Background: One of the most compelling medical challenges of this century is the treatment
of cancer and among them, skin cancer is the most common type. Thus, current treatments need to be
renewed continuously to handle this challenge.
Objective: This review presents considerations which can be employed during the development of
nanosized formulations dedicated to the topical treatment of skin cancer. We aimed to collect and organize
literature data on the treatment options for skin cancer in order to determine the required quality
attributes of an effective dermal anticancer formulation.
Method: With the consideration of the Quality by Design (QbD) approach related to the development
of new pharmaceutical formulations, a cost-saving process ensuring a high-quality product taking into
account patient expectations, industrial and regulatory aspects can be achieved. Furthermore, this concept
is highly recommended by regulatory agencies.
Results: Our work discusses the current therapies, active agents, drug carrier systems, and evaluation
methods in connection with the treatment of skin cancer and outlines Critical Quality Attributes which
need to be considered during the development of a nanosized dermal anticancer formulation.
Conclusion: The first part of this review summarizes the most important topical treatment therapies for
skin cancer and highlights the future therapeutic perspectives, focusing on the benefits of nanotechnology
and dermal administration. The second part outlines the critical points of nanosized dermal anticancer
formulation development in the view of QbD approach. Our research emphasizes the application
of QbD method for a rationalized and more effective anticancer formulation development process.