The development of generic preparations that are bioequivalent to a reference listed drug (RLD) is faced with challenges because some critical attributes of RLDs are commonly unknown to developers. In order to determine these attributes, Raman mapping-based reverse engineering in this study to analyze a model sustained-release tablet of nifedipine. The Raman mapping results indicate that the size and size distribution of nifedipine are critical to its release pattern and bioavailability. The tablets with a particle size of nifedipine comparable to that of a commercial product, Adalat^®-L, showed similar in vitro release profiles to the RLD. Moreover, a pharmacokinetic study in human volunteers proved the bioequivalence of the two preparations. In conclusion, Raman mapping-based reverse engineering has the potential to facilitate the development of generic preparations.

中文翻译：

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基于拉曼图的逆向工程促进缓释硝苯地平片剂的开发

开发与参考上市药物 (RLD) 生物等效的仿制药制剂面临挑战，因为开发人员通常不知道 RLD 的一些关键属性。为了确定这些属性，本研究采用基于拉曼图的逆向工程分析了硝苯地平缓释片的模型。拉曼图结果表明，硝苯地平的大小和大小分布对其释放模式和生物利用度至关重要。硝苯地平颗粒大小与市售产品 Adalat ^{®相当的片剂}-L，显示出与 RLD 相似的体外释放曲线。此外，在人类志愿者中进行的药代动力学研究证明了这两种制剂的生物等效性。总之，基于拉曼图的逆向工程具有促进仿制药开发的潜力。