Vol. 14, Issue 1 (2025)

Author(s):
Hany Mahmoud Sayed

Abstract:
Microcrystalline cellulose (MCC) is a widely used excipient in pharmaceutical formulations due to its excellent compressibility, binding properties, and ability to enhance drug release. This study aimed to evaluate the impact of MCC particle size, binder concentration, and compression force on key tablet quality attributes, including hardness, friability, disintegration time, and dissolution rate. A full factorial Design of Experiments (DoE) approach was employed, consisting of 27 experimental runs with variations in MCC particle size (50, 100, and 200 µm), binder concentration (2%, 5%, and 10%), and compression force (5, 10, and 15 kN). Tablets were prepared using wet granulation, followed by compression using a single-punch tablet press. Process Analytical Technology (PAT) tools, including Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC), X-ray Diffraction (XRD), and Scanning Electron Microscopy (SEM), were employed to characterize the materials. Statistical analysis, including ANOVA and multiple linear regression, was conducted to assess the significance of formulation parameters. The results indicated that higher compression force significantly increased tablet hardness while reducing friability (p<0.05). Binder concentration influenced disintegration time, with higher binder levels leading to prolonged tablet breakdown (p<0.05). MCC particle size demonstrated a direct impact on dissolution, where smaller MCC particles resulted in faster drug release due to increased surface area (p<0.05). The optimal formulation parameters identified were a compression force of 10 kN, binder concentration of 5%, and MCC particle size of 100 µm to balance mechanical strength and drug release properties. This study underscores the importance of optimizing MCC-based formulations to achieve pharmaceutical quality standards. Future research should explore alternative MCC sources, novel excipient interactions, and PAT advancements for improved tablet manufacturing and regulatory compliance.