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Export Date: 27 September 2021
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This paper presents new machine vision–based methods for indirect real-time quantification of ultralow drug content during continuous twin-screw wet granulation and tableting. Granulation was performed with a solution containing carvedilol (CAR) as API in the ultralow dose range (0.05 w/w% in the granule) and the addition of riboflavin (RI) as a coloured tracer. An in-line calibration in the range of 0.047–0.058 w/w% was prepared for the measurement of CAR concentration using colour analysis (CA) and particle size analysis (PSA), and the validation with HPLC resulted in respective relative errors of 2.62% and 2.30% showing great accuracy. To improve the technique, a second in-line calibration was conducted in a broader CAR concentration range of 0.039–0.063 w/w% utilizing only half the amount of RI (0.045 w/w%), while doubling the output of the granulation line to 2 kg/h, producing a relative error of 4.51% and 4.29%, respectively. Finally, it was shown that the CA technique can also be carried on to monitor the CAR content of tablets in the 42–62 μg dose range with a relative error of 5.20%. Machine vision was proven to be a potent indirect method for the in-line, determination and monitoring of ultralow API content during continuous manufacturing.
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<div class="JournalArticle Publication short-list"> <div class="authors"> <span class="author-name" mtid="10083505"> <a href="/gui2/?type=authors&mode=browse&sel=10083505" target="_blank">Ficzere, Máté</a> </span> <span class="author-type"> </span> ; <span class="author-name" mtid="10073271"> <a href="/gui2/?type=authors&mode=browse&sel=10073271" target="_blank">Mészáros, Lilla Alexandra</a> </span> <span class="author-type"> </span> ; <span class="author-name" mtid="10068478"> <a href="/gui2/?type=authors&mode=browse&sel=10068478" target="_blank">Madarász, Lajos</a> </span> <span class="author-type"> </span> ; <span class="author-name" > Novák, Márk </span> <span class="author-type"> </span> ; <span class="author-name" mtid="10039089"> <a href="/gui2/?type=authors&mode=browse&sel=10039089" target="_blank">Nagy, Zsombor Kristóf ✉</a> </span> <span class="author-type"> </span> ; <span class="author-name" mtid="10062618"> <a href="/gui2/?type=authors&mode=browse&sel=10062618" target="_blank">Galata, Dorián László</a> </span> <span class="author-type"> </span> </div ><div class="title"><a href="/gui2/?mode=browse¶ms=publication;32242466" mtid="32242466" target="_blank">Indirect monitoring of ultralow dose API content in continuous wet granulation and tableting by machine vision</a></div> <div class="pub-info"> <span class="journal-title">INTERNATIONAL JOURNAL OF PHARMACEUTICS</span> <span class="journal-volume">607</span> <span class="page"> Paper: 121008 , 11 p. </span> <span class="year">(2021)</span> </div> <div class="pub-end"><div class="identifier-list"> <span class="identifiers"> <span class="id identifier oa_GOLD" title=" Gold "> <a style="color:blue" title="10.1016/j.ijpharm.2021.121008" target="_blank" href="https://doi.org/10.1016/j.ijpharm.2021.121008"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000696814300003" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000696814300003"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85113264455" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85113264455"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="34391851" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=34391851&dopt=Abstract"> PubMed </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:black" title="https://linkinghub.elsevier.com/retrieve/pii/S0378517321008140" target="_blank" href="https://linkinghub.elsevier.com/retrieve/pii/S0378517321008140"> Egyéb URL </a> </span> </span> </div> <div class="short-pub-prop-list"> <span class="short-pub-mtid"> Közlemény:32242466 </span> <span class="status-holder"><span class="status-data status-ADMIN_APPROVED"> Admin láttamozott </span></span> <span class="pub-core">Forrás Idéző </span> <span class="pub-type">Folyóiratcikk (Szakcikk ) </span> <!-- && !record.category.scientific --> <span class="pub-category">Tudományos</span> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 6</span> | Független: 4 | Függő: 2 | Nem jelölt: 0 | WoS jelölt: 6 | Scopus jelölt: 6 | WoS/Scopus jelölt: 6 | DOI jelölt: 6 </div> </div> </div> </div><div class="JournalArticle Publication long-list">
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<span class="authorAux-mtmt"> Gyógyszertechnológia</span>)
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<span class="author-affil"><span title="Budapesti Műszaki és Gazdaságtudományi Egyetem">BME</span>/<span title="Vegyészmérnöki és Biomérnöki Kar">VBK</span>/Szerves Kémia és Technológia Tanszék</span>
;
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<span class="authorAux-mtmt"> szerves kémia</span>)
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<span class="author-affil"><span title="Budapesti Műszaki és Gazdaságtudományi Egyetem">BME</span>/<span title="Vegyészmérnöki és Biomérnöki Kar">VBK</span>/Szerves Kémia és Technológia Tanszék</span>
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<div class="title"><a href="/gui2/?mode=browse¶ms=publication;32242466" target="_blank">Indirect monitoring of ultralow dose API content in continuous wet granulation and tableting by machine vision</a></div> <div> <span class="journal-title">INTERNATIONAL JOURNAL OF PHARMACEUTICS</span>
<span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/0378-5173">0378-5173</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1873-3476">1873-3476</a>)</span>:
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Paper 121008.
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<span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 6</span>
| Független: 4
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| <span class="status-data status-ADMIN_APPROVED"> Admin láttamozott
</span>
Forrás Idéző
| <span class="type-subtype">Folyóiratcikk
( Szakcikk
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| <span class="pub-category">Tudományos</span>
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<div class="lastModified">Utolsó módosítás: 2022.10.10. 18:43 Andódy Katalin (BME admin4)
</div>
<pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Export Date: 27 September 2021
CODEN: IJPHD
Correspondence Address: Nagy, Z.K.; Department of Organic Chemistry and Technology, Műegyetem rakpart 3, Hungary; email: zsknagy@oct.bme.hu</pre>
</div></div>