İlaç Formülasyonu Geliştirilmesinde Deney Tasarımı (DoE) Seçimi ve Kullanımı

Son yıllarda ilaç formülasyonu geliştirilmesinde deney tasarımı (DoE) kullanımı artmış olmasına rağmen hala yeterli seviyede değildir. Özellikle katı ve yarı-katı dozaj formları gibi birçok bileşeni olan ve çıktılara etkisi bilinmeyen birçok proses parametresinin bulunduğu formülasyonlarda kullanılmasının ne kadar yararlı olduğu bilinmektedir. Ancak formülasyon geliştirmede deneme-yanılma gibi eski yaklaşımlar yerine DoE kullanılması ne kadar önemli ise, bu DoE’nin doğru kullanımı ve seçimi de bir o kadar önemlidir. Doğru seçilmeyen bir DoE tipi veya uygun olmayacak şekilde yapılan deneme ve ölçümler, sadece boşa kaynak ve zaman harcanması ile sonuçlanmaz, çoğu zaman kafa karıştırıcı veya yanıltıcı veriler de üretir. Bu derlemede DoE, uygun DoE tipinin seçimi, istatiksel eleme ile faktör sayısının düşürülmesi ve yanıt yüzeyi modellemesi (RSM) ile ilaç formülasyonlarının optimizasyonu hakkında özet bilgi verilmesi amaçlanmış olup, bu yöntemlerin ilaç formülasyonu geliştirmedeki uygulamalarından da kısaca bahsedilmiştir. Doğru DoE tipinin seçilerek uygulanması sayesinde; gerçekleştirilen az sayıdaki denemelerden çok fazla kaliteli bilgi (matematiksel modeller) üretilebilir. Bu sayede geliştirme süresi ve maliyeti ciddi oranda azaltılabilir. Ayrıca geliştirilen ürün, değişkenliklere karşı hassas olmayan sağlam bir prosese sahip olabilir.

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