ES2206692T3 - Pelicula soluble en agua o capa soluble en agua de humectabilidad inmediata para aplicacion oral. - Google Patents

Pelicula soluble en agua o capa soluble en agua de humectabilidad inmediata para aplicacion oral.

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ES2206692T3
ES2206692T3 ES97911237T ES97911237T ES2206692T3 ES 2206692 T3 ES2206692 T3 ES 2206692T3 ES 97911237 T ES97911237 T ES 97911237T ES 97911237 T ES97911237 T ES 97911237T ES 2206692 T3 ES2206692 T3 ES 2206692T3
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prepared according
water
film
ethoxy
water soluble
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Horst Georg Zerbe
Anthony J. Serino
Jian-Hwa Guo
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LTS Lohmann Therapie Systeme AG
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LTS Lohmann Therapie Systeme AG
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0208—Tissues; Wipes; Patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/39—Derivatives containing from 2 to 10 oxyalkylene groups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4906—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom
    • A61K8/4926—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom having six membered rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A61K8/731—Cellulose; Quaternized cellulose derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
    • A61K8/817—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen; Compositions or derivatives of such polymers, e.g. vinylimidazol, vinylcaprolactame, allylamines (Polyquaternium 6)
    • A61K8/8176—Homopolymers of N-vinyl-pyrrolidones. Compositions of derivatives of such polymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/90—Block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
    • A61K8/922—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of vegetable origin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Oil, Petroleum & Natural Gas (AREA)
  • Physiology (AREA)
  • Emergency Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Nutrition Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Neurology (AREA)
  • Pulmonology (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
  • General Preparation And Processing Of Foods (AREA)
  • Absorbent Articles And Supports Therefor (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Materials For Medical Uses (AREA)
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  • Solid-Sorbent Or Filter-Aiding Compositions (AREA)
  • Dental Preparations (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)

Abstract

SE DESCRIBE UNA PREPARACION PARA APLICACION EN LA CAVIDAD ORAL, QUE TIENE UNA CAPA O PELICULA QUE SE ADHIERE A LA MEMBRANA MUCOSA, CARACTERIZADA PORQUE LA CAPA O PELICULA ADHESIVA CONTIENE UNA MEZCLA HOMOGENEA FORMADA POR UN POLIMERO SOLUBLE EN AGUA, UNA MEZCLA DE MATERIALES SUPERFICIACTIVOS NO IONICOS, UN POLIALCOHOL, UNA SUSTANCIA ACTIVA COSMETICA O FARMACEUTICA Y UN AGENTE AROMATIZANTE O AROMATICO.

Description

Película soluble en agua o capa soluble en agua de humectabilidad inmediata para aplicación oral.
La presente invención divulga un preparado que contiene principios activos farmacéuticos y/o principios activos refrescantes para el aliento, para utilización en la cavidad bucal. El soporte comprende polímeros hidrosolubles en combinación con determinados ingredientes y posee una acción terapéutica y/o cosmética. La película se aplica y se seca utilizando tecnologías de recubrimiento actuales y presenta una humectabilidad inmediata, seguida de una rápida disolución/desintegración durante su aplicación en la cavidad bucal.
En el estado de la técnica se conocen sistemas de dosificación para utilización en la cavidad bucal, que se pegan a la mucosa (mucoadhesivos) y tienen por objeto transferir principios activos terapéuticos y/o cosméticos a la mucosa bucal. La patente US 5.047.244 describe un soporte adhesivo sobre la mucosa bucal para la transferencia controlada a través del tejido de la mucosa de un principio activo terapéutico, el cual contiene una matriz polimérica anhidra, pero susceptible de hidratación, y dióxido de silicio amorfo.
Opcionalmente se puede añadir una película insoluble en agua para conferir un carácter no adhesivo a la superficie. La WO 91/06270 del mismo inventor divulga una película de tres capas para la transferencia prolongada de un principio activo en la cavidad bucal.
Del mismo modo, la patente US 4.876.092 divulga un preparado plano, adhesivo, que comprende una capa adhesiva con determinados polímeros hidrosolubles y no hidrosolubles y un soporte insoluble en agua, el cual se adhiere a la mucosa de la boca y transfiere un principio activo a la cavidad bucal.
Ninguno de los dispositivos mencionados es totalmente soluble en agua, por lo que quedan residuos insolubles en la cavidad bucal, incluso después de alcanzarse el objetivo terapéutico, produciendo en el paciente una cierta sensación desagradable en la boca, provocada principalmente por el residuo insoluble de la capa soporte.
Se ha realizado una serie de ensayos para reducir la sensación desagradable en la cavidad bucal producida por la rigidez de la capa soporte, que consisten en la introducción de películas soporte blandas. Los documentos EP 0 200 508 y EP 0 381 194 proponen la utilización como soportes blandos de películas de polietileno, acetato de polivinilo, copolímeros de etileno y acetato de vinilo, láminas metálicas, laminados de tela o papel con una película plástica, y materiales similares, siendo materiales preferentes las resinas sintéticas como el polietileno, homopolímeros de acetato de vinilo y etilenvinilacetato.
El documento CA 1 263 312 divulga, asimismo, la utilización de materiales de soporte blandos a base de poliolefinas como el polietileno, polipropileno, poliéster, PVC, así como borras.
No obstante, estos materiales dejan una cantidad apreciable de residuos procedentes de la película soporte insoluble en agua y, por tanto, siguen provocando en el paciente una sensación desagradable. Una solución muy sencilla para soslayar este problema consistía en desarrollar películas adhesivas sobre las mucosas, que se desintegraran totalmente o se disolvieran en la saliva.
Fuchs y Hillmann (DE 24 49 865.5) han fabricado películas homogéneas hidrosolubles para la administración por vía bucal de hormonas. Propusieron la utilización de derivados celulósicos hidrosolubles como la hidroxietilcelulosa, hidroxipropilcelulosa o la metilhidroxipropilcelulosa como filmógenos.
Las patentes DE 36 30 603 y EP 0 219 762 divulgan la utilización de polímeros hinchables tipo gelatinas o almidón de maíz como filmógenos, los cuales se desintegran lentamente en la cavidad bucal después de la aplicación, liberando el principio activo contenido en la película. Estos mismos polímeros pueden utilizarse también para fabricar películas destinadas a la higiene dental, de acuerdo con la memoria descriptiva de la patente EP 0 452 446.
Sin embargo, estos preparados también producen una sensación desagradable en la boca, provocada en particular por su rigidez inicial y su tardanza en ablandarse. De todo ello se desprende que existe una demanda para una composición de aplicación en la cavidad bucal, que produzca una sensación agradable en la boca.
La presente invención divulga procedimientos y preparados, mediante los cuales puede evitarse la sensación desagradable por fabricación de una película o una capa, que presenta humectabilidad inmediata, para aplicación sobre la mucosa de la boca, y mediante la cual se alcanza una resistencia a la rotura en la película libre, que permite recubrir, elaborar y empaquetar sin problemas productos agradables para el consumidor.
La presente invención se refiere a una película/capa de disolución rápida, la cual se adhiere a la cavidad bucal, transfiriendo uno o varios principios activos farmacéuticos o cosméticos, conteniendo dicha película/capa uno o varios polímeros hidrosolubles, uno o varios polioles, una combinación de determinados plastificantes o sustancias tensioactivas y uno o varios principios activos. La formulación puede contener a voluntad colorantes, edulcorantes, saborizantes, potenciadores de sabor u otros correctores, como los que se utilizan habitualmente para modificar el sabor de determinadas formulaciones destinadas a la aplicación en la cavidad bucal. La película resultante se caracteriza por una humectabilidad inmediata, la cual permite que la película se ablande inmediatamente después de aplicarse al tejido de la mucosa, de modo que se evita la persistencia de una sensación desagradable en la boca del paciente, así como por una resistencia a la rotura adecuada para operaciones normales de recubrimiento, corte, partición y envasado.
La película mucoadhesiva de la presente invención contiene como componentes fundamentales un polímero hidrosoluble o una combinación de polímeros hidrosolubles, una mezcla de sustancias tensioactivas no fónicas, uno o varios polialcoholes y uno o varios principios activos farmacéuticos o cosméticos.
Los polímeros utilizados para la película mucoadhesiva comprenden polímeros hidrófilos y/o dispersables en agua. Los polímeros de preferencia son los derivados celulósicos hidrosolubles. Se prefiere particularmente la hidroxipropilmetilcelulosa, hidroxietilcelulosa e hidroxipropilcelulosa, solas o formando mezclas. A título de ejemplo se citan a continuación otros polímeros apropiados, sin limitación de la invención: polivinilpirrolidona, carboximetilcelulosa, alcohol olivinílico, alginato sódico, polietilenglicol, gomas naturales como la resina de xantano, tragacanto, resina de guar, resina de acacia, goma arábiga, poliacrilatos dispersables en agua como el ácido poliacrílico, copolimero de metilmetacrilato, copolímeros carboxivinílicos. La concentración del polímero hidrosoluble en la película acabada puede ser de 20 a 75% en peso. Se prefiere una concentración entre 50 y 75% en peso.
Para la película mucoadhesiva se utiliza una mezcla de sustancias tensioactivas consistente en dos componentes. El primero es un éster graso de sorbitán polioxietilenado o un copolímero de bloque \alpha-hidro-\omega-hidroxipoli(etoxi)-poli(propoxi)-poli(etoxi), mientras que el segundo es un éter alquílico polioxietilenado o un derivado de aceite de ricino polioxietilenado.
El valor HLB preferente del éster graso de sorbitán polioxietilenado debe estar entre 10 y 20, siendo de especial preferencia un intervalo de 13 a 17. El copolímero de bloque \alpha-hidro-\omega-hidroxipoli(etoxi)-poli-(propoxi)-poli(etoxi) debe contar con un mínimo de 35 unidades propoxi, preferentemente con un mínimo de 50 unidades propoxi.
El éter alquílico polioxietilenado debe tener un valor HLB entre 10 y 20, preferentemente no inferior a 15. El derivado polioxietilenado de aceite de ricino debe tener un valor HLB entre 14 y 16.
Para conseguir la ansiada humectabilidad inmediata se mantiene el cociente entre el primer y segundo componente de una mezcla tensioactiva binaria entre 1:10 y 1:1, preferentemente entre 1:5 y 1:3.
La concentración total de sustancias tensioactivas en la película final depende de las características del resto de los componentes, pero debe estar normalmente entre 0,1 y 5% en peso.
El polialcohol se necesita para alcanzar el grado de flexibilidad de la película deseada. Entre los polialcoholes utilizados se encuentran, vgr., la glicerina, polietilenglicol, propilenglicol, monoglicéridos de ácidos grasos, u otros polialcoholes utilizados en farmacia. La concentración de polialcohol en la masa seca de la película es habitualmente de 0,1 a 5% en peso.
La película es particularmente idónea para la transferencia de una amplia gama de principios activos farmacéuticos a través de las membranas mucosas de un paciente, especialmente a través de la mucosa bucal.
Son particularmente idóneos los principios activos terapéuticos, que presentan problemas de absorción debido a su limitada solubilidad, degradación en el tracto gastrointestinal o metabolismo extensivo.
Como ejemplo de principios activos terapéuticos útiles se cita: los hipnóticos, sedantes, antiepilépticos, aminas simpaticomiméticas, psiconeurotrópicos, bloqueadores neuromusculares, antiespasmódicos, antihistamínicos, antialérgicos, cardiotónicos, antiarrítmicos, diuréticos, hipotensores, vasoconstrictores, antitusígenos, expectorantes, hormonas tiroideas, hormonas sexuales, antidiabéticos, principios activos antitumorales, antibióticos, así como productos quimioterapéuticos y narcóticos. La cantidad a incorporar a la película depende del tipo de principio activo, y suele estar entre 0,01 y 20% en peso, aunque puede ser superior cuando es preciso para alcanzar el resultado deseado.
Los principios activos cosméticos comprenden refrescantes para el aliento como mentol, otras sustancias saborizantes, aromáticas u olorosas, como las utilizadas habitualmente para la higiene bucal, y/o principios activos para la higiene dental y/o bucal, vgr. bases de amonio cuaternario. La acción de las sustancias saborizantes y aromáticas puede reforzarse con potenciadores como el ácido tartárico, ácido cítrico, la vainillina o similares.
Los colorantes que se incorporan a la película tienen que ser inocuos, y su aplicación en cosmética debería estar autorizada por los organismos competentes.
La película mucoadhesiva de la invención puede fabricarse del modo siguiente:
El polialcohol o los polialcoholes, las sustancias tensioactivas, los plastificantes y otros posibles componentes, exceptuando los polímeros solubles o dispersables en agua, se disuelven con una cantidad suficiente de un disolvente compatible. Entre los disolventes compatibles se encuentran, vgr., el agua y los alcoholes o sus mezclas. Tras la preparación de una solución clara se añade lentamente bajo agitación y calentando, en caso necesario, el polímero dispersable en agua o la mezcla de polímeros dispersables en agua hasta que se forma una solución clara y homogénea. Esta se aplica sobre un soporte y se seca hasta que se forma una película. El material soporte tiene que tener una tensión superficial, que permita distribuir uniformemente la solución polimérica en todo el ancho de recubrimiento previsto sin que se absorba la solución y se cree una unión destructiva entre el soporte y el recubrimiento.
Los ejemplos de materiales adecuados comprenden películas de polietilen-tereftalato sin siliconar, papel Kraft sin siliconar, papel Kraft impregnado con polietileno o película de polietileno sin siliconar.
La aplicación de la solución sobre el material soporte puede realizarse mediante cualquiera de los dispositivos habituales. Una técnica de aplicación preferente es mediante una extendedora de rodillos.
El espesor de capa de la película resultante depende de la concentración de sólidos en la solución de recubrimiento, así como del ancho de ranura de la máquina de recubrimiento y puede oscilar entre 5 y 200 \mum. El secado de la película se lleva a cabo en baño de aire caliente utilizando un horno de secado, un túnel de secado, una secadora de vacío o cualquier otra instalación de secado apropiada, que no afecte a la efectividad del principio o principios activos ni a las sustancias saborizantes. Para garantizar la ausencia de una sensación desagradable en la boca, el espesor de la película no debe sobrepasar 70 \mum.
Para mayor conveniencia se puede cortar la película en trozos de tamaño adecuado y envasarse.
La invención se ilustra a continuación mediante los ejemplos siguientes.
Ejemplo 1
Se mezclan por agitación 15 g de sorbita, 6 g de glicerina, 0,5 g de polisorbato 80 (Tween 80), 2 g de Brij 35, 25 g de esencia de limón y piperita, 3 g de aspartamo, 15 g de 1mentol y 3 g de ácido cítrico a 60°C en una mezcla de 250 g de agua y 250 g de etanol hasta obtener una solución clara.
A esta solución se añaden lentamente con agitación 30 g de hidroxipropilmetilcelulosa hasta obtener una solución clara y homogénea. La solución resultante se deja enfriar a temperatura ambiente y se aplica mediante una instalación normal de recubrimiento/secado sobre un material soporte adecuado, vgr. papel Kraft sin siliconar recubierto de polietileno. La ranura de recubrimiento y la velocidad de la cinta tienen que ajustarse de manera que se obtenga un espesor de película seca entre 20 y 50 \mum. La temperatura de secado depende de la longitud del horno de secado y de la velocidad del material y tiene que ajustarse de manera que se elimine de la película todo el disolvente, o al menos la mayor parte de él. La película resultante se separa del soporte y se corta convenientemente en trozos de tamaño y forma apropiados.
Ejemplo 2
Se mezclan por agitación 3 g de sorbita, 1,5 de Kollidon 30 (proveedor: BASF), 5 g de glicerina, 5 g de propilenglicol, 5 g de polietilenglicol, 4 g de polisorbato 80 (Tween 80), 8 g de Brij 35, 12 g de esencia de piperita, 0,8 g de aspartamo, a 60°C en una mezcla de 400 g de agua y 400 g de etanol. A la solución clara se añaden lentamente bajo agitación 28 g de hidroxipropilmetilcelulosa. Una vez disuelto todo el polímero se enfría la solución hasta temperatura ambiente y se aplica sobre un soporte en las mismas condiciones de recubrimiento y de secado del ejemplo 1. La película seca se corta en trozos de tamaño y forma convenientes.
Ejemplo 3
Se disuelven con agitación 15 g de sorbita, 22,5 g de glicerina, 2,5 g de propilenglicol, 2,5 g de Brij 35, 2,5 g de Poloxamer 407, 3,5 g de Cremophor RH 40, 9 g de esencia de hierbabuena, 0,5 g de aspartamo a 60°C en una mezcla de 250 g de agua y 250 g de etanol. A la solución clara se añaden lentamente bajo agitación constante 75 g de hidroxipropilcelulosa. Se aplica la solución clara sobre un soporte y se seca en las condiciones anteriormente indicadas en el ejemplo 1; la película seca se corta en trozos de tamaño y forma convenientes.

Claims (10)

1. Preparado para utilización en la cavidad bucal con una película o una capa que se pega sobre la mucosa (mucoadhesiva), dotada de humectabilidad inmediata, conteniendo una mezcla homogénea constituida por
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uno o varios polímeros hidrosolubles,
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una mezcla de sustancias tensioactivas no iónicas,
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uno o varios polialcoholes,
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uno o varios principios activos cosméticos o farmacéuticos y, según los casos,
-
una o varias sustancias saborizantes o aromáticas, caracterizado por estar constituida la mezcla de sustancias tensioactivas no iónicas por dos componentes, siendo el primero de ellos un éster graso de sorbitán polioxietilenado o un copolímero de bloque \alpha-hidro-\omega-hidroxi-poli(etoxi)-poli(propoxi)-poli(etoxi), y el segundo un éter alquílico polioxietilenado o un derivado de aceite de ricino polioxietilenado, manteniéndose el cociente entre el primer y el segundo componente de la mezcla tensioactiva binaria entre 1:10 y 1:1.
2. Preparado según la reivindicación 1, caracterizado por mantenerse el cociente entre el primer y el segundo componente de la mezcla tensioactiva binaria entre 1:5 y 1:3.
3. Preparado según las reivindicaciones 1 ó 2, caracterizado por estar el valor HLB del éster graso de sorbitán polioxietilenado entre 10 y 20.
4. Preparado según una o varias de las reivindicaciones precedentes, caracterizado por tener el éter alquílico polioxietilenado un valor HLB entre 10 y 20.
5. Preparado según una o varias de las reivindicaciones precedentes, caracterizado por tener el derivado de aceite de ricino polioxietilenado un valor HLB entre 14 y 16.
6. Preparado según una o varias de las reivindicaciones precedentes, caracterizado por contener el copolímero de bloque \alpha-hidro-\omega-hidroxi-poli(etoxi)-poli(propoxi)poli(etoxi) al menos 35 unidades propoxi.
7. Preparado según una o varias de las reivindicaciones precedentes, caracterizado por comprender el polímero hidrosoluble hidroxipropilmetilcelulosa, hidroxietilcelulosa, hidroxipropilcelulosa, polivinilpirrolidona, carboximetilcelulosa, alcohol polivinílico, alginato sódico, polietilenglicol, resina de xantano, tragacanto, resina de guar, resina de acacia, goma arábiga, ácido poliacrílico, copolímero de metilmetacrilato, copolímeros carboxivinílicos o sus mezclas.
8. Preparado según una o varias de las reivindicaciones precedentes, caracterizado por estar seleccionado el polialcohol del grupo que comprende la glicerina, polietilenglicol, propilenglicol y monoglicéridos de ácidos grasos.
9. Preparado según una o varias de las reivindicaciones precedentes, caracterizado por estar seleccionado el principio activo terapéutico del grupo que comprende los hipnóticos, sedantes, antiepilépticos, aminoanalépticos, psiconeurotrópicos, bloqueadores neuromusculares, antiespasmódicos, antihistamínicos, antialérgicos, cardiotónicos, antiarrítmicos, diuréticos, hipotensores, vasoconstrictores, antitusígenos, expectorantes, principios activos antitumorales, hormonas tiroideas, hormonas sexuales, antidiabéticos, antibióticos, así como productos quimioterapéuticos y narcóticos.
10. Preparado según la reivindicación 1, caracterizado por comprender el principio activo cosmético un refrescante para el aliento como mentol, sustancias saborizantes, aromáticas u olorosas, como las utilizadas habitualmente para la higiene bucal, y/o principios activos para la higiene dental y/o bucal, como las bases de amonio cuaternario.
ES97911237T 1996-11-11 1997-10-22 Pelicula soluble en agua o capa soluble en agua de humectabilidad inmediata para aplicacion oral. Expired - Lifetime ES2206692T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19646392 1996-11-11
DE19646392A DE19646392A1 (de) 1996-11-11 1996-11-11 Zubereitung zur Anwendung in der Mundhöhle mit einer an der Schleimhaut haftklebenden, Pharmazeutika oder Kosmetika zur dosierten Abgabe enthaltenden Schicht

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ES03014213T Expired - Lifetime ES2322699T3 (es) 1996-11-11 1997-10-22 Lamina o capa soluble en agua, que presenta humectabilidad inmediata para la aplicacion oral.
ES97911237T Expired - Lifetime ES2206692T3 (es) 1996-11-11 1997-10-22 Pelicula soluble en agua o capa soluble en agua de humectabilidad inmediata para aplicacion oral.

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ES03014213T Expired - Lifetime ES2322699T3 (es) 1996-11-11 1997-10-22 Lamina o capa soluble en agua, que presenta humectabilidad inmediata para la aplicacion oral.

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NO991921D0 (no) 1999-04-22
US20120114705A1 (en) 2012-05-10
HUP9904207A2 (hu) 2000-04-28
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ZA9710093B (en) 1998-05-25
US6709671B2 (en) 2004-03-23
US20040156885A1 (en) 2004-08-12
DE59712993D1 (de) 2009-03-19
SK285999B6 (sk) 2008-01-07
US20010046511A1 (en) 2001-11-29
NO991921L (no) 1999-04-22
DE59710670D1 (de) 2003-10-02
ATE247954T1 (de) 2003-09-15
US6284264B1 (en) 2001-09-04
PL190376B1 (pl) 2005-12-30
NZ335063A (en) 2000-12-22
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NO20053307L (no) 1999-04-02
MY125548A (en) 2006-08-30
US5948430A (en) 1999-09-07
HU0500666D0 (en) 2005-09-28
HU228464B1 (en) 2013-03-28
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TW533083B (en) 2003-05-21
JP4817721B2 (ja) 2011-11-16
ES2322699T3 (es) 2009-06-25
IL169984A0 (en) 2009-02-11
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EP1362584A1 (de) 2003-11-19
US6177096B1 (en) 2001-01-23
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KR100604995B1 (ko) 2006-07-26
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NO325073B1 (no) 2008-01-28
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ID22526A (id) 1999-10-28
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EP0936905A1 (de) 1999-08-25
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