Patterlini Virginia, Guareschi Fabiola, D'Angelo Davide, Baldini Simone, Meto Suada, Mostafa Kamal Dalia, Fabrizzi Paolo, Buttini Francesca, Mösges Ralph, Sonvico Fabio
Dipartimento di Scienze Degli Alimenti e del Farmaco, Università di Parma, Parco Area delle Scienze 27/A, 43124 Parma, Italy.
Menarini Group, Via Sette Santi 1-3, 50131 Florence, Italy.
Pharmaceutics. 2024 Jul 26;16(8):989. doi: 10.3390/pharmaceutics16080989.
The deposition, residence time, and dissolution profile of nasal suspensions containing corticosteroids play a key role in their in vivo efficacy after administration. However, the conventional methods available to characterize nasal products appear to be unsuitable to exhaustively cover these aspects. The work aims to investigate technological aspects of Ryaltris (mometasone furoate and olopatadine hydrochloride nasal spray) compared to other commercial anti-allergic nasal products, namely, Dymista (azelastine hydrochloride and fluticasone propionate), Nasonex (mometasone furoate), and Avamys (fluticasone furoate). Innovative characterization methods were combined with more traditional approaches to investigate the anti-allergic nasal sprays. These methods applied together allowed to differentiate between the different products and provided a clear picture of the nasal product behavior in terms of drug dissolution and deposition. In particular, the dissolution tests were performed exploiting the Respicell apparatus, an innovative technique that allows for the investigation of inhalation products. Then, formulation viscosities were considered along with a formulation flow test on an inclined plane. Finally, the intranasal deposition profile of the commercial formulations was determined using a silicon nasal cast. The results highlight in vitro significant differences in terms of viscosity as well as dissolution rate of the nasal products, with Ryaltris showing a higher viscosity and lower flow compared to other products, which, along with a corticosteroid faster dissolution rate than Dymista, suggest a potential advantage in terms of clinical behavior.
含皮质类固醇的鼻用混悬剂的沉积、驻留时间和溶解曲线在给药后的体内疗效中起着关键作用。然而，现有的用于表征鼻用产品的常规方法似乎不适用于全面涵盖这些方面。这项工作旨在研究与其他市售抗过敏鼻用产品（即，Dymista（盐酸氮卓斯汀和丙酸氟替卡松）、Nasonex（糠酸莫米松）和Avamys（糠酸氟替卡松））相比，Ryaltris（糠酸莫米松和盐酸奥洛他定鼻喷雾剂）的技术方面。将创新的表征方法与更传统的方法相结合来研究抗过敏鼻喷雾剂。这些方法一起应用能够区分不同的产品，并在药物溶解和沉积方面清晰呈现鼻用产品的行为。特别是，利用Respicell装置进行了溶解试验，这是一种用于研究吸入产品的创新技术。然后，考虑了制剂粘度以及在斜面上的制剂流动试验。最后，使用硅制鼻模确定了市售制剂的鼻内沉积曲线。结果突出显示了鼻用产品在粘度以及溶解速率方面的体外显著差异，与其他产品相比，Ryaltris显示出更高的粘度和更低的流动性，这与一种皮质类固醇比Dymista更快的溶解速率一起，表明在临床行为方面具有潜在优势。
