Transdermal patches present certain attributes that make the efficacy, safety, and quality of the product and must be controlled in the laboratory through analytical techniques to ensure the performance and safety of the transdermal delivery system (or TDS). Some of them correspond to tests that are common to other pharmaceutical forms. However, due to the particular characteristics of transdermal patches, there are specific procedures that apply to TDSs and that are described in internationally recognized regulations and pharmacopoeias.
The use of Quality by Design (QbD) concept to medicated plasters (patches) development gives us the certainty to obtain safety and reliable products for patients with verifiable efficacy, long before they enter their production stage.
One of the essential problems in the management of data is the obtention of a sample using an objective and scientific approach. Several procedures exist and are reliable to that purpose.
The progress of the Pharmaceutical Industry has undoubtedly contributed to the effective treatment or prevention of numerous diseases. This advance has been so important that access to it has been declared a human right. Parallel to the appearance of new medicines, society faces increased health spending that jeopardizes their accessibility by low-income sectors.
The kind and quantity of clinical studies required for the submission of a regulatory application for a generic patch are different than those required for other pharmaceutical forms. Learn how complex these studies can become in the light of current guidelines.