La fase di passaggio dal principio attivo alla forma farmaceutica (somministrata al paziente) L una delle tappe fondamentali del percorso che va dalla scoperta di una nuova molecola farmacologicamente attiva alla sua immissione in commercio PRINCIPIO ATTIVO FORMA FARMACEUTICA pdfMachine A pdf writer that produces quality PDF files with ease! Produce quality PDF files in seconds and preserve the integrity of your original documents. Compatible across nearly all Windows platforms, simply open the document you want to convert, click “print”, select the “Broadgun pdfMachine printer” and that’s it! Get yours now!
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La fase di passaggio dal principio attivo alla forma
farmaceutica (somministrata al paziente) è una delle tappe
fondamentali del percorso che va dalla scoperta di una
nuova molecola farmacologicamente attiva alla sua
immissione in commercio
PRINCIPIO ATTIVO
FORMA FARMACEUTICA
id5322906 pdfMachine by Broadgun Software - a great PDF writer! - a great PDF creator! - http://www.pdfmachine.com http://www.broadgun.com
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Si potrà assistere ad ampie fluttuazioni periodiche
dell�attività terapeutica ed alla comparsa di effetti tossici.
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� Il farmaco viene rilasciato in quantità ottimale, al momento opportuno e nel posto giusto?
� E� possibile eliminare o almeno ridurre gli effetti secondari indesiderati?
� Il paziente può facilmente seguire le indicazioni e le posologie prescritte?
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luogo del rilascio del principio attivo, allo scopo di raggiungere determinati obiettivi terapeutici, non ottenibili con le forme farmaceutiche convenzionali (forme farmaceutiche che determinano una pronta liberazione del principio attivo).
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Rilasciare il farmaco in quantitàottimale, al momento opportuno e nel
posto giusto.
Eliminare o almeno ridurre gli effetti indesiderati.
Migliorare la �compliance� del paziente.
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FFRMLa velocità di cessione del sistema deve essere:
Uguale nel tempo e indipendente dalla quantità di farmaco presente (cinetica ordine zero)
Uguale alla velocità di eliminazione
Kc = velocità di cessione = velocità di eliminazione
= Ke Cd Vd
Kc = cost. velocità cessione ordine zero
Ke = cost. velocità eliminaz. primo ordine
Cd = concentrazione farmaco
Vd = volume apparente di distribuzione
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La quantità di farmaco contenuta in una FFRM (Dtot)è costituita da una dose iniziale ceduta
immediatamente per raggiungere la concentrazione terapeutica (Di) e da una dose di mantenimento (Dm)
La dose di mantenimento è uguale al prodotto della velocità di cessione di ordine
zero per la durata dell�azione
Dtot = Di +Kc Td
Dtot = Di + Dm
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Emivita plasmatica breve (3-4), specie se associata ad un basso indice terapeutico
Buona caratteristiche di assorbibilità
Idoneo profilo metabolico
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La sua durata d�azione è in relazione al mantenimento di una certa concentrazione
plasmatica
Non è possibile, a causa di uno sfavorevole indice terapeutico, prolungarne la durata d�azione
aumentando la dose
Non richiede periodi di wash-out frequenti e prolungati
Gli effetti collaterali sono in relazione ad un�elevata concentrazione plasmatica iniziale e/o nel luogo di somministrazione
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� Ad unità singola: consistono in un�unitàsingola che passa senza disgregarsi attraverso il tratto gastrointestinale
� Ad unità multiple: consistono in un�unitàsingola che si disgrega nello stomaco liberando un elevato numero di subunità
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� VELOCITA�: aumento della velocità di dissoluzione o riduzione della velocità di rilascio
� SITO: rilascio in specifiche regioni del tratto gastrointestinale o rallentamento della velocità di transito gastrointestinale
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Sono costituiti da un nucleo centrale contenente il principio attivo sotto forma di dispersione o
sospensione racchiuso da una membrana polimerica
2. FORME FARMACEUTICHE
Vengono realizzati in forma di compresse, capsule o microcapsule
3. POLIMERI IMPIEGATI
Etilcellulosa e idrossipropilcellulosa Acrilati e metacrilatiCopolimeri vinile acetato/etilene
Siliconi
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Facile controllo della cinetica di rilascio mediante i parametri strutturali (equazione diffusionale di Fick)
Impiego di minime dosi di farmaco
Scarso contatto del farmaco con l�ambiente esterno
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Il rilascio è controllato dalla diffusione del farmaco attraverso la parete polimerica che
lo riveste o attraverso il reticolo microporosoche intercala le catene macromolecolari del
polimero
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Non sono adatti al rilascio di farmaci ad elevato PM
�Lag time� e �Burst effect�
La rottura o fessurazione del sistema comporta una massiccia diffusione di farmaco all�esterno
Le tecnologie produttive sono impegnative e costose
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Il principio attivo è omogeneamente disperso in una matrice polimerica.
2. FORME FARMACEUTICHE
Vengono realizzati in forma di compresse.
3. POLIMERI IMPIEGATI
Viene impiegata una vasta gamma di polimeri con differenti caratteristiche chimico-fisiche a
seconda del tipo di matrice che si vuole ottenere
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Facilità di preparazione. Impiego di minime dosi di farmaco
Alti livelli di sicurezza
Possibilità di veicolare principi attivi anche ad alto peso molecolare
6. SVANTAGGI
Difficoltà di ottenere cinetiche di rilascio di ordine zero
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Sono costituite da microparticelle polimeriche la cui struttura è rappresentata da un nucleo centrale di farmaco rivestito da una membrana polimerica.
Sistemi Reservoir
Possono essere mononucleate o polinucleate.
Il nucleo può essere formato da un solido, un liquido
una soluzione o una sospensione. Oltre al principio attivo possono essere presenti stabilizzanti, diluenti, ritardanti o promotori del rilascio.
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Caratteristiche richieste alla membrana polimerica:
� Elevata coesività con il nucleo
� Compatibilità chimico-fisica con il nucleo
� Resistenza, flessibilità, impermeabilità e stabilità
È possibile aggiungere coloranti, plastificanti, edulcoranti, diluenti, e sostanze capaci di modificare il rilascio del principio attivo.
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Sono costituite da microparticelle polimeriche la cui struttura è rappresentata da una matrice polimerica omogenea in cui il farmaco èdisperso (microsfere).
La matrice è di natura polimerica o lipidica
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Le sostanze utilizzate per la preparazione devono essere
� Chimicamente inerti
� Non tossiche
� Biocompatibili
� Biodegradabili
� Facilmente sterilizzabili
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Targeting passivoIntrodotte nell�organismo queste particelle sono identificate
come corpi estranei dal sistema immunitario. La localizzazione a livello dei diversi organi bersaglio può
dipendere Dalle dimensioni Dalla via di somministrazione
Targeting attivoLa superficie viene resa più idrofila e stabilizzata stericamente
legando polimeri idrofili. Per avere selettività verso il sito target si può legare alla particella:
Zuccheri Anticorpi monoclonali
Oppure preparare particelle magnetiche utilizzando colloidi a base di derivati di alluminio, nickel, cobalto, rame,
argento, manganese o platino
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� Conversione di liquidi in pseudosolidi (vitamina E)
� Protezione dall�ambiente esterno (Vit. A)� Riduzione della volatilità� Superamento di incompatibilità
� Mascheramento di odori e sapori� Riduzione di problemi di irritazione
gastrointestinale.
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