Critical attributes of transdermal drug delivery system (TDDS)--a generic product development review.
Bioequivalence testing of transdermal drug delivery systems (TDDS) has always been a subject of high concern for generic companies due to the formulation complexity and the fact that they are subtle to even minor manufacturing differences and hence should be clearly qualified in terms of quality, safety and efficacy. In recent times bioequivalence testing of transdermal patches has gained a global attention and many regulatory authorities worldwide have issued recommendations to set specific framework for demonstrating equivalence between two products. These current regulatory procedures demand a complete characterization of the generic formulation in terms of its physicochemical sameness, pharmacokinetics disposition, residual content and/or skin irritation/sensitization testing with respect to the reference formulation. This paper intends to highlight critical in vitro tests in assessing the therapeutic equivalence of products and also outlines their valuable applications in generic product success. Understanding these critical in vitro parameters can probably help to decode the complex bioequivalence outcomes, directing the generic companies to optimize the formulation design in reduced time intervals. It is difficult to summarize a common platform which covers all possible transdermal products; hence few case studies based on this approach has been presented in this review.
Dr Reddy's Laboratories, Centre of Excellence - Bio Studies, IPDO, Innovation Plaza , Bachupally, Hyderabad, Andhra Pradesh , India.
P K
PK
Ruby
Shriram M
SM
Pathak
Deepika
D
Aggarwal
D002626:Chemistry, Pharmaceutical; D017277:Drug Approval; D016503:Drug Delivery Systems / Q000592:standards*; D016568:Drugs, Generic / Q000592:standards*; D006801:Humans; D066298:In Vitro Techniques; D012869:Skin Absorption; D013810:Therapeutic Equivalency; D057968:Transdermal Patch / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
D016568:Drugs, Generic
Bioequivalence; clinical; in vitro; regulatory; transdermal