The stability of a novel synthetic peptide-type hemostatic material under digestive enzyme

Abstract

Background

A synthetic peptide ‘TDM-623’ is a promising hemostatic material for endoscopic surgery in the gastrointestinal tract. However, its stability under gastric/pancreatic secretion has yet to be shown. Hence, this study verified the stability of TDM-623 under digestive enzyme.

Material and methods

TDM-623 (1 mL) was applied to a dish and left at 37 °C for gel formation. Artificial gastric/pancreatic juice and saline were applied to each dish (n = 10). The stability of TDM-623 was evaluated at 0 min-48 h. The evaluation methods were the peptide amount dissolved in the solvent measured by high-performance liquid chromatography and morphological changes revealed by photography and eosin staining, as well as physical changes found by weight.

Results

The amount of dissolved peptides originating from the TDM-623 gel after gastric juice exposure was negligible compared to its original amount: a maximum of 10.3% dissolved after 48 h. No significant amounts of dissolved peptides were seen at any timepoint of exposure to pancreatic juice. Also, there were neither morphological nor physical changes after exposure to digestive enzymes for 48 h.

Conclusion

This study suggests that TDM-623 is sufficiently stable under digestive enzyme. TDM-623 is thus expected to be a durable hemostatic material that protect wound left by endoscopic surgery.

Keywords:

• TDM-623
• stability
• digestive enzyme
• endoscopic surgery

Disclosure statement

Dr. Yuto Kubo has conflicts of interest or financial ties by the Japan Consortium for Advanced Surgical Endoscopy (J-CASE) at 2019 and the Japanese Foundation for Research and Promotion of Endoscopy at 2019. Mr. Tomo Kobayashi, Mr. Naoki Yamamoto, Mr. Kiyotsugu Isaka, Dr. Kotaro Yamashita, Dr. Takuro Saito, Dr. Koji Tanaka, Dr. Tomoki Makino, Dr. Tsuyoshi Takahashi, Dr. Yukinori Kurokawa, Dr. Makoto Yamasaki, Dr. Hidetoshi Eguchi, Dr. Yuichiro Doki, and Dr. Kiyokazu Nakajima have no conflicts of interest or financial ties to disclose.

Additional information

Funding

This study was funded by the Japan Consortium for Advanced Surgical Endoscopy (J-CASE) at 2019 and the Japanese Foundation for Research and Promotion of Endoscopy at 2019, respectively.