Quality by Design Topical Formulations

Pharmaceutical companies are currently investing a significant amount of their resources in developing advanced carrier systems. These systems are designed to deliver drugs over an extended period with minimal side effects, which improves patient compliance and decreases variability that is often associated with intermittent dosing. The utilization of the Quality by Design (QbD) methodology has been shown to improve the efficacy of drug development and regulatory processes, leading to quicker access to high-quality topical dermatological and transdermal products. Moreover, this approach could decrease costs for both the healthcare system and consumers. In order to adopt the QbD approach, it is necessary to establish the Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) for a pharmaceutical product. This entails evaluating potential risks to determine Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs). Subsequently, a Design Space should be defined through the use of Design of Experiments (DoEs). Additionally, it is important to establish a Control Strategy and uphold a commitment to continuous improvement and innovation throughout the product’s lifecycle. In this chapter, we will discuss the creation and assessment of Critical Quality Attributes (CQAs) for both topical and transdermal products. These products can range from basic semisolid formulations and patches to more advanced nanotechnological-based technologies.