...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>International Journal of Pharmaceutics >Development of a novel combination tablet containing trimebutine maleate and mosapride citrate for the treatment of functional dyspepsia.
【24h】

Development of a novel combination tablet containing trimebutine maleate and mosapride citrate for the treatment of functional dyspepsia.

机译：包含马来酸曲美布汀和柠檬酸莫沙必利的新型组合片剂的开发，用于治疗功能性消化不良。

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

To develop a novel combination tablet which contained 100 mg trimebutine maleate and 5 mg mosapride citrate (TMCT) for the treatment of functional dyspepsia, the wet granulation method was used to prepare TMCTs with various amounts of diluents and stabilizers. The levels of impurities, the stability and the dissolution of the TMCTs were investigated. The oral bioavailability of drugs in the TMCTs was then evaluated and compared to the simultaneous oral administration of trimebutine maleate-loaded and mosapride citrate-loaded commercial products in the beagle dog. Among the diluents tested, D-mannitol was selected, since the microcrystalline cellulose and lactose did not inhibit the production of drug impurities due to their hygroscopic properties and chemical interactions, respectively. Furthermore, succinic acid was selected as the stabilizer because it gave the lowest level of total drug impurities of the organic acids tested. The combination tablet of trimebutine maleate and mosapride citrate prepared with D-mannitol and succinic acid gave a total drug content higher than 95% and total impurities lower than 0.5% at 25 degrees C/60% RH and 40 degrees C/75% RH during a 6-month period, indicating that the tablets were stable for at least 6 months. Furthermore, this combination tablet showed a similar dissolution to the trimebutine maleate-loaded and mosapride citrate-loaded commercial products and gave insignificantly different absorption compared to these commercial products in beagle dogs. Thus, the combination tablet of trimebutine maleate and mosapride citrate prepared with D-mannitol and succinic acid would be a stable and effective oral pharmaceutical product for the treatment of functional dyspepsia.
机译：为了开发一种包含100 mg马来酸曲美布汀和5 mg柠檬酸莫沙必利（TMCT）的新型组合片剂，用于治疗功能性消化不良，采用湿法制粒的方法制备了具有各种稀释剂和稳定剂的TMCT。研究了杂质含量，TMCT的稳定性和溶解度。然后评估TMCTs中药物的口服生物利用度，并将其与比格犬同时口服马来酸曲美布汀和柠檬酸莫沙必利的商品同时口服给药。在测试的稀释剂中，选择D-甘露醇是因为微晶纤维素和乳糖分别由于其吸湿性和化学相互作用而不会抑制药物杂质的产生。此外，选择琥珀酸作为稳定剂是因为它使所测试的有机酸中的总药物杂质含量最低。用D-甘露醇和琥珀酸制备的马来酸曲美布汀和柠檬酸莫沙必利的组合片剂在25摄氏度/ 60％相对湿度和40摄氏度/ 75％相对湿度下的总药物含量高于95％，总杂质低于0.5％ 6个月的时间，表明该片剂至少可稳定6个月。此外，这种组合片剂显示出与负载马来酸曲美布汀和负载莫沙必利柠檬酸盐的商业产品相似的溶出度，并且与这些商业产品相比在比格犬中的吸收没有明显差异。因此，用D-甘露醇和琥珀酸制备的马来酸曲美布汀和柠檬酸莫沙必利的组合片剂将是用于治疗功能性消化不良的稳定和有效的口服药物产品。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号