Ready-to-use parenteral amiodarone: a feasibility study towards a long-term stable product formulation
ObjectivesTo determine the feasibility of preparing a long-term stable ready-to-use parenteral amiodarone formulation using cyclodextrins as dissolution enhancer.MethodsA preformulation study was performed with different molar ratios of hydroxypropyl-beta-cyclodextrin (HP-BCD) or sulfobutylether-bet...
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Veröffentlicht in: | European journal of hospital pharmacy : science and practice 2017-03, Vol.24 (2), p.110-114 |
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creator | Jacobs, Maartje S Luinstra, Marianne Moes, Jan Reindert Chan, Tiffany C Y Minovic, Isidor Frijlink, Henderik W Woerdenbag, Herman J |
description | ObjectivesTo determine the feasibility of preparing a long-term stable ready-to-use parenteral amiodarone formulation using cyclodextrins as dissolution enhancer.MethodsA preformulation study was performed with different molar ratios of hydroxypropyl-beta-cyclodextrin (HP-BCD) or sulfobutylether-beta-cyclodextrin (SBE-BCD) to amiodarone in order to investigate enhancement of amiodarone's water solubility. Further, effects of pH and temperature on the dissolution rate during production were investigated. Shelf-life was determined for a ready-to-use iso-osmotic preparation of 1.8 mg/mL amiodarone with SBE-BCD in a molar ratio of 1:3. Amiodarone content was assessed using a validated high-pressure liquid chromatography ultraviolet method.ResultsAmiodarone–SBE-BCD in a molar ratio of 1:3 at pH 4.0–5.0 yielded the best results in terms of increased solubility and dissolution time (90 min). With SBE-BCD, a smaller molar ratio to amiodarone was needed than with HP-BCD. The amiodarone content of the final formulation stored 12 months at 21°C in daylight remained unchanged.ConclusionsA ready-to-use or ready-to-administer amiodarone product, prepared in a hospital pharmacy, for intravenous application in an acute clinical setting is a feasible option from a chemical, physical and microbiological point of view. The availability of such a product will have a significant impact on medication safety, and production should therefore be considered. |
doi_str_mv | 10.1136/ejhpharm-2015-000860 |
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Further, effects of pH and temperature on the dissolution rate during production were investigated. Shelf-life was determined for a ready-to-use iso-osmotic preparation of 1.8 mg/mL amiodarone with SBE-BCD in a molar ratio of 1:3. Amiodarone content was assessed using a validated high-pressure liquid chromatography ultraviolet method.ResultsAmiodarone–SBE-BCD in a molar ratio of 1:3 at pH 4.0–5.0 yielded the best results in terms of increased solubility and dissolution time (90 min). With SBE-BCD, a smaller molar ratio to amiodarone was needed than with HP-BCD. The amiodarone content of the final formulation stored 12 months at 21°C in daylight remained unchanged.ConclusionsA ready-to-use or ready-to-administer amiodarone product, prepared in a hospital pharmacy, for intravenous application in an acute clinical setting is a feasible option from a chemical, physical and microbiological point of view. The availability of such a product will have a significant impact on medication safety, and production should therefore be considered.</description><identifier>ISSN: 2047-9956</identifier><identifier>EISSN: 2047-9964</identifier><identifier>DOI: 10.1136/ejhpharm-2015-000860</identifier><identifier>PMID: 31156915</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Cardiac arrhythmia ; Caustic soda ; Chromatography ; Decomposition ; Feasibility studies ; Glucose ; Heat ; Original ; Sodium</subject><ispartof>European journal of hospital pharmacy : science and practice, 2017-03, Vol.24 (2), p.110-114</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go tohttp://www.bmj.com/company/products-services/rights-and-licensing/2016</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-b425t-22ad7174188438a0c383178ca6ee09b5ed8b2d217e6a60f40ac6a6caee6e418f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6451646/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6451646/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31156915$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jacobs, Maartje S</creatorcontrib><creatorcontrib>Luinstra, Marianne</creatorcontrib><creatorcontrib>Moes, Jan Reindert</creatorcontrib><creatorcontrib>Chan, Tiffany C Y</creatorcontrib><creatorcontrib>Minovic, Isidor</creatorcontrib><creatorcontrib>Frijlink, Henderik W</creatorcontrib><creatorcontrib>Woerdenbag, Herman J</creatorcontrib><title>Ready-to-use parenteral amiodarone: a feasibility study towards a long-term stable product formulation</title><title>European journal of hospital pharmacy : science and practice</title><addtitle>Eur J Hosp Pharm</addtitle><description>ObjectivesTo determine the feasibility of preparing a long-term stable ready-to-use parenteral amiodarone formulation using cyclodextrins as dissolution enhancer.MethodsA preformulation study was performed with different molar ratios of hydroxypropyl-beta-cyclodextrin (HP-BCD) or sulfobutylether-beta-cyclodextrin (SBE-BCD) to amiodarone in order to investigate enhancement of amiodarone's water solubility. Further, effects of pH and temperature on the dissolution rate during production were investigated. Shelf-life was determined for a ready-to-use iso-osmotic preparation of 1.8 mg/mL amiodarone with SBE-BCD in a molar ratio of 1:3. Amiodarone content was assessed using a validated high-pressure liquid chromatography ultraviolet method.ResultsAmiodarone–SBE-BCD in a molar ratio of 1:3 at pH 4.0–5.0 yielded the best results in terms of increased solubility and dissolution time (90 min). With SBE-BCD, a smaller molar ratio to amiodarone was needed than with HP-BCD. The amiodarone content of the final formulation stored 12 months at 21°C in daylight remained unchanged.ConclusionsA ready-to-use or ready-to-administer amiodarone product, prepared in a hospital pharmacy, for intravenous application in an acute clinical setting is a feasible option from a chemical, physical and microbiological point of view. The availability of such a product will have a significant impact on medication safety, and production should therefore be considered.</description><subject>Cardiac arrhythmia</subject><subject>Caustic soda</subject><subject>Chromatography</subject><subject>Decomposition</subject><subject>Feasibility studies</subject><subject>Glucose</subject><subject>Heat</subject><subject>Original</subject><subject>Sodium</subject><issn>2047-9956</issn><issn>2047-9964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNqNkV9L5DAUxYPsojLrNxAp-BxNmj9NfRBEdFcQBNHncNvcOh3aZkzSlfn2Gxkd9G2fcuGc88u9HEKOOTvjXOhzXC3XSwgjLRlXlDFmNNsjhyWTFa1rLX_sZqUPyFGMfcOUEKaWot4nB4JzpWuuDkn3iOA2NHk6RyzWEHBKGGAoYOy9g-AnvCig6BAyoh_6tClimt2mSP4NgotZG_z0QnNozAo0Q6YE7-Y2FZ0P4zxA6v30i_zsYIh49PEuyPPtzdP1H3r_8Pvu-uqeNrJUiZYluIpXkhsjhQHWCiN4ZVrQiKxuFDrTlK7kFWrQrJMM2jy0gKgxhzqxIJdb7npuRnRtviYfY9ehHyFsrIfeflemfmlf_F-rpeJa6gw4_QAE_zpjTHbl5zDlnS03lRCi1EZll9y62uBjDNjtfuDMvhdkPwuy7wXZbUE5dvJ1u13os45sON8amnH1f8h_pbugPQ</recordid><startdate>20170301</startdate><enddate>20170301</enddate><creator>Jacobs, Maartje S</creator><creator>Luinstra, Marianne</creator><creator>Moes, Jan Reindert</creator><creator>Chan, Tiffany C Y</creator><creator>Minovic, Isidor</creator><creator>Frijlink, Henderik W</creator><creator>Woerdenbag, Herman J</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope></search><sort><creationdate>20170301</creationdate><title>Ready-to-use parenteral amiodarone: a feasibility study towards a long-term stable product formulation</title><author>Jacobs, Maartje S ; Luinstra, Marianne ; Moes, Jan Reindert ; Chan, Tiffany C Y ; Minovic, Isidor ; Frijlink, Henderik W ; Woerdenbag, Herman J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b425t-22ad7174188438a0c383178ca6ee09b5ed8b2d217e6a60f40ac6a6caee6e418f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Cardiac arrhythmia</topic><topic>Caustic soda</topic><topic>Chromatography</topic><topic>Decomposition</topic><topic>Feasibility studies</topic><topic>Glucose</topic><topic>Heat</topic><topic>Original</topic><topic>Sodium</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jacobs, Maartje S</creatorcontrib><creatorcontrib>Luinstra, Marianne</creatorcontrib><creatorcontrib>Moes, Jan Reindert</creatorcontrib><creatorcontrib>Chan, Tiffany C Y</creatorcontrib><creatorcontrib>Minovic, Isidor</creatorcontrib><creatorcontrib>Frijlink, Henderik W</creatorcontrib><creatorcontrib>Woerdenbag, Herman J</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>European journal of hospital pharmacy : science and practice</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jacobs, Maartje S</au><au>Luinstra, Marianne</au><au>Moes, Jan Reindert</au><au>Chan, Tiffany C Y</au><au>Minovic, Isidor</au><au>Frijlink, Henderik W</au><au>Woerdenbag, Herman J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Ready-to-use parenteral amiodarone: a feasibility study towards a long-term stable product formulation</atitle><jtitle>European journal of hospital pharmacy : science and practice</jtitle><addtitle>Eur J Hosp Pharm</addtitle><date>2017-03-01</date><risdate>2017</risdate><volume>24</volume><issue>2</issue><spage>110</spage><epage>114</epage><pages>110-114</pages><issn>2047-9956</issn><eissn>2047-9964</eissn><abstract>ObjectivesTo determine the feasibility of preparing a long-term stable ready-to-use parenteral amiodarone formulation using cyclodextrins as dissolution enhancer.MethodsA preformulation study was performed with different molar ratios of hydroxypropyl-beta-cyclodextrin (HP-BCD) or sulfobutylether-beta-cyclodextrin (SBE-BCD) to amiodarone in order to investigate enhancement of amiodarone's water solubility. Further, effects of pH and temperature on the dissolution rate during production were investigated. Shelf-life was determined for a ready-to-use iso-osmotic preparation of 1.8 mg/mL amiodarone with SBE-BCD in a molar ratio of 1:3. Amiodarone content was assessed using a validated high-pressure liquid chromatography ultraviolet method.ResultsAmiodarone–SBE-BCD in a molar ratio of 1:3 at pH 4.0–5.0 yielded the best results in terms of increased solubility and dissolution time (90 min). With SBE-BCD, a smaller molar ratio to amiodarone was needed than with HP-BCD. The amiodarone content of the final formulation stored 12 months at 21°C in daylight remained unchanged.ConclusionsA ready-to-use or ready-to-administer amiodarone product, prepared in a hospital pharmacy, for intravenous application in an acute clinical setting is a feasible option from a chemical, physical and microbiological point of view. The availability of such a product will have a significant impact on medication safety, and production should therefore be considered.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>31156915</pmid><doi>10.1136/ejhpharm-2015-000860</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Cardiac arrhythmia Caustic soda Chromatography Decomposition Feasibility studies Glucose Heat Original Sodium |
title | Ready-to-use parenteral amiodarone: a feasibility study towards a long-term stable product formulation |
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