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Pertimbangan Biofarmasetika
dalam desain produk obat
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• Pertimbangan farmasetika :
Dosis
Bentuk sediaan
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Rate limiting steps padaabsorpsi obat
Proses absorpsi sistemik :
1. Desintegrasi produk obat
2. Dissolusi obat dalam lingkungan berair3. Absorpsi melintasi membran masuk ke
sirkulasi sistemik
Rate limiting step merupakan tahapan yglambat dalam satu seri proses kinetika
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Faktor-faktor farmasetika ygmempengaruhi bioavailabilitas obat
Seorang farmasis harus mempertimbangkanhal-hal berikut dalam menetukanmendesain produk obat :
• Tipe produk obat
• Sifat-sifat exipients dalam produk obat
•
Sifat-sifat fisikokimia molekul obat
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• Beberapa faktor :
Desintegrasi : merupakan kualiti kontroldalam pembuatan tablet
Dissolusi : merupakan suatu proses dimanaobat melarut dalam pelarutnya.
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Persamaan Noyes dan whitney
dC DAK
---- = ------ ( Cs – C )
dt h
dC/dt = laju dissolusi
D = konstanta laju difusi
A = luas permukaan partikel
K = koefisien partisi
Cs = konsentrasi obat dalam lapisan stagnant
C = konsentrasi obat dalam bulk solvent
h = ketebalan lapisan stagnant
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Faktor yg mempengaruhi disolusi
• Sifat fisikokimia obat
luas permukaan, bentuk geometrik partikel
obat, dll• Faktor formulasi yg mempengaruhi
disolusi
excipient, proses manufaktur, dll
• Faktor lingkungan
pH, temperatur, viskositas, dll
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Perimbangan biofarmasetika1. Pertimbangan farmakodinamik:
– efek terapeutik yg dituju
– Efek toksik
– Efek samping
2. Pertimbangan obat :
• Sifat fisikokima bahan obat
3. Pertimbangan produk obat :
– Farmakokinetika obat
– Bioavailabilitas obat
– Rute pemberian obat
– Bentuk sediaan yg diinginkan
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4. Pertimbangan pasien
– Kecocokan dan penerimaan produk obat
– Harga
5. Pertimbangan manufaktur :
– Harga
– Ketersediaan raw material
– Stabilitas
– Kontrol kualitas
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Pertimbangan utama
1. Keamanan2. Efikasi
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