Taller Biodisponibilidad de medicamentos, María Eugenia Olivera.pdf

Dra. Olivera- Costa Rica 2014

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Prof. Dra. María Eugenia Olivera

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CONSIDERACIONES BIOFARMACÉUTICAS EN EL DISEÑO DE MEDICAMENTOS La respuesta biológica a la administración de un fármaco es el resultado de la interacción fármaco-receptor fármaco-receptor.. Su magnitud depende de la concentración en el sitio de acción. Su concentración depende del tipo de formulación administrada, su absorción, distribución y excreción.

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absorción

Distribución

Sitio de acción

excreción

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Dra. Olivera- Costa Rica 2014

Eventos de absorción, metabolismo y excreción de los fármacos luego de su administración por varias rutas ADMINISTRACIÓN ORAL

TRACTO GASTROINTESTINAL

fármaco

ADMINISTRACIÓN RECTAL SISTEMA CIRCULATORIO

fármaco

ADMINISTRACIÓN IV ADMINISTRACIÓN IM TEJIDOS

SITIOS

metabolito

   N     Ó    I    C    E    R    C    X    E

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Principios generales de la absorción de fármacos  Antes de llegar al sitio de acción en concentraciones concentraciones efectivas, un fármaco deberá atravesar una serie de barreras. CLASIFICACIÓN DE LAS MEMBRANAS CORPORALES

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Absorción: tipos de transporte

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Difusión pasiva 1° Ley de Fick J= P(δC)= kD/h kD/h (  (δC)

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Difusión pasiva Ecuación de Henderson-Hasselbach

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Difusión pasiva paracelular El cemento intracelular previene la libre

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Endocitosis Es un proceso común en la captación de virus pero no en el tr ans port por te de

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Dra. Olivera- Costa Rica 2014

32

Evaluación de la permeabilidad a través de membranas

En membranas • En cultivos celulares • Nuevos avances •

Permite estudiar absorción pasiva y activa

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Dra. Olivera- Costa Rica 2014

Evaluación de la permeabilidad

33

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Dra. Olivera- Costa Rica 2014

34

ACCIÓN MEDICAMENTOSA

METABOLISMO LIBERACIÓN

 ABSORCIÓN

DISTRIBUCIÓN

BIOFASE

RESPUESTA

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Concepto de biodisponibilidad Velocidad o cantidad a la cual un fármaco o componente activo, absorbido a partir de la formulación farmacéutica que ac ción. lo contiene, se hace disponible en su lugar de acción (FDA) Velocidad y magnitud a la cual un principio p rincipio activo o componente activo, absorbido a partir de la formulación que lo contiene, alcanza la circulación sistémica. (APhA)

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Dra. Olivera- Costa Rica 2014

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Biodisponibilidad s/ FA 7 En sentido amplio, velocidad y cantidad con la cual el principio activ o es absorbido desde la forma farmacéutica y se encuentra disponible en forma inalterada en el/los sitio/s de acción. En la mayoría de los casos no es posible medir la concentración de principio activo en el/los sitio/s de acción. No obstante, se considera que la concentración del principio activo en la circul ación general se encuentran en equilibrio con la concentración en el/los sitio/s de acción. La Biodisponibilidad puede, entonces, ser definida como la velocidad y cantidad (tasa y grado de disponibilidad) con la cual el principio activo es absorbido desde

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62

Dra. Olivera- Costa Rica 2014

Como estimamos la bioequivalencia? Parámetros farmacocinéticos del producto X

Parámetros farmacocinéticos del producto R

Se

acepta

que

X

y

R

son

bioequivalentes si los parámetros de biodisponibilidad entre ambas formulaciones analizados por métodos estadísticos, no difieren en más de un valor especificado. Se prueba que las diferencias están dentro de márgenes preestablecidos que se juzgan

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Relación entre los procesos de disolución y absorción

Pef : coeficiente de permeabilidad efectiva

P ar ámetro metro repr r epres es enta entativo tiv o de la c apac pac i dad dad del del  fárma  fár macc o de atraves trav es ar la membr membra ana

Modelo dinámico de disolución: relaciona los procesos de

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Modelo dinámico de disolución Q= Pef  x S  x Cd tres=  x R2 x L/ 

 

tabs= R/P ef

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65

Parámetros adimensionales Permiten deducir la influencia de la dosis y el proceso de disolución en la absorción de los fármacos

D0= Número de dosis ( )

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Número de Dosis (D0) D0 = Q0/V0 Cs Q0: dosis

Si el Fármaco es altamente soluble en agua D0 no es un parámetro crítico. Si D0 < 0.1 => Condiciones sink

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Número de Disolución (D n)

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Número de Absorción Absorción

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Representación gráfica tridimensional tridimensional de la influencia de los parámetros adimensionales adimensionales en la fracción de dosis absorbida

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RELACIÓN ENTRE DOSIS, SOLUBILIDAD SOLUBILIDAD Y BIODISPONIBILIDAD DIGOXINA: Dosis: 0.5 mg Cs: 0.024 mg/ml  V: 20.8 ml

BD= 60%

GRISEOFULVINA: Dosis: 500 mg BD= muy baja, errática Cs: 0.015 mg/ml Ultramicronizac.~ 50%

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SISTEMA DE CLASIFICACIÓN BIOFARMACÉUTICO (SCB)

Relevancia Relevancia para formas farmacéuticas sólidas de administración oral y acción sistémica cuyos principios activos deban disolverse o liberarse previo a la absorción Mas del 70% DE LAS FORMULACIONES ACTUALMENTE COMERCIALIZADAS

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Fracción de dosis absorbida en función de su

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SISTEMA DE CLASIFICACIÓN BIOFARMACÉUTICA BIOFARMACÉUTICA (SCB)

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