PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Topics Review
Case study about development of a novel spray-type adhesion barrier system
Hiroyuki ISHIHARATaishi NIIMINaotaka CHINOMiho KAIYuki SOMAEiji WATANABETetsuro KAWANISHI
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2020 Volume 22 Issue 1 Pages 6-11

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Abstract

We developed a novel spray-type dextrin hydrogel-based adhesion barrier designed to create a site-specific barrier on a target. Our novel hydrogel is composed of Powder A, which mainly contains N-hydroxysuccinimide-modified carboxymethyl dextrin and trehalose as a stabilizing agent, and Powder B, which is composed of sodium carbonate and sodium hydrogen carbonate. The spray device has several unique specifications that can be used under laparoscopic surgery. Furthermore, the shape and the appearance are characteristic so that this device can be appropriately used in a clinical situation. Here, we introduce the development process of a novel spray-type adhesion barrier as the case study of medical device.

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© 2020 Parenteral Drug Association Japan Chapter
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