Raman Mapping-Based Reverse Engineering Facilitates Development of Sustained-Release Nifedipine Tablet

Author:

Sun Ningyun,Chang Liang,Lu YiORCID,Wu WeiORCID

Abstract

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.

Publisher

MDPI AG

Subject

Pharmaceutical Science

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