Development and Characterization of a Microcrystalline Cellulose-based co-Processed Excipient using Design of Experiment Approach

Abstract

The study aims to develop a co-processed excipient (CPE) containing microcrystalline cellulose (MCC) and crospovidone (CPV) using the wet massing technique. Preformulation studies were carried out on CPE to characterize its physicochemical properties. Optimization of the formulation of CPE was carried out using a mixture of experimental designs. The optimization study suggested a composite excipient containing MCC (99 %) and CPV (1 %). Solid state characterization of CPE revealed a material that is predominantly crystalline in nature. The particle size of CPE increased in comparison to starting material. FT-IR confirmed the compatibility of MCC and CPV when co-processed together to yield a single composite excipient. There was a decrease in moisture content and moisture sorption capacity of CPE when compared to MCC. Powder characterization revealed an improvement in bulk flow properties of CPE relative to MCC. In summary, the physicochemical properties obtained suggest that CPE will be a suitable tableting excipient in solid dosage formulation by direct compression.

Quality by Design Approaches in Pharmaceutical Development and Solid Dosage Forms Production: A Narrative Overview

“…Its wide range of applications includes experimental design, variable screening, transfer function determination, design optimization, and robust design creation (26). In essence, DOE serves as a flexible tool for identifying influential inputs on outcomes in various contexts (27).…”