(057) A Biodissolvable Film for Rapid, Targeted Drug Delivery in Vestibulodynia

Abstract Introduction Vestibulodynia (VBD) is a prevalent condition characterized by chronic discomfort in the vulvar vestibule, often presenting as searing or shooting pain upon pressure. Despite the fact that VBD affects millions of women, the underlying cause of VBD remains unknown. Standard first-line treatment includes symptom management with topical lidocaine in the form of ointments, creams, or gels – however, these formulations can be ineffective or counterproductive to pain management. Messy application leads to improper delivery of drug to the appropriate tissues, leading to suboptimal anesthetic effect while inadvertently desensitizing non-target tissues. Slow absorption and thick residues can result in drug transfer to sexual partners, interfering with sexual function and intimacy. An urgent need exists for new, effective, easy-to-use therapies to provide targeted and lasting pain relief without compromising normal tissue function of the user or their sexual partner. Objective To address the challenges associated with existing formulations of lidocaine, our team has developed a rapidly dissolving film for pain relief for women with VBD. The key innovations of our technology include: (1) fast, complete dissolution, eliminating the need for product removal and reducing the presence of drug-containing residues after application, (2) rapid drug delivery for near-immediate pain control, (3) high pliability to ensure comfortable conformation to the tissue surface, (4) V-shaped design to specifically target the vestibule while minimizing drug effects in non-target areas, and (5) features that offer maximized convenience and discreetness. Methods Our team has designed a fully dissolvable film loaded with lidocaine for rapid, targeted vestibular delivery. Using a water-soluble, biocompatible polymer and a non-toxic plasticizer, we prepared films using the solvent-casting method. We characterized properties of drug free films, including mechanical strength, dissolution, and in vivo toxicity. We then performed testing of drug-loaded films, including in vitro drug release, ex vivo tissue permeation, and in vivo local drug delivery. Results Our team has demonstrated that films immersed in water dissolve completely in seconds ( 10s), facilitating rapid drug release. Agarose-based drug release testing showed that 100% drug release occurs within 1 hour and occurs more rapidly from films than from lidocaine ointment or cream. We proved that lidocaine in films is able to penetrate tissue using an ex vivo porcine skin model, and drug penetration is increased by 150% in 10 minutes using film-based delivery compared to ointment. Finally, we showed that drug-free films do not induce any toxicological damage to tissue upon intravaginal delivery, and that local lidocaine concentration profiles are similar for film and ointment delivery. Conclusions We have proven that our film enables rapid and effective lidocaine delivery, in line with or exceeding the capabilities of conventional dosage forms. Meanwhile, our film strategy offers numerous advantages to users, including reduced messiness, enhanced targeting, and minimized risk of drug transfer to self or sexual partners. In the future, we hope to demonstrate the capability of this platform to deliver other therapies used in the treatment of VBD patients, with the goal of increasing quality of life for the millions of women suffering from this condition. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Poppi Biotherapies.