Abstract：
The development of oral pediatric forms by pharmaceutical companies is still insufficient. In fact, many drugs used in paediatric oncology, such as temozolomide, are not labeled and adapted for paediatric use. Temozolomide (TMZ) is an alkylating agent used as the standard of care for many adult and pediatric brain tumours, such as neuroblastoma, glioblastoma and medulloblastoma. The present study was carried out to propose a suitable and palatable formulation of the oral liquid preparation of TMZ. The suspension is composed of TMZ suspended in SyrSpend SF pH 4, as well as TMZ crystallization stabilizing agents and sweetening agents. To reach this formulation, several taste-masking agents were evaluated. Here, we describe the method of preparation of the formation as well as the monocentric population treated with the formulation over a 5-year period. A 20 mg/mL TMZ suspension was developed. TMZ suspension is stable for 6 weeks, stored between 2 and 8 degrees, protected from light, and compatible with nasogastric tubes. Thirty-eight patients participated in the palatability study and choose cola flavour, and 104 patients were treated in Gustave Roussy with the developed suspension; no unexpected event was reported. To conclude, we propose here a new TMZ liquid formulation which is stable for at least 6 weeks and well-tolerated with extensive feedback.
摘要：
制药公司对口服儿科形式的开发仍然不足。事实上,许多用于儿科肿瘤的药物，如替莫唑胺，没有标签，也不适合儿科使用。替莫唑胺（TMZ）是一种烷化剂，用作许多成人和小儿脑肿瘤的护理标准，比如神经母细胞瘤，胶质母细胞瘤和髓母细胞瘤。进行本研究以提出合适且适口的TMZ口服液体制剂。悬浮液由悬浮在SyrSpendSFpH4中的TMZ以及TMZ结晶稳定剂和甜味剂组成。为了达到这个提法，评估了几种掩味剂。这里,我们描述了地层的制备方法以及在5年内用该制剂处理的单中心种群。开发了20mg/mLTMZ悬浮液。TMZ悬浮液稳定6周，储存在2到8度之间，避光保护，与鼻胃管相容。38名患者参加了适口性研究并选择了可乐口味，104例患者在GustaveRoussy中使用已开发的悬浮液进行治疗;未报告意外事件。最后，我们在此提出了一种新的TMZ液体制剂，该制剂稳定至少6周，并且在广泛的反馈下具有良好的耐受性。
