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Raman Mapping-Based Reverse Engineering Facilitates Development of Sustained-Release Nifedipine Tablet
Pharmaceutics  (IF6.321),  Pub Date : 2022-05-13, DOI: 10.3390/pharmaceutics14051052
Ningyun Sun, Liang Chang, Yi Lu, Wei Wu

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.