Effect of compression process parameters on the physical properties and in vitro release mechanism of the press-coated nifedipine matrix sustained-release tablets

Nov. 1, 2023, midnight - by Yibin Guo , Peifu Xiao , Heyang Dong , Xueting Guo , Tian Yin , Yu Zhang , Haibing He , Yanjiao Wang , Jingxin Gou , Xing Tang

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Our objective is to elucidate the impact of compression process parameters on the physical characteristics and release kinetics of press-coated tablets (PCTs) with dual reservoirs. The critical compression force, marking the transition from plastic deformation to elastic deformation, was identified as 12.15 kN for the core tablets and 20.08 kN for the coat layer powder. Below 12.15 kN, the compression process of the coat layer caused the core tablets to undergo flattening, subsequent compression, and alterations in surface area. This, in turn, led to further compression of the coat layer in both axial and radial dimensions, resulting in reduced porosity and increased tensile strength. Release testing demonstrated a dual-reservoir sequential release mechanism in the PCTs, involving super case II transport in the coat layer and irregular transport in the core tablets, with the compression force of the core tablets identified as a crucial process parameter. In summary, the design of release profiles can be achieved by adjusting the drug distribution within the dual reservoirs and manipulating the process parameters of PCTs.

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