Formulation and Characterization of Vaginal Capsules and Tablets Providing Fast Release  of Live Lactobacillus spp.

Aleksandar Aleksovski; Haniehsadat  Hosseini; Hajar  Alkhafaji; Michaëla  Leite; Ander Sagasta; Viviane Leopold

doi:10.5937/arhfarm75-61941

Aleksandar Aleksovski Bacthera AG, Basel, Switzerland
Haniehsadat Hosseini Bacthera AG, Basel, Switzerland; Institute of Pharma Technology, School of Life Sciences, University of Applied Sciences Northwestern Switzerland, Muttenz, Switzerland
Hajar Alkhafaji Bacthera A/S, Hørsholm, Denmark
Michaëla Leite Bacthera AG, Basel, Switzerland
Ander Sagasta Bacthera AG, Basel, Switzerland
Viviane Leopold Bacthera AG, Basel, Switzerland

DOI: https://doi.org/10.5937/arhfarm75-61941

Keywords: vaginal drug delivery, live biotherepeutic products, immediate release, capsule, tablets

Abstract

Live biotherapeutic products (LBPs) are gaining significant medical importance as a new approach in the prevention and treatment of various conditions in the female population. This study investigated the design, development, and evaluation of immediate-release (IR) vaginal dosage forms containing live Lactobacillus spp., with the aim of enabling fast and effective drug delivery in the vaginal environment. Capsule and tablet formulations were developed using different excipients and appropriate manufacturing processes (encapsulation and direct compression) and systematically evaluated for their robustness and performance. The results demonstrated that all capsule formulations exhibited suitable flowability and uniformity of dosage units, with hard gelatine capsules (HGC) providing the most favourable disintegration times compared to hydroxypropyl methylcellulose (HPMC) and pullulan capsules. Tablet formulations based on microcrystalline cellulose (MCC) achieved optimal hardness, friability, and disintegration, especially under lower compression forces, confirming MCC’s multifunctional role as a filler, binder, and disintegrant. Importantly, both dosage forms maintained Lactobacillus viability with only minor losses (~0.5 log), preserved the acidic vaginal environment (pH 4.2), and demonstrated robustness under simulated biorelevant conditions. These findings highlight that IR vaginal capsules and tablets can be effectively tailored to deliver live biotherapeutics with rapid onset of action, thereby advancing microbiome-based strategies for women’s health.

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