Transdermal is the only technical publication devoted exclusively to readers involved in development and production of pharmaceuticals delivered through the skin.
Latest FocusWinning Strategies for Outsourcing Your Transdermal PatchWhen choosing a contract manufacturing organization (CMO) for your transdermal patch, your success depends not only on the capabilities and culture of the company you select but also on the timing of its involvement in the project. By selecting the right CMO and partnering early in the process, you’ll have a much better chance of ensuring manufacturability, optimizing cost-effectiveness, and meeting desired launch dates.General FeaturesEarly Stage Technologies for Dermal and Transdermal Drug Delivery: Magnetophoresis and ElectretMacromolecules (>600Da) and hydrophilic molecules penetrate poorly across the skin due to the barrier function of the stratum corneum. Therefore, formulation scientists use chemical and physical permeation enhancers to enhance penetration. Researchers have investigated iontophoresis, electroporation, sonophoresis, microneedles, and laser-based techniques already as potential technologies for dermal and transdermal drug delivery. In addition, many interesting technologies are still in the early stage of development. Recently, scientists have studied novel technologies for cutaneous drug delivery.Prescription Drug Advertising: The FDA’s Continuing Efforts to Regulate and Clarify Drug AdsIn most cases, the FDA does not view advertisements before companies disseminate them; often it sees them at the same time as the consuming public. To ensure that the information in prescription-drug advertising is truthful, balanced, and accurately communicated to the public, the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) has been active in implementing new programs, such as the Bad Ad Program launched in 2010, to bolster its regulatory efforts. The FDA recently published a Year-in-Review report summarizing the first year of that program, which is aimed at healthcare professionals (HCPs) to assist in identifying bad ads.Prototype TestingUse of the excised-skin model to evaluate percutaneous absorption is widespread, not only in the development of transdermal drug products but also in the development of topical drug and cosmetic products and in the field of toxicological risk assessment. In particular, the latter area has triggered a detailed review of in-vitro methodology by a number of expert groups in the last decade and has led to publication of documents that explicitly describe the manner in which researchers should conduct studies if they are to obtain quantitatively accurate results.
