ES2640572T3 - Formulaciones parenterales mejoradas de agentes farmacéuticos lipófilos y procedimientos de preparación y uso de las mismas - Google Patents
Formulaciones parenterales mejoradas de agentes farmacéuticos lipófilos y procedimientos de preparación y uso de las mismas Download PDFInfo
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- ES2640572T3 ES2640572T3 ES12719541.0T ES12719541T ES2640572T3 ES 2640572 T3 ES2640572 T3 ES 2640572T3 ES 12719541 T ES12719541 T ES 12719541T ES 2640572 T3 ES2640572 T3 ES 2640572T3
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Abstract
Una solución homogénea no acuosa que comprende un agente farmacéutico lipófilo solubilizado y un disolvente polimérico líquido anfifílico, el cual es polietilenglicol (PEG) líquido, siendo la formulación básicamente libre de disolventes orgánicos no poliméricos, agua y partículas no solubilizadas, en la que el agente farmacéutico lipófilo es un azol antifúngico o es el agente anticanceroso Busulfán (1,4-butanodiol dimetanosulfonato), y en la que el agente farmacéutico lipófilo solubilizado tiene una concentración de al menos 2 mg/ml, en la que la solución continúa estable y básicamente libre de partículas no solubilizadas durante al menos 40 días cuando se almacena a temperatura ambiente, y en la que la solución no comprende un tensioactivo.
Description
Maprotilina HCl, mazindol, mebendazol, Meclizina HCl, ácido meclofenámico, medazepam, medigoxina, medroxiprogesterona acetato, ácido mefenámico, Mefloquina HCl, megestrol acetato, melfalán, mepenzolato bromuro, meprobamato, meptazinol, mercaptopurina, mesalazina, mesna, mesoridazina, mestranol, metadona, metaqualona, metocarbamol, metoína, metotrexato, metoxsaleno, metsuximida, meticlotiazida, metilfenidato, 5 metilfenobarbitona, metil-p-hidroxibenzoato, metilprednisolona, metiltestosterona, metiprilón, metisergida maleato, metoclopramida, metolazona, metoprolol, metronidazol, Mianserina HCl, miconazol, midazolam, mifepristona, miglitol, minociclina, minoxidil, mitomicina C, mitotano, mitoxantrona, mofetilmicofenolato, molindona, montelukast, morfina, Moxifloxacina HCl, nabumetona, nadolol, nalbufina, ácido nalidíxico, nandrolona, naftaceno, naftaleno, naproxeno, naratriptán HCl, natamicina, nelarabina, nelfinavir, nevirapina, nicardipina HCl, nicotin amida, ácido nicotínico, nicoumalona, nifedipina, nilutamida, nimodipina, nimorazol, nisoldipina, nitrazepam, nitrofurantoina, nitrofurazona, nizatidina, nofetumomab, noretisterona, norfloxacina, norgestrel, nortriptilina HCl, nistatina, oestradiol, ofloxacino, olanzapina, omeprazol, omoconazol, ondansetrón HCl, oprelvekina, ornidazol, oxaliplatino, oxamniquina, oxantelembonato, oxaprozina, oxatomida, oxazepam, oxcarbazepina, oxfendazol, oxiconazol, oxprenolol, oxifenbutazona, oxifenciclimina HCl, paclitaxel, palifermina, pamidronato, ácido p-aminosalicílico, pantoprazol, 15 parametadiona, paroxetina HCl, pegademasa, pegaspargasa, pegfilgrastim, pemetrexeddisodio, penicilamina, pentaeritritol tetranitrato, pentazocin, pentazocina, pentobarbital, pentobarbitona, pentostatina, pentoxifilina, perfenazina, perfenazina pimozida, perileno, fenacemida, fenacetina, fenantreno, fenindiona, fenobarbital, fenolbarbitona, fenolftaleína, fenoxibenzamina, fenoxibenzamina HCl, fenoximetil penicilina, fensuximida, fenilbutazona, fenitoina, pindolol, pioglitazona, pipobroman, piroxicam, pizotifeno maleato, compuestos de platino, plicamicina, polienos, polimixina B, porfimersodio, posaconazol (Posa), pramipexol, prasterona, pravastatina, praziquantel, prazosina, prazosina HCl, prednisolona, prednisona, primidona, probarbital, probenecid, probucol, procarbazina, proclorperazina, progesterona, proguanilo HCl, prometazina, propofol, propoxur, propranolol, propilparabeno, propiltiouracilo, prostaglandina, pseudoefedrina, pteridina-2-metil-tiol, pteridina-2-tiol, pteridina-4metil-tiol, pteridina-4-tiol, pteridina-7-metil-tiol, pteridina-7-tiol, pirantelembonato, pirazinamida, pireno, piridostigmina, 25 pirimetamina, quetiapina, quinacrina, quinapril, quinidina, quinidina sulfato, quinina, quinina sulfato, rabeprazol sodio, ranitidina HCl, rasburicasa, ravuconazol, repaglinida, reposal, reserpina, retinoides, rifabutina, rifampicina, rifapentina, rimexolona, risperidona, ritonavir, rituximab, rizatriptán benzoato, rofecoxib, ropinirol HCl, rosiglitazona, sacarina, salbutamol, salicilamida, ádico salicílico, saquinavir, sargramostim, secbutabarbital, secobarbital, sertaconazol, sertindol, sertralina HCl, simvastatina, sirolimus, sorafenib, esparfloxacina, espiramicina, espironolactona, estanolona, estanozolol, estavudina, estilbestrol, estreptozocina, estricnina, sulconazol, sulconazol nitrato, sulfacetamida, sulfadiazina, sulfamerazina, sulfametazina, sulfametoxazol, sulfanilamida, sulfatiazol, sulindac, sulfabenzamida, sulfacetamida, sulfadiazina, sulfadoxina, sulfafurazol, sulfamerazina, sulfa-metoxazol, sulfapiridina, sulfasalazina, sulfinpirazona, sulpirido, sultiame, sumatriptán succinato, sunitinib maleato, tacrina, tacrolimus, talbutal, tamoxifeno citrato, tamulosina, targretina, taxanos, tazaroteno, telmisartán, temazepam,
35 temozolomida, tenipósido, tenoxicam, terazosina, terazosina HCl, terbinafina HCl, terbutalina sulfato, terconazol, terfenadina, testolactona, testosterona, tetraciclina, tetrahidrocannabinol, tetroxoprim, talidomida, tebaína, teobromina, teofilina, tiabendazol, tiamfenicol, tioguanina, tioridazina, tiotepa, totoína, timina, tiagabina HCl, tibolona, ticlopidina, tinidazol, tioconazol, tirofibán, tizanidina HCl, tolazamida, tolbutamida, tolcapona, topiramato, topotecán, toremifeno, tositumomab, tramadol, trastuzumab, trazodona HCl, tretinoína, triamcinolona, triamtereno, triazolam, triazoles, triflupromazina, trimetoprim, trimipramina maleato, trifenileno, troglitazona, trometamina, tropicamida, trovafloxacina, tibamato, ubidecarenona (coenzima Q10), ácido undecenoico, uracilo, uracil mostaza, ácido úrico, ácido valproico, valrubicina, valsartán, vancomicina, venlafaxina HCl, vigabatrina, vinbarbital, vinblastina, vincristina, vinorelbina, voriconazol, xantina, zafirlukast, zidovudina, zileutón, zoledronato, ácido zoledrónico, zolmitriptán, zolpidem y zopiclona.
45 En aspectos particulares, los agentes pueden ser Busulfán, taxano u otros agentes anticancerosos; o alternativamente, itraconazol (Itra) y posaconazol (Posa) u otros miembros de la clase general de compuestos de azol. Azoles antifúngicos ilustrativos incluyen a) imidazoles tales como miconazol, ketoconazol, clotrimazol, econazol, omoconazol, bifonazol, butoconazol, fenticonazol, isoconazol, oxiconazol, sertaconazol, sulconazol y tioconazol, b) triazoles tales como fluconazol, itraconozacol, isavuconazol, ravuconazol, Posaconazol, voriconazol, terconazol y c) tiazoles tales como abafungina. Otros fármacos que se pueden solubilizar con este planteamiento incluyen, pero no se limitan a, fármacos hipertiroideos tales como carimazol, agentes anticancerosos como agentes citotóxicos tales como derivados de epipodofilotoxina, taxanos, bleomicina, antraciclinas, así como compuestos de platino y análogos de camptotecina. También pueden incluir otros antibióticos antifúngicos, tales como equinocandinas escasamente solubles en agua, polienos (por ejemplo, Anfotericina B y Natamicina) así como
55 agentes antibacterianos (por ejemplo, polimixina B y colistina), y fármacos antivirales. Los agentes también pueden incluir un agente psiquiátrico tal como un agente antipsicótico, agente antidepresivo, o agentes analgésicos y/o tranquilizantes tales como benzodiacepinas. Los agentes también pueden incluir un agente que altera el nivel de conciencia o un agente anestésico, tal como propofol. En un más amplio aspecto, la presente invención puede proporcionar procedimientos para solubilizar y administrar de manera segura muchos principios farmacéuticamente activos escasamente solubles en agua.
Como ventaja adicional, cualquier composición descrita en el presente documento puede obviar la necesidad de un tensioactivo, por tanto, no se puede usar un tensioactivo de éster de ácido graso de polietilenglicol (PEG) (pero no el propio PEG) u otros tensioactivos en ciertos aspectos. En otros aspectos, se puede usar un tensioactivo conocido en la técnica.
8
anfifílico secundario. De este modo la preparación física del principio farmacéuticamente activo se puede prevenir, produciendo así una formulación madre. En un aspecto adicional, el procedimiento puede comprender mezclar el complejo principio farmacéuticamente activo disuelto/disolvente anfifílico (por ejemplo, PEG) con un diluyente acuoso final para proporcionar una formulación de uso clínico que se puede administrar parenteralmente. Por 5 ejemplo, el disolvente orgánico es acetona o cloroformo, o dietil éter, con o sin adición de una pequeña cantidad de un ácido para facilitar la protonación del principio farmacéuticamente activo para incrementar la atracción electrostática al disolvente secundario. Preferiblemente el disolvente anfifílico secundario es un polímero tal como PEG. El principio farmacéuticamente activo puede ser un agente alquilante de ADN bifuncional tal como Busulfán (Bu) o, alternativamente, puede ser un agente antimicrobiano tal como un compuesto de azol usado para tratar infecciones fúngicas o parasíticas, o agente hipnótico o sedativo usado en marcos psiquiátricos o anestésicos, o alternativamente puede ser un agente usado para el control del síntoma tal como un agente anestésico o que altera el nivel de conciencia tal como un anestésico general. Además, para incrementar la atracción electrostática estable entre el principio farmacéuticamente activo y el disolvente anfifílico tal como PEG, la extracción bajo vacío se puede ampliar significativamente para eliminar el exceso de ácido (libre) del complejo fármaco/PEG. Por último, el
15 procedimiento puede comprender la etapa de mezclar la formulación madre con un diluyente secundario, tal como un fluido de infusión acuoso, para permitir la administración del principio farmacéuticamente activo en un animal doméstico o más preferiblemente, en un ser humano.
La invención también puede incluir un procedimiento para tratar un sujeto que tiene una enfermedad o afección sensible o que responde a un agente farmacéutico lipófilo, que comprende: administrar parenteralmente al sujeto una cantidad disuelta terapéuticamente eficaz de una composición que comprende una solución o una formulación anteriormente descrita, en el que la solución o formulación tiene el agente farmacéutico lipófilo al cual la enfermedad
o afección es sensible o responde.
En un aspecto particular, la invención también incluye un procedimiento para tratar una enfermedad sensible o que responde a Bu que comprende: administrar parenteralmente una cantidad terapéuticamente eficaz de una
25 composición de Bu al paciente. La composición de Bu se puede preparar disolviendo Bu en un primer disolvente que comprende un disolvente orgánico volátil, preferiblemente acetona, mezclando a continuación la solución con un segundo disolvente anfifílico, preferiblemente PEG, evaporando posteriormente el primer disolvente orgánico bajo vacío para crear una formulación madre de Bu en PEG, y diluyendo opcionalmente con un segundo diluyente acuoso, tal como un fluido de infusión acuoso.
Otra realización más de la invención está dirigida a un procedimiento para la administración parenteral de Bu a un paciente que comprende: proporcionar Bu en un disolvente hidrófobo volátil y orgánico, mezclado posteriormente con un segundo disolvente no volátil anfifílico; evaporar el primer disolvente hidrófobo para producir una formulación madre de Bu que se puede o bien administrar directamente al paciente, o mezclar la formulación madre con un diluyente acuoso secundario para formar un fluido de infusión; y administrar el fluido de infusión a un paciente. Por
35 ejemplo, el primer disolvente orgánico volátil es acetona, y el disolvente anfifílico secundario es PEG-400.
Las vías de administración pueden incluir, pero no se limitan a, administración intravascularmente, intracavitariamente, intratecalmente, subcutáneamente, intramuscularmente o tópicamente. El sujeto puede ser un mamífero, particularmente un animal doméstico o un ser humano.
En ciertos aspectos, el sujeto tiene un cáncer o una necesidad de acondicionamiento del sujeto para realizar un trasplante de médula ósea o un trasplante de células madre hematopoyéticas y el agente farmacéutico lipófilo es Busulfán. En otros aspectos, el sujeto tiene una enfermedad fúngica, de levadura o moho y el agente farmacéutico lipófilo es un agente de azol. En aspectos adicionales, el sujeto tiene una enfermedad psiquiátrica o una necesidad de control sintomático y el agente farmacéutico lipófilo es un agente psiquiátrico, tal como un agente antipsicótico, antidepresivo o un agente analgésico. El sujeto tiene una necesidad de alterar el nivel de conciencia o inducir
45 anestesia general o sedación de conciencia y el agente farmacéutico lipófilo es un agente que altera el nivel de conciencia o un anestésico como Propofol.
Otros objetos y ventajas de la invención se exponen en parte en la descripción que sigue y, en parte, serán obvios a partir de esta descripción, o se pueden aprender a partir de la práctica de la invención.
Breve descripción de los dibujos
Las siguientes figuras forman parte de la presente memoria y están incluidas para demostrar más ciertos aspectos de la invención. La invención se puede entender mejor en referencia a uno o más de estos dibujos en combinación con la descripción detallada de las realizaciones específicas presentadas en el presente documento.
Figuras 1A-B. (A) Un gráfico que muestra la estabilidad de Busulfán a temperatura ambiente en la formulación de uso final de Bu/VE-acetona/PEG (es decir, vehículo de disolvente madre prototipo) que contiene Bu a una
55 concentración aproximada de 5 mg/ml después de extracción bajo vacío de acetona. (B) La formulación madre se diluye con D5A a 1 mg/ml (parte superior) y a 0,5 mg/ml (inferior). El eje X representa el tiempo en horas, y el eje Y representa la concentración medida en mg/ml.
Figura 2. Curva patrón de la concentración de Busulfán frente al área bajo la curva (ABC; área bajo la curva,
10 5
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25
30
35
40
45
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término usado para indicar el área medido real de un pico en un cromatograma, y también para el área bajo la concentración en plasma frente a la curva de tiempo durante varias horas después de la administración de un fármaco a un animal o ser humano) para el ensayo de cromatografía líquida de alta resolución (HPLC) usado en los estudios de estabilidad in vitro y farmacología in vivo. El eje X muestra la concentración en µg/ml, y el eje Y muestra la ABC. Se preparó una curva patrón análoga para los estudios de farmacología.
Figura 3. Cromatogramas obtenidos a partir del ensayo de HPLC en los estudios de estabilidad. Los inventores usaron la columna Nova-Pak C18 de Waters (tamaño de perla de 4 µm; 150 mm x 3,9 mm). El volumen de muestra inyectado era de 30 µl. Las condiciones de la HPLC se describen en el Ejemplo 1.
Figura 4. Un gráfico que muestra el potencial hemolítico de la formulación de uso de Bu/VE-acetona/PEG/D5A, y la misma formulación (“disolvente”) sin Busulfán. El eje x muestra el contenido de disolvente en porcentaje en volumen (v/v). El eje y muestra la fracción calculada de glóbulos rojos no hemolizados.
Figuras 5A-C. Gráfico que representa la actividad citotóxica de Busulfán en la formulación de uso clínico PEG/D5A frente a las líneas celulares humanas KBM-3 (A) (Andersson y col., 1992) y KBM-7 (B) (Andersson y col., 1987; Andersson y col., 1995), valoradas in vitro con el ensayo con MTT. El eje X muestra la concentración de Bu en µg/ml; el eje Y muestra la fracción de supervivencia celular calculada. Como control positivo sirvieron células expuestas en paralelo a Busulfán en DMSO. (C) muestra la actividad citotóxica de DMA sola en el ensayo con MTT a la concentración más alta alcanzada cuando se usó DMA-Bu como control positivo en las líneas celulares KBM3, KBM7, B5/Bu250-6, y en la OCI-AML3 (Wang y col., 1991). Los últimos resultados corresponden a una concentración que se puede alcanzar cuando se usa DMA-Bu para terapia pre-TCMH con dosis repetidas durante 3 a 4 días.
Figura 6. Sensibilidad de tres de las líneas celulares a Bu en DMSO y en la nueva formulación en relación con los efectos citotóxicos alcanzados con la formulación de DMA-Bu. Digno de mención es la fracción de toxicidad significativamente mayor/supervivencia inferior en concentraciones de Bu crecientes con la formulación de DMA-Bu y, en particular, en la línea celular KBM-3 la contribución de DMA a la citotoxicidad total es significativa. A partir de los datos parece que los efectos de DMA y Bu son sinérgicos más que aditivos (Chou y Talalay, 1984). Por el contrario, la actual formulación novedosa y la formulación de referencia DMSO-Bu ejercen virtualmente efectos citotóxicos idénticos en todas las líneas celulares ensayadas y no hay efecto(s) tóxico(s) añadido(s) a partir del vehículo disolvente.
Figura 7A-C. Cromatogramas de muestras de plasma extraídas como se describe más adelante en el Ejemplo 3 y, a continuación, analizados con HPLC. (A) El panel superior muestra una muestra blanco de plasma, (B) el panel medio muestra una muestra de plasma humano enriquecido con Busulfán en la nueva formulación (vehículo disolvente de uso prototipo de Bu/VE-acetona/PEG/DSW) a 10 µg/ml, con un tiempo de retención de aproximadamente 2,8 minutos. (C) El panel inferior muestra un cromatograma del estudio de farmacología, en el que un ratón es inyectado con Busulfán a 10 mg/kg. El cromatograma era de una muestra sacada 20 minutos después de la inyección del fármaco.
Figura 8. Gráfico que muestra el cambio en la concentración en plasma durante 4 horas después de la inyección de 10 mg/kg de Busulfán en ratones. El eje X muestra el tiempo después de la dosificación en horas. El eje Y muestra la concentración de Busulfán en µg/ml de plasma. La semivida de Busulfán aparente está en el intervalo aproximado de 2,5 a 3,5 horas bajo las condiciones usadas con esta nueva formulación, similar a lo que previamente se ha informado para la DMA-Bu en ratas y en humanos (Bhagwatwar y col., 1996; Russell y col., 2002; De Lima y col., 2004 Madden y col., 2007).
Figuras 9A-B. Estabilidad de (A) Itra y (B) Posa en una formulación variante durante un periodo de 3 semanas a TA.
Figuras 10A-B. Estabilidad de (A) Itra y (B) Posa en las formulaciones de uso final diluidas en D5A.
Figura 11. Fotografía del ensayo de sensibilidad in vitro de especies de Aspergillus a Itraconazol en la nueva formulación, para detalles véase el texto.
Figuras 12A-D. Cromatogramas de Itra y Posa de la HPLC como plasma solo, y plasma enriquecido con Itra y Posa en los estudios de estabilidad.
Figuras 13A-C. Cromatogramas de plasma blanco (panel superior), Posa después del enriquecimiento del plasma humano (panel medio), así como Posa en una muestra obtenida 2 horas después de inyección IV de 5 mg/kg de Posa en ratones (panel inferior) como se describe más adelante en el protocolo experimental en el texto.
Figuras 14A-B. Concentraciones en plasma después de la inyección de Itra (Fig. 14A; durante 2 horas) y Posa (Fig. 14B; durante 30 horas) inyectadas a una dosis de 5 mg/kg lentamente IV (durante 3 a 4 min) como se describe más adelante en los procedimientos en el texto. Las concentraciones en plasma están en un intervalo similar al previamente descrito en humanos tratados con los correspondientes fármacos orales en un marco
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clínico. La figura muestra el resultado promedio de 2 experimentos diferentes, los momentos y las concentraciones individuales se detallan en la tabla adjunta.
Descripción detallada de las realizaciones preferidas
Ciertos aspectos de la presente invención se dirigen a formulaciones novedosas que contienen agentes lipófilos
5 tales como Busulfán o agentes antiinfecciosos, perteneciendo preferiblemente a la clase general de compuestos descritos como azoles, que se pueden administrar parenteralmente. Un aspecto de la invención proporciona un agente lipófilo solubilizado en complejo, vehículos farmacéuticamente aceptables de modo que el agente disuelto continúa físicamente y químicamente estable durante tiempo prologado. La invención permite la administración parenteral del fármaco en dosis necesarias para obtener efectos farmacéuticos significativos tales como efectos
10 citotóxicos e inmunosupresores en sujetos como humanos y animales domésticos sin toxicidad indebida de cualquier componente del vehículo disolvente usado. Realizaciones ilustrativas de la invención permiten la administración parental, por ejemplo, intravascular o intratecal o intracavitaria de agentes solubilizados para incrementar la seguridad de la administración clínica del fármaco. Como resultado, se puede conseguir un control mejorado de enfermedades que son sensibles a este agente tal como enfermedades malignas y autoinmunes.
15 En ciertos aspectos, se puede proporcionar un procedimiento de preparación de (a) principio(s) farmacéuticamente activo(s) difícil(es) de solubilizar, “insoluble(s) en agua” o lipófilo(s) para uso parenteral. Principios farmacéuticamente activos lipófilos adecuados pueden incluir Busulfán, agentes de azol tales como Itra y Posa, o cualquier agente lipófilo conocido en la técnica, como se ilustra en el presente documento. Ciertos aspectos de la presente invención, que se pueden basar en el principio de cosolvencia, pero sin desear quedar ligado a teoría
20 alguna, usan una serie novedosa de vehículos diluyentes compuesto para solubilizar agentes lipófilos, tales como Busulfán, itraconazol (Itra) y posaconazol (Posa), sin afectar a su actividad farmacéutica mientras se mejora la solubilidad acuosa y estabilidad. Además, los disolventes preferidos son, en las concentraciones propuestas y dosis totales usadas, no tóxicos y seguros para humanos y mamíferos, lo más preferiblemente en humanos y animales domésticos.
25 Los procedimientos pueden comprender primero disolver el principio farmacéuticamente activo en un disolvente hidrófobo volátil primario seguido de mezcla de un segundo disolvente anfifílico no volátil. Los procedimientos además pueden comprender separar (por ejemplo, por extracción bajo vacío) el disolvente volátil primario para proporcionar una formulación madre clínicamente aceptable que comprende el agente y el disolvente anfifílico. Los procedimientos pueden comprender opcionalmente diluir la formulación madre con un disolvente acuoso, tal como
30 un fluido de infusión como D5A o D10A o SSN. Preferiblemente, el disolvente volátil primario es acetona y el segundo disolvente anfifílico es PEG-400.
Además de acetona y PEG, se pueden usar otros disolventes orgánicos para formar el vehículo disolvente sin apartarse del espíritu y alcance de la invención. Un disolvente volátil puede ser un disolvente sencillo o una mezcla de disolventes que son volátiles, incluyendo agua y disolventes que son más volátiles que el agua. Ejemplos no 35 limitantes de disolventes volátiles que se pueden usar en la presente invención incluyen acetona, cloroformo, hidrocarburos alifáticos, acetato de etilo, glicol éteres, dietil éter, acetato de isoamilo, alcohol desnaturalizado, metanol, etanol, alcohol isopropílico, propanol, hidrocarburos C4-C6, butano, isobuteno, pentano, hexano, acetona, clorobutanol, acetato de etilo, fluoro-cloro-hidrocarburos, turpentina, metil etil cetona, metil éter, hidrofluorocarburos, etil éter, 1,1,1,2-tetrafluoretano, 1,1,1,2,3,3,3-heptafluoropropano, 1,1,1,3,3,3 hexafluoropropano, y combinaciones
40 de los mismos. El disolvente volátil se puede separar básicamente por evaporación para formar una solución homogénea que comprende el agente y el disolvente líquido anfifílico básicamente libre del disolvente volátil. El uso del término “básicamente” cuando se refiere a la separación de los disolventes volátiles significa que una mayoría del(los) disolvente(s) que se incluye(n) en la formulación inicial se ha separado.
Disolventes anfifílicos no volátiles pueden ser uno o más disolventes que son menos volátiles que el agua.
45 Igualmente, un disolvente no volátil se define como un disolvente que es menos volátil que el agua. Preferiblemente, el disolvente no volátil puede contener sustancias que son líquidos a temperatura ambiente. Después de la evaporación del disolvente volátil, la mayoría del sistema disolvente no volátil debería continuar en una solución homogénea que comprenda el agente lipófilo.
Para algunos agentes hidrófobos, en fármacos particulares que contienen grupos funcionales (amino) reactivos no
50 cargados, la atracción electrostática entre el disolvente anfifílico tal como PEG y el principio farmacéuticamente activo se puede aumentar añadiendo un agente de protonación tal como un ácido orgánico o HCl, o un alcohol tal como alcohol bencílico, al primer disolvente orgánico antes de mezclar el fármaco solubilizado con PEG. Después de la separación del primer disolvente orgánico a la formulación de uso final se llega por la mezcla de un fluido de infusión acuoso clínicamente aceptable. Si la última etapa preferida de uso de un agente de protonación (ácido) para
55 incrementar la atracción electrostática entre el principio farmacéuticamente activo y PEG, a continuación, se puede utilizar una extracción bajo vacío prolongada para asegurar la extracción no solamente del primer disolvente orgánico sino también del ácido libre restante. Dicha separación de ácido libre en exceso permitirá prolongar la semivida del principio farmacéuticamente activo cuando se une al agente anfifílico tal como PEG. Si se utiliza el último planteamiento entonces se prefiere que la reconstitución antes de la administración in vivo se haga usando
60 D5A o D10A acidificado como diluyente final para mantener la atracción electrostática óptima entre el principio
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estado disponible, sino únicamente una suspensión coloidal o microcristalina en hidroxipropil-betaciclodextrina (Willems y col., 2001).
Como se muestra en los Ejemplos, cuando se inyectaron Itraconazol (Itra) y Posaconazol (Posa) a una dosis de 5 mg/kg de PC en ratones después de disolver y diluir de una manera análoga (datos de estabilidad para la 5 formulación madre y de uso final mostrados en las Fig. 9 y 10, de diez minutos a al menos 2 horas después de la inyección de fármaco las concentraciones de Posa en plasma continuaron en el intervalo de 3 a 5 µg/ml, y también se detectó Itra a más de 0,5 µg/ml durante el mismo intervalo de tiempo). Estos intervalos de concentración son similares a los expuestos cuando se administra una dosis oral equivalente de cada fármaco en una situación clínica (Woestenborghs y col., 1987; Notheis y col., 2006; Courtney y col., 2003; Jang y col., 2010), y estas concentraciones
10 excedieron claramente las concentraciones inhibidoras mínimas de cepas de moho prototipos que son patógenas a humanos inmunocomprometidos.
Se usaron una diversidad de procedimientos biológicos y químicos para demostrar que formulaciones de Bu y azol preferidas son estables a aproximadamente 5 mg/ml durante varias semanas a TA. Como se muestra en los Ejemplos, una de tales formulaciones (Bu/VE-acetona/PEG) es estable para más de 40 o incluso 60 días, y conserva 15 la actividad citotóxica completa cuando se ensaya in vitro frente a líneas celulares leucémicas humanas. Se disolvió Bu comercialmente disponible en DMSO y se usó como sistema disolvente de referencia (“D” o “DMSO”) para el ensayo de citotoxicidad in vitro. La formulación DMA-Bu se incluyó en algunos experimentos como control positivo en paralelo; debido a los efectos citotóxicos sinérgicos añadidos de DMA la última formulación era claramente más tóxica en las líneas celulares humanas ensayadas. El vehículo novedoso Bu/VE-acetona/PEG/dextrosa es en sí
20 mismo virtualmente no tóxico analizado en el ensayo de hemolisis. Por último, se usó una de las formulaciones novedosas para mostrar que las concentraciones de Bu citocidas/concentraciones de azol antifúngicas se mantienen durante varias horas en un modelo murino después de inyección IV de 10 mg/kg de PC y 5 mg/kg de PC, respectivamente.
Aunque una realización preferida de la invención usa acetona y PEG, con D5A como diluyente secundario, se
25 pueden usar otros vehículos disolventes/diluyentes que son no tóxicos y seguros para la administración humana. No se han experimentado efectos adversos clínicos serios a partir del uso de estos diluyentes. Como alternativas a solo acetona, uno podría también usar acetona acidificada para permitir la protonación de grupos reactivos en el principio farmacológicamente activo hidrófobo para aumentar más su solubilidad y formación de complejo con PEG, probablemente debido a la atracción electrostática mejorada entre el soluto y PEG. Alternativamente, es posible usar
30 otros disolventes orgánicos volátiles, tales como cloroformo por sí mismo o cloroformo acidificado. Por ejemplo, la acetona comprende entre 1 y 100 % del primer disolvente y PEG es el segundo disolvente madre preferido; como alternativa, la acetona comprende entre 95 y 100 % del primer disolvente y un agente de protonación, tal como un ácido o un alcohol, comprende entre 0 y 5 % del primer disolvente.
Fluidos de infusión útiles incluyen, pero no se limitan a, solución salina normal y dextrosa en agua, o dextrosa en
35 agua mezclada con un agente de protonación tal como un ácido (Martin y Matzke, 1982), o dextrosa en agua mezclada con una pequeña cantidad de un disolvente anfifílico tal como PEG para disminuir más el riesgo de precipitación cuando se añade el diluyente acuoso terminal a la formulación madre del fármaco. Alternativamente, el fluido de infusión puede ser un fluido de infusión emulsión basado en lípido tal como aquellos usados para la nutrición parenteral (Fortner y col., 1975). Antes de la dilución con el fluido de infusión, la composición puede
40 comprender entre 1 y 20 mg/ml de un agente lipófilo tal como Bu y, más preferiblemente, comprende entre 1 y 5 mg/ml de un agente lipófilo tal como Bu. Preferiblemente, la composición madre no diluida es estable durante más de 30 días a TA. Se estableció el uso clínico de solución salina normal (SSN), dextrosa en agua (5 a 10 %) y emulsiones lipídicas acuosas, medios rutinarios para corregir el equilibrio de fluido y electrolito y suministrar nutrición parenteral. También se usan mucho solución salina normal y dextrosa en agua para diluir diversas medicaciones
45 para su uso IV. La emulsión lipídica acuosa aún no se ha encontrado uso generalizado como diluyente farmacéutico, pero se ha sugerido este uso (Fortner y col., 1975). Igualmente, la administración intravenosa de ácido (clorhídrico) se ha usado para la corrección (rápida) de acidosis metabólica seria, pero no se ha descrito como medio para aumentar la protonación para mantener las fuerzas de atracción electrostática entre un principio farmacéuticamente activo y disolventes hidrófobos/anfifílico dispares antes de la administración en mamíferos (Martin y Matzke, 1982).
50 En una realización particularmente preferida, el diluyente secundario es dextrosa en agua al 5 a 10 % y la composición comprende entre 0,5 y 2,0 mg/ml de Bu después de la dilución en el diluyente secundario. Esta composición diluida es estable durante al menos 12 a 15 horas a TA.
Las soluciones novedosas de la invención no se limitan a Bu, sino también se pueden usar para facilitar la administración parenteral de otros fármacos hidrófobos, y de difícil solubilización, también conocidos como 55 insolubles en agua. Como se indica, tales agentes incluyen, pero no se limitan a, agentes citotóxicos tales como derivados de epipodofilotoxina, taxanos, Bleomicina, antraciclinas, así como compuestos de platino y camptotecina. También incluyen antibióticos, tales como polienos escasamente solubles en agua y azoles (por ejemplo, Anfotericina B y Natamicina, así como los azoles antifúngicos que incluyen, pero no se limitan a, itraconazol y posaconazol) así como agentes antibacterianos, (por ejemplo, polimixina B), agentes antivirales y fármacos
60 traquilizantes/anestésicos tales como benzodiacepinas, Propofol y agentes antipsicóticos.
Ejemplos adicionales de agentes lipófilos que se pueden usar de acuerdo con la presente invención incluyen, pero
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nitrato de econazol, fluconazol, flucitosina, griseofulvina, Itraconazol, ketoconazol, miconazol, natamicina, nistatina, nitrato de sulconazol, oxiconazol, Posaconazol, terbinafina HCl, terconazol, tioconazol y ácido undecenoico;
(xvi) agentes antigota seleccionados de alopurinol, probenecid y sulfinpirazona;
(xvii) agentes antihipertensivos seleccionados de amlodipina, benidipina, benezepril, candesartán, captopril, darodipina, dilitazem HCl, diazóxido, doxazosina HCl, enalapril, eposartán, losartán mesilato, felodipina, fenoldopam, fosenopril, guanabenz acetato, irbesartán, isradipina, lisinopril, minoxidil, nicardipina HCl, nifedipina, nimodipina, nisoldipina, fenoxibenzamina HCl, prazosina HCl, quinapril, reserpina, terazosina HCl, telmisartán y valsartán;
(xviii) agentes antimalaria seleccionados de amodiaquina, cloroquina, cloroproguanilo HCl, halofantrina HCl, mefloquina HCl, proguanilo HCl, pirimetamina y sulfato de quinina;
(xix) agentes antimigraña seleccionados de dihidroergotamina mesilato, ergotamina tartrato, frovatriptán, metisergida maleato, naratriptán HCl, pizotifeno maleato, rizatriptano benzoato, sumatriptán succinato y zolmitriptán;
(xx) agentes antimuscarínicos seleccionados de atropina, benzhexol HCl, biperideno, etopropazina HCl, hisociamina, mepenzolato bromuro, oxifenciclimina HCl y amida trópica;
(xxi) agentes antiparkinson seleccionados de mesilato de bromocriptina, lisurida maleato, pramipexol, ropinirol HCl y tolcapona;
(xxii) agentes antiprotozoo seleccionados de atovaquona, benznidazol, clioquinol, docoquinato, diiodohidroxiquinolina, diloxamida furoato, dinitolmida, furazolidona, metronidazol, nimorazol, nitrofurazona, ornidazol y tinidazol;
(xxiii) agentes antitiroideos seleccionados de carbimazol y propiltiouracilo;
(xxiv) agente antitusivo tal como benzonatato;
(xxv) agentes antivirales seleccionados de abacavir, amprenavir, delavirdina, efavirenz, indinavir, lamivudina, nelfinavir, neviparina, ritonavir, saquinavir y estavudina;
(xxvi) ansiolíticos, sedantes, hipnóticos y neurolépticos seleccionados de alprazolam, amilobarbitona, barbitona, bentazepam, bromazepam, bromperidol, brotizolam, butobarbitona, carbromal, clordiazepóxido, clormetiazol, clorpromazina, clorprotixeno, clonazepam, clobazam, clotiazepam, clozapina, diazepam, droperidol, etinamato, flunanisona, flunitrazepam, triflupromazina, flupentixol decanoato, flufentixol decanoato, flurazepam, gabapentina, haloperidol, lorazepam, lormetazepam, medazepam, meprobamato, mesoridazina, metaqualona, metilfenidato, midazolam, molindona, nitrazepam, olanzapina, oxazepam, pentobarbitona, perfenazina pimozida, prochlorperazina, propofol, pseudoefedrina, quetiapina, risperidona, sertindol, sulpirida, temazepam, tioridazina, triazolam, zolpidem y zopiclona;
(xxvii) beta bloqueantes seleccionados de acebutolol, alprenolol, atenolol, labetalol, metoprolol, nadolol, oxprenolol, pindolol y propanolol;
(xxviii) agentes inotrópicos cardiacos seleccionados de anrinona, digitoxina, digoxina, enoximona, lanatósido C y medigoxina;
(xxix) corticoides seleccionados de beclometasona, betametasona, budesónido, cortisona acetato, desoximetasona, dexametasona, fludrocortisona acetato, flunisolida, fluocortolona, fluticasona propionato, hidrocortisona, metilprednisolona, prednisolona, prednisona y triamcinolona;
(xxx) diuréticos seleccionados de acetazolamida, amirolida, bendroflumetiazida, bumetanida, clorotiazida, clortalidona, ácido etacrínico, frusemida, metolazona, espironolactona y triamtereno;
(xxxi) agentes gastrointestinales seleccionados de bisacodilo, cimetidina, cisaprida, difenoxilato HCl, domperidona, famotidina, lanosprazol, loperamida, mesalazina, nizatidina, omeprazol, ondansetrón HCl, pantoprazol, rabeprazol sodio, ranitidina HCl y sulfasalazina;
(xxxii) antagonistas del receptor de histamina H1 y H2 seleccionados de acrivastina, astemizol, clorfeniramina, cinnarizina, cetrizina, clemastina fumarato, ciclizina, ciproheptadina HCl, dexclorfeniramina, dimenhidrinato, fexofenadina, flunarizina HCl, loratadina, meclizina HCl, oxatomida y terfenadina;
(xxxiii) agentes queratolíticos seleccionados de acitretina, calciprotieno, calcifediol, calcitriol, colecalciferol, ergocalciferol, etretinato, retinoides, targretina y tazaroteno;
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(xxxiv) agentes reguladores de lípido/hipolipidémicos seleccionados de atorvastatina, bezafibrato, cerivastatina, ciprofibrato, clofibrato, fenofibrato, fluvastatina, gemfibrozil, hesperetina, lovastatina, pravastatina, probucol y simvastatina;
(xxxv) relajantes musculares seleccionados de ciclobenzaprina, dantroleno sodio y tizanidina HCl;
5 (xxxvi) analgésicos opioides seleccionados de codeína, dextropropoxifeno, diamorfina, dihidrocodeína, fentanilo, meptazinol, metadona, morfina, nalbufina y pentazocina;
(xxxvii) hormonas sexuales seleccionadas de citrato de clomifeno, cortisona acetato, danazol, dehidroepiandrosterona, etinil estradiol, finasterida, fludrocortisona, fluoximesterona, medroxiprogesterona acetato, megestrol acetato, mestranol, metiltestosterona, mifepristona, noretisterona, norgestrel, oestradiol,
10 estrógenos conjugados, progesterona, rimexolona, estanozolol, estilbestrol, testosterona y tibolona;
(xxxviii) estimulantes seleccionados de anfetamina, dexafentamina, dexfenfluramina, fenfluramina y mazindol;
(xxxix) agentes nutracéuticos seleccionados de calcitriol, carotenos, crisina, dihidrotaquisterol, flavonoides, hesperitina, jasmonatos, ácido lipoico, luteína, licopeno, ácidos grasos esenciales, ácidos grasos no esenciales, naringenina, fitonadiol, quercetina, vitaminas incluidas la vitamina A, vitamina B2, vitamina D y derivados,
15 vitamina E y vitamina K, coenzima Q10 (ubiquinona), extractos vegetales y minerales.
Los analgésicos se pueden usar en ciertos aspectos de la invención. Un analgésico (también conocido como un calmante) es cualquier miembro del grupo de fármacos usados para mitigar el dolor (conseguir analgesia). La palabra analgésico deriva del griego an-(“sin”) y algos (“dolor”).
Los fármacos analgésicos actúan de diversas maneras sobre el sistema nervioso periférico y central; incluyen
20 paracetamol (para-acetilaminofenol, también conocido en los EE.UU. como acetaminophen), los fármacos antiinflamatorios no esteroides (FAINE) tales como los salicilatos, y fármacos opioides tales como morfina y opio. Son distintos de anestésicos, los cuales eliminan reversiblemente la sensación.
Los fármacos antiinflamatorios no esteroides, normalmente abreviados como FAINE o NAID, pero también referidos como agentes/analgésicos antiinflamatorios no esteroides (AAINE) o medicinas antiinflamatorias no esteroides 25 (MAINE), son fármacos con efectos analgésicos y antipiréticos (reductores de fiebre) y los cuales tienen, en dosis mayores, efectos antiinflamatorios. Los FAINE generalmente están indicados para el alivio sintomático de las siguientes afecciones: artritis reumatoides, osteoartritis, artropatías inflamatorias (por ejemplo, espondilitis anquilosante, artritis psoriásica, síndrome de Reiter), gota aguda, dismenorrea (dolor menstrual), dolor de hueso metastásico, dolor de cabeza y migraña, dolor posoperativo, dolor suave a moderado debido a inflamación y lesión
30 de tejido, pirexia (fiebre), íleo, cólico renal o infantes neonatos cuyo ductus arteirosus no está cerrado dentro de las 24 horas del nacimiento.
El inhibidor selectivo de COX-2 es una forma de fármaco antiinflamatorio no esteroide (FAINE) que guía directamente COX-2, una enzima responsable de la inflamación y el dolor. La selectividad para COX-2 reduce el riesgo de ulceración péptica, y es la característica principal de celecoxib, rofecoxib y otros miembros de esta clase
35 de fármaco. COX-2 selectivamente no parece reducir otros efectos adversos de FAINE (muy en particular un riesgo incrementado de insuficiencia renal), y algunos resultados han mostrado un incremento en el riesgo de ataque cardiaco, trombosis y apoplejía por un incremento relativo en tromboxano. Rofecoxib es un ejemplo.
Flupirtina es un abridor del canal de K+ que actúa centralmente con propiedades antagonistas de NMDA débiles. Se usa en Europa para dolor moderado a fuerte y las migrañas y sus propiedades relajantes musculares. No tiene
40 propiedades anticolinérgicas y se cree que está desprovisto de cualquier actividad sobre los receptores de dopamina, serotonina o histamina. No es adictivo y no desarrolla tolerancia.
En pacientes con dolor crónico o neuropático, diversas otras sustancias pueden tener propiedades analgésicas. Se ha demostrado que antidepresivos tricíclicos, especialmente amitriptilina, mejoran el dolor en lo que parece ser una manera central. Nefopam se usa en Europa para aliviar el dolor con opioides concurrentes. El mecanismo exacto de
45 carbamazepina, gabapentina y pregabalina está igualmente confuso, pero estos anticonvulsivos se usan para tratar dolor neuropático con diferentes grados de éxito. Los anticonvulsivos son lo más frecuentemente usados para dolor neuropático ya que su mecanismo de acción tiende a inhibir la sensación de dolor.
Los antidepresivos se pueden usar en ciertos aspectos de la invención. Los antidepresivos tricíclicos (ATC) son compuestos químicos heterocíclicos usados principalmente como antidepresivos. Los TAC se descubrieron primero
50 a principio de la década de 1950 y posteriormente se introdujeron a últimos de la década. Se llaman por su estructura química, la cual contiene tres anillos de átomos. Los antidepresivos tetracíclicos (TeCA), que contienen cuatro anillos de átomos, son un grupo muy relacionado de compuestos antidepresivos.
Los ATC incluyen siguientes agentes que en su mayoría son inhibidores de recaptación de serotonina y/o norepinefrina: Amitriptilina (Elavil, Triptizol, Laroxil), Amitriptilinóxido (Amioxid, Ambivalon, Equilibrin), Butriptilina 55 (Evadyne), Clomipramina (Anafranil), Demexiptilina (Deparon, Tinoran), Desipramina (Norpramin, Pertofrane),
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Dibenzepina (Noveril, Victoril), Dimetacrina (Istonil, Istonyl, Miroistonil), Dosulepina/Dotiepina (Prothiaden), Doxepina (Adapin, Sinequan), Imipramina (Tofranil, Janimine, Praminil), Imipraminóxido (Imiprex, Elepsin), Lofepramina (Lomont, Gamanil), Melitraceno (Deanxit, Dixeran, Melixeran, Trausabun), Metapramina (Timaxel), Nitroxazepina (Sintamil), Nortriptilina (Pamelor, Aventil), Noxiptilina (Agedal, Elronon, Nogedal), Pipofezina (Azafen/Azaphen),
5 Propizepina (Depressin, Vagran), Protriptilina (Vivactil), Quinupramina (Kevopril, Kinupril, Adeprim, Quinuprina).
Así como los siguientes compuestos atípicos: Amineptina (Survector, Maneon, Directim) – inhibidor de recaptación de Norepinefrina-dopamina; Iprindol (Prondol, Galatur, Tetran) – antagonista del receptor de 5-HT2; Opipramol (Insidon, Pramolan, Ensidon, Oprimol) – antagonista del receptor δ; Tianeptina (Stablon, Coaxil, Tatinol) potenciador de la recaptación de serotonina selectiva; Trimipramina (Surmontil) – receptor del antagonista de 5-HT2.
10 En los últimos tiempos, los ATC se han reemplazado en gran parte en el uso clínico en la mayor parte del mundo por novedosos antidepresivos tales como inhibidores selectivos de recaptación de serotonina (ISRS) e inhibidores de recaptación de serotonina-norepinefrina (IRSN), que generalmente tienen perfiles de efectos secundarios más favorables, aunque todavía a veces se prescriben para ciertas indicaciones.
Los inhibidores selectivos de recaptación de serotonina o inhibidor de recaptación específicos a serotonina (ISRS)
15 son una clase de compuestos generalmente usados como antidepresivos en el tratamiento de depresión, trastornos de ansiedad y algunos trastornos de personalidad. También generalmente son eficaces y se usan en el tratamiento de algunos casos de insomnio. La indicación principal para ISRS es depresión clínica. Los ISRS frecuentemente se prescriben para trastornos de ansiedad, tales como ansiedad social, trastornos de pánico, trastorno obsesivocompulsivo (TOC), trastornos alimenticios, dolor crónico y ocasionalmente, para trastorno de estrés postraumático
20 (TEPT). Aunque no específicamente indicado por los fabricantes, a veces están prescritos para tratar el síndrome del intestino irritable (SII), Liquen simplex crónico y eyaculación prematura. Todos los ISRS están aprobados en los EEUU para su uso con trastornos psiquiátricos como se resume en el “Diagnostic and Statistical Manual of Mental Disorders” (DSM IV).
Se cree que los ISRS incrementan el nivel extracelular de la serotonina neurotransmisora mediante la inhibición de
25 su recaptación dentro de la célula presináptica, incrementando el nivel de serotonina en la hendidura sináptica disponible para unirse al receptor posináptico. Tienen grados variantes de selectividad para los otros trasportadores de monoamina, con ISRS puros que tienen solamente afinidad débil para el transportador de noradrenalina y dopamina.
Los fármacos ISRS incluyen (nombres comerciales en paréntesis): citalopram (Celexa, Cipramil, Cipram, Dalsan,
30 Recital, Emocal, Sepram, Seropram, Citox, Cital); dapoxetina (Priligy); escitalopram (Lexapro, Cipralex, Seroplex, Esertia); fluoxetina (Prozac, Fontex, Seromex, Seronil, Sarafem, Ladose, Motivest, Flutop, Fluctin (EUR), Fluox (NZ), Depress (UZB), Lovan (AUS); fluvoxamina (Luvox, Fevarin, Faverin, Dumyrox, Favoxil, Movox); indalpina (Upstene) (discontinuo); paroxetina (Paxil, Seroxat, Sereupin, Aropax, Deroxat, Divarius, Rexetin, Xetanor, Paroxat, Loxamine, Deparoc); sertralina (Zoloft, Lustral, Serlain, Asentra); vilazodona (Viibyrd); zimelidina (Zelmid, Normud)
35 (discontinuo).
Inhibidores de recaptación de serotonina-norepinefrina (IRSN) son una clase de fármacos antidepresivos en el tratamiento de depresión grave y otros trastornos de humor. A veces también se usan para tratar trastornos de ansiedad, trastorno obsesivo-compulsivo (TOC), trastorno por déficit de atención e hiperactividad (TDAH), dolor neuropático crónico, síndrome de fibromialgia (SFM) y para el alivio de síntomas de la menopausia.
40 Los IRSN actúan sobre e incrementan los niveles de dos neurotransmisores en el cerebro que se sabe que juegan una parte importante en el humor, siendo estos serotonina y norepinefrina. Esto se puede contrastar con los inhibidores selectivos de recaptación de serotonina más ampliamente usados (ISRS) que solamente actúan sobre serotonina.
Ejemplos de IRSN incluyen:
45 Venlafaxina (Effexor) – El primer IRSN y el más frecuentemente usado. Se introdujo por Wyeth en 1994. Los efectos de recaptación de venlafaxina son dosis dependiente. A dosis bajas (<150 mg/día) actúa solamente sobre la transmisión serotonérgica. A dosis moderadas (>150 mg/día) actúa sobre sistemas serotonérgicos y noradrenérgicos, mientras que a dosis alta (>300 mg/día) también afecta a la neurotransmisión dopaminérgica.
Desvenlafaxina (Pristiq) – El metabolito activo de venlafaxina. Se crece que funciona de una manera similar,
50 aunque alguna evidencia sugiere índices de respuesta inferiores en comparación con venlafaxina y duloxetina. Fue introducida por Wyeth en Wyeth en mayo de 2008.
Duloxetina (Cymbalta, Yentreve) – Por Eli Lilly and Company, se ha aprobado para el tratamiento de depresión y dolor neuropático en agosto de 2004. Duloxetina está contraindicada en pacientes con abuso de alcohol o enfermedad de hígado crónica, ya que la duloxetina puede incrementar los niveles de ciertas enzimas del 55 hígado que pueden conducir a hepatitis aguda u otras enfermedades en ciertos pacientes en riesgo. Actualmente, el riesgo de daño de hígado parece solamente ser para pacientes ya en riesgo, a diferencia de la nefazodona antidepresiva que, aunque poco frecuente, puede causar espontáneamente insuficiencia de hígado
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FDA para manía aguda, depresión bipolar, agitación psicótica, mantenimiento bipolar y otras indicaciones. Los antipsicóticos atípicos pueden incluir: Amisulprida (Solian), Aripiprazol (Abilify), Asenapina (Saphris), Blonanserina (Lonasen), Clotiapina (Entumine), Clozapina (Clozaril), Iloperidona (Fanapt), Lurasidona (Latuda), Mosapramina (Cremin), Olanzapina (Zyprexa), Paliperidona (Invega), Perospirona (Lullan), Quepin (Specifar), Quetiapina
5 (Seroquel), Remoxiprida (Roxiam), Risperidona (Risperdal), Sertindol (Serdolect), Sulpirida (Sulpirid, Eglonyl), Ziprasidona (Geodon, Zeldox), Zotepina (Nipolept), Bifeprunox (DU-127.090), Pimavanserina (ACP-103), Vabicaserina (SCA-136). Estos antipsicóticos de tercera generación pueden incluir Aripiprazol (Abilify) o agonistas parciales de dopamina.
Los anestésicos se pueden usar en ciertos aspectos de la invención. Un anestésico es un fármaco que causa
10 anestesia -pérdida reversible de sensación. Contrastan con los analgésicos (calmantes), que alivian el dolor sin sensación de eliminación. Estos fármacos generalmente se administran para facilitar la cirugía. Una amplia diversidad de fármacos se usa en la práctica anestésica moderna. Muchos se usan rara vez fuera de la anestesia, aunque otros se usan frecuentemente por todas las disciplinas. Los anestésicos se caracterizan en dos clases: anestésicos generales, que causan una pérdida reversible de consciencia, y anestésicos locales, que causan una
15 pérdida reversible de la sensación para una región limitada del cuerpo mientras se mantiene la conciencia. Combinaciones de anestésicos a veces se usan por su efectos sinérgicos y terapéuticos aditivos, sin embargo, también se pueden incrementar los efectos adversos.
Los anestésicos locales son agentes que previenen la transmisión de impulsos nerviosos sin causar inconsciencia. Actúan uniéndose a canales de sodio rápidos desde dentro (en un estado abierto). Los anestésicos locales pueden 20 ser o bien éster o basados en amida. Los anestésicos locales éster (por ejemplo, procaína, ametocaína, cocaína) generalmente son inestables en solución y de rápida actuación, y las reacciones alérgicas son comunes. Ejemplos no limitantes de anestésicos locales pueden incluir procaína, ametocaína, cocaína, lidocaína (también conocida como Lignocaína), prilocaína, bupivacaína, levobupivacaína, ropivacaína, mepivacaína y dibucaína. Los anestésicos locales de amida (por ejemplo, lidocaína, prilocaína, bupivicaína, levobupivacaína, ropivacaína, mepivacaína y 25 dibucaína) generalmente son estables al calor, con una larga semivida (alrededor de 2 años). Tienen un inicio más lento y una semivida más larga que los anestésicos éster, y son normalmente mezclas racémicas, con la excepción de levobupivacaína (que es S(-)-bupivacaína) y ropivacaína (S(-)-ropivacaína). Estos agentes generalmente se usan dentro de las técnicas regionales y epidurales o espinales, debido a su mayor duración de acción, que proporcionan adecuada analgesia para la cirugía, parto y alivio sintomático. Solamente agentes anestésicos locales libres de
30 conservantes se pueden inyectar intratecalmente.
Un anestésico general es un fármaco que trae aproximadamente una pérdida reversible de conciencia. Estos fármacos generalmente se administran por un anestesista para inducir o mantener anestesia general para facilitar la cirugía. El(los) mecanismo(s) biológico(s) de la acción de los anestésicos generales no están bien entendidos. Los anestésicos de inyección se usan para la inducción y mantenimiento de un estado de inconsciencia. Los
35 anestesistas prefieren usar inyecciones intravenosas, ya que son más rápidas, generalmente menos dolorosas y más fiables que las inyecciones intramusculares o subcutáneas. Entre los fármacos más ampliamente usados están: Propofol, Etomidato, Barbituratos tales como metohexital y tiopentona/tiopental, derivados de Benzodiacepina tales como midazolam y Ketamina.
Las composiciones de la invención tienen un número de usos. La invención puede incluir un procedimiento para
40 tratar una enfermedad que es sensible o responde a un tratamiento con fármaco lipófilo que comprende: administrar parenteralmente una cantidad terapéuticamente eficaz de una composición de fármaco parenteral como se describió anteriormente a un paciente.
Enfermedades o afecciones que se pueden tratar incluyen, pero no se limitan a, cáncer, leucemia aguda y crónica, linfoma de Hodgkin y de no Hodgkin, un trastorno mieloproliferativo, un trastorno autoinmune y ya que forma la base 45 de la quimioterapia de combinación se pretende que prepare un paciente para el trasplante de células madre hematopoyéticas, enfermedades infecciosas, afecciones o enfermedad psicótica, o una necesidad de control de síntoma. Preferiblemente, la composición se puede administrar intravascularmente, pero cuando se determina por circunstancias clínicas específicas también se puede dar intratecalmente, intracavitaria (tal como, por ejemplo, intraperitonealmente, o intrapleuralmente) entre otras vías para tratar localmente enfermedad avanzada. Después de
50 mezclar con o suspender en una base de pomada adecuada, la composición también se puede aplicar tópicamente, tal como en el tratamiento de un linfoma de linfocito T periférico o en el caso de usar la composición como un sistema disolvente base para una composición antiinfecciosa adecuada para la administración tópica para conseguir un remedio para una enfermedad infecciosa localizada o inflamatoria. El paciente puede ser cualquier animal. Más preferiblemente, el animal es un mamífero, y lo más preferiblemente, un ser humano.
55 El término “cantidad terapéuticamente eficaz” como se usa en esta solicitud significa que una cantidad suficiente de la composición se añade para conseguir el efecto terapéutico deseado u otro efecto, por ejemplo, para transitoriamente conseguir el control del síntoma, o alterar el nivel de conciencia del paciente. La cantidad real usada variará en base de los factores tales como el tipo de la afección médica, la edad, sexo, salud, especie y peso del paciente, y el tipo de uso y duración de uso, así como otros factores conocidos por los expertos en la técnica.
60 Otra realización más de la invención está dirigida a un procedimiento para administrar parenteralmente un agente
21
estudios de fiabilidad y estabilidad de la formulación.
La Fig. 14 representa cromatogramas del ensayo en plasma de Itra y Posa en el estudio de farmacología. Los datos están a continuación en la Tabla 3.
Tabla 3. Aclaramiento de a) Itraconazol y b) Posaconazol después de la inyección de 5 mg/kg IV en ratones Swiss Webster
- a) Itraconazol
- Tiempo, min
- ug/ml media SD
- 10
- 3,59 3,23 0,76
- 2,13
- 3,34
- 3,86
- 30
- 1,31 1,62 0,44
- 1,93
- 60
- 0,77 0,77
- 120
- 0,64 0,71 0,09
- 0,77
- b) Posaconazol
- Tiempo, horas
- ug/ml media SD
- 0,2
- 3,43 3,68 1,34
- 1,88
- 4,59
- 4,82
- 2,0
- 4,99 4,77 0,38
- 4,85
- b) Posaconazol
- Tiempo, horas
- ug/ml media SD
- 5,03
- 4,21
- 7,0
- 2,61 3,23 0,88
- 3,86
- 24
- 0,03 0,35 0,28
- 0,56
- 0,47
- 30
- 0,14 0,16 0,13
- 0,29
- 0,04
28
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