Intertek to present at the Transdermal & Intradermal Drug Delivery Systems 2016 conference on extractables and leachables, September 12-13, 2016
Transdermal and intradermal drug delivery systems are a growing area interest and a proven alternative route of administration to oral and parenteral routes. The driving forces for this growing interest include achieving a better patient experience, avoiding the pain and discomfort of needles whilst also offers enhancements in bioavailability and improvement in safety and efficacy by providing sustained and controlled drug plasma levels. However, this particular drug formulation has its own unique challenges, from regulatory and as well as analytical point of view.
As conference sponsors, Intertek experts will be present during Transdermal & Intradermal Drug Delivery Systems 2016, September 12-13, 2016, (Philadelphia, USA), to discuss how our pharmaceutical contract services expertise can support your transdermal and intradermal drug delivery development programs and manufacturing activities. In particular, our team will provide updates on regulatory updates, related to extractables / leachables, GMP stability studies, analytical method development and validation, presenting solutions to FDA deficiency letter(s) and case studies.
Learn more about the event
The two-day Transdermal and Intradermal Drug Delivery Systems, 2016 conference brings together the leading researchers in the field to share the most recent advances in the design, formulation, and delivery of skin-mediated therapies and vaccines.
Our expert Dr Gyorgy Vas, Business Technical Scientific Liasion, Intertek Pharmaceutical Services, Whitehouse, NJ, USA will deliver the presentation: Extractable And Leachable Testing For Transdermal Drug Delivery Systems.
Email our team to request a copy of the presentation.
Date and Time: September 13th , 2016, 4pm EDT.
Transdermal drug delivery systems are relatively complex pharmaceutical products. The formulation contains multiple excipients and in addition a dermal contact adhesive. The performance of the delivery systems depends on the quality of the dermal adhesive and the formulation, which delivers the drug at a pre-determined rate. The dermal delivery route is becoming more and more popular since the effect of the delivered drug can be localized, which may reduce the systemic side effects.
However, since the formulation has extended contact time, besides the drug being delivered includes excipients, degradation products and packaging related components can also be “delivered” via the same route of administration. The complex formulation combined with the low-level testing requirement present very challenging analytical tasks. Component identification, analytical method development and validation are not as simple as for the components present at a ppm level or above.
This presentation will focus on different test approaches, to present options for leachable testing, how to evaluate the actual leachables and validate analytical methods, what requires non-routine extraction methods, and detection capability down to ppb level.
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