Immediate-Release Rosuvastatin Calcium and Sustained-Release Gliclazide Bilayer Tablet: Formulation and In Vitro Evaluation
Abstract: Type 2 diabetes mellitus (T2DM) commonly coexists with dyslipidemia, creating a need to manage glycemic and lipid risk. This study developed a bilayer tablet with an immediate-release (IR) solid-dispersion layer of poorly water-soluble rosuvastatin calcium and a hydrophilic matrix-based sustained-release (SR) layer of gliclazide. Rosuvastatin solid dispersions were prepared by solvent evaporation using polyvinylpyrrolidone K30, polyethylene glycol 6000, or hydroxypropyl methylcellulose (HPMC) E5 at drug-to-carrier ratios of 1:1, 1:2, and 1:3. The selected dispersion used HPMC E5 at 1:3. Gliclazide matrix tablets were prepared with HPMC K4M, K15M, or K100M; the formulation containing 50 mg HPMC K100M was selected. In vitro, the optimized bilayer released 99% of rosuvastatin within 60 min and 90% of gliclazide over 12 h. Gliclazide release was best fitted by the Higuchi model (R? = 0.9973), while the Korsmeyer-Peppas exponent (n = 0.8212) was consistent with anomalous release. Dissolution profiles remained close to initial values after 3 months of accelerated storage at 40 ? 2 ?C/75 ? 5% RH. These results support the in-vitro feasibility of the bilayer design; pharmacokinetic, clinical, and longer-term stability conclusions cannot be drawn from these experiments.
Keywords: Rosuvastatin calcium; Gliclazide; solid dispersion; sustained-release matrix; bilayer tablet
How to Cite?: Perumal M, G. Mariyappan, J. Karthi, Prakash Murugan, "Immediate-Release Rosuvastatin Calcium and Sustained-Release Gliclazide Bilayer Tablet: Formulation and In Vitro Evaluation", Volume 15 Issue 10, October 2026, International Journal of Science and Research (IJSR), Pages: 1204-1210, https://www.ijsr.net/getabstract.php?paperid=SR261018193058, DOI: https://dx.doi.org/10.21275/SR261018193058