A clinically relevant formulation for direct administration of nerve specific fluorophores to mitigate iatrogenic nerve injury.

Autor: Barth CW; Biomedical Engineering Department, Oregon Health & Science University, Portland, OR, 97201, USA., Shah VM; Department of Pharmaceutical Sciences, College of Pharmacy, Oregon State University, Portland, OR, 97201, USA., Wang LG; Biomedical Engineering Department, Oregon Health & Science University, Portland, OR, 97201, USA., Masillati AM; Biomedical Engineering Department, Oregon Health & Science University, Portland, OR, 97201, USA., Al-Fatease A; Department of Pharmaceutical Sciences, College of Pharmacy, Oregon State University, Portland, OR, 97201, USA; Department of Phamaceutics, College of Pharmacy, 62529, King Khalid University, Abha, Saudi Arabia., Husain Rizvi SZ; Department of Pharmaceutical Sciences, College of Pharmacy, Oregon State University, Portland, OR, 97201, USA., Antaris AL; Intuitive Surgical, 1020 Kifer Road, Sunnyvale, CA, 94086, USA., Sorger J; Intuitive Surgical, 1020 Kifer Road, Sunnyvale, CA, 94086, USA., Rao DA; School of Pharmacy, Pacific University, Hillsboro, OR, 97123, USA., Alani AWG; Biomedical Engineering Department, Oregon Health & Science University, Portland, OR, 97201, USA; Knight Cancer Institute, Oregon Health & Science University, Portland, OR, 97201, USA; Department of Pharmaceutical Sciences, College of Pharmacy, Oregon State University, Portland, OR, 97201, USA., Gibbs SL; Biomedical Engineering Department, Oregon Health & Science University, Portland, OR, 97201, USA; Knight Cancer Institute, Oregon Health & Science University, Portland, OR, 97201, USA. Electronic address: gibbss@ohsu.edu.
Jazyk: angličtina
Zdroj: Biomaterials [Biomaterials] 2022 May; Vol. 284, pp. 121490. Date of Electronic Publication: 2022 Mar 28.
DOI: 10.1016/j.biomaterials.2022.121490
Abstrakt: Iatrogenic nerve injury significantly affects surgical outcomes. Although intraoperative neuromonitoring is utilized, nerve identification remains challenging and the success of nerve sparing is strongly correlated with surgeon experience levels. Fluorescence guided surgery (FGS) offers a potential solution for improved nerve sparing by providing direct visualization of nerve tissue intraoperatively. However, novel probes for FGS face a long regulatory pathway to achieve clinical translation. Herein, we report on the development of a clinically-viable, gel-based formulation that enables direct administration of nerve-specific probes for nerve sparing FGS applications, facilitating clinical translation via the exploratory investigational new drug (eIND) guidance. The developed formulation possesses unique gelling characteristics, allowing it to be easily spread as a liquid followed by rapid gelling for subsequent tissue hold. Optimization of the direct administration protocol with our gel-based formulation enabled a total staining time of 1-2 min for compatibility with surgical procedures and successful clinical translation.
(Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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