Development of a novel one-step production system for injectable liposomes under GMP

There are few methods available for injectable liposome production under good manufacturing practices (GMP). Injectable liposome production processes under GMP generally consist of liposome formation, size homogenization, organic solvent removal, liposome concentration control and sterilization. How...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Pharmaceutical development and technology 2018-07, Vol.23 (6), p.602-607
Hauptverfasser: Araki, Ryo, Matsuzaki, Takashi, Nakamura, Ayumi, Nakatani, Daisaku, Sanada, Shoji, Fu, Hai Ying, Okuda, Keiji, Yamato, Masaki, Tsuchida, Shota, Sakata, Yasushi, Minamino, Tetsuo
Format: Artikel
Sprache:eng
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page 607
container_issue 6
container_start_page 602
container_title Pharmaceutical development and technology
container_volume 23
creator Araki, Ryo
Matsuzaki, Takashi
Nakamura, Ayumi
Nakatani, Daisaku
Sanada, Shoji
Fu, Hai Ying
Okuda, Keiji
Yamato, Masaki
Tsuchida, Shota
Sakata, Yasushi
Minamino, Tetsuo
description There are few methods available for injectable liposome production under good manufacturing practices (GMP). Injectable liposome production processes under GMP generally consist of liposome formation, size homogenization, organic solvent removal, liposome concentration control and sterilization. However, these complicated and separate processes make it difficult to maintain scalability, reproducibility and sterility. To overcome these limitations, we developed a novel one-step in-line closed liposome production system that integrated all production processes by combining the in-line thermal mixing device with modified counterflow dialysis. To validate the system, we produced liposomal cyclosporine A (Lipo-CsA) and lyophilized the liposomes. The three independent pilot batches were highly reproducible and passed the quality specifications for injectable drugs, demonstrating that this system could be used under GMP. The accelerated stability test suggested that the liposomes would be stable in long-term storage. This one-step system facilitates a fully automated and unattended production of injectable liposomes under GMP.
doi_str_mv 10.1080/10837450.2017.1290106
format Article
fullrecord <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_1879196240</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1879196240</sourcerecordid><originalsourceid>FETCH-LOGICAL-p141t-c9869e8c2eead21d734a3d458e88ca7a9d03112d214ff224e9168910a863c8003</originalsourceid><addsrcrecordid>eNo1UE1Lw0AUXASxtfoTlD16SX1vd7sfR6lahYoe6jlssy-QkmRjNhH6741YLzMwMwzDMHaDsESwcD-BNGoFSwFoligcIOgzNkdwJnNWmxm7TOkAgNbB6oLNhJWohXZztnukb6pj11A78Fhyz9s4CTy2lKWBOt71MYzFUMWWp-OkNLyMPa_aAxWD39fE66qLKTaU-NgG6vnm7eOKnZe-TnR94gX7fH7arV-y7fvmdf2wzTpUOGTFNM2RLQSRDwKDkcrLoFaWrC288S6ARBSTpcpSCEUOtXUI3mpZWAC5YHd_vdPIr5HSkDdVKqiufUtxTDla49BpoX6jt6fouG8o5F1fNb4_5v9PyB9ntV7Y</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1879196240</pqid></control><display><type>article</type><title>Development of a novel one-step production system for injectable liposomes under GMP</title><source>EBSCOhost Business Source Complete</source><creator>Araki, Ryo ; Matsuzaki, Takashi ; Nakamura, Ayumi ; Nakatani, Daisaku ; Sanada, Shoji ; Fu, Hai Ying ; Okuda, Keiji ; Yamato, Masaki ; Tsuchida, Shota ; Sakata, Yasushi ; Minamino, Tetsuo</creator><creatorcontrib>Araki, Ryo ; Matsuzaki, Takashi ; Nakamura, Ayumi ; Nakatani, Daisaku ; Sanada, Shoji ; Fu, Hai Ying ; Okuda, Keiji ; Yamato, Masaki ; Tsuchida, Shota ; Sakata, Yasushi ; Minamino, Tetsuo</creatorcontrib><description>There are few methods available for injectable liposome production under good manufacturing practices (GMP). Injectable liposome production processes under GMP generally consist of liposome formation, size homogenization, organic solvent removal, liposome concentration control and sterilization. However, these complicated and separate processes make it difficult to maintain scalability, reproducibility and sterility. To overcome these limitations, we developed a novel one-step in-line closed liposome production system that integrated all production processes by combining the in-line thermal mixing device with modified counterflow dialysis. To validate the system, we produced liposomal cyclosporine A (Lipo-CsA) and lyophilized the liposomes. The three independent pilot batches were highly reproducible and passed the quality specifications for injectable drugs, demonstrating that this system could be used under GMP. The accelerated stability test suggested that the liposomes would be stable in long-term storage. This one-step system facilitates a fully automated and unattended production of injectable liposomes under GMP.</description><identifier>EISSN: 1097-9867</identifier><identifier>DOI: 10.1080/10837450.2017.1290106</identifier><identifier>PMID: 28316269</identifier><language>eng</language><publisher>England</publisher><ispartof>Pharmaceutical development and technology, 2018-07, Vol.23 (6), p.602-607</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27915,27916</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28316269$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Araki, Ryo</creatorcontrib><creatorcontrib>Matsuzaki, Takashi</creatorcontrib><creatorcontrib>Nakamura, Ayumi</creatorcontrib><creatorcontrib>Nakatani, Daisaku</creatorcontrib><creatorcontrib>Sanada, Shoji</creatorcontrib><creatorcontrib>Fu, Hai Ying</creatorcontrib><creatorcontrib>Okuda, Keiji</creatorcontrib><creatorcontrib>Yamato, Masaki</creatorcontrib><creatorcontrib>Tsuchida, Shota</creatorcontrib><creatorcontrib>Sakata, Yasushi</creatorcontrib><creatorcontrib>Minamino, Tetsuo</creatorcontrib><title>Development of a novel one-step production system for injectable liposomes under GMP</title><title>Pharmaceutical development and technology</title><addtitle>Pharm Dev Technol</addtitle><description>There are few methods available for injectable liposome production under good manufacturing practices (GMP). Injectable liposome production processes under GMP generally consist of liposome formation, size homogenization, organic solvent removal, liposome concentration control and sterilization. However, these complicated and separate processes make it difficult to maintain scalability, reproducibility and sterility. To overcome these limitations, we developed a novel one-step in-line closed liposome production system that integrated all production processes by combining the in-line thermal mixing device with modified counterflow dialysis. To validate the system, we produced liposomal cyclosporine A (Lipo-CsA) and lyophilized the liposomes. The three independent pilot batches were highly reproducible and passed the quality specifications for injectable drugs, demonstrating that this system could be used under GMP. The accelerated stability test suggested that the liposomes would be stable in long-term storage. This one-step system facilitates a fully automated and unattended production of injectable liposomes under GMP.</description><issn>1097-9867</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNo1UE1Lw0AUXASxtfoTlD16SX1vd7sfR6lahYoe6jlssy-QkmRjNhH6741YLzMwMwzDMHaDsESwcD-BNGoFSwFoligcIOgzNkdwJnNWmxm7TOkAgNbB6oLNhJWohXZztnukb6pj11A78Fhyz9s4CTy2lKWBOt71MYzFUMWWp-OkNLyMPa_aAxWD39fE66qLKTaU-NgG6vnm7eOKnZe-TnR94gX7fH7arV-y7fvmdf2wzTpUOGTFNM2RLQSRDwKDkcrLoFaWrC288S6ARBSTpcpSCEUOtXUI3mpZWAC5YHd_vdPIr5HSkDdVKqiufUtxTDla49BpoX6jt6fouG8o5F1fNb4_5v9PyB9ntV7Y</recordid><startdate>201807</startdate><enddate>201807</enddate><creator>Araki, Ryo</creator><creator>Matsuzaki, Takashi</creator><creator>Nakamura, Ayumi</creator><creator>Nakatani, Daisaku</creator><creator>Sanada, Shoji</creator><creator>Fu, Hai Ying</creator><creator>Okuda, Keiji</creator><creator>Yamato, Masaki</creator><creator>Tsuchida, Shota</creator><creator>Sakata, Yasushi</creator><creator>Minamino, Tetsuo</creator><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>201807</creationdate><title>Development of a novel one-step production system for injectable liposomes under GMP</title><author>Araki, Ryo ; Matsuzaki, Takashi ; Nakamura, Ayumi ; Nakatani, Daisaku ; Sanada, Shoji ; Fu, Hai Ying ; Okuda, Keiji ; Yamato, Masaki ; Tsuchida, Shota ; Sakata, Yasushi ; Minamino, Tetsuo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p141t-c9869e8c2eead21d734a3d458e88ca7a9d03112d214ff224e9168910a863c8003</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Araki, Ryo</creatorcontrib><creatorcontrib>Matsuzaki, Takashi</creatorcontrib><creatorcontrib>Nakamura, Ayumi</creatorcontrib><creatorcontrib>Nakatani, Daisaku</creatorcontrib><creatorcontrib>Sanada, Shoji</creatorcontrib><creatorcontrib>Fu, Hai Ying</creatorcontrib><creatorcontrib>Okuda, Keiji</creatorcontrib><creatorcontrib>Yamato, Masaki</creatorcontrib><creatorcontrib>Tsuchida, Shota</creatorcontrib><creatorcontrib>Sakata, Yasushi</creatorcontrib><creatorcontrib>Minamino, Tetsuo</creatorcontrib><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Pharmaceutical development and technology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Araki, Ryo</au><au>Matsuzaki, Takashi</au><au>Nakamura, Ayumi</au><au>Nakatani, Daisaku</au><au>Sanada, Shoji</au><au>Fu, Hai Ying</au><au>Okuda, Keiji</au><au>Yamato, Masaki</au><au>Tsuchida, Shota</au><au>Sakata, Yasushi</au><au>Minamino, Tetsuo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development of a novel one-step production system for injectable liposomes under GMP</atitle><jtitle>Pharmaceutical development and technology</jtitle><addtitle>Pharm Dev Technol</addtitle><date>2018-07</date><risdate>2018</risdate><volume>23</volume><issue>6</issue><spage>602</spage><epage>607</epage><pages>602-607</pages><eissn>1097-9867</eissn><abstract>There are few methods available for injectable liposome production under good manufacturing practices (GMP). Injectable liposome production processes under GMP generally consist of liposome formation, size homogenization, organic solvent removal, liposome concentration control and sterilization. However, these complicated and separate processes make it difficult to maintain scalability, reproducibility and sterility. To overcome these limitations, we developed a novel one-step in-line closed liposome production system that integrated all production processes by combining the in-line thermal mixing device with modified counterflow dialysis. To validate the system, we produced liposomal cyclosporine A (Lipo-CsA) and lyophilized the liposomes. The three independent pilot batches were highly reproducible and passed the quality specifications for injectable drugs, demonstrating that this system could be used under GMP. The accelerated stability test suggested that the liposomes would be stable in long-term storage. This one-step system facilitates a fully automated and unattended production of injectable liposomes under GMP.</abstract><cop>England</cop><pmid>28316269</pmid><doi>10.1080/10837450.2017.1290106</doi><tpages>6</tpages></addata></record>
fulltext fulltext
identifier EISSN: 1097-9867
ispartof Pharmaceutical development and technology, 2018-07, Vol.23 (6), p.602-607
issn 1097-9867
language eng
recordid cdi_proquest_miscellaneous_1879196240
source EBSCOhost Business Source Complete
title Development of a novel one-step production system for injectable liposomes under GMP
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-15T03%3A49%3A16IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Development%20of%20a%20novel%20one-step%20production%20system%20for%20injectable%20liposomes%20under%20GMP&rft.jtitle=Pharmaceutical%20development%20and%20technology&rft.au=Araki,%20Ryo&rft.date=2018-07&rft.volume=23&rft.issue=6&rft.spage=602&rft.epage=607&rft.pages=602-607&rft.eissn=1097-9867&rft_id=info:doi/10.1080/10837450.2017.1290106&rft_dat=%3Cproquest_pubme%3E1879196240%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1879196240&rft_id=info:pmid/28316269&rfr_iscdi=true