ÖZET
Bilim ve teknolojideki ilerlemelere bağlı olarak tedavide kullanılan ürünler incelendiğinde oftalmolojinin yenilikçi ilaçların, tıbbi cihazların ve ilaç-tıbbi cihaz kombinasyon ürünlerinin araştırma-geliştirme, preklinik ve klinik çalışmalarının yapıldığı öncelikli bir konumda yer aldığı gözlenmektedir. Oküler uygulamalarda ilaçların absorpsiyonu arttırmak, metabolizma ve eliminasyonu azaltmak, oküler doku ve kompartmanlarda kalış sürelerini uzatmak ve oküler bariyerleri aşmak amacıyla geliştirilen taşıyıcı sistemler arasında lipozomlar, miseller, nanoemülsiyonlar, nanopartiküller gibi kolloidal yapıda ya da göz içine yerleştirilen implant şeklinde kontrollü salım sağlayan sistemler bulunmaktadır. Ayrıca gen ya da hücre kökenli sistemlerin kullanıldığı daha karmaşık yapıda, ileri tedaviler kapsamında olan risk düzeyi yüksek ürünler ile araştırmalar yapılmaktadır. Bu derlemede oküler ilaç, gen ve hücresel taşıyıcı sistemler, bunlar ile ilişkili olan ürünler ve ileri tedavi tıbbi ürünlerindeki gelişmeler, ilacın (tıbbi ürünün) tanımı ve yasal düzenlemelerdeki güncel değişiklikleri göz önüne alan, bir bakış açısı ile sunulmaktadır.
Anahtar Kelimeler:
Oküler taşıyıcı sistemler, oküler gen ve hücresel taşıyıcı sistemler, kolloidal ilaç ve gen taşıyıcı sistemler, ileri tedavi tıbbi ürünleri, ulusal ve uluslararası mevzuat
Sonuç
Tedaviye sunuluşuna kadar geçen sürenin oldukça uzun olduğu bilinen lipozomlar ile başlatılan ilaç taşıyıcı sistemler kapsamındaki çalışmalardan, günümüzde hücrenin kendisinin ilaç, biyolojik tıbbi ürün ve ileri tedavi tıbbi ürünü olduğu veya rejeneratif tıpta ileri tedavi ilacı statüsü verildiği ve rejeneratif ilaç olarak tanımlandığı ileri aşamalara ulaşılmıştır. Bu süreçte kolloidal taşıyıcı sistemler olarak bilinen lipozom ve nanopartikül gibi dozaj şekilleri günümüzde “nanoilaçlar” ya da “nanofarmasötikler” olarak isimlendirilmiş ve nanoteknoloji alanında yer almıştır. Farklı yapıdaki ürünler ile göz hastalıklarının tedavisi için yeni nanoilaçların geliştirilmesi çalışmaları sürdürülmekte ve oküler implantlar tedavide kullanılmaktadır. Yüksek moleküler ağırlıklı ilaçların salımını sağlayan hücreleri içeren sistemler ve ileri tedavi tıbbi ürünleri kapsamında çalışmalar devam etmekte ve göz hastalıklarının tedavisi önceliği korumaktadır.
Risk taşıyan farklı yapıdaki nanoilaçların, gen ve hücresel taşıyıcı sistemlerin ve ileri tedavi tıbbi ürünlerinin geliştirildiği ve klinik araştırmaların devam ettiği bu süreç ulusal ve uluslararası yasal düzenlemelerin değiştiği ve harmonize edildiği bir dönemi içermektedir. Kronik hastalıklarda veya tedavi edilemeyen göz hastalıklarında ihtiyacın karşılanması için bir ümit oluşturan ve özellikle çok işlem gören hücrelerden elde edilerek, yüksek risk taşıyan ilaçların geliştirilmesinde ulusal ve uluslararası yasal düzenlemelere uyum önem taşımaktadır. Bu ürünlerin Ar-Ge’den kliniğe daha hızlı geçişinde geliştirme aşamalarında farmasötik kalite güvencelerinin sağlanarak üretimleri kritik bir basamağı oluşturmaktadır. Bu bağlamda farmasötik kalite sistemlerinin yasal gereksinimlerini karşılayan iyi imalat uygulamaları koşularına sahip alt yapıların öncelikle oluşturulmasına ve mültidisipliner araştırma ekibine ihtiyaç duyulmaktadır.
Etik
Hakem Değerlendirmesi: Editörler kurulu tarafından değerlendirilmiştir.
Yazarlık Katkıları
Konsept: Türkan Eldem, Dizayn: Türkan Eldem, Veri Toplama veya İşleme: Türkan Eldem, Analiz veya Yorumlama: Türkan Eldem, Bora Eldem, Literatür Arama: Türkan Eldem, Yazan: Türkan Eldem, Bora Eldem.
Çıkar Çatışması: Türkan Eldem bir patent (TR 199701683B, TPE 2005) sahibi olup, başka bir çıkar çatışması bildirmemiştir. Bora Eldem Novartis, Bayer, Allergan ve Thea danışmanlığını yapmaktadır.
Finansal Destek: Yazarlar bu derleme çalışması için finansal destek almadıklarını bildirilmiştir.
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