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Influences of Sodium Carbonate on Physicochemical Properties of Lansoprazole in Designed Multiple Coating Pellets

机译:碳酸钠对兰索拉唑在设计的多层包衣微丸中理化性质的影响

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摘要

Lansoprazole (LSP), a proton-pump inhibitor, belongs to class II drug. It is especially instable to heat, light, and acidic media, indicating that fabrication of a formulation stabilizing the drug is difficult. The addition of alkaline stabilizer is the most powerful method to protect the drug in solid formulations under detrimental environment. The purpose of the study was to characterize the designed multiple coating pellets of LSP containing an alkaline stabilizer (sodium carbonate) and assess the effect of the stabilizer on the physicochemical properties of the drug. The coated pellets were prepared by layer–layer film coating with a fluid-bed coater. In vitro release and acid-resistance studies were carried out in simulated gastric fluid and simulated intestinal fluid, respectively. Furthermore, the moisture-uptake test was performed to evaluate the influence of sodium carbonate on the drug stability. The results indicate that the drug exists in the amorphous state or small (nanometer size) particles without crystallization even after storage at 40°C/75% for 5 months. The addition of sodium carbonate to the pellet protects the drug from degradation in simulated gastric fluid in a dose-dependent manner. The moisture absorbed into the pellets has a detrimental effect on the drug stability. The extent of drug degradation is directly correlated with the content of moisture absorption. In conclusion, these results suggest that the presence of sodium carbonate influence the physicochemical properties of LSP, and the designed multiple coating pellets enhance the drug stability.
机译:质子泵抑制剂Lansoprazole(LSP)属于II类药物。它对于热,光和酸性介质尤其不稳定,这表明难以制备稳定药物的制剂。添加碱性稳定剂是在有害环境下保护固体制剂中药物的最有效方法。该研究的目的是表征包含碱性稳定剂(碳酸钠)的LSP的多个包衣药丸的特性,并评估稳定剂对药物理化性质的影响。包衣的小丸是用流化床包衣机进行层层薄膜包衣制备的。分别在模拟胃液和模拟肠液中进行了体外释放和抗酸研究。此外,进行吸湿试验以评估碳酸钠对药物稳定性的影响。结果表明,即使在40°C / 75%下存储5个月后,该药物也以无定形状态存在或小(纳米大小)颗粒而没有结晶。将碳酸钠添加到药丸中可以防止药物以剂量依赖的方式在模拟胃液中降解。吸收到药丸中的水分对药物稳定性有不利影响。药物降解的程度与吸湿量直接相关。总之,这些结果表明碳酸钠的存在会影响LSP的理化性质,并且设计的多种包衣小丸可增强药物稳定性。

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