**2.3 Smart dosage form design and development**

The physic-chemical and pharmacological properties of the medicaments determine the critical attributes for novel dosage form development. The objectives of the novel dosage form development by using QbD for identification of attributes and to achieve desired patient requirements that the resultant product should possess to exhibit intended therapeutic response. The smart dosage form development must invariably be scientific, systemic, and with basic risk management facilitation to achieve these predefined objectives. The CQAs identification is strongly and thoroughly based on the understanding of product and manufacturing process. These CQAs must be controlled to get reproducible and desired results. **Table 1** summarizes the different CQAs for medicaments, additives, in-process


#### **Table 1.**

*Different critical attributes to formulate a novel dosage form [12].*

materials, and dosage form [14, 15]. On the basis of suitable statistical methods such as DoE (design of experiments), proper risk assessment, and management tools can escort to a good and knowledge-based smart dosage form development. Further, understanding of CQAs helps to set up flexible and meaningful regulatory product specifications. Knowledge of smart drug delivery development can facilitates QbD and increase the manufacturing capability (**Figure 1**) [16].
