromuro de Hexadimefrina y Proíaminas. 107. Hepaíoprofecíores íales como S-Adenozilmefionina, Beíaína, Cafecina, Ciíolona, Malotitato, Orazamida, Fosforilcolina, Protoporfirina IX, Grupo Silimarin, Acido Tióíico y Tiopronina. 108. Inmunomoduladores íales como Amiprilosa, Bucilamina, Difiocarb Sodio, Inosina Pranobex, Inlerferon-y, lníerleucina-2, Lenlinan, Murocíasin, Plalonin, Procodazol, Telramisol, Timomodulina, Timopenfina y Ubenimex. 109. Inmunosupresores lales como Azaíioprina, Ciclosporinas y
Mizoribina. 110. Resinas de intercambio de ion tales como Resina
Carbacrílica, Resina Colestiramina, Colesíipol, Polidexido, Resodec y Polistiren Sulfonato de Sodio. 111. Hormona estimilante de lactación tales como Prolactina.
112. Agonistas de LH-RH tales como Buserelina, Goserelina, Leuprolida, Nafarelina, y Triptorelina. 113. Agentes Lipotrópicos tales como N-Aceíilmeíionina, Cloruro de Colina, Deshidrocolaío de Colina, Ciíraío diácido de Colina, Inositol, Lecitina y Meíionina. 114. Supresores de Lupus erifemaíoso lales como Triglicolamaío de Bismuto-Sodio, Subsalicilato de Bismuto, Cloroquina e Hidroxicloroquina. 115. Corticoides Minerales tales como Aldosterona, Desoxicorticoesterona, Acetato de Desoxicorticoesterona y
Fludrocortisona. 116. Fármacos Mióticos tales como Carbacol, Fisostigmina, Pilocarpina y Pilocarpus. 117. Inhibidores de oxidasa' de monoamina tales como Deprenilo, Iproclozida, Iproniazid, Isocarboxazid, Moclobemida,
Octomoxina, Pargiiina, Fenelzina, Fenoxipropazina,
Pivalilbenzhidrazina, Prodipina, Toloxatona y Tranilcipromina. 118. Agentes mucolíticos tales como Acetilcisteína, Bromhexina, Carbocisteína, Domiodol, Letoesteína, Lisozima, Clorhidrato de Mecisteína, Mesna, Sobrerol, Estepronina, Tiopronina y Tiloxapol. 119. Relajantes de músculo (esquelético) tales como Afloqualona, Alcuroniuo, Besilato de Atracurio, Baclofen, Benzoctamina, Cloruro de Benzoquinonio, C-Calebasina, Carisoprodol, Clormezanona, Carbamato de Clorfenesina, Clorproetazina, Ciozoxazona, Curare, Ciclarbamato, Ciclobenzaprina, Dantroleno, Bromuro de Decamefonio, Diazepam, Eperisona, Bromuro de Fazadinio, Flumetramida, Trietyoduro de Galamina, Bromuro de Hexacarbacolina, Bromuro de Hexafluorenio, Idrocilamida, Meíil sulfaío de Lauexio, Lepfodacíilina, Memaníina, Mefenesina, Mefenoxalona, Mefaxalona, Mefocarbamol, Yoduro de Metocurina, Nimetazepam, Orfenadrina, Bromuro de Pancuronio, Fenprobamalo, Feniramidol, Bromuro de Pipecurio, Promoxolano, Sulfaío de Quinina, Estiramato, Bromuro de Succinilcolina, Cloruro de Succinilcolina, Yoduro de Succinilcolina, Bromuro de Suxeíonio, Teírazepam,
Tiocolquicosida, Tizanidina, Tolperisona, Cloruro de Tubocurarina, Bromuro de Vecuronio y Zoxolamina. 120. Aníagonisías Narcóíicos íales como Amifenazol, Ciclazocina, Levallorfan, Nadida, Nafmfeno, Nalorfina Dinicoíinaío de Malorfina, Naloxona y Nalírexona. 121. Ageníes Neuroproíectores tales como Dizocilpina. 122. Agentes Nooírópicos tales como Aceglutamida, Aceíilcarniíina, Aniracetam, Bifematlana, Exifona, Fipexido, Idebenona, Clorhidrafo de Indeloxazuna, Nizofenona, Oxiracefam, Piracetam, Propentofilina, Piriíinol y Tacrina. 123. Ageníes ogíálmicos fales como 15-Ceíoprosíaglandinas. 124. Hormona ovárica íales como Relaxina. 125. Fármacos oxiíócicos lales como Carboprosl, Cargutocin, Deaminooxitocin, Ergonovina, Gemeprost, Metilergoriovina, Oxitocin, Pituitaria (Posterior), Prostaglandina E2, Prostaglandina F2a y Esparteina. 126. Inhibidores de Pepsina tales como Amilosulfato de Sodio.
127. Estimulantes peristálticos tales como Cisaprida. 128. Progestógenos tales como Alilestrenol, Anagestona, Acetato de Clormadinona, Acetato de Deimadinona, Demegestona,
Desogestrel, Dimetisterona, Didrogesterona, Etisterona, Etinodiol, Aceíafo de Flurogeslona, Geslodeno, Caproafo de Gesfonorona, Haloprogesíerona, 17-Hidroxi-16-metilen Progesterona, 17a-Hidroxiprogesterona, Caproato de 17 -Hidroxigesterona, Linestrenol, Medrogesíona, Medroxiprogesíerona, Acéfalo de Megeslrol,
Melengestrol, Noretindrona, Noretinjodrel, Norgesterona,
Norgestimato, Norgestrel, Norgestrienona, Norvinisterona,
Pentagestrona, Progesterona, Promegestona, Quingestrona y Trengestona. 129. Inhibidores de prolactina tales como Metergolina. 130. Prosíaglandinas y análogos de prosíaglandinas íales como Arbaprosíil, Carboprosf, Enprosíil, Bemeprosí, Limaprosl, misoprosíol, Oroprosfil, Prosíaciclina, Prosfaglandina E-i, Prosíaglandina E2, Prosíaglandina en F2a, Rioprosíil, Rosaprosíol, Sulprosíona y Trimoprosíil. 131. Inhibidores de Proíeasa tales como Aprotinina, Camostat, Gabexaío y Nafamoslaí. 132. Esíimulaníes Respiratorios tales como Almiírina, Bemegrida, Dióxido de Carbono, Cropropamida, Croíefamida, Dimeflina, Dimorfolamina, Doxapram, Efamivan, Pominoben, Lobelina, Mepixanox, Melamivarn, Nicefamida, Picrofoxin, Pimeclona, Piridofilina, Succinaío de Sodio y Tacrina. 133. Agenfes de esclerosis fales como Eíanolamina, Elilamina, Acido 2- Hexildecanoico, Polidocanol, Bisulfalo de Quinina, Clorhidraío de Quinina Urea, Ricinoleaío de Sodio, Telradecil Sulfaío de sodio y Tribenosida. 134. Sedaníes e hipnóficos, incluyendo: ureidas acíclicas tales como Acecarbromal, Apronalida, Bomisovalum, Capurida, Carbromal y Ectilurea; Alcoholes tales como Clorhexadol, Etclorvinol, Meparfinol,
4-Meíil-5-íiazoleeíanol, Alcohol fer-Penlíiico- y 2,2,2-Tricloroeíanol;
Amidas íales como Bufoclamida, Dietílbromoacetamida, Ibroíamida, Isovaleril Dietilamida, Niaprazina, Tricetamida, Trimefozina, Zolpidem y Zopiclona; Derivados de ácido barbilúrico íales como Alobarbiíal,
Ainobarbifal, Aprobarbital, Barbital, Bralabarbital, Buíabarbifal Sodio, Bufalbital, Butalilonal, Butetal, Carbubarb, Ciclobarbital, Ciclopenfobarbifal, Enalilpropimal, ácido 5-Eíil-5-(1-piperidil) barbitúrico, ácido 5-Furfuril-5-isopropilbarbifúrico, Hepíabarbiíal, Hexetal Sodio, Hexobarbital, Mefobarbital, Metitural, Narcobarbital, Nealbarbital, Peníobarbital Sodio, Fenaiimal, Fenobarbital, Fenobarbital Sodio, Acido Fenilmetilbarbiíúrico, Probarbilal, Propalilonal, Proxibarbal, Reposal, Secobarbiíal Sodio, Talbulal, Teírabarbiíal, Vinbarbiíal Sodio y Vinilbital; Derivados de Benzodiazepina íales como Brolizolam,
Doxefazepam, Esíazolam, Fluniírazepam, Flurazepam, Haloxazolam, Loprazolam, Loirmetazepam, Nitrazepam, Quazepam, Tamazepam y Triazolam; Bromuros tales como Bromuro de Ammonio, Bromuro de Calcio, Bromolactobionaío de Calcio, Bromuro de Liíio, Bromuro de Magnesio, Bromuro de Poíassio y Bromuro de Sodio; Carbamafos íales como Eíinamaío ferciario-Carbamafo de Amilo, Hexaprpimaío, Carbamaío de Meparfinol, Novonal y Tricolorouretano; Derivados Clórales tales como Carbocloral, Cloral Betaína,
Cloral Pormamida, Cloral Hidrafo, Cloralaníipirina,
Dichioralfenazona, Peníaeriíriíol Cloral y Triclofos; Piperidindionas iales como Glutehimida, Metiprilon,
Piperidiona, Piriíildiona, Taglutimida'y Talidomida; Derivados Quinazolona tales como Etaqualona, Mecloqualona y
Meíaqualona; y Otros tales como Acetal, Acetofenona, Aldol, Valerato de Ammonio, Amfenidona, a-Bromoisovaleraío de d-Bornilo, Isovalerafo de d-Bornilo, Bromoform, 2-Efilbuíanoaío de Calcio, Caríinafo, a-Clorolosa, Clomeíiazol, Cypripedio, Doxilamina, Efodroxizina, Eíomidaío, Penadiazol, Homofenazina, Acido Bromhídrico, Mecloxamina, Valeralo de Menfilo, Opio, Paraldehído, Periapina, Propiomazina, Rilmazafone, Oxibaío de Sodio, Sulfonatilmetano y Sulfonmefano. 135. Ageníes Trombolííicos fales como APSAC, Plasmina, Pro- Uroquinasa, Esírepfoquinasa, Acíivador de íejido de Plasminógeno y Uroquinasa; 136. Hormonas Tirofrópicas íales como TRH y TSH. 137. Uricosúricos lales como Benzbromarona, Elebenecid, Acido Orótico, Oxicincofen, Probenecid, Sulfinpirazona, Ticrinafen y
Zoxazolamina. 138. Vasodilatores (cerebral) tales como Benciclano, Cinarizína, Citicolina, Ciclandelato, Ciclonicato, Dicloracetato de Diisopropilamina, Eburnamonina, Penoxedil, Flunarizina, Ibudilast, Ifenprodil, Nafronil, Nicametato, Nicergolina, Nimodipina,
Papaverina, Pentifilina, Tinofedrina, Vincamina, Vinpocetina y Viquidil. 139. Vasodilatores (coronarios) tales como Amotrifeno, Bendazol, Hemisuccinato de Benfurddilo, Benziodarona, Cloacizina, Cromonar, Clobenfurol, Clunitrato, Dilazep, Dipiridamol,
Droprenilamina, Efloxato, Eritritol, Tetranitrato de Eritritilo, Etafenona, Fendilina, Ploredil, Ganglefeno, Hexestrol Bis (ß-dietilaminoetil éter), Hexobendina, Tosilato de Itramina, Kelina, Lidoflazina, Hexanitrato de Manitol, Medibazina, Nicorandil, Nitroglicerina, Tetranitrato de Pentaeritritol, Pentrinitrol, Perhexilina, Pimefilina, Prenilamina, Nitrato de Propatilo, Piridofilina, Trapidil, Tricromil, Trimetazidina, Trolnitrato Fosfato y Visnadina. 140. Vasodilatores (periféricos) tales como Nicotinato de Aluminio, Bametan, Benciclano, Betahistina, Bradquinina, Brovincamina, Bufoniode, Buflomedil, Butalamina, Cetiedil, Ciclonicaío, Cinepazida, Cinarizine, Ciclandelafo, Dicloracetato de Diisopropilamina, Eledoisin, Fenoxidil, Flunarisina, Heronicato, líenprodil, Niacinafo de Inosifol, Isoxsuprina, Calidin, Calicreína, Moxisiliío, Nafronilo, Nicamefaío, Nicergolina, Nicofuranosa, Alcohol Nicotinílico, Nilidrina, Pentililina, Pentoxifilina, Piribedil,
Proíaglandina E,, Sulocíidilo y Niacinaío de Xaníinal. 141. Vasoproíecíores tales como Benzarona, Bioflavonoides, Cromocarb, Clobeosida, Diosmin, Dobesilato de Calcio, Escina, Rolescutol, Leucocianidina, Metescuf ¡lina, Quercetin, Rutin y Troxerutin.
142. Vifamínas, fueníes de viíamina y extractos de vitamina tales como Viíamins A, B, C, D, E, and K sus derivados, Calciferoles, Glicirrhiza y Mecobalamin. 143. Agentes de Vulnerables tales como Acetilcisíeína, Alaníoína, Asiaíicosida, Yoduro de Cadexomer, Quiíina, Dextranomer y Oxaceprol. 144. Aníicoagulantes íales como heparina. 145. Varios, tales como eritropoyetina (hemaíinica), Filgrastim, Finasterida (Hipertrofia de Próstata Benigna) e Interferón Beía 1 -Alfa (Esclerosis Múltiple). La lista anterior de agentes activos se basa en aquellas categorías y especies de fármacos establecidas en las páginas TER-1 a TER-28 de Te Merck Index, 12o. Edición, Merck & Co. Rahway N. J. (1996). Esta referencia se incorpora aquí por referencia en su toíalidad. Los agenles aclivos contenidos en la composición bioadhesiva pueden ser de formas diferentes dependiendo de la solubilidad y caraclerísíicas de liberación deseadas, lales como moléculas neuíras, componentes de complejos moleculares y sales farmacéuticamente aceptables, ácidos o bases libres, o sales cuaternarias de los mismos, o como combinaciones de éstos. Los derivados simples de los fármacos tales como éteres, esteres y amidas farmacéuticamente aceptables, y similares, los cuales tienen características de retención y liberación deseables, pero los cuales son fácilmente metabolizados al pH del cuerpo, enzimas, formas pro-
activas, profármacos y similares, también pueden ser empleados. El agente activo puede comprender bases anestésicas locales incluyendo bases orgánicas débiles, las cuales son lipofílicas por naturaleza y de esta manera pobremente solubles en agua. Sin embargo, dichas bases íípicamente reaccionarán con ácidos orgánicos o inorgánicos para formar sales de adición de ácido solubles en agua, acidas. De esía manera, el término "base" cuando se utiliza con referencia a un ageníe anestésico significa la forma no ionizada de un anestésico que puede desarrollar un par de electrones para formar un enlace covalente. El término "ácido" cuando se utiliza con referencia a un agente anestésico significa una subsíancia que puede lomar un par de elecfrones para formar un enlace covalente. El término "sal" cuando se uíiliza con referencia a un agente anestésico significa la forma producida por una base anestésica después de su reacción con un ácido orgánico o inorgánico. Los agentes anestésicos locales adecuados para uíilizarse en la prácíica de esta invención incluyen amidas y éteres. Ejemplos de las amidas son lidocaína, prilocaína, mepivacaína, bupivacaína, dibucaína y etidocaína. Los ésíeres incluyen procaína, íetracaína, propoxicaína, cloroprocaína, benzocaína, picraío de butamben, cocaína, hexilcaína, piperocaína, oxiprocaína y proparacaína. Oíros anestésicos locales adecuados para utilizarse en la práctica de esta invención incluyen ciclometicaína, dimetisoquina, cetocaína, diperodon, diclonina y pramoxina, todos típicamente administrados
en la forma del clorhidrato de adición o sale_s de sulfato. Las sales de adición de ácido de los agentes anestésicos adecuados para la presente invención incluyen cualquier sal orgánica o inorgánica farmacéuticamenle aceptable, no tóxica, la cual en ciertas modalidades no es salicilato. Las sales inorgánicas típicas son los halogenuros de hidrógeno, especialmeníe los clorhidratos, carbonatos, boratos, fosfatos, sulfatos, sulfaíos ácidos, bromhidralos, niíratos, azúfreos y arsenaíos. Las sales orgánicas típicas son sales de ácidos mono y policarboxílicos tales como citrato, tartrato, malato, cinamaío, oxalato, formato, succinato y fíalatos. La forma de base y la forma de sal de un agenle anestésico adecuado incorporado en la presente composición preferiblemeníe debe ser diferente de los agentes anestésicos para lograr la duración máxima del agente anesíésico combinado. El término "diferente" cuando se utiliza con referencia a un agenle anestésico significa que la forma de sal en cualquier combinación no es una sal de la forma de base utilizada en la combinación dada. En ciertas modalidades de esta invención, los agentes activos comprenden un ageníe anestésico local de base libre que se selecciona del grupo que consiste de lidocaína, procaína, propoxícaína, mepivacaína, prilocaína, diclonina, pramoxina, benzocaína y cloroprocaína, en combinación con la forma de sal de un agente anestésico diferente. La forma de sal preferiblemente es una seleccionada dei grupo que comprende sales de prilocaína, teíracaína, bupivacaína, diclonina, dibucaína, etidocaína y lídocaína.
En las modalidades de esta invención que comprenden una composición tanto de una forma de base libre como una forma de sal de un agente anesíésico, la relación de la forma de base libre a la forma de sal en la composición 'dependerá de varios facíores, principalmente: (1) la identidad de la sal y la base utilizadas; (2) la duración deseada de acción; y (3) la rapidez deseada del efeclo anesíésico. Como una regla general en el caso de aplicación a la mucosa, las relaciones base a sal son íales que la forma de base libre preferiblemeníe debe penetrar la mucosa y estar en su efectividad pico dentro de aproximadamente 2 a 30 minutos, mieníras que la forma de sal preferiblemente debe penetrar la mucosa y debe estar a su efectividad pico en un período de aproximadamente 10 a 75 minutos. La duración de la anestesia variará de aproximadamenle 2 minutos a varias horas, hasta 24 horas, dependiendo de la combinación de base/sal seleccionada y la duración dei tiempo de aplicación. En la práctica para lograr esíe efecto la cantidad en peso de la forma de base normalmente estará en un exceso de la caníidad en peso de la forma de sal. El término "inicio de anestesia" significa el íiempo para obtener el efecto sobre los nervios individuales. El inicio de la anestesia principalmente depende de la solubilidad del lípido, tamaño molecular y cantidad de forma no ionizada disponible del anestésico local. De esta manera, el anestésico con una alta solubilidad de lípido o un bajo pK2, o ambos, tiene un inicio de anestesia mucho más rápido.
El término "duración de la anestesia" como se utiliza en la présenle, significa el período duraníe el cual el anestésico local en forma medible bloquea la conducción de nervios. Lo anterior depende de todos los faclores lisiados para el'inicio de la anestesia, así como del grado de unión de proteína del agente anestésico. Una base libre de agente anestésico puede penetrar la piel intacta a un grado limitado, y más rápidamente penetrar a la piel si las capas de queratina son corroídas. En el caso de mucosa, la base libre anestésica penetrará mucho más rápidamente debido a la diferente composición de queratina y la diferencia resultante en el carácter hidrofílico según comparado con el estrato córneo de la piel intacta. Como regla general, las formas de sai de agentes anestésicos no penetran apreciablemeníe en la piel intacía, sino que las formas de base no ionizadas penetran a un grado limitado. Ambas formas, sal y base, peneírarán capas de queraíina corroídas o desgasíadas. La forma de sal, así como la forma de base penelrarán, a un grado difereníe, la mucosa debido al carácter hidrofílico de la mucosa, según comparado con el estraío córneo de la piel intacía. Generalmeníe, entre más alto es el contenido de lípido de la membrana de mucosa, más rápidamente será absorbida la forma de base del agente anestésico. Por lo íanío, cuando la composición bioadhesiva es utilizada para aplicarse a la mucosa bucal, los diferentes contenidos de lípido de las encías (gingiva) y la mucosa alveolar deben ser mantenidos en mente con el fin de obtener la
velocidad óptima de penetración. Aunque los solicilaníes no prelenden estar unidos a ninguna teoría o mecanismo propuesto de operación, se cree que la forma de base de un agente anestésico, ia cuál es soluble en lípidos, tiene un rápido inicio de anestesia, ya que entra a la membrana de nervios lipo-proteína eviíando la despolarización e intercambio iónico implicados en la conducción de estímulo. Por oíro lado, la forma de sal de un ageníe anestésico que no es soluble en lípidos, penetra a la membrana de nervios lipo-proleína solamente después de la capacidad reguladora de pH de la piel o tejido de mucosa que convierte la sal a la base, el resultado final siendo un inicio retrasado de anesíesia. Las formas de sal de los agentes anestésicos se seleccionan con base en el inicio de anesíesia y la duración de anesíesia. El ajuste de la relación de base a sal afecta el inicio relativo así como la duración de anestesia. Entre más grande es la cantidad de agente anestésico que tiene un rápido inicio de acción, más corto es el tiempo para el inicio de la anestesia. Similarmente, entre más grande es la cantidad de agente anestésico teniendo una duración prolongada de anesíesia, más prolongada es la duración de la anestesia. Además, la composición puede incluir otros fármacos utilizados concomitantemeníe. El Cuadro 1 a continuación resume el pico y duración de acción de los anestésicos locales seleccionados basados principalmente en la aplicación a la piel o membrana de mucosa.
CUADRO 1 Anestésico Dosis Mínima Dosis Máxima Efecto Pico Duración del Efecto
Local para Adultos para Adultos (mg) (minuto) (minutos)
Dibucaína 25 <15 120-240
Lidocaína 750 2-5 30-60
Benzocaína 5000 1 30-60
Cocaína 50 2-5 30-120
Tetracaína 50 3-8 30-60
Dlclonina 100 <10 <60
Pramoxina 200 3-5 NA
NA: No disponible. Fuente: Druq Facts and Comparisons. edición 1990, J. B. Lippincott Company, St. Louis, MO. Pág.601.
En general, la velocidad relativa del inicio de anestesia y la duración de anesíesia para cualquier forma dada de un ageníe anesíésico está disponible en la literaíura o puede ser calculada a través de pruebas estándares para la dosis de transmucosa. El tiempo de inicio, así como la duración de anestesia variarán de individuo a individuo así como con base en el sitio de aplicación. Cuando la composición se aplica a íejidos dérmicos altamente queratinizados, el índice de anestesia puede tomar tanto como 2 a 4 horas. El término "cantidad terapéuticamente efectiva" como se utiliza en la presente con referencia al agente activo, significa la cantidad de agente activo suficiente para producir el efecto deseado, local o sistémico, cuando se aplica tópicamente en la duración del uso pretendido. Las cantidades necesarias son conocidas en la literatura o pueden ser determinadas a través de métodos conocidos en la técnica, pero íípicamente varían de aproximadameníe 0.1 a
aproximadamenle 20,000 mg, y de preferencia alrededor de 0.1 a aproximadameníe 1,000 mg, y muy preferiblemenfe de aproximadamente 0.1 a aproximadamente 500 mg por adulto ser humano con un peso de aproximadamente 75 kilogramos, dependiendo de los agentes activos seleccionados y el silio de aplicación. El único límiíe superior de la caníidad del agente activo es aquel de que la composición preferiblemente debe estar substancialmente libre de cristales del agente activo y la caníidad de solvente utilizado no sea suficiente para afectar indeseablemeníe las propiedades bioadhesivas de la composición. La dosis y cantidades de unidad de dosis terapéuíicas pueden ser estimadas a través de daíos de flujo ¡n vitro utilizando piel de cadáver de ser humano o, alíernativameníe, utilizando piel de animal como se describe en la patente de E.U.A. No. 4,751,087. La concentración, así como la cantidad del agenle activo por área unitaria, principalmente por centímelro cuadrado o cúbico, puede variar independientemente con el fin de lograr el efecto terapéutico deseado. Por ejemplo, las concentraciones más altas de base anestésica contenida en la forma de dosis de espesor reducido dará como resultado un anestésico con un inicio rápido y una duración corta. Las altas concentraciones de la base de anestésico contenida en una forma de dosis de espesor incrementado (mg más alto de anestésico por centímetro cuadrado o cúbico) dará como resultado una anestesia potente con un rápido inicio y una duración larga. Las concentraciones bajas de la base anestésica en una forma
de dosis de espesor reducido darán como .resultado una anesíesia moderada con inicio más largo y una duración corla. Las bajas concentraciones de la base anestésica contenida en una forma de dosis de espesor incrementado tendfán una anestesia moderada con inicio más largo y duración más larga. Como se muestra en la explicación anterior, la habilidad para variar la concentración de agentes activos de muy baja (aproximadamente 1%) a alta (40% o superior) de la composición total, cuando se combina con la habilidad para revestimientos delgados (aproximadamente 0.0025 cm) o gruesos (aproximadamente 1.27 cm o más) permite que el practicante de la invención varíe la dosis según sea necesaria para el sitio particular de aplicación tópica y efectos terapéuíicos. Las composiciones bioadhesivas de la presente invención también pueden contener uno o más solventes o cosolventes. Dichos solventes y cosolventes son aquellos conocidos en la técnica, y son substancias farmacéuticamente aceptables, no tóxicas, preferiblemente líquidos, los cuales no afectan substancial y negaíivameníe las propiedades bioadhesivas o solubilidad de los agentes activos a las conceníraciones utilizadas. El solvente y cosolvente pueden ser para el agente activo o para los materiales bioadhesivos, o ambos. El solvente preferiblemente es un alcohol polihídrico o combinación de alcoholes polihídricos. El solvente debe incluir alrededor de 5% a aproximadamente 50%, y muy preferiblemente alrededor de 10% a 30% en peso del peso seco de la composición bioadhesiva total de un solvente que se sabe que
plastifica la composición bioadhesiva. Los plastificantes particularmente útiles son glicoles tales como glicol dipropilénico y propileno, ácidos grasos tales como ácido oleico y ácido linoleíco, esteres de ácido graso tales como Yniristaío de isopropilo, aceites vegetales, animales y de pescado tales como aceite de ricino hidrogenado, cañóla, aceite de bacalao y lanolina, aceite mineral, glicerina, lecitina, tocoferol y acetato de tocoferiio. Alternativamente, los fármacos que son líquidos a temperatura ambiente, tales como nitroglicerina, nicotina, selegilina y similares, pueden ser utilizados como plastificantes. El uso de un solvente (abarcando tanto solventes como plastificaníes) también se ha encontrado que mejora la apariencia y lextura de la composición íerminada, particularmeníe para las modalidades de PVP y, de karaya. Específicamente, la inclusión de un solvente en la composición bioadhesíva se cree que ocasiona que las partículas de goma de karaya en polvo se hinchen o gelifiquen cuando se agregan a una mezcla o combinación conteniendo PVP solventes y agente activo (sí la composición bioadhesiva no eslá siendo uíilizada como una capa adhesiva separada). Cuando se íermina, la composición bioadhesiva tendrá un acabado más blando, más liso que una composición bíoadhesiva que no contenga solventes. Una composición bioadhesiva que no contenga ningún solvente generalmente tendrá propiedades adecuadas de desgaste y de esta manera no está fuera del alcance de la presente invención. Sin embargo, el uso de solventes es preferido por las razones
observadas anteriormente. El término "alcohol polihídrico" significa cualquier polialcohol orgánico e incluye glicol dipropilénico, glicol propilénico, glicol polietilénico, glicerina, glicol butilénico, glicol hexilénico, polioxietileno, glicol polipropilénico, sorbiíol, glicol etilénico, y similares. Otros solveníes adecuados incluyen ácidos grasos tales como ácido oleico, ácido linoleíco, ácido cáprico y similares. Polietileno, polipropileno y éteres de ácidos grasos, así como esteres grasos o aleonóles. Los solventes adecuados adicionales incluyen otros solventes no volátiles, no tóxicos comúnmente utilizados en composiciones transdérmicas o de transmucosa para solubilizar agentes activos. Los alcoholes polihídricos anteriormente mencionados pueden incluir aquellos que tengan de 2 a 6 grupos hidroxilo alcohólicos. Dichos alcoholes polihídricos incluyen glicoles, trioles y polioles teniendo de 4 a 6 grupos hidroxilo alcohólicos. Los típicos de dichos glicoles son glicoles que coníienen de 2 a 6 áíomos de carbono, por ejemplo, glicol etilénico, glicol propilénico, glicoi butilénico, glicol polietilénico (peso molecular promedio de aproximadamente 200-8,000, de preferencia alrededor de 200 a 6,000), etc. Ejemplos de dichos trioles incluyen glicerina, trimetilolpropano, etc. Los polioles son ilusírados por sorbitoi (sorbit), polivinilpirrolidona, etc. Estos alcoholes polihídricos pueden ser utilizados ya sea individualmente o en combinación (preferiblemeníe de 2 a 3). De esta manera, por ejemplo, se puede emplear glicerina o glicol dipropilénico solo, o una
mezcla ya sea de glicerina o glicol dipropilénico con glicol butilénico. Entre estos alcoholes polihídricos, aquellos que satisfacen los requerimientos importanles para el ajuste y mantenimiento de suavidad de la superficie interna de 1a invención, la compatibilidad o co-dispersabilidad con los otros componentes, y proporcionar una consistencia apropiada de la composición, pueden ser utilizados libremente. Aquellos que son de baja volaíiiidad son generalmente preferidos y, a este respecto, el glicol dipropilénico, glicerina, glicol propilénico, glicol buíilénico y sorbitol son solventes apropiados de acuerdo con la invención. Aunque la cantidad exacía de los alcoholes polihídricos o ácidos grasos, esteres, éíeres o alcoholes, que puedan ser utilizados en la composición, dependa de la naturaleza y caníidad de los otros componentes, y por lo tanto no pueda ser establecida en iérminos generales, la proporción puede variar hasta aproximadamente 30% en peso, preferiblemente alrededor de 5% a aproximadamente 20% en peso, y muy preferiblemente de alrededor de 5 a aproximadamente 10% en peso basado en el peso seco de la composición bioadhesiva total. Ei término "solubilizado" significa que en el solvente, y subsecueníemeníe la composición bioadhesiva, exisíe una dispersión ínííma del agente activo a nivel molecular, crisíalino o iónico, de manera que los cristales del agente activo no pueden ser detecíados utilizando un microscopio teniendo una amplificación de 25X. Como tal, el agente activo es denominado en la presente como estando en
la forma "no cristalizada" cuando están las composiciones de la preseníe invención. En general, la concentración de agente acíivo farmacéuticamenie solubilizado puede variar de aproximadameníe 1% a aproximadameníe 50%, muy preferiblemeníe alrededor de 2.5% a 40% y óptimameníe alrededor de 5% a aproximadameníe 30% en peso del peso seco de la composición bioadhesiva íolal. En una modalidad preferida de la invención, para adminislración fópica de un agente activo individual, el cetoprofen en la forma de ácido libre es utilizada en una concentración de entre 2% y 30% en peso del peso seco de la composición bioadhesiva total. En general, para la administración tópica de una combinación de agentes anestésicos, ia relación en peso de base libre a las formas de sal es de aproximadamente 90:10 a aproximadamente 40:60, de preferencia alrededor de 75:25 a 50:50, y muy preferiblemente alrededor de 70:30 a 60:40. Para oirás sales, las relaciones son compatibles con base en cantidades molares relativas. Generalmente, la relación en peso de base a sal es de entre aproximadamente 1:2 a aproximadamente 4:1. En una modalidad preferida de la invención para una combinación de agentes anestésicos, la relación es de aproximadameníe 2:1 de base a sal, respecíivamente, la base utilizado es lidocaína y la sal utilizada es una sal de prilocaína, bupivacaína, diclonina, mepivacaína, o tetracaína, preferiblemente la sal de clorhidrato. Las concentraciones más altas de agentes activos,
principalmente hasta 50% en peso, pueden .ser logradas típicamente mezclando tales agentes con un solvente apropiado, de preferencia a una temperatura elevada por ejemplo alrededor de 70 a 100°C, para obtener una mezcla, preferiblemente una solución, de los agentes activos que después se agregan a los materiales bioadhesivos. La omisión del solvente típicamente producirá una composición final llena de cristales o una masa cristalina. La selección del solvente para una combinación de agentes activos depende la forma del agente, entre otros, si está en la forma de base libre, de ácido libre o de sal de adición de ácido. Los solventes adecuados para la forma de sal de agentes anestésicos son típicameníe solventes orgánicos polares. Los solventes orgánicos polares preferiblemente son alcoholes polihídricos como se discutió anleriormente. Los oíros solveníes adecuados ya sea para la forma de base libre o la forma de adición de ácido de los agentes anestésicos son aquellos solveníes que se sabe que se disuelven uno o ambos de esios dos tipos de formas incluyendo cetonas cíclicas tales como 2-pirrolidona, N-(2-hidroxietil) pirrolidona, N-metilpirrolidona, 1 -dodeciiazacicloheptan-2-ona y oirás alqui-azacicloalquil-2-onas n-subsíiíuidas (azonas) dimeíilformamida y sulfóxido de dimelilo. Oíros solvenfes adecuados para la forma de base libre de un ageníe anesíésico incluyen compuesíos de desorden de cubiería de célula que se saben que son útiles en preparaciones farmacéuticas tópicas, dichos compuestos se cree que ayudan en la penetración en la mucosa desordenando la
estrucíura de lípido de las cubiertas de céjula dei estrato corneo. Algunos de estos compuestos están generalmente abarcados por la fórmula: R-X en donde R es un alquilo de cadena recta de aproximadamente
7 a 16 átomos de carbono, un alquenilo no terminal de aproximadamenfe 7 a 22 áíomos de carbono o un alquilo de cadena ramificada de aproximadameníe 13 a 22 áíomos de carbono, y X es -OH, -COOCH3, COOC2H5, -OCOCH3, -SOCH3, -P(CH3)20, -COOCH2H4OC2H4OH, -COOCH (CHOH)4CH2OH, -COOCH2CHOHCH3, -COOCH2CH (OR") CH2ORX -(OCH2CH2)mOH, -COOR', o -CONR'2, en donde R es -H, -CH3, -C2H5, -C3H7 OR - C2H4OH; R" es-H o un alquenilo no terminal de aproximadamente 7 a 22 átomos de carbono; y m es un entero positivo de 2 a 6; siempre que cuando R" sea un alquenilo y X sea -OH o -COOH, por lo menos un doble enlace está en la configuración cis. La composición bioadhesiva también puede contener agentes que se sabe que aceleran el suministro de los agentes activos a íravés de la piel o mucosa. Esíos ageníes han sido denominados como mejoradores de peneíración o permeación, aceleradores, auxiliares y promoíores de absorción, y son colecíivamenfe denominados como "mejoradores". Algunos ejemplos de mejoradores son alcoholes monohídricos tales como etanol y alcoholes isopropílico, butílico y bencílico o alcoholes dihídricos tales como glicol etilénico, glicol dietilénico o
glicol propilénico-glicol dipropilénico y _ glicol trimetilénico, o alcoholes polihídricos tales como glicerina, sorbitol y glicol polieíilénico, los cuales mejoran la solubilidad del fármaco; éíeres de glicol polietilénico de alcoholes álifáticos (íales como ceíílico, laurílico, oleílico y esíearílico) incluyendo éíer laurílico de polioxietileno (4), éter oleílico de polioxietileno (2) y éter oleílico de polioxietileno (10) comercíalmente disponible bajo las marcas BRIJ® 30, 93 y 97 de ICI Americas, Inc., y BRIJ® 35, 52, 56, 58, 72, 76, 78, 92, 96, 700 y 721; grasas y aceiíes vegelales, animales y de pescado íales como aceiíe de oliva y de ricino, escualeno y lanolina; ésleres de ácido graso tales como oleato de propilo, oleato de decilo, palmitafo de isopropilo, palmitato de glicol, laurato de glicol, miristato de dodecilo, miristafo de isopropilo y estearato de glicol, los cuales mejoran la capacidad de difusión del fármaco; alcoholes de ácido graso tales como alcohol oleico y sus derivados; amidas de ácido graso tales como oleamida y sus derivados; urea y derivados de urea tales como alantoína los cuales afecfan la habilidad de queraíina para reíener la humedad; solveníes polares lales como fosfóxido de dimelildecilo, sulfóxido de dimetiloctilo, dimetil laurii amida, dodecil pirrolidona, isosorbitol, dimetilacetonida, sulfóxido de dimetilo, sulfóxido de dimetiletilo y dimetilformamida que afectan la permeabilidad de la queratina; ácido salicílico que suaviza la queraíina; aminoácidos que ayudan a la penelración; nicotinato de bencilo, el cual es un agente que puede abrir el folículo del cabello; y agentes tensoactvios alifáticos de peso molecular más alto tales
como sales de lauriisulfato que cambian el estado de la superficie de la piel y fármacos administrados y esteres de sorbitol y anhídrido de sorbitol tales como polisorbato 20 comercialmenfe disponible bajo la marca Tween® 20 de ICI Americas, l'nc, así como oíros polisorbaíos fales como 21, 40, 60, 61, 65, 80, 81, y 85. Oíros mejoradores incluyen ácidos oleico y linoleíco, ácido ascórbico, paníenol, hidroxifolueno buíilado, locoferol, aceíaío de íocoferol, linoleafo de íocoferilo. En una modalidad de la présenle invención, la composición bioadhesiva comprende una mezcla de por lo menos un bioadhesivo insoluble en agua y por lo menos un bioadhesivo soluble en agua, un agente activo y un solvente farmacéuticamente aceptable comprendiendo un solvente que se sabe que plastifica la composición bioadhesiva total. En una modalidad preferida, el solvente farmacéuticamente aceptable está en una cantidad preferida de aproximadamente 20% a aproximadamente 52% en peso basado en el peso seco de la composición total, ia porción de plastificante del cual representa aproximadamente 10% a 30% en peso basado en ei peso seco de la composición total, y los bacteriales bioadhesivos varían en una cantidad de aproximadamente 20% a aproximadamente 55% en peso basado en el peso seco de la composición bioadhesiva total. Muy preferiblemente, la composición bioadhesiva de la presente invención comprende alrededor de 10% a 40% en peso de un bioadhesivo de polisacárido, alrededor de 10% a 40% en peso de un bioadhesivo
soluble en agua, alrededor de 10% a 60% en peso de un solvente y alrededor de 5% a 40% en peso de un agente activo, basado en peso seco de la composición bioadhesiva total y además puede estar compuesto de un aglutinante en ' una cantidad suficiente para aglutinar los otros ingredieníes. Las modalidades preferidas comprenden una mezcla de PVP soluble y oíro bioadhesivo, preferiblemente una goma. En particular, se ha encontrado inesperadamente que cuando se emplea goma de karaya como el bioadhesivo de polisacárido y se emplea PVP soluble como el bioadhesivo soluble en agua, con un solvente farmacéuticamente acepíable que comprenda un solveníe que se sepa que plasfifique la composición bioadhesiva total, se forma una composición bioadhesiva que también es un bioadhesivo sensible a la presión. Esle resulíado es complelamenfe inesperado, ya que ni la goma de karaya ni la PVP soluble sola es un adhesivo sensible a ia presión. La formación de una composición b?oadhesiva/adhesiva sensible a la presión se forma cuando la goma de karaya y PVP se emplean a una relación de enlre 1:10 y 10:1. En general, la composición bioadhesiva puede íener ios siguieníes íipos y caníidades de ingredíeníes:
Ingrediente Escala Típica Escala Preferida Escala Óptima (% en peso) (% en peso) (% en peso)
Bioadhesiva 5 a 50 10 a 40 20 a 30 VP 5 a 50 10 a 40 15 a 30
Solvente 5 a 70 10 a 60 20 a 53 Agente Activo 1 a 50 2.5 a 40 5 a 30
La caníidad y el íipo de PVP requerida en las modalidades preferidas dependerá de la canlidad y el íipo de fármaco présenle en la composición bioadhesiva, así como el lipo de bioadhesivo, pero puede ser fácilmente determinada a través de experimentación rutinaria. Típicamente, la PVP está presente en una cantidad de aproximadamente 5% a aproximadamente 50% en peso, de preferencia alrededor de 10% a 40% en peso del peso seco de la composición bioadhesiva total. Sin embargo, la cantidad de PVP puede ser tan alta como 20%, por ejemplo, hasta 40%, dependiendo del fármaco particular utilizado y de las propiedades deseadas de la mezcla. La PVP preferiblemente tiene un peso molecular de aproximadamente 2,000 a 1,200,000, de preferencia de 5,000 a 100,000, y muy preferiblemente de 7,000 a 54,000. La PVP que tiene un peso molecular de aproximadamente 1,000,000 a aproximadamente 1,500,000 también es preferida. Las PVPs son vendidas a la industria farmacéutica bajo los nombres comerciales de KOLLIDON por BASF AG, Ludwigshafen, Alemania; PLASDONE, POLYPLASDONE y COPOLYMER 958 por ISP Technologies, Wayne, New Jersey. Las PVPs preferidas son
KOLLIDON 12PF, 17PF, 25, 30, 90 y VA-64.. En olra modalidad preferida de la invención, la composición bioadhesiva incluye un adhesivo sensible a la presión. Ei lérmino "adhesivo sensible a la presión" como se uíiliza en la présenle se refiere a un maíerial viscoelásíico, el cual se adhiere instaníáneamente a la mayoría de las superficies con aplicación de una presión muy ligera y permanece en forma pegajosa permaneníemente. El polímero es un adhesivo sensible a la presión deníro del significado del término como se utiliza en la présenle, si tiene las propiedades de un adhesivo sensible a la presión per se o funciona como un adhesivo sensible a la presión a través de la mezcla con espesantes, plastificantes u otros aditivos. Los adhesivos sensibles a la presión adecuados incluyen todos los polímeros naiurales y sintéíicos no tóxicos conocidos o adecuados para utilizarse en los dispositivos transdérmicos tales como adhesivos hidrofóbicos incluyendo elasíómeros naturales o sintéíicos íales como políisobuíileno, estireno, polibutadieno, copolímeros de bloque de esíireno-isopreno, poliuretanos, poliacrílicos, polisiloxanos y copolímeros de estireno/buíadieno. Los adhesivos sensibles a la presión paríicularmente preferidos son polímeros acrílicos y más paríicularmente polímeros acrílicos a base de solventes. El término "polímero acrílico" preíende ser utilizado intercambiablemeníe con los iérminos polímero de acrilato, polímeros adhesivos de poliacrilato y poliacrílicos como se utiliza en la presente y se conocen en la técnica. El término "a base
de solvente" se utiliza en la presente para ilustrar substancialmente libre de agentes tensoactivos. Los polímeros acrílicos útiles en la práctica de la invención son polímeros de uno o más monómerós de ácidos acrílicos y otros monómeros copolimerizables. Los polímeros acrílicos también incluyen copolímeros de acrilatos de alquilo y/o metacrilatos y/o monómeros secundarios copolimerizables o monómeros con grupos funcionales. Variando la cantidad de cada tipo de monómero agregado, las propiedades cohesivas del polímero acrílico resultaníe pueden ser cambiadas como es conocido en la técnica. En general, el polímero acrílico está compuesío de por lo menos 50% en peso de un monómero de acriiato o acrilaio de alquilo, de 0 a 20% de un monómero funcional copolimerizable con el acrilato y de 0 a 40% de otros monómeros. Los monómeros de acriiato que pueden ser utilizados incluyen ácido acrílico, ácido metacrílico, acrilato de butilo, metacrilato de butilo, acrilato de hexilo, metacrilato de hexilo, acrilato de 2-etiibutilo, metacrilato de 2-etil butilo, acrilato de isobutilo, metacrilato de isooctilo, acrilaío de 2-etilhexilo, meíacrilato de 2-meíilhexilo, acrilato de decilo, metacrilato de decilo, acrilato de dodecilo, metacrilato de dodecilo, acrilato de tridecilo y metacrilato de tridecilo. Los monómeros funcionales, copolimerizables con los acrilatos o metacrilatos de alquilo anteriores, que pueden ser utilizados incluyen ácido acrílico, ácido metacrílico, ácido maléico, anhídrido
maléico, acriiato de hidroxietilo, acriLato de hidroxipropilo, acrilamida, dimetilacrilamida, acrilonitrilo, acrilato de dimetilaminoetilo, metacrilato de dimetiiaminoetilo, acrilato de ter-buíiiaminoeíiio, metacrilaío de tér-buíilaminoetilo, acrilato de metoxieíilo, metacrilato de metoxietilo, y otros monómeros teniendo por lo menos un doble enlace insaturado que participa en la reacción de copolimerización en una molécula y un grupo funcional sobre su cadena lateral tal como un grupo carboxilo, un grupo hidroxilo, un grupo sulfóxido, un grupo amino, un grupo amido y un alcoxilo, así como una variedad de otras unidades monoméricas incluyendo alquileno, alquileno hidroxi substituido, alquileno substituido con ácido carboxílico, alcanoato de vinilo, vinilpirrolidona, vinilpiridina, vinilpirazina, vinilpirrol, vinilimidazol, vinilcaprolactama, viniloxazol, acetato de vinilo, propionato de vinilo y vinilmorfolina. Otros delalles y ejemplos de adhesivos acrílicos que son adecuados en la práctica de ia invención se describen en Satas, "Acrylic Adhesives", Handbook of Pressure-Sensitive Adhesive Technology, 2° edición, pág. 396-456 (D. Satas, ed.), Van Nosírand Reinhold, New York (1989). Los adhesivos acrílicos adecuados están comercialmente disponibles e incluyen los adhesivos de poliacrilato vendidos bajo las marcas comerciales de DURO-TAK por National Síarch Company, Bridgewater, New Jersey; GELVA por Monsanto, Sí. Louis, Missouri; HRJ por Schenectady International, Inc., Schenectady, New York; MORSTIK por Morton International, Inc., Chicago, Illinois; y
EUDRAGIT RL y RS por Roehm Pharma GmbH, Darmstadí, República Federal de Alemania. La cantidad del adhesivo sensible a la presión utilizado depende de la conceníración del agéníe acfivo uíilizado para lograr un agente terapéuíico. Típicamenfe, el adhesivo sensible a la presión esíá en una caníidad de aproximadameníe 10% a aproximadamenle 60% en peso del peso seco de la composición bioadhesiva total y de preferencia alrededor de 15 a 50%, y muy preferiblemente alrededor de 20 a 40% en peso basado en el peso seco de la composición bioadhesiva tofal. En oíra modalidad más de ia presente invención, la composición bioadhesiva comprende alrededor de 10% a 60% en peso de un polímero acrílico a base de solvente, de aproximadamenle 20% a aproximadamenle 50% en peso de un polímero de PVP, de aproximadamente 20% a aproximadamente 3% en peso de por lo menos un solvente, y aproximadamente 10% a aproximadamente 25% en peso de un agente activo basado en el peso en seco de la composición bioadhesiva total, y además puede comprender un aglutinante en una cantidad suficiente para aglutinar los otros ingrediente. Otra vez, el agente activo deseado para la administración tópica puede ser solubilizado dentro de la composición bioadhesiva o puede ser administrado separadamente.
Además de los ingredientes anleriores, también se pueden incorporar varios aditivos y excipientes farmacéuticamente aceptables disponibles para aquellos expertos en la técnica. Estos
aditivos incluyen agentes espesantes, los cuales son particularmente útiles en aquellas modalidades en donde el agente activo no plastifica la composición bioadhesiva, íales como hidrocarburos alifáíicos, hidrocarburos alifáticos y aromáíicos mixíos, hidrocarburos aromáficos, hidrocarburos aromáticos substiíuidos, ésíeres hidrogenados, politerpenos y rosinas de madera hidrogenadas. Los aditivos adicionales incluyen aglutinantes tales como lecitina, los cuales "agluíinan" los oíros ingredienles, o ageníes Teológicos (espesaníe) que conlienen silicón íales como sílice ahumada, arena de grado reacíivo, sílice precipitada, sílice amorfa, dióxido de silicio coloidal, sílice fusionada, gel de sílice, cuarzo y materiales de sílice en partículas comercialmente disponibles como Syloid®, Cabosil®, Aerosil® y Whifeliíe®, para propósitos de mejorar la consistencia uniforme o fase continua de la composición final. Otros aditivos y excipientes incluyen diluyentes, estabilizadores, llenadores, arcillas, agentes reguladores de pH, biocidas, humectantes, anti-irritaníes, anfioxidanles, conservadores, ageníes saborizaníes, colóranles, pigmenlos y similares. Dichos aditivos o excipientes típicamente son utilizados en cantidades de hasta 25% en peso de la composición bioadhesiva y de preferencia alrededor de 0.1% a aproximadamente 10% en peso. Las composiciones de acuerdo con la presente invención pueden ser preparadas mezclando uno o más bioadhesivos, en forma de polvo o líquida, con la PVP y el agente activo, con o sin un adhesivo sensible a la presión, preferiblemente en un solvente de
peso molecular más bajo, volátil, apropiado. Cuando se utiliza un bioadhesivo sensible a la presión, preferiblemente el solvente de peso molecular más bajo, volátil es un solvente orgánico suministrado con el adhesivo sensib'le a la presión, por ejemplo, el adhesivo acrílico. Los líquidos típicos para utilizarse tales como solventes volátiles, distintos de la polimerización por emulsión (típicamente acuoso), individualmente o en combinación con otros solventes volátiles o no volátiles son líquidos orgánicos polares y no polares volátiles lales como alcanoles de peso molecular más bajo (por ejemplo, isopropanol y elanol) aromáticos tales como derivados de benceno (por ejemplo, xileno y tolueno), alcanos y cicloalcanos de peso molecular más bajo (por ejemplo, hexano, heptano y ciciohexano) y éster de ácido alcanoico íal como acefaío de eíilo o buíilo. Preferiblemeníe, la mezcla es colada a íemperalura ambienle y presión seguido por evaporación de los solveníes voláliles, por ejemplo, a íravés de la evaporación a femperaíuras ligeramenfe elevadas, para formar la mezcla bioadhesiva. Los solvenfes no voiáíiles o de punió de ebullición más alio íales como polioles ufilizados en la composición permanecen ahí. Una unidad o disposiíivo individual (por lo general denominado con un "sistema de suminístro")comprendiendo la presente invención puede ser preparado en cualquier forma conocida por aquellos expertos en la técnica. Un método general ilustrativo de preparación es como sigue:
1. Cantidades apropiadas del polímero de PVP, adhesivos sensibles a la presión, solventes y/o cosolventes, mejoradores, aditivos y excipientes son combinados y mezclados concienzudamente en un recipieníe. 2. Uno o más agenles acíivos después son agregados a la mezcla y se realiza la agiíación hasía que el agente(s) se mezcla uniformemente ahí, si la composición bioadhesiva está siendo utilizada tanío como el adhesivo como la fuente de agente activo. De otra manera, no se agrega ningún agente activo. 3. Las canfidades apropiadas de otros materiales bioadhesivos, tales como goma de karaya, también pueden ser agregadas a la mezcla que contiene el agente activo y mezclarse concienzudameníe. 4. La composición después es transferida a una operación de revestimiento, en donde es colocada como revestimienío sobre un forro de liberación a un espesor específico controlado. La composición revestida después se hace pasar a través de un horno con el fin de impulsar todos los solveníes de. procesamiento voláíiles.
. La composición revestida sobre el forro de liberación después se pone en contacío con un respaldo (capa) y se devana en rodillos. 6. Los sistemas de suministro de forma y íamaño apropiados son cortados con dado del material enrollado y después se colocan en bolsas. El orden de los pasos, la cantidad de los ingredientes y la
cantidad y el tiempo de agitación o mezclado pueden ser variables importantes del proceso, que dependerán de los polímeros específicos, agentes activos, solventes y/o cosolventes, mejoradores y aditivos y excipientes utilizados en la composición. Estos factores pueden ser ajustados por aquellos expertos en la técnica, mientras se manfenga en meníe los objelos de lograr un agenfe acíivo solubilizado y proporcionar un producío uniforme. Se cree que un número de oíros mélodos, por ejemplo, oíros méíodos para reveslir respaldos que son bien conocidos en la lécnica íales como barra de Mayer, laminado sobre cuchilla, exírusión, colado, calandrado y moldeo, o cambiando el orden de cieríos pasos, por ejemplo, en una modalidad, los ageníes aneslésicos se disuelven en un soiveníe, preferiblemente un alcohol polihídrico y después la mezcla resultante es agregada a los otros componentes bioadhesivos anles del revesfimienío, pueden ser realizados y fambién darán resulfados deseables. Los inveníores de la présenle han enconlrado que, sin embargo, agregando el bioadhesivo sin la PVP, tal como goma de karaya, a una mezcla que contiene la PVP y solventes, la composición bioadhesiva terminada tendrá un acabado más lizo y más suave. La capa de respaldo, típicamente oclusiva a la penetración de agua, sirve para retener y mantener la composición bioadhesiva dispuesta sobre la misma en un tamaño y forma definidos, evita la pérdida del agente activo y/o mejoradores hacia el ambiente, hace
que la unidad individual o sistema de suministro (junto con el forro de liberación) sea transportable, y generalmente proporcione protección tanío aníes como después de la aplicación de la unidad o sislema a un sujelo. Los maferiales adecuados que pueden ser uíilizados, individualmeníe, en combinación, como laminados o como coexírusiones para formar la capa de respaldo son bien conocidos en la técnica, e incluyen películas o láminas de polietileno, poliéster, polipropileno, poliuretano, poliolefina, alcohol poliviníiico, cloruro de polivinilo, polivinilideno, poliamida, resinas de acetaío de vinilo, BAREX®, copolímeros de efileno/acetato de vinilo, copolímeros de etileno/acrilato de etilo, películas depositadas de metal-vapor o sus láminas, láminas o películas de hule, láminas o película de resina sintéíica expandida, felas no fejidas, íelas, felas de punió, ropa, hojas y papeles. La capa de respaldo generalmeníe tiene un espesor en la escala de 2 a 1000 micrómefros y la composición bioadhesiva generalmeníe es dispuesía sobre la capa de respaldo en un espesor que varía- de aproximadamente 12 a 250 'micrómetros. La capa' de respaldo puede ser pigmentada, por ejemplo, coloreada ya sea para coincidir con o distinguirse inversa y fácilmente del sitio de aplicación, y/o contener impresión, marcación u otros medios de identificación y/o capacidad de verificación de la unidad o el mismo sistema. La capa de respaldo además puede hacerse opaca o substancialmente opaca, (es decir, evitando la luz o ciertas
longiludes de onda de energía de que penetren o pasen a fravés de la misma), íal como a íravés de meíalización, llenadores, finías, colóranles y similares, con el propósilo de proteger agentes activos fotosensibles, tales como cetoprofe , de la degradación y/o evilar reacciones fotoalérgicas o irritaciones en el sujeto. El forro de liberación o tira desprendible también pretende evilar la pérdida del agente activo y/o mejoradores hacia el ambiente, y hacer que la unidad individual o el sistema de suministro (junto con la capa de respaldo) sea transportable, así como generalmente proteger la composición bioadhesiva de la contaminación y similares hasta su aplicación a un sujeto. El forro de liberación típicamente también es impermeable y oclusivo, y debe ser compatible con los bioadhesivos particulares y/o agentes activos con el fin de no interferir con su aplicación tópica final y efecto terapéutico. Los materiales adecuados que pueden ser utilizados, individualmente, en combinación, como laminados o como coextrusiones para formar el forro de liberación también son bien
• conocidos en' la técnica e incluyen cualquier material adecuado para la capa de respaldo. Cuando el forro de liberación está compuesto de un material que típicamente no se libera con facilidad (es decir, no es fácilmente removido o separado de la composición bioadhesiva), por ejemplo papel, un material de revestimiento tal como silicón puede ser aplicado al forro de liberación a través de cualquier medio convencional. Los forros de liberación preferidos son películas
comercialmenle disponibles de DuPont, Wilmington, Delaware, bajo el nombre comercial de Mylar®, y películas revestidas con fluoropolímero (silicón) comercialmente disponibles de Rexam Reléase, Oak Brook, Illinois bajo eTnombre comercial de FL2000® y MRL2000, y de 3M Corporation, St. Paul, Minnesota, bajo el nombre comercial de ScotchPak® 1022. La configuración de una unidad individual o sistema de suministro de la presente invención puede ser de cualquier forma, preferiblemente una forma geométrica definida, y tamaño (es decir, área de superficie de aplicación) según sea necesario o deseable. La forma es lograda a través de técnicas convencionales, por ejemplo, cortando o perforando, y dichas técnicas se describen por ejemplo en las pateníes de E.U.A. Nos. 5,032,207, 5,405,486 y 5,656,285. El sitio pretendido de aplicación es un factor importante para determinar el tamaño y la forma de una unidad individual o sistema de suminislro de la preseníe invención, y puede ser ajustado por aquellos expertos en la íécnica según sea necesario para efecfuar la íerapia. Típicameníe, el íamaño no debe exceder de 100 cm2. Los tamaños • . preferidos varían • de .aproximadamente 0.1 cm2 .a aproximadamente 60 cm2, y una escala muy preferida es de aproximadamente 1.5 cm2 a aproximadamente 30 cm2, y óptimamente de aproximadamente 2.0 cm2 a aproximadameníe 10 cm2. Las composiciones bioadhesivas de la presente invención preferiblemente comprenden los agentes activos solubilizados en la
misma, y se unen directamente a la piel a mucosa después de la remoción del forro de liberación. Alternativamente, la composición adhesiva puede ser utilizada, sin un ageníe acfivo, en un ageníe e suminisíro de capas múlfiples como una capa adhesiva "subyaceníe" (es decir, se une direcfamenfe a la piel o mucosa después de la remoción del forro de liberación), en donde el ageníe acfivo es solubilizado o conlenido en una o más de las oirás capas separadas, y esías oirás capas pueden o no pueden comprender modalidades de las composiciones bioadhesivas de la preseníe invención. En otro aspecto, la composición bioadhesiva de la presente invención puede ser utilizada, sin un agente activo, en un sistema de suministro de tipo depósito como un adhesivo subyacente o una capa o anillo adhesivo periférico, en donde el agenfe activo es utilizado o está coníenido en un depósito o cavidad separado, y dicho depósito o cavidad puede o no puede comprender las modalidades de las composiciones bioadhesivas de la preseníe invención. Si la composición bioadhesiva es uíilizada como un anillo adhesivo • alrededor del. depósito de agente activo o cavidad de' fármaco, la capa bioadhesiva es periférica al depósito de agente activo. Si la composición bioadhesiva es utilizada como una capa adhesiva subyaceníe separada ala capa que coníiene el agente activo, la capa adhesiva está adyacente a y en contacío con una primera superficie principal de la capa de agenfe acíivo. La composición entonces puede incluir una capa de respaldo, la cual
esíá en coníacío con una segunda superficie principal de la capa de ageníe acíivo que está opuesta a la primera superficie principal de la capa de agente activo; y un forro de liberación removible, el cual está en contacío con una segunda' superficie principal de la capa adhesiva, que esfá opuesía a la primera superficie principal de la capa de ageníe acíivo. Si la capa bioadhesiva es ulilizada sin un agenle acfivo como una capa subyacente separada, el espesor de la capa subyacente generalmente esíá en la escala de un espesor de una a 10 milimicras, muy preferiblemente de 50.8 a 203.2 mieras y de preferencia un espesor de 101.6 a 152.4 mieras. Una modalidad especialmente preferida para la composición bioadhesiva incluye; PVP soluble; un polisacárido preferiblemente una goma natural, muy preferiblemente goma de karaya; un plastificaníe separado, el cual preferiblemeníe es glicerina; un solvenle separado, el cual preferiblemenfe es un alcohol polihídrico y muy preferiblemeníe un glicol propilénico; y uno o más ageníes acíivos si la fuenle de ageníe acíivo no está separada de la composición bioadhesiva. Las cantidades de cada componeníe (agenle aclivo no incluido) son en porcentaje en peso basado en el peso seco combinado de por lo menos uno del polímero de polivinilpirrolidona soluble, la goma de karaya, el alcohol polihídrico y la glicerina, como se muestra a continuación
Ingrediente Escala Típica Escala Preferida Escala Óptima (% en peso) (% en peso) (% en peso)
Goma de Karaya 10 a 50 10 a 40 25 a 35
PVP 5 a 30 7a 15 9a 13
Glicol Propilénico 7 a 40 15 a 35 25 a 30
Glicerina 10 a 50 20 a 40 25 a 35
Si la composición bioadhesiva contiene uno o más agentes activos, las cantidades de los componentes anteriores pueden ser ajustadas por aquellos expertos en la técnica dependiendo de la cantidad y el tipo de uno o más agentes activos. Una relación en peso preferida de goma de karaya a glicerina es de 10:1 a 1:2, muy preferiblemente alrededor de 1:1. Una relación en peso preferida de goma de karaya a glicol propilénico es de 10:1 a 1:1, muy preferiblemenfe alrededor de 1:0.8. Una relación en peso preferida de la PVP a goma de karaya es de 1:1 a 1:7, de preferencia de 1:3 a 1:4. Se ha enconírado que si la composición especialmente preferida en el cuadro anterior es utilizada como una capa adhesiva separada, enlonces la composición es capaz de reducir el íiempo requerido para la adhesión de una composición al tejido de mucosa a tal grado que la composición se adhiere al tejido de mucosa subsfancialmeníe en el momenío del coníacío sin ninguna presión adicional. Los siguienfes ejemplos describirán aún más la présenle invención y se uíilizan solamenfe para propósifos de ilusíración, y no deben ser considerados como limitantes de la invención aquí descrita.
El porceníaje (%) según utilizado en eJ Ejemplo 1 se refiere al porcentaje de la formulación líquida en una base de peso a peso y las temperafuras se dan en grados Celsius (°C).
EJEMPLO 1 Ingrediente % (P/P)
Bioadhesivo (goma de karaya) 21 Polivinilpirrolidona 12 Solveníe (glicoi propilénico) 7 Solveníe (glicerina) 19 Base de ageníe anesíésico (base de lidocaína) 28 Sal de ageníe aneslésico (clorhidralo de prilocaína) 14
El produelo final es fabricado mezclado primero la base de lidocaína, clorhidrato de prilocaína, glicol propilénico, PVP y glicerina a aproximadamente 70 a 90°C hasta que todo el fármaco se disuelve. La solución después se enfría de 20 a 35°C antes de agregar la goma de karaya. Una vez que se agrega la goma de karaya, la composición final es aplicada a un material de respaldo adecuado tal como una película de poliéster no tejida (por ejemplo, la película vendida bajo el nombre comercial de Sontara 8100, fabricada por DuPont de Nemours, E. I. y Co., Wilmington, Delaware) y se calienta aproximadamente 100°C para acelerar la formación a su forma finita final.
EJEMPLO 1a En el Ejemplo 1a, se preparó una composición como sigue sin un fármaco. La composición después pudo ser utilizada sola como una capa adhesiva subyacente, o se' pudo agregar un agente activo, antes de la remoción de los solvenles de procesamiento volátiles.
Ingredientes p/p %(seco)
Bioadhesivo (goma de karaya) 31.4 Polivinilpirrolidona (Kollidon K90) 10.4 Solvente (glicol propilénico) 26.8 Plastificante (glicerina) 31.4
EJEMPLO 2 Se preparó una composición bioadhesiva combinando 20.59% p/p en húmedo de goma de karaya, 10.59% p/p en húmedo de PVP soluble (PLASDONE K90), 7.94% p/p en húmedo de ácido oleico, 45.0% p/p de etanol y 15.88% p/p en húmedo de cetoprofen en un recipiente apropiado, y se mezcló concienzudamente hasta que la mezcla se hizo completamente homogénea. La composición resultante tuvo las concentraciones de ingrediente en una base en peso seco, es decir, después de la remoción del solvente de proceso volátil (etanol).
EJEMPLO 2 COMPONENTE % EN PESO Bioadhesivo (goma de karaya) 35.36 Polivinilpirrolidona (PLASDONE K90)' 19.19 Acido oleico 15.15 Cetoprofen 30.30 100.00
En los siguientes ejemplos, el método del Ejemplo 2 se utilizó con las cantidades apropiadas de materiales de partida para producir composiciones teniendo las siguientes concentraciones de ingrediente, en un porcentaje en peso por peso seco de la composición bioadhesiva total. Los solventes volátiles, en donde está indicado por ( ), no están presentes en la composición final. Además, los fármacos en los ejemplos 21-29 son dispersados en la composición final en lugar de ser solubilizados.
Claims (27)
- REIVINDICACIONES 1.- Una composición bioadhesiva en una forma flexible, finita para la aplicación tópica de uno o más agentes activos que resulta de una mezcla que comprende: (a) por lo menos un polímero de polivinilpirrolidona soluble (PVP); (b) por lo menos un bioadhesivo; (c) una cantidad terapéuticamente efectiva de uno o más agentes activos; y (d) opcionalmente uno o más solventes, en donde la composición está substancialmente libre de agua. 2.- Una composición de acuerdo con la reivindicación 1, en donde el bioadhesivo comprende un polisacárido. 3.- Una composición de acuerdo con la reivindicación 1, en donde el bioadhesivo comprende una goma natural. 4.- Una composición de acuerdo con la reivindicación 1, en donde el bioadhesivo comprende coma de karaya. 5.- Una composición de acuerdo con la reivindicación 1, en donde la composición incluye uno o más solventes. 6.- Una composición de acuerdo con la reivindicación 5, en donde uno o más solventes incluyen un solvente separado y un plastificante separado. 1.- Una composición de acuerdo con la reivindicación 6, en donde al menos un bioadhesivo comprende goma de karaya y en donde el solvente separado comprende un. alcohol polihídrico y el plastificaníe separado comprende glicerina. 8.- Una composición de acuerdo con la reivindicación 7, en donde por lo menos una PVP soluble esíá présenle en una caníidad de 5-30% en peso, la goma de karaya esíá presente en una cantidad de 10-50% en peso, el alcohol polihídrico está presente en una cantidad de 7-40% en peso y la glicerina está presente en una cantidad de 10-50% en peso, todos basados en el peso combinado de por io menos uno de PVP soluble, la goma de karaya, el alcohol polihídrico y la glicerina. 9.- Una composición de acuerdo con la reivindicación 7, en donde por lo menos una PVP soluble está presente en una caníidad de 7-15% en peso, la goma de karaya esfá présenle en una cantidad de 20-40% en peso, el alcohol polihídrico está presente en una cantidad de 15-35% en peso y la glicerina está presente en una cantidad de 20-40% en peso, iodos basados en el peso combinado de por lo menos uno de PVP soluble, la goma de karaya, el alcohol polihídrico y la glicerina. 10.- Una composición de acuerdo con la reivindicación 7, en donde la relación en peso de por lo menos una PVP a goma de karaya es de 1:1 a 1:7. 11.- Una composición de acuerdo con la reivindicación 7, en donde la relación en peso de por lo menos una PVP a goma de karaya es de 1:3 a 1:4. 12.- Una composición de acuerdo con la reivindicación 7, en donde la relación en peso de la goma de karaya a glicerina es de 10:1 a 1:2. 13.- Una composición de acuerdo con la reivindicación 7, en donde la relación en peso de la goma de karaya a glicol propilénico es de 10:1 a 1:1. 14.- Una composición de acuerdo con la reivindicación 7, en donde el alcohol polihídrico comprende giicol propilénico. 15.- Una composición de acuerdo con la reivindicación 1, en donde uno o más agenfes aclivos se seleccionan del grupo que consisíe de: anesíésicos, aníi-inflamaforios, analgésicos, aníimigrañas, aníimicrobianos, ageníes deníales, anfibiólicos, anoréxicos, fármacos de polipépíido, fármacos de proíeína, agonisías de opioide, aníagonisías de opioide, aníiemélicos, antineoplásticos, aníiparquinsonianos, aníidiuréíicos, hormonas, broncodilaíadores, esfimulaníes y agentes del sistema nervioso cenlral, oxióíicos y vasodilaíadores. 16.- Una composición para la administración de uno o más agentes activos que comprende: (a) una fuente de uno o más agentes acíivos; y (b) una capa adhesiva adapíada para adherirse al íejido dérmico de mucosa y que resulía de una mezcla que comprende: (i) por lo menos un polímero de polivinilpirrolidona soluble (PVP); (ii) por lo menos un bioadhesivo; y (iii) opcionalmeníe uno o más solventes, en donde la fueníe (a) incluye una Capa separada que coníiene uno o más agentes activos que ia capa adhesiva (b). 17.- Una composición de acuerdo con la reivindicación 16, en donde una primera superficie prinóipal de la capa adhesiva está adyacenfe a y en coníacfo con una primera superficie principal de la capa separada. 18.- Una composición de acuerdo con la reivindicación 17, que comprende además: (c) una capa de respaldo que esíá en contacto con una segunda superficie principal de la capa separada que está opuesta a la primera superficie principal de la capa separada; y (d) un forro de liberación removible que está en coníacto con una segunda superficie principal de la capa adhesiva que está opuesta a la primera superficie principal de la capa separada. 19.- Una composición de acuerdo con la reivindicación 16, en donde la fuente (a) incluye un depósito de agente acíivo y la capa adhesiva es periférica al depósifo de ageníe acfivo. 20.- Una composición de acuerdo con la reivindicación 16, en donde la capa adhesiva incluye uno o más solveníes, en donde uno o más solveníes comprende un solvente separado y un plastificaníe separado, y en donde por lo menos un bioadhesivo comprende goma de karaya. 21.- Una composición de acuerdo con la reivindicación 20, en donde el solveníe separado comprende un alcohol polihídrico y en donde el plasíificaníe separado comprende glicerina. 22.- Un méíodo para la administración íópica prolongada de uno o más ageníes acíivos a un sujeío, que comprende los pasos de: (a) proporcionar la composición de la reivindicación 1; y (b) poner en coníacío un área de la piel o membrana mucosa con dicha composición para adminislrar uno o más agenfes acíivos. 23.- Un méíodo para la adminislración fópica prolongada de uno o más ageníes acfivos a un sujeío, que comprende los pasos de: (a) proporcionar la composición de la reivindicación 16; y (b) poner en conlacío un área de la piel o membrana mucosa con al menos una capa adhesiva para adminisírar uno o más ageníes activos. 24.- Un mélodo para producir la composición de acuerdo con la reivindicación 1, que comprende mezclar: (a) por lo menos un polímero de polivinilpirrolidona soluble; (b) por lo menos un bioadhesivo; (c) una cantidad terapéuficameníe efecíiva de uno o más ageníes acíivos; y (d) opcionalmeníe uno o más solveníes, para formar una composición. 25.- Un mélodo para producir la composición de acuerdo con la reivindicación 16, que comprende: (a) formar una fueníe de ageníe activo que comprenda uno o más agentes activos; y (b) formar una capa adhesiva separada adaptada para adherirse al tejido dérmico o de mucosa, que comprende mezclar: (i) por lo menos un polímero de polivinilpirrolidona soluble; (ii) por lo menos un bioadhesivo; y (iii) opcionalmeníe uno ó más solveníes. 26.- Un méíodo para reducir el tiempo requerido para la adhesión de una composición al tejido de mucosa, que comprende: aplicar la composición de acuerdo con la reivindicación 16 al tejido de mucosa, por lo que la composición se adhiere al tejido de mucosa substancialmenle en el momento de contacto sin ninguna presión adicional. 27.- Una composición de acuerdo con la reivindicación 1, en donde el polímero de polivinilpirrolidona soluble tiene un peso molecular de aproximadamente 1,000,000 a aproximadamente 1,500,000.
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US60/061,155 | 1997-09-26 |
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