Dadkhah Adrin, Gutowski Tobias, Wansing Eva-Maria, von Hugo Alexander, Woessmann Wilhelm, Winkler Beate, Franke Gefion, Baehr Michael, Langebrake Claudia
University Medical Center Hamburg-Eppendorf, Hospital Pharmacy, Hamburg, Germany.
University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation, Hamburg, Germany.
Int J Pharm X. 2025 Aug 22;10:100380. doi: 10.1016/j.ijpx.2025.100380. eCollection 2025 Dec.
Dexamethasone (Dexa) is widely used for the prophylaxis of chemotherapy-induced nausea and vomiting. In pediatric patients, individual dosing often requires the manipulation of commercial tablets, leading to dose inaccuracies, higher treatment complexity and poor acceptance due to Dexa's intensely bitter taste. This study aimed to develop 3D-printed chewable Dexa tablets with effective taste masking for pediatric oncology. Tablets were produced using semi-solid extrusion (SSE). The impact of excipients on printability and taste masking was evaluated, and the thermal stability of Dexa was assessed using DSC and TGA. Further assessments included disintegration, in vitro dissolution, content and mass uniformity, short-term stability and a sensory evaluation in healthy adult volunteers. The tablets demonstrated excellent uniformity of mass (average RSD 0.75 %) and API content (99.35 % ± 2.92 %). Disintegration times ranged from 96 s (2 mg) to 733 s (12 mg). Complete drug release was achieved within 2 h. Thermal analysis showed no degradation of Dexa, and storage stability was confirmed for at least 5 weeks. A substantial reduction in bitterness was observed. In conclusion, SSE enabled the reproducible production of child-appropriate, individually dosed Dexa chewable tablets with effective taste masking, supporting their clinical application in pediatric oncology.
地塞米松（Dexa）广泛用于预防化疗引起的恶心和呕吐。在儿科患者中，个体化给药通常需要对市售片剂进行处理，这会导致剂量不准确、治疗复杂性增加，且由于地塞米松味道极苦，患者接受度较差。本研究旨在开发用于儿科肿瘤学的具有有效掩味功能的3D打印可咀嚼地塞米松片剂。采用半固体挤出（SSE）法制备片剂。评估了辅料对可打印性和掩味的影响，并使用差示扫描量热法（DSC）和热重分析法（TGA）评估了地塞米松的热稳定性。进一步的评估包括崩解、体外溶出、含量和质量均匀性、短期稳定性以及在健康成年志愿者中的感官评价。这些片剂表现出优异的质量均匀性（平均相对标准偏差0.75%）和原料药含量（99.35%±2.92%）。崩解时间从96秒（2毫克）到733秒（12毫克）不等。在2小时内实现了药物的完全释放。热分析表明地塞米松没有降解，并且证实其储存稳定性至少为5周。苦味明显降低。总之，半固体挤出法能够可重复生产适合儿童的、个体化给药的具有有效掩味功能的地塞米松可咀嚼片剂，支持其在儿科肿瘤学中的临床应用。
