Objective To determine the critical quality attributes of carboxymethylcellulose sodium (CMC-Na), prepare nimesulide sustained-release tablets as model formulations with CMC-Na samples with different functional properties, and evaluate their in vitro drug release characteristics to clarify the individual influences of particle size, viscosity and molecular weight of CMC-Na on the release profiles of the model drug preparations.

Methods The particle size and particle size distribution of CMC-Na were characterized by laser particle size analyzer, and rotational viscometer was adopted to test the corresponding viscosity values; gel permeation chromatography coupled with multi-angle laser light scattering (GPC-MALLS) was utilized for the determination of molecular weight and molecular weight distribution; the paddle method specified in the relevant general chapters of the Chinese Pharmacopoeia (2025 edition) was applied to investigate the in vitro release performance of the prepared model sustained-release tablets.

Results The measured particle sizes of tested CMC-Na specimens ranged from 44 μm to 154 μm with span values for particle size distribution varying between 1.40 and 3.31; apparent discrepancies in viscosity were observed among CMC-Na grades from different specifications, while all determined viscosity data fell within respective specification limits; the weight-average molecular weight ranged from 10⁵ to 10⁶, their polydispersity index (PDI) was 1.7 to 9.0, and radius of gyration (Rg) ranged from 63.8 nm to 218.4 nm; a positive correlation was verified between molecular weight and viscosity for different CMC-Na grades sourced from the same manufacturer. Particle size of CMC-Na exerted no significant effect on the release behavior of the model drug from sustained-release tablets; viscosity and molecular weight significantly influenced the in vitro drug release, and the release rate of sustained-release tablets gradually decreased with the increase in viscosity or molecular weight.

Conclusion CMC-Na exerts favorable sustained and controlled release effects during the in vitro drug release of the model drug nimesulide sustained-release tablets. The research findings provide certain guiding significance and practical value for new drug research and development, pharmaceutical quality improvement, as well as the consistency evaluation of generic drugs.

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