Mycophenolate sodium

Zhang J, et al. Acta Pharmaceutica Sinica B, 2017, 7(3), 347-352.

This study investigated the pharmacokinetics of enteric-coated mycophenolate sodium (EC-MPS) in 28 Han kidney transplant recipients. Patients received multiple escalating oral doses of 540, 720, or 900 mg EC-MPS twice daily in combination with tacrolimus over six days. Serial blood samples were collected from 0 to 12 h post-administration, and plasma mycophenolic acid (MPA) concentrations were quantified using UPLC-UV. Key PK parameters, including Cmax, AUC0-12h, C0, and Tmax, were analyzed to assess dose proportionality. Results demonstrated nonlinear pharmacokinetics: Cmax and AUC0-12h increased less than proportionally with dose escalation, and substantial inter-individual variability was observed. This experimental application highlights the importance of precise dosing strategies for EC-MPS in transplant therapeutics.

Silva VFPE, et al. Clinics, 2011, 66(8), 1451-1455.

This study evaluated the impact of mycophenolate sodium on mucociliary clearance using a controlled rodent bronchial section and anastomosis model. Sixty rats underwent left bronchial resection and anastomosis, with the right bronchus serving as an internal control. Post-surgery, animals were administered either saline (control) or mycophenolate sodium for 7, 15, or 30 days. At each time point, 10 rats per group were sacrificed for assessment. Experimental measurements included in vitro mucus transportability, in situ mucociliary transport velocity, and ciliary beat frequency, enabling a comprehensive evaluation of airway defense functionality. Results demonstrated a significant decrease in ciliary beat frequency and mucociliary transport velocity in mycophenolate-treated bronchi by day 30, highlighting its potential effect on airway defense mechanisms.

Xu G, et al. Transplant Immunology, 2023, 81, 101923.

This study evaluated the pharmacokinetic equivalence of Ruiyirong versus Myfortic mycophenolate sodium enteric-coated tablets in healthy volunteers. Forty-eight subjects were randomized into a three-period, crossover design receiving test and reference formulations on days 1, 8, and 15. Plasma concentrations were measured to determine Cmax, AUC0-t, and AUC0-∞. The 90% confidence intervals for geometric mean ratios of these parameters were within the FDA-defined bioequivalence range of 80-125%. Eight predictive equations for AUC estimation were tested using a limited sampling strategy; four demonstrated high intragroup (R = 0.857-0.971) and intergroup (R = 0.896-0.974, P < 0.001) agreement with minimal predictive error. Adverse events were low, confirming tolerability. This approach highlights Mycophenolate sodium's experimental application in pharmacokinetic monitoring and bioequivalence testing.