Łyszczarz Ewelina, Brniak Witold, Szafraniec-Szczęsny Joanna, Majka Tomasz M, Majda Dorota, Zych Marta, Pielichowski Krzysztof, Jachowicz Renata
Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University Medical College, Medyczna 9, 30-688 Cracow, Poland.
Department of Chemistry and Technology of Polymers, Faculty of Chemical Engineering and Technology, Cracow University of Technology, Warszawska 24, 31-155 Cracow, Poland.
Pharmaceutics. 2021 Jul 22;13(8):1122. doi: 10.3390/pharmaceutics13081122.
Orodispersible films (ODFs) address the needs of pediatric and geriatric patients and people with swallowing difficulties due to fast disintegration in the mouth. Typically, they are obtained using the solvent casting method, but other techniques such as 3D printing and electrospinning have already been investigated. The decision on the manufacturing method is of crucial importance because it affects film properties. This study aimed to compare electrospun ODFs containing aripiprazole and polyvinyl alcohol with films prepared using casting and 3D printing methods. Characterization of films included DSC and XRD analysis, microscopic analysis, the assessment of mechanical parameters, disintegration, and dissolution tests. Simplified stability studies were performed after one month of storage. All prepared films met acceptance criteria for mechanical properties. Electrospun ODFs disintegrated in 1.0 s, which was much less than in the case of other films. Stability studies have shown the sensitivity of electrospun films to the storage condition resulting in partial recrystallization of ARP. These changes negatively affected the dissolution rate, but mechanical properties and disintegration time remained at a desirable level. The results demonstrated that electrospun fibers are promising solutions that can be used in the future for the treatment of patients with swallowing problems.
口腔崩解片（ODFs）可满足儿科和老年患者以及因吞咽困难的人群的需求，因为它们在口腔中能快速崩解。通常，它们是通过溶剂浇铸法制备的，但其他技术如3D打印和静电纺丝也已被研究。制造方法的选择至关重要，因为它会影响薄膜的性能。本研究旨在比较含阿立哌唑和聚乙烯醇的静电纺丝ODFs与采用浇铸和3D打印方法制备的薄膜。薄膜的表征包括DSC和XRD分析、显微镜分析、力学参数评估、崩解和溶出试验。储存一个月后进行了简化的稳定性研究。所有制备的薄膜均符合力学性能的验收标准。静电纺丝ODFs在1.0秒内崩解，这比其他薄膜的崩解时间短得多。稳定性研究表明，静电纺丝薄膜对储存条件敏感，导致阿立哌唑部分重结晶。这些变化对溶出速率产生了负面影响，但力学性能和崩解时间仍保持在理想水平。结果表明，静电纺丝纤维是一种很有前景的解决方案，未来可用于治疗吞咽困难的患者。
