Implementing risk-based quality by design for development and optimization of flavored oral disintegrating mini tablets

Abstract

Paediatric patients differ from adult in various aspects of pharmacotherapy, including the abilities of drug admistration, medicine related toxicity and taste partialities. It is very much important that paediatrics drugs should best fit the child's size, age, various physiologic conditions of the children. The objective of present study was to develop oral disintegrating mini tablet of paracetamol employing quality by design approach. Quality target product profile and critical quality attributes for paracetamol oral disintegrating mini tablet were identified. Potential factors affecting the quality of final formulation were identified by constructing fishbone diagram and risk assessment matrix. Screened factors were further optimized by employing the central composite design. 2D and 3D contour plots were drawn for determining the optimum concentration of selected critical parameters. Developed mathematical model were found to be appropriate to define the disintegration time and hardness with 93.18% and 90.27% validity. Various quality control test were defined for the direct compression method. Developed formulation were characterized for the various methods like hardness, friability, disintegration time and in vitro drug release profile and results were found to be satisfactory. The study offers a systematic study for design and optimization of patient compliant dosage form involving quality by design practices.