Abstract
Development of an impeccable pharmaceutical product is always challenging in terms of process development and the product quality. Formulations meant for transdermal applications are sophisticated systems employing a plethora of constituents and using the traditional hit and trial approach of formulation design will lead to a troublesome job. This chapter enables one to understand about the various critical quality attributes and critical material attributes that affect the quality target profile of the transdermal product. Transdermal drug delivery systems (TDDS) are specially designed systems that are meant to deliver therapeutic agents across the skin of the patient for systemic effects. These systems are a type of controlled release drug delivery systems that tend to deliver therapeutic agents at a fixed rate over a protracted period of time. Quality by Design (QbD) being a scientific method that take into account various risk factors (risk assessment), quality target product profile (QTPP), critical quality attributes (CQA), and a control strategy for the process and product development. QbD aims at development of a TDDS product to deliver the optimum amount of drug across the skin while minimizing the amount of drug load, thus resulting in the least possible amount of residual drug substance. QbD leads to better understanding of the product and manufacturing process that contributes to profound assessment of the effects of variations in raw materials and the manufacturing process on drug product quality.
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Mishra, M., Raza, K. (2021). Design of Experiments for the Development of Transdermal Drug Products. In: Beg, S. (eds) Design of Experiments for Pharmaceutical Product Development. Springer, Singapore. https://doi.org/10.1007/978-981-33-4351-1_4
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DOI: https://doi.org/10.1007/978-981-33-4351-1_4
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