Pharmacologist US Food and Drug Administration Silver Spring, Maryland
Dissolving Microneedle (DMN) arrays consists of micron-sized polymeric needles that bypass stratum corneum to deliver the drug under skin. The topographical and mechanical characteristics of microneedles (hardness and skin insertion), drug distribution in microneedles and drug release are some of the important critical quality attributes (CQAs). Development of discriminatory testing methods to assess these CQAs are still challenging. In addition, it is critical to identify and optimize formulation and process variables that may impact these CQAs to enable further improvement of DMNs. This presentation will focus on role of formulation variables (drug: polymer ratio) that may affect topographical and mechanical properties, drug distribution in microneedles and drug release. The presentation will also discuss the pros and cons of various characterization methods for assessing the quality and performance of DMNs. Presentation will also discuss the evaluation of topographical characteristics and drug distribution in DMNs using artificial intelligence (AI) assisted imaging analysis.
Learning Objectives:
The presentation will enrich the audience in understanding the microneedle technology, scientific criticality regarding its formulation and manufacturing, the quality considerations, and the impact of quality on product performance.
The audience will learn how AI segmentation may be employed to evaluate the topographical and spatial distribution of the drug in a dissolving microneedle array.
The presentation will provide insight in developing a discriminatory drug release testing method and associated challenges.