Amaç: Bu tasarım çalışması "International Conference on Harmonization" rehberleri kapsamındaki tasarımda kalite yaklaşımı çerçevesinde uygulanmıştır. Yapay sinir ağları (ANN) kullanılarak ketiapin fumaratın değiştirilmiş salımlı tablet formülasyonunun kalitesi değerlendirilmiş ve referans ürüne benzer olan yeni bir formülasyon tespit edilmiştir. Gereç ve Yöntemler: On iki farklı formül üretilmiş ve test edilmiştir. Referans ürünün analiz sonuçları ve deneysel sonuçlarımız çıktı olarak Intelligensys Ltd. şirketine ait programlarında ANN'nin eğitimi için kullanılmıştır. Bulgular: INForm V.4 ANN programı tarafından önerilen yeni bir formülasyon (F13) ile gastrointestinal sistemdeki üç farklı pH da çözünme testleri yapılmıştır. Bu formülasyonun uygunluğu da f2 benzerlik testi sonuçları karşılaştırılarak doğrulanmıştır. Sonuç: Bu programların kullanılması, çoklu değerlendirme yöntemleri ve daha düşük maliyetle Ar-Ge süreçlerini desteklemekte ve alternatif formülasyonlar daha hızlı tespit edilebilmektedir. Anahtar kelimeler: Ketiapin fumarat, tasarımda kalite, yapay sinir ağları, bulanık mantık, uzatılmış salım tabletler, yaş granülasyon Objectives: This design study was implemented within the scope of the quality by design approach, which included the "International Conference on Harmonization" guidelines. We evaluated the quality of a modified-release tablet formulation of quetiapine fumarate, which was designed using artificial neural networks (ANN), and determined a new formulation that was similar to the reference product. Materials and Methods: Twelve different formulations were produced and tested. The reference product's results and our experimental results were used as outputs for the training of the ANN programs of Intelligensys Ltd. Results: Dissolution tests were performed with the new formulation (F13) suggested by the INForm V.4 ANN program in three different pHs of the gastrointestinal system. The compliance of this formulation was confirmed by comparing the results with an f2 similarity test. Conclusion: Use of these programs supports research and development processes with multiple evaluation methods and alternative formulations may be determined faster and at lower cost.

Edible mushrooms aside being taken as foods, are used in ethnomedicine in the management of various ailments notably tumours and related ailments whose pathophysiology are linked to oxidative stress. This study investigated the anti-mitotic, and antibacterial activities of the aqueous extract of the edible mushroom Pleurotus ostreatus based on ethno-medicine.The Allium cepa anti-mitotic assay model was used for anti-proliferative investigation of the defatted aqueous ethanol extract at concentration range of: 10.00 -0.08 ng/mL following a two-fold serial dilution approach. Methotrexate (0.25 ng/mL) and portable water were used as reference standard for positive control and negative control respectively. The student t-test was used for statistical analysis (p < 0.05). Antibacterial susceptibility evaluation against clinical isolates of selected pathogenic organisms: Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumonia, Staphylococcus aereus, and Bacillus subtilis was done using the Agar dilution method at 1000 and 10 µg/mL. The aqueous extract showed a dose and time dependent anti-mitotic activity with the three higher doses: 10.00, 5.00 and 2.50 ng/mL exhibiting complete inhibition of mitosis which was comparable to the reference drug methotrexate (0.25 ng/mL) after 96 hours incubation period. Although the aqueous extract was not bacteriocidal at the test concentration, a dose dependent bacteriostatic effect against E. coli, and B. subtilis was observed. The observed anti-mitotic activity of this mushroom validates its ethnomedicinal use in the treatment of tumours and related diseases.