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Development and characterization of trimethobenzamide hydrochloride containing orally disintegrating tablets
Journal of Drug Delivery Science and Technology ( IF 4.5 ) Pub Date : 2023-09-19 , DOI: 10.1016/j.jddst.2023.104980
Ozge Didem Uluhan , Tugba Gulsun , Selma Sahin

Orally disintegrating tablets have been developed to rapidly disintegrate in saliva within seconds after administration, without the need for drinking water or any specific administration conditions. Therefore, they are more suitable dosage forms than conventional tablets for use in patients with swallowing difficulties or neurological diseases, pediatric and geriatric patients. Nausea and vomiting are diseases that are common in the clinic and limit the daily life of the patients. Trimethobenzamide hydrochloride is an antiemetic drug widely used in the acute treatment of nausea and vomiting. In this study, orally disintegrating tablet formulations of trimethobenzamide hydrochloride were developed using direct compression and freeze-drying techniques. Physicochemical characterization studies were carried out on the developed formulations. All formulations except F4, F8, F11 and F12 were disintegrated within 3 min in both distilled water and simulated saliva (pH 6.8). Permeability studies across Caco-2 cell lines proved that excipients used in the formulations increased the permeability of trimethobenzamide hydrochloride. Based on the results, it can be concluded that, trimethobenzamide hydrochloride containing orally disintegrating tablets may be beneficial in patients where rapid onset of action is required.



中文翻译:

盐酸三甲氧苯甲酰胺口腔崩解片的研制及表征

口腔崩解片已被开发成在给药后数秒内在唾液中快速崩解,无需饮用水或任何特定的给药条件。因此,它们是比常规片剂更适合吞咽困难或神经系统疾病患者、儿童和老年患者使用的剂型。恶心、呕吐是临床常见病,限制了患者的日常生活。盐酸三甲苯甲酰胺是一种止吐药,广泛用于急性恶心和呕吐的治疗。在本研究中,采用直接压片和冷冻干燥技术开发了盐酸三甲氧苯甲酰胺口腔崩解片制剂。对开发的制剂进行了物理化学特性研究。除 F4、F8、F11 和 F12 外,所有制剂均在蒸馏水和模拟唾液(pH 6.8)中于 3 分钟内崩解。Caco-2 细胞系的渗透性研究证明,制剂中使用的赋形剂增加了盐酸三甲氧苯甲酰胺的渗透性。基于这些结果,可以得出结论,含有盐酸甲氧苯甲酰胺的口腔崩解片对于需要快速起效的患者可能是有益的。

更新日期:2023-09-19
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