In the realm of medical procedures, advancements are continually sought to enhance efficacy and mitigate risks. One such area of focus is polypectomies, where the use of submucosal injection solutions has emerged as a promising strategy to reduce complications. However, the landscape is marked by a scarcity of standardized options, posing challenges for clinicians. Addressing this gap, the Research and Innovation Unit of the Pharmacy Service at the Clinical Hospital of Santiago de Compostela (CHUS) has unveiled a novel hydrogel formulation designed to optimize the excision technique for intestinal polyps.

Over a two-year span, a dedicated team led by Iria Varela, a pharmacist at the CHUS Pharmacy Service and a Rio Hortega Researcher in the Research and Innovation Unit, embarked on a quest to revolutionize polypectomy practices. The genesis of their endeavor stemmed from a collaboration proposal from a Valencia-based hospital, which sparked interest in utilizing hydrogels—a domain in which their research group boasted expertise, particularly in ophthalmic product formulation.

Varela underscores the prevailing reality: a majority of available agents were not expressly indicated for such use. While the FDA has sanctioned some products for this purpose, their accessibility in Spain remains limited. Consequently, endoscopy rooms often resort to diverse, non-standardized solutions, underscoring the urgent need for innovation.

Collaborating with the Digestive Service, the pharmacists discerned an unmet need in the field. Varela elucidates the prevailing practices, ranging from saline solutions to blends of gelafundin with methylene blue and adrenaline. Recognizing the potential for an agent facilitating prolonged elevation and reduced injection frequency, the team set out to refine the polypectomy technique.

The journey commenced with the formulation of a binary mixture of poloxamers and hyaluronic acid, chosen for their established pharmaceutical utility. Poloxamers, in particular, exhibit a unique temperature-dependent behavior, transitioning from a liquid state at room temperature to a robust gel at body temperature—earning them the moniker of «smart hydrogels.» Leveraging this property, the team crafted a hydrogel optimized for endoscopic injection and subsequent solidification within the body.

The project unfolded through meticulous phases, including mixture design, assessment of injectability and viscosity, in vitro cytotoxicity studies, and ex vivo and in vivo trials on porcine mucosa. Currently undergoing clinical evaluation as a magistral formula developed by the Pharmacy Service, the hydrogel has demonstrated promising results in its nascent stages.

Characterized galenically and conforming to requisite standards, the novel hydrogel not only streamlines endoscopy room operations but also ensures consistent availability. The collaborative effort drew upon the expertise of the Pharmacy faculty at the University of Santiago de Compostela, alongside research groups from CIMUS and the Rof Codina Veterinary Hospital in Lugo.

With clinical trials underway at multiple centers, including those in Alicante and Elche, Varela envisions the hydrogel as a catalyst for refining polypectomy techniques, envisaging a reduction in complications and procedural durations. The ongoing study, comparing the novel solution with current practices, heralds a paradigm shift in procedural protocols, poised to elevate patient outcomes and streamline clinical workflows.

Article written by Christine Wei-li Lee



Diario Farma