Preparation and characterization of gelatin sponge millispheres injectable through microcatheters

Noboru Yamashita1, Katsumi Saitou1, Akira Takagi1, Atsushi Maruyama21Pharmaceutical Research and Technology Labs, Institute for Technology, Astellas Pharma Inc., 180 Ozumi, Yaizu-shi, Shizuoka-ken 425-0072, Japan; 2Institute for Materials Chemistry and Engineering, Kyushu University, 744-CE11 Motook...

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Autores principales:	Noboru Yamashita, Katsumi Saitou, Akira Takagi, Atsushi Maruyama
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2009
Materias:	Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/870623ce0f2948a58b740862f9f5d47e
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spelling	oai:doaj.org-article:870623ce0f2948a58b740862f9f5d47e2021-12-02T08:09:13ZPreparation and characterization of gelatin sponge millispheres injectable through microcatheters1179-1470https://doaj.org/article/870623ce0f2948a58b740862f9f5d47e2009-01-01T00:00:00Zhttp://www.dovepress.com/preparation-and-characterization-of-gelatin-sponge-millispheres-inject-a2806https://doaj.org/toc/1179-1470Noboru Yamashita1, Katsumi Saitou1, Akira Takagi1, Atsushi Maruyama21Pharmaceutical Research and Technology Labs, Institute for Technology, Astellas Pharma Inc., 180 Ozumi, Yaizu-shi, Shizuoka-ken 425-0072, Japan; 2Institute for Materials Chemistry and Engineering, Kyushu University, 744-CE11 Motooka, Nishi-ku, Fukuoka 819-0395, JapanObjective: Millimeter size gelatin sponges are commonly used as an embolic agent for transcatheter arterial embolization (TAE). However the preparation of the fragments is troublesome and carries a risk of contamination. The purpose of this study was to develop gelatin sponge millispheres (GSMs), a convenient and reliable agent, and characterize them in vitro.Method: The size of GSMs was controlled by modifying the previously reported method to include the use of caprylic triglyceride and isopropanol. Analytical and microbiological tests were conducted to detect impurities (caprylic triglyceride, isopropanol, endotoxins, bacteria, and fungus). The effects of syringe volume (1.0 to 5.0 ml) and contrast media viscosity (1.6 to 13.6 mPa * s) on the in vitro injectability of GSMs through microcatheters of various inner diameters (ID) (0. 43 to 0.53 mm) were examined via in-line pressure monitoring.Results: The GSMs were found to be water-insoluble particles containing interconnected pores. The short and long diameters of the GSMs were 1.82 &plusmn; 0.2 mm and 2.37 &plusmn; 0.3 mm, respectively. The results of tests for impurities indicated that GSMs have the general properties necessary for medical devices. The GSMs were successfully injected without clogging through a microcatheter (ID: 0.53 mm) attached to a 1.0 or 2.5 ml syringe.Conclusion: GSMs have the basic properties and injectability necessary to be considered reliable biomaterials (eg, embolic agents).Keywords: embolic agents, gelatin sponge millispheres, injectable scaffolds, interconnected pores, microcatheter Noboru YamashitaKatsumi SaitouAkira TakagiAtsushi MaruyamaDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2009, Iss default, Pp 19-25 (2009)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Noboru Yamashita Katsumi Saitou Akira Takagi Atsushi Maruyama Preparation and characterization of gelatin sponge millispheres injectable through microcatheters
description	Noboru Yamashita1, Katsumi Saitou1, Akira Takagi1, Atsushi Maruyama21Pharmaceutical Research and Technology Labs, Institute for Technology, Astellas Pharma Inc., 180 Ozumi, Yaizu-shi, Shizuoka-ken 425-0072, Japan; 2Institute for Materials Chemistry and Engineering, Kyushu University, 744-CE11 Motooka, Nishi-ku, Fukuoka 819-0395, JapanObjective: Millimeter size gelatin sponges are commonly used as an embolic agent for transcatheter arterial embolization (TAE). However the preparation of the fragments is troublesome and carries a risk of contamination. The purpose of this study was to develop gelatin sponge millispheres (GSMs), a convenient and reliable agent, and characterize them in vitro.Method: The size of GSMs was controlled by modifying the previously reported method to include the use of caprylic triglyceride and isopropanol. Analytical and microbiological tests were conducted to detect impurities (caprylic triglyceride, isopropanol, endotoxins, bacteria, and fungus). The effects of syringe volume (1.0 to 5.0 ml) and contrast media viscosity (1.6 to 13.6 mPa * s) on the in vitro injectability of GSMs through microcatheters of various inner diameters (ID) (0. 43 to 0.53 mm) were examined via in-line pressure monitoring.Results: The GSMs were found to be water-insoluble particles containing interconnected pores. The short and long diameters of the GSMs were 1.82 &plusmn; 0.2 mm and 2.37 &plusmn; 0.3 mm, respectively. The results of tests for impurities indicated that GSMs have the general properties necessary for medical devices. The GSMs were successfully injected without clogging through a microcatheter (ID: 0.53 mm) attached to a 1.0 or 2.5 ml syringe.Conclusion: GSMs have the basic properties and injectability necessary to be considered reliable biomaterials (eg, embolic agents).Keywords: embolic agents, gelatin sponge millispheres, injectable scaffolds, interconnected pores, microcatheter
format	article
author	Noboru Yamashita Katsumi Saitou Akira Takagi Atsushi Maruyama
author_facet	Noboru Yamashita Katsumi Saitou Akira Takagi Atsushi Maruyama
author_sort	Noboru Yamashita
title	Preparation and characterization of gelatin sponge millispheres injectable through microcatheters
title_short	Preparation and characterization of gelatin sponge millispheres injectable through microcatheters
title_full	Preparation and characterization of gelatin sponge millispheres injectable through microcatheters
title_fullStr	Preparation and characterization of gelatin sponge millispheres injectable through microcatheters
title_full_unstemmed	Preparation and characterization of gelatin sponge millispheres injectable through microcatheters
title_sort	preparation and characterization of gelatin sponge millispheres injectable through microcatheters
publisher	Dove Medical Press
publishDate	2009
url	https://doaj.org/article/870623ce0f2948a58b740862f9f5d47e
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_version_	1718398610396151808

Preparation and characterization of gelatin sponge millispheres injectable through microcatheters

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