Mucoadhesive 3D printed vaginal ovules to treat endometriosis and fibrotic uterine diseases

Teworte, Sarah, Aleandri, Simone, Weber, Jessica R., Carone, Marianna, Luciani, Paola
2023 · doi:10.5281/zenodo.7213433 · W6950509461
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⚙ AI-generated summary by gemini-2.5-flash-lite, 2026-07-09 ⓘ

A 3D-printed, alginate-based vaginal ovule with mucoadhesive properties was developed for controlled pirfenidone release, addressing a need for improved endometriosis and fibrotic uterine disease treatments.

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⚙ AI-generated deep summary by claude@2026-07, 2026-07-09 · read from full text ⓘ

The paper describes the development of mucoadhesive 3D-printed semisolid vaginal ovules containing pirfenidone, a repurposed drug candidate, aimed at treating endometriosis and other fibrotic uterine diseases. Using semisolid extrusion additive manufacturing and an alginate-based formulation, the authors compared the ovules to those made with standard excipients and found improved in vitro controlled release in standard and biorelevant tests, along with better mucoadhesive properties in ex vivo assays. In an endometriotic epithelial cell line (12Z) monolayer, pirfenidone required 24 hours of exposure to reduce metabolic activity, motivating sustained-release design; the work does not present in vivo or clinical efficacy data. This paper is centrally about endometriosis — it develops a vaginally delivered, sustained-release pirfenidone ovule specifically to target endometriotic epithelial cells and improve local residence and delivery.

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Abstract

Gynaecological health is a neglected field of research that includes conditions such as endometriosis, uterine fibroids, infertility, viral and bacterial infections, and cancers. There is a clinical need to develop dosage forms for gynecological diseases that increase efficacy and reduce side effects and explore new materials with properties tailored to the vaginal mucosa and milieu. Here, we developed a 3D printed semisolid vaginal ovule containing pirfenidone, a repurposed drug candidate for endometriosis. Vaginal drug delivery allows direct targeting of the reproductive organs via the first uterine pass effect, but vaginal dosage forms can be challenging to self-administer and retain in situ for periods of more than 1–3 h. We show that a semisoft alginate-based vaginal suppository manufactured using semisolid extrusion additive manufacturing is superior to vaginal ovules made using standard excipients. The 3D-printed ovule showed a controlled release profile of pirfenidone in vitro in standard and biorelevant release tests, as well as better mucoadhesive properties ex vivo. An exposure time of 24 h of pirfenidone to a monolayer culture of an endometriotic epithelial cell line, 12Z, is necessary to reduce the cells’ metabolic activity, which demonstrates the need for a sustained release formulation of pirfenidone. 3D printing allowed us to formulate mucoadhesive polymers into a semisolid ovule with controlled release of pirfenidone. This work enables further preclinical and clinical studies into vaginally administered pirfenidone to assess its efficacy as a repurposed endometriosis treatment.
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Mucoadhesive 3D printed vaginal ovules to treat endometriosis and fibrotic uterine diseases Authors/Creators Description Gynaecological health is a neglected field of research that includes conditions such as endometriosis, uterine fibroids, infertility, viral and bacterial infections, and cancers. There is a clinical need to develop dosage forms for gynecological diseases that increase efficacy and reduce side effects and explore new materials with properties tailored to the vaginal mucosa and milieu. Here, we developed a 3D printed semisolid vaginal ovule containing pirfenidone, a repurposed drug candidate for endometriosis. Vaginal drug delivery allows direct targeting of the reproductive organs via the first uterine pass effect, but vaginal dosage forms can be challenging to self-administer and retain in situ for periods of more than 1–3 h. We show that a semisoft alginate-based vaginal suppository manufactured using semisolid extrusion additive manufacturing is superior to vaginal ovules made using standard excipients. The 3D-printed ovule showed a controlled release profile of pirfenidone in vitro in standard and biorelevant release tests, as well as better mucoadhesive properties ex vivo. An exposure time of 24 h of pirfenidone to a monolayer culture of an endometriotic epithelial cell line, 12Z, is necessary to reduce the cells’ metabolic activity, which demonstrates the need for a sustained release formulation of pirfenidone. 3D printing allowed us to formulate mucoadhesive polymers into a semisolid ovule with controlled release of pirfenidone. This work enables further preclinical and clinical studies into vaginally administered pirfenidone to assess its efficacy as a repurposed endometriosis treatment. Files 1-s2.0-S0928098723001318-main.pdf Files (8.7 MB) | Name | Size | Download all | |---|---|---| | md5:d27daabf982e9430e70e73a9509b5cae | 8.7 MB | Preview Download |

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endometriosisinfertility

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