Formulation of directly compressible tablets from Psidium guajava, Mangifera indica, and Moringa oleifera using the Quality-by-Design (QbD) Approach

Author: Ethel Andrea C. Ladignon, Bienvenido S. Balotro, Kimberly P. Castro

Category: Pharmacy

Abstract:

Quality-by-Design (QbD) is a concept which aims to provide a systematic approach to product development based on sound science and quality risk management. In this study QbD approach was applied to obtain optimized formulations of directly compressible tablets of Psidium guajava, Mangifera indica, and Moringa oleifera ethanolic leaf extracts. To do this, risk assessment as part of QbD was conducted to identify the critical quality attributes (CQAs) from the quality target products’ profile (QTPPs). A 3-level factorial design was used which generated nine formulation trials, and statistical treatment and interpretation of the formulation data utilizing Design Expert^® 10 were the basis of the selection of the optimized formulation. All excipients used were found compatible in the formulations based on compatibility and stability studies. Most of the formulations met the acceptance criteria for different quality control parameters. There was also no significant change in the alpha-glucosidase inhibition activity between the positive control, crude extracts, and the formulated herbal tablets (p >0.05). Optimum formulations of the ethanolic leaf extracts were obtained. The data gathered may be used to design new formulation for scale-up production.

Keywords: QbD, factorial design, directly compressible tablets, alpha-glucosidase inhibition, IC50