Janigová Natália, Elbl Jan, Pavloková Sylvie, Gajdziok Jan
Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University, Palackeho Trida 1946/1, 612 00 Brno, Czech Republic.
Pharmaceutics. 2022 Jan 21;14(2):250. doi: 10.3390/pharmaceutics14020250.
Orodispersible films are an innovative dosage form. Their main advantages are the application comfort and the possibility of personalization. This work aimed to evaluate the influence of different drying times on the properties of orodispersible films of various thicknesses, prepared in two different semisolid extrusion 3D printing setups. In the first experiment, drying times were dependent on the overall print time of each batch. In the second setup, the drying time was set equal according to the longest one. The evaluated parameters were films' weight uniformity, thickness, moisture content, surface pH, disintegration time, hardness, and tensile strength. Upon statistical comparison, significant differences in the moisture content were found, subsequently affecting the disintegration time. Moreover, statistically significant differences in films' mechanical properties (hardness, tensile strength) were also described, proving that moisture content simultaneously affects film plasticity and related properties. In conclusion, a mutual comparison of the manufactured orodispersible films showed that the drying time affects their physical and mechanical properties. The in-process drying setup was proved to be sufficient while allowing quicker manufacturing.
口腔崩解膜是一种创新剂型。它们的主要优点是使用舒适且具有个性化的可能性。本研究旨在评估不同干燥时间对在两种不同的半固体挤出3D打印设置中制备的各种厚度口腔崩解膜性能的影响。在第一个实验中,干燥时间取决于每批的总打印时间。在第二个设置中,根据最长的干燥时间将其设置为相等。评估的参数包括膜的重量均匀性、厚度、水分含量、表面pH值、崩解时间、硬度和拉伸强度。经统计比较,发现水分含量存在显著差异,随后影响了崩解时间。此外,还描述了膜的机械性能(硬度、拉伸强度)的统计学显著差异,证明水分含量同时影响膜的可塑性和相关性能。总之,对制备的口腔崩解膜进行相互比较表明,干燥时间会影响其物理和机械性能。过程中的干燥设置被证明是足够的,同时允许更快的制造。