Vaginal Drug Delivery for Local and Systemic Applications

Dear Colleagues,

There has been growing interest in delivering drugs via the vaginal route for local and systemic delivery. The large surface area, high vasculature, access to the lymphatic system and potential for drug delivery throughout the female reproductive tract makes the vagina a desirable route of administration. As a result, this route has been exploited for delivering a wide variety of drugs including antimicrobials, antifungals, contraceptives, anticancer drugs, and labor-inducing drugs. In addition to small molecule drugs, labile drugs such as antibodies, proteins, genes, and probiotics have also been delivered via the vaginal route. A range of dosage forms designed for this route of administration allows for both immediate and sustained drug delivery.

Despite these advantages, due to the dynamic nature of this compartment, a number of challenges and knowledge gaps exist, driving a need to advance scientific knowledge in this area. There are several questions that need to be addressed in order to realize the full potential of vaginal drug delivery. New reports show a considerable presence of efflux and uptake transporters and metabolizing enzymes. At this point, their role in drug exposure to tissues or systemic circulation is unknown. Questions still remain regarding whether the excipients used in pharmaceutical products have any effect on innate protective factors such as the glycome and the microbiome. The role of the microbiome on drug stability, drug distribution and pharmacokinetics is an additional fascinating new area of research in the field. The first PBPK models are being developed. Such models would facilitate the translation of newly developed vaginal products more efficiently to the clinic. However, there exists a lack of critical data describing the physical and functional attributes of the female lower reproductive tract to facilitate optimal model development. Further, extensive characterization of the attributes that could predict in vivo performance such as drug dissolution, spreadability, and mucoadhesiveness are limited due to the unavailability of compendial methods for the evaluation of these critical factors.

Unlike oral and other traditional routes of delivery, the vaginal route is not a common route for drug delivery and hence women’s preferences for product attributes are not clearly known. The topic of product acceptability by women is critical to the development of effective vaginal products. New data is being developed in this area, which can contribute to a better definition of target product specifications. Behavioral and social research combined with product development efforts will shape the future of vaginal product design.

This Special Issue welcomes any topics regarding aspects that impact vaginal drug delivery research including research toward a better understanding of the biological components that impact drug disposition within the female lower reproductive tract, novel vaginal drug delivery systems, the design of new vaginal products, new animal or imaging methods to evaluate vaginal products, novel in vitro experimental methods to facilitate vaginal product development, compartment-specific modeling, in vitro–in vivo relationships, behavioral research, and preclinical assessments.

Prof. Lisa Cencia Rohan
Dr. Sravan Kumar Patel
Guest Editors

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