The Impact of the Lamination Pressure on the Properties of Electrospinned Nanofibrous Films

The purpose of this work is to explore the preparation of nanofibrous orally dispersible films (ODFs) by needleless electrospinning from the active pharmaceutical ingredient (API) Tadalafil using particles suspended in a solution of polymers and other excipients. The prepared films were characterized by a combination of scanning electron microscopy, mechanical tests, measurements of the disintegration time and dissolution characteristic, X-ray diffraction, and differential scanning calorimetry. Furthermore, we investigated the impact of lamination pressures in the range of 0 to 5 bars combined with films at various relative humidity values on the mechanical properties of the ODF. An increase in lamination pressure resulted in higher Young’s modulus values, with the maximum value observed for a sample laminated at a pressure of 5 bar and the maximum stress and strain of the prepared ODF at a lamination pressure of 1.2 bar. Moreover, there was a significant increase in the disintegration time with increase in lamination pressure. The disintegration time ranged from 0.35 s for non-laminated samples to 12 s for samples laminated at a pressure of 5 bar. On the contrary, the lamination pressure did not reveal to have any impact on the dissolution kinetics. These results confirmed that the lamination pressure can improve the processability of ODFs without affecting the API dissolution kinetics.

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About this article: Dominik Švára, Barbora Kopřivová, Tomáš Picek, Petr Mikeš, Anna Kluk, Miroslav Šoóš,
The Impact of the Lamination Pressure on the Properties of Electrospinned Nanofibrous Films, European Journal of Pharmaceutical Sciences, 2022, 106170, ISSN 0928-0987, https://doi.org/10.1016/j.ejps.2022.106170. (https://www.sciencedirect.com/science/article/pii/S0928098722000550)

Materials
The chemicals used for the preparation of the samples were polyethylene oxide (PEO) with a molecular weight of 100 kDa from Sigma Aldrich (Germany), hydroxypropyl methylcellulose (HPMC E5) from JRS Pharma (Germany) with a molecular weight of 28.7 kDa. Sucrose, sucralose, sodium lauryl sulfate (SDS), and spearmint aroma were purchased from Sigma Aldrich (Germany). Isopropanol (IPA) with a purity of 99.5% was purchased from Penta Chemicals (Czech Republic). Tadalafil, kindly provided by Zentiva k.s., was used as a model drug to examine the effect of the formulation on its behavior. It is used to treat erectile dysfunction, benign prostatic hyperplasia, or pulmonary arterial hypertension, and its formulation in ODFs would be of practical interest. It belongs to the BCS II class of drugs and has pH-independent solubility in water media. Inorganic salts were used to maintain a set value of humidity. The chosen salts were KCl (85% R.H.), NaNO2 (60% R.H.), and MgCl2 (32% R.H.). All salts were purchased from Penta Chemicals (Czech Republic).