Party Petra, Ambrus Rita
Faculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös Street 6, 6720 Szeged, Hungary.
Micromachines (Basel). 2023 Jun 30;14(7):1348. doi: 10.3390/mi14071348.
Pulmonary drug transport has numerous benefits. Large surface areas for absorption and limited drug degradation of the gastrointestinal system are provided through the respiratory tract. The administration is painless and easy for the patient. Due to their better stability when compared to liquid formulations, powders have gained popularity among pulmonary formulations. In the pharmaceutical sector, quality assurance and product stability have drawn a lot of attention. Due to this, it was decided to perform a long-term stability study on a previously developed, nanosized dry powder inhaler (DPI) formulation that contained meloxicam. Wet milling was implemented to reduce the particle size, and nano spray-drying was used to produce the extra-fine inhalable particles. The particle diameter was determined using dynamic light scattering and laser diffraction. Scanning electron microscopy was utilized to describe the morphology. X-ray powder diffraction and differential scanning calorimetry were applied to determine the crystallinity. In an artificial lung medium, the in vitro dissolution was studied. The Andersen Cascade Impactor was used to investigate the in vitro aerodynamic characteristics. The stability test results demonstrated that the DPI formulation maintained its essential qualities after 6 and 12 months of storage. Consequently, the product might be promising for further studies and development.
肺部药物输送有诸多益处。呼吸道提供了用于吸收的大表面积以及胃肠道系统中有限的药物降解。给药对患者而言无痛且简便。与液体制剂相比，粉末制剂稳定性更佳，因而在肺部制剂中颇受青睐。在制药领域，质量保证和产品稳定性备受关注。因此，决定对先前研发的含美洛昔康的纳米级干粉吸入剂（DPI）制剂开展长期稳定性研究。采用湿磨法降低粒径，并使用纳米喷雾干燥法制备超细微可吸入颗粒。通过动态光散射和激光衍射测定粒径。利用扫描电子显微镜描述形态。应用X射线粉末衍射和差示扫描量热法测定结晶度。在人工肺介质中研究体外溶出度。使用安德森级联撞击器研究体外空气动力学特性。稳定性测试结果表明，DPI制剂在储存6个月和12个月后仍保持其基本品质。因此，该产品有望用于进一步的研究和开发。
