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DESIGN AND EVALUATION OF MUCOADHESIVE CAPSULE FORMULATIONS OF LIVE BIOTHERAPEUTIC PRODUCT FOR VAGINAL DELIVERY OF LACTOBACILLUS SPP.

ALEKSANDAR ALEKSOVSKI 1*, HANIEHSADAT HOSSEINI 1,2, HAJAR ALKHAFAJI 3, MICHAËLA LEITE 1, ANDER SAGASTA 1, VIVIANE LEOPOLD 1, OLIVER GERMERSHAUS 2

1 Bacthera AG, Hochbergerstrasse 60A, 4057 Basel, Switzerland
2 Institute of Pharma Technology, School of Life Sciences, University of Applied Sciences Northwestern Switzerland, Hofackerstrasse 30, 4132 Muttenz, Switzerland
3 Bacthera A/S, Kogle Alle 6, DK-2970 Hørsholm, Denmark

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Live biotherapeutic products (LBPs) represent a promising therapeutic platform for women's health, primarily by addressing vaginal and reproductive conditions through microbiome modulation. This study explores the design and evaluation of mucoadhesive capsule formulations for targeted, continuous delivery of Lactobacillus spp., directly into the vaginal cavity. By leveraging the anatomical and physiological features of the vagina, together with an understanding of the mucoadhesive and drug-release properties of several polymers, the research aims to optimise localised drug delivery of a living bacterial strain. Various capsule shells, polymers and polymer combinations were assessed for physico-chemical and biorelevant properties, as well as bacterial viability. Pullulan capsules demonstrated superior mucoadhesive properties, and the formulation combining Carbomer and PEO emerged as optimal, offering sustained adhesion and viable bacterial delivery in simulated vaginal conditions. These findings underscore the potential of mucoadhesive LBPs in enhancing vaginal health through targeted, prolonged and biocompatible delivery systems.