20.500.12556/RUL-148360 Application of quality by design principles to the development of oral lyophilizates containing olanzapine Oral lyophilizates are intended for application to the oral cavity or for dispersing in water. The purposes of this research were: (i) to set up the quality by design approach in the development of oral lyophilizates for drug incorporation; and (ii) to evaluate the established approach by comparing its outcomes with experimentally obtained results. Within the knowledge space, properties about drugs, excipients, and the lyophilization process were acquired, followed by the determination of critical quality attributes via risk identification. Risks were assessed by failure mode and effective analysis, which recognized critical material attributes, i.e., type, concentration, particle size, solubility of drug and excipients, while as main critical process parameters, cooling rate, shelf temperature, and chamber pressure during drying were pointed out. Additionally, design space was established using the Minitab$^®$ 17 software and valued with an 88.69% coefficient of determination. A detailed comparison between the model and experimental results revealed that the proposed optimal compositions match in the total concentration of excipients (6%, w/w) in the pre-lyophilized liquid formulation, among which mannitol predominates. On the other hand, a discrepancy regarding the presence of gelatin was detected. The conclusion was that the set model represents a suitable onset toward optimization of drug-based oral lyophilizates development, preventing unnecessary investment of time and resources. oral lyophilizate lyophilization quality by design disintegration time Minitab$^®$ peroralni liofilizati liofilizacija kakovost po zasnovi čas razpadanja Minitab$^®$ sušenje farmacevtska tehnologija true false true Angleški jezik Slovenski jezik Članek v reviji 2023-08-18 11:19:05 2023-08-18 11:19:10 2023-08-24 12:03:19 0000-00-00 00:00:00 2023 0 0 16 str. iss. 7, art. 1967 Vol. 15 2023 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 542.47:661.12 1999-4923 10.3390/pharmaceutics15071967 160781059 pharmaceutics-15-01967-v2.pdf pharmaceutics-15-01967-v2.pdf 1 B140DFBBA6F6F019E8400C24BF47A2F5 189dcba7bbb0002f5d4065ce4a79397523284764855d3a15c541fa731d35e1e6 88f6ab2b-3da8-11ee-b9d7-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=172534 https://www.mdpi.com/1999-4923/15/7/1967 1 4622a2cf-3da8-11ee-b9d7-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=172533 Fakulteta za farmacijo 0 0 0