Experimental design for a pharmaceutical formulation: optimisation and robustness

In pharmaceutical industries, the formulator is usually faced with the optimisation of the excipient mixture composition aimed to prepare a product with the required characteristics. Experimental research methodology represents an efficient approach for solving such optimisation problems. Planning m...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Journal of pharmaceutical and biomedical analysis 1998-10, Vol.18 (1-2), p.57-65
Hauptverfasser: Campisi, B., Chicco, D., Vojnovic, D., Phan-Tan-Luu, R.
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page 65
container_issue 1-2
container_start_page 57
container_title Journal of pharmaceutical and biomedical analysis
container_volume 18
creator Campisi, B.
Chicco, D.
Vojnovic, D.
Phan-Tan-Luu, R.
description In pharmaceutical industries, the formulator is usually faced with the optimisation of the excipient mixture composition aimed to prepare a product with the required characteristics. Experimental research methodology represents an efficient approach for solving such optimisation problems. Planning mixture experiments using specific designs allows to analyse the blending properties of each mixture component and estimate an empirical model approximating the response of interest as a function of excipient proportions. In this study the evolution of theophylline solubility in a four-component system with constraints was analysed using two mixture design approaches: a classical mixture component proportion approach and a mathematically independent variable approach. An optimal region characterised by high solubility values was found and further explored in order to verify the insensitivity of theophylline solubility to slight variations of the excipient mixture composition.
doi_str_mv 10.1016/S0731-7085(98)00175-7
format Article
fullrecord <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_69101842</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0731708598001757</els_id><sourcerecordid>69101842</sourcerecordid><originalsourceid>FETCH-LOGICAL-c389t-c77cc056f60a4dfe291ca21d1182fc8b8c22017c10412553023f6e581a0383713</originalsourceid><addsrcrecordid>eNqFkMtKAzEUhoMotVYfoTALEV2M5jIzSdyIlHqBgogK7kKaOaORuZnMiL69aTvUpauQ_N85OedDaErwOcEku3jCnJGYY5GeSnGGMeFpzHfQmAjOYpolr7tovEX20YH3HxjjlMhkhEZSZEwmbIwe598tOFtB3ekyysHbtzoqGhfpqH3XrtIG-s6akIXHqi91Z5v6MmrazlbWr2-RrvPINcvedzV4f4j2Cl16OBrOCXq5mT_P7uLFw-397HoRGyZkFxvOjcFpVmRYJ3kBVBKjKckJEbQwYikMpWEnQ3BCaJoyTFmRQSqIxkwwTtgEnWz6tq757MF3KgxkoCx1DU3vVSaDJpHQAKYb0LjGeweFasPC2v0ogtVKpVqrVCtPSgq1Vql4qJsOH_TLCvJt1eAu5MdDrn0QVDhdG-v_mmfBNZcBu9pgEGR8WXDKGwu1gdw6MJ3KG_vPIL97XJA_</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>69101842</pqid></control><display><type>article</type><title>Experimental design for a pharmaceutical formulation: optimisation and robustness</title><source>MEDLINE</source><source>ScienceDirect Journals (5 years ago - present)</source><creator>Campisi, B. ; Chicco, D. ; Vojnovic, D. ; Phan-Tan-Luu, R.</creator><creatorcontrib>Campisi, B. ; Chicco, D. ; Vojnovic, D. ; Phan-Tan-Luu, R.</creatorcontrib><description>In pharmaceutical industries, the formulator is usually faced with the optimisation of the excipient mixture composition aimed to prepare a product with the required characteristics. Experimental research methodology represents an efficient approach for solving such optimisation problems. Planning mixture experiments using specific designs allows to analyse the blending properties of each mixture component and estimate an empirical model approximating the response of interest as a function of excipient proportions. In this study the evolution of theophylline solubility in a four-component system with constraints was analysed using two mixture design approaches: a classical mixture component proportion approach and a mathematically independent variable approach. An optimal region characterised by high solubility values was found and further explored in order to verify the insensitivity of theophylline solubility to slight variations of the excipient mixture composition.</description><identifier>ISSN: 0731-7085</identifier><identifier>EISSN: 1873-264X</identifier><identifier>DOI: 10.1016/S0731-7085(98)00175-7</identifier><identifier>PMID: 9863943</identifier><identifier>CODEN: JPBADA</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Biological and medical sciences ; Chemistry, Pharmaceutical - methods ; Component proportion approach ; Cosolvent mixture optimisation ; Drug Compounding - methods ; Drug Compounding - standards ; Experimental mixture design ; General pharmacology ; Mathematically independent variable approach ; Medical sciences ; Models, Theoretical ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; Reproducibility of Results ; Research Design ; Sensitivity and Specificity ; Solubility ; Theophylline - chemistry ; Theophylline solubility</subject><ispartof>Journal of pharmaceutical and biomedical analysis, 1998-10, Vol.18 (1-2), p.57-65</ispartof><rights>1998 Elsevier Science B.V.</rights><rights>1999 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c389t-c77cc056f60a4dfe291ca21d1182fc8b8c22017c10412553023f6e581a0383713</citedby><cites>FETCH-LOGICAL-c389t-c77cc056f60a4dfe291ca21d1182fc8b8c22017c10412553023f6e581a0383713</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/S0731-7085(98)00175-7$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>309,310,314,780,784,789,790,3550,23930,23931,25140,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=1651979$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9863943$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Campisi, B.</creatorcontrib><creatorcontrib>Chicco, D.</creatorcontrib><creatorcontrib>Vojnovic, D.</creatorcontrib><creatorcontrib>Phan-Tan-Luu, R.</creatorcontrib><title>Experimental design for a pharmaceutical formulation: optimisation and robustness</title><title>Journal of pharmaceutical and biomedical analysis</title><addtitle>J Pharm Biomed Anal</addtitle><description>In pharmaceutical industries, the formulator is usually faced with the optimisation of the excipient mixture composition aimed to prepare a product with the required characteristics. Experimental research methodology represents an efficient approach for solving such optimisation problems. Planning mixture experiments using specific designs allows to analyse the blending properties of each mixture component and estimate an empirical model approximating the response of interest as a function of excipient proportions. In this study the evolution of theophylline solubility in a four-component system with constraints was analysed using two mixture design approaches: a classical mixture component proportion approach and a mathematically independent variable approach. An optimal region characterised by high solubility values was found and further explored in order to verify the insensitivity of theophylline solubility to slight variations of the excipient mixture composition.</description><subject>Biological and medical sciences</subject><subject>Chemistry, Pharmaceutical - methods</subject><subject>Component proportion approach</subject><subject>Cosolvent mixture optimisation</subject><subject>Drug Compounding - methods</subject><subject>Drug Compounding - standards</subject><subject>Experimental mixture design</subject><subject>General pharmacology</subject><subject>Mathematically independent variable approach</subject><subject>Medical sciences</subject><subject>Models, Theoretical</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Reproducibility of Results</subject><subject>Research Design</subject><subject>Sensitivity and Specificity</subject><subject>Solubility</subject><subject>Theophylline - chemistry</subject><subject>Theophylline solubility</subject><issn>0731-7085</issn><issn>1873-264X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1998</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkMtKAzEUhoMotVYfoTALEV2M5jIzSdyIlHqBgogK7kKaOaORuZnMiL69aTvUpauQ_N85OedDaErwOcEku3jCnJGYY5GeSnGGMeFpzHfQmAjOYpolr7tovEX20YH3HxjjlMhkhEZSZEwmbIwe598tOFtB3ekyysHbtzoqGhfpqH3XrtIG-s6akIXHqi91Z5v6MmrazlbWr2-RrvPINcvedzV4f4j2Cl16OBrOCXq5mT_P7uLFw-397HoRGyZkFxvOjcFpVmRYJ3kBVBKjKckJEbQwYikMpWEnQ3BCaJoyTFmRQSqIxkwwTtgEnWz6tq757MF3KgxkoCx1DU3vVSaDJpHQAKYb0LjGeweFasPC2v0ogtVKpVqrVCtPSgq1Vql4qJsOH_TLCvJt1eAu5MdDrn0QVDhdG-v_mmfBNZcBu9pgEGR8WXDKGwu1gdw6MJ3KG_vPIL97XJA_</recordid><startdate>19981001</startdate><enddate>19981001</enddate><creator>Campisi, B.</creator><creator>Chicco, D.</creator><creator>Vojnovic, D.</creator><creator>Phan-Tan-Luu, R.</creator><general>Elsevier B.V</general><general>Elsevier Science</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>19981001</creationdate><title>Experimental design for a pharmaceutical formulation: optimisation and robustness</title><author>Campisi, B. ; Chicco, D. ; Vojnovic, D. ; Phan-Tan-Luu, R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c389t-c77cc056f60a4dfe291ca21d1182fc8b8c22017c10412553023f6e581a0383713</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1998</creationdate><topic>Biological and medical sciences</topic><topic>Chemistry, Pharmaceutical - methods</topic><topic>Component proportion approach</topic><topic>Cosolvent mixture optimisation</topic><topic>Drug Compounding - methods</topic><topic>Drug Compounding - standards</topic><topic>Experimental mixture design</topic><topic>General pharmacology</topic><topic>Mathematically independent variable approach</topic><topic>Medical sciences</topic><topic>Models, Theoretical</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Reproducibility of Results</topic><topic>Research Design</topic><topic>Sensitivity and Specificity</topic><topic>Solubility</topic><topic>Theophylline - chemistry</topic><topic>Theophylline solubility</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Campisi, B.</creatorcontrib><creatorcontrib>Chicco, D.</creatorcontrib><creatorcontrib>Vojnovic, D.</creatorcontrib><creatorcontrib>Phan-Tan-Luu, R.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Campisi, B.</au><au>Chicco, D.</au><au>Vojnovic, D.</au><au>Phan-Tan-Luu, R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Experimental design for a pharmaceutical formulation: optimisation and robustness</atitle><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle><addtitle>J Pharm Biomed Anal</addtitle><date>1998-10-01</date><risdate>1998</risdate><volume>18</volume><issue>1-2</issue><spage>57</spage><epage>65</epage><pages>57-65</pages><issn>0731-7085</issn><eissn>1873-264X</eissn><coden>JPBADA</coden><abstract>In pharmaceutical industries, the formulator is usually faced with the optimisation of the excipient mixture composition aimed to prepare a product with the required characteristics. Experimental research methodology represents an efficient approach for solving such optimisation problems. Planning mixture experiments using specific designs allows to analyse the blending properties of each mixture component and estimate an empirical model approximating the response of interest as a function of excipient proportions. In this study the evolution of theophylline solubility in a four-component system with constraints was analysed using two mixture design approaches: a classical mixture component proportion approach and a mathematically independent variable approach. An optimal region characterised by high solubility values was found and further explored in order to verify the insensitivity of theophylline solubility to slight variations of the excipient mixture composition.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>9863943</pmid><doi>10.1016/S0731-7085(98)00175-7</doi><tpages>9</tpages></addata></record>
fulltext fulltext
identifier ISSN: 0731-7085
ispartof Journal of pharmaceutical and biomedical analysis, 1998-10, Vol.18 (1-2), p.57-65
issn 0731-7085
1873-264X
language eng
recordid cdi_proquest_miscellaneous_69101842
source MEDLINE; ScienceDirect Journals (5 years ago - present)
subjects Biological and medical sciences
Chemistry, Pharmaceutical - methods
Component proportion approach
Cosolvent mixture optimisation
Drug Compounding - methods
Drug Compounding - standards
Experimental mixture design
General pharmacology
Mathematically independent variable approach
Medical sciences
Models, Theoretical
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Reproducibility of Results
Research Design
Sensitivity and Specificity
Solubility
Theophylline - chemistry
Theophylline solubility
title Experimental design for a pharmaceutical formulation: optimisation and robustness
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-06T09%3A39%3A09IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Experimental%20design%20for%20a%20pharmaceutical%20formulation:%20optimisation%20and%20robustness&rft.jtitle=Journal%20of%20pharmaceutical%20and%20biomedical%20analysis&rft.au=Campisi,%20B.&rft.date=1998-10-01&rft.volume=18&rft.issue=1-2&rft.spage=57&rft.epage=65&rft.pages=57-65&rft.issn=0731-7085&rft.eissn=1873-264X&rft.coden=JPBADA&rft_id=info:doi/10.1016/S0731-7085(98)00175-7&rft_dat=%3Cproquest_cross%3E69101842%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=69101842&rft_id=info:pmid/9863943&rft_els_id=S0731708598001757&rfr_iscdi=true