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Application of quality by design principles to the development of oral lyophilizates containing olanzapine [Elektronski vir]Bjelošević Žiberna, Maja ; Ahlin Grabnar, PegiOral 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.Source: Pharmaceutics [Elektronski vir]. - ISSN 1999-4923 (Vol. 15, iss. 7, art. 1967, 2023, 16 str.)Type of material - e-article ; adult, seriousPublish date - 2023Language - englishCOBISS.SI-ID - 160781059
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Author | Bjelošević Žiberna, Maja ; Ahlin Grabnar, Pegi |
Title | Application of quality by design principles to the development of oral lyophilizates containing olanzapine [Elektronski vir] |
Publication date | 2023-07-17 |
COBISS.SI-ID | 160781059 |
Publication version in repository | Publisher's version |
Publication licence | Creative Commons Attribution 4.0 International |
Embargo | Immediate publication for public |
Project(s) from which the publication was funded
Title | Acronym | Project ID | Funder |
---|---|---|---|
Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih | P1-0189-2018 |
Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije |
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Razvoj visokokoncentriranih proteinskih formulacij in vrednotenje kinetike absorpcije po subkutani aplikaciji | L1-3160-2021 |
Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije |
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Bjelošević Žiberna, Maja | 38497 |
Ahlin Grabnar, Pegi | 15490 |
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