An Advanced Twin-Screw Granulation Technology: The use of Non-Volatile Solvents with High Solubilizing Capacity
Purpose Twin-screw wet granulation (TSWG) is a manufacturing process that offers several advantages for the processing of water-insoluble active pharmaceutical ingredients (APIs) and has been used for increasing the solubility and dissolution rates. Here we introduce a novel TSWG approach with reduc...
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| Veröffentlicht in: | AAPS PharmSciTech 2024-07, Vol.25 (6), p.174, Article 174 |
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| creator | Kolipaka, Siva Satyanarayana Junqueira, Laura Andrade Ross, Steven Garg, Vivek Mithu, Md Sadeque Hossein Bhatt, Saumil Douroumis, Dennis |
| description | Purpose
Twin-screw wet granulation (TSWG) is a manufacturing process that offers several advantages for the processing of water-insoluble active pharmaceutical ingredients (APIs) and has been used for increasing the solubility and dissolution rates. Here we introduce a novel TSWG approach with reduced downstream processing steps by using non-volatile solvents as granulating binders.
Methods
Herein, TSWG was carried out using Transcutol a non-volatile protic solvent as a granulating binder and dissolution enhancer of ibuprofen (IBU) blends with cellulose polymer grades (Pharmacoat
®
603, Affinisol™, and AQOAT
®
).
Results
The physicochemical characterisation of the produced granules showed excellent powder flow and the complete transformation of IBU into the amorphous state. Dissolution studies presented immediate release rates for all IBU formulations due to the high drug-polymer miscibility and the Transcutol solubilising capacity.
Conclusions
Overall, the study demonstrated an innovative approach for the development of extruded granules by processing water-insoluble APIs with non-volatile solvents for enhanced dissolution rates at high drug loadings.
Graphical Abstract |
| doi_str_mv | 10.1208/s12249-024-02890-y |
| format | Article |
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Twin-screw wet granulation (TSWG) is a manufacturing process that offers several advantages for the processing of water-insoluble active pharmaceutical ingredients (APIs) and has been used for increasing the solubility and dissolution rates. Here we introduce a novel TSWG approach with reduced downstream processing steps by using non-volatile solvents as granulating binders.
Methods
Herein, TSWG was carried out using Transcutol a non-volatile protic solvent as a granulating binder and dissolution enhancer of ibuprofen (IBU) blends with cellulose polymer grades (Pharmacoat
®
603, Affinisol™, and AQOAT
®
).
Results
The physicochemical characterisation of the produced granules showed excellent powder flow and the complete transformation of IBU into the amorphous state. Dissolution studies presented immediate release rates for all IBU formulations due to the high drug-polymer miscibility and the Transcutol solubilising capacity.
Conclusions
Overall, the study demonstrated an innovative approach for the development of extruded granules by processing water-insoluble APIs with non-volatile solvents for enhanced dissolution rates at high drug loadings.
Graphical Abstract</description><identifier>ISSN: 1530-9932</identifier><identifier>EISSN: 1530-9932</identifier><identifier>DOI: 10.1208/s12249-024-02890-y</identifier><identifier>PMID: 39085532</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Biochemistry ; Biomedical and Life Sciences ; Biomedicine ; Biotechnology ; Cellulose - chemistry ; Chemistry, Pharmaceutical - methods ; Drug Compounding - methods ; Drug Liberation ; Ethylene Glycols ; Excipients - chemistry ; Ibuprofen - chemistry ; Particle Size ; Pharmacology/Toxicology ; Pharmacy ; Polymers - chemistry ; Powders - chemistry ; Research Article ; Solubility ; Solvents - chemistry ; Technology, Pharmaceutical - methods ; Water - chemistry</subject><ispartof>AAPS PharmSciTech, 2024-07, Vol.25 (6), p.174, Article 174</ispartof><rights>The Author(s) 2024</rights><rights>2024. The Author(s).</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c342t-5192bbe8cd22c8b04deed2dfd376fb461979c3777e359419581a46771574cc8f3</cites><orcidid>0000-0002-6461-2327</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1208/s12249-024-02890-y$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1208/s12249-024-02890-y$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39085532$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kolipaka, Siva Satyanarayana</creatorcontrib><creatorcontrib>Junqueira, Laura Andrade</creatorcontrib><creatorcontrib>Ross, Steven</creatorcontrib><creatorcontrib>Garg, Vivek</creatorcontrib><creatorcontrib>Mithu, Md Sadeque Hossein</creatorcontrib><creatorcontrib>Bhatt, Saumil</creatorcontrib><creatorcontrib>Douroumis, Dennis</creatorcontrib><title>An Advanced Twin-Screw Granulation Technology: The use of Non-Volatile Solvents with High Solubilizing Capacity</title><title>AAPS PharmSciTech</title><addtitle>AAPS PharmSciTech</addtitle><addtitle>AAPS PharmSciTech</addtitle><description>Purpose
Twin-screw wet granulation (TSWG) is a manufacturing process that offers several advantages for the processing of water-insoluble active pharmaceutical ingredients (APIs) and has been used for increasing the solubility and dissolution rates. Here we introduce a novel TSWG approach with reduced downstream processing steps by using non-volatile solvents as granulating binders.
Methods
Herein, TSWG was carried out using Transcutol a non-volatile protic solvent as a granulating binder and dissolution enhancer of ibuprofen (IBU) blends with cellulose polymer grades (Pharmacoat
®
603, Affinisol™, and AQOAT
®
).
Results
The physicochemical characterisation of the produced granules showed excellent powder flow and the complete transformation of IBU into the amorphous state. Dissolution studies presented immediate release rates for all IBU formulations due to the high drug-polymer miscibility and the Transcutol solubilising capacity.
Conclusions
Overall, the study demonstrated an innovative approach for the development of extruded granules by processing water-insoluble APIs with non-volatile solvents for enhanced dissolution rates at high drug loadings.
Graphical Abstract</description><subject>Biochemistry</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Biotechnology</subject><subject>Cellulose - chemistry</subject><subject>Chemistry, Pharmaceutical - methods</subject><subject>Drug Compounding - methods</subject><subject>Drug Liberation</subject><subject>Ethylene Glycols</subject><subject>Excipients - chemistry</subject><subject>Ibuprofen - chemistry</subject><subject>Particle Size</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><subject>Polymers - chemistry</subject><subject>Powders - chemistry</subject><subject>Research Article</subject><subject>Solubility</subject><subject>Solvents - chemistry</subject><subject>Technology, Pharmaceutical - methods</subject><subject>Water - chemistry</subject><issn>1530-9932</issn><issn>1530-9932</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><recordid>eNp9kLtOwzAUhi0EgnJ5AQbkkSXgS25mqyqgSBUMLayW45y0Rqld7KRVeHpSWhATg2XrnO__JX8IXVJyQxnJbwNlLBYRYXF_ckGi7gANaMJJJARnh3_eJ-g0hHdCGKeCH6MTLkieJJwNkBtaPCzXymoo8WxjbDTVHjb40Svb1qoxzuIZ6IV1tZt3d3i2ANwGwK7Cz85Gb27L1ICnrl6DbQLemGaBx2a-2I7awtTm09g5HqmV0qbpztFRpeoAF_v7DL0-3M9G42jy8vg0Gk4izWPWRAkVrCgg1yVjOi9IXAKUrKxKnqVVEadUZELzLMuAJyKmIsmpitMso0kWa51X_Axd73pX3n20EBq5NEFDXSsLrg2SkzwVSdqL6FG2Q7V3IXio5MqbpfKdpERuRcudaNmLlt-iZdeHrvb9bbGE8jfyY7YH-A4I_crOwct313rb__m_2i91Monz</recordid><startdate>20240731</startdate><enddate>20240731</enddate><creator>Kolipaka, Siva Satyanarayana</creator><creator>Junqueira, Laura Andrade</creator><creator>Ross, Steven</creator><creator>Garg, Vivek</creator><creator>Mithu, Md Sadeque Hossein</creator><creator>Bhatt, Saumil</creator><creator>Douroumis, Dennis</creator><general>Springer International Publishing</general><scope>C6C</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><orcidid>https://orcid.org/0000-0002-6461-2327</orcidid></search><sort><creationdate>20240731</creationdate><title>An Advanced Twin-Screw Granulation Technology: The use of Non-Volatile Solvents with High Solubilizing Capacity</title><author>Kolipaka, Siva Satyanarayana ; Junqueira, Laura Andrade ; Ross, Steven ; Garg, Vivek ; Mithu, Md Sadeque Hossein ; Bhatt, Saumil ; Douroumis, Dennis</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c342t-5192bbe8cd22c8b04deed2dfd376fb461979c3777e359419581a46771574cc8f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Biochemistry</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Biotechnology</topic><topic>Cellulose - chemistry</topic><topic>Chemistry, Pharmaceutical - methods</topic><topic>Drug Compounding - methods</topic><topic>Drug Liberation</topic><topic>Ethylene Glycols</topic><topic>Excipients - chemistry</topic><topic>Ibuprofen - chemistry</topic><topic>Particle Size</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><topic>Polymers - chemistry</topic><topic>Powders - chemistry</topic><topic>Research Article</topic><topic>Solubility</topic><topic>Solvents - chemistry</topic><topic>Technology, Pharmaceutical - methods</topic><topic>Water - chemistry</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kolipaka, Siva Satyanarayana</creatorcontrib><creatorcontrib>Junqueira, Laura Andrade</creatorcontrib><creatorcontrib>Ross, Steven</creatorcontrib><creatorcontrib>Garg, Vivek</creatorcontrib><creatorcontrib>Mithu, Md Sadeque Hossein</creatorcontrib><creatorcontrib>Bhatt, Saumil</creatorcontrib><creatorcontrib>Douroumis, Dennis</creatorcontrib><collection>Springer Nature OA Free Journals</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>AAPS PharmSciTech</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kolipaka, Siva Satyanarayana</au><au>Junqueira, Laura Andrade</au><au>Ross, Steven</au><au>Garg, Vivek</au><au>Mithu, Md Sadeque Hossein</au><au>Bhatt, Saumil</au><au>Douroumis, Dennis</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>An Advanced Twin-Screw Granulation Technology: The use of Non-Volatile Solvents with High Solubilizing Capacity</atitle><jtitle>AAPS PharmSciTech</jtitle><stitle>AAPS PharmSciTech</stitle><addtitle>AAPS PharmSciTech</addtitle><date>2024-07-31</date><risdate>2024</risdate><volume>25</volume><issue>6</issue><spage>174</spage><pages>174-</pages><artnum>174</artnum><issn>1530-9932</issn><eissn>1530-9932</eissn><abstract>Purpose
Twin-screw wet granulation (TSWG) is a manufacturing process that offers several advantages for the processing of water-insoluble active pharmaceutical ingredients (APIs) and has been used for increasing the solubility and dissolution rates. Here we introduce a novel TSWG approach with reduced downstream processing steps by using non-volatile solvents as granulating binders.
Methods
Herein, TSWG was carried out using Transcutol a non-volatile protic solvent as a granulating binder and dissolution enhancer of ibuprofen (IBU) blends with cellulose polymer grades (Pharmacoat
®
603, Affinisol™, and AQOAT
®
).
Results
The physicochemical characterisation of the produced granules showed excellent powder flow and the complete transformation of IBU into the amorphous state. Dissolution studies presented immediate release rates for all IBU formulations due to the high drug-polymer miscibility and the Transcutol solubilising capacity.
Conclusions
Overall, the study demonstrated an innovative approach for the development of extruded granules by processing water-insoluble APIs with non-volatile solvents for enhanced dissolution rates at high drug loadings.
Graphical Abstract</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>39085532</pmid><doi>10.1208/s12249-024-02890-y</doi><orcidid>https://orcid.org/0000-0002-6461-2327</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1530-9932 |
| ispartof | AAPS PharmSciTech, 2024-07, Vol.25 (6), p.174, Article 174 |
| issn | 1530-9932 1530-9932 |
| language | eng |
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| source | MEDLINE; SpringerLink Journals |
| subjects | Biochemistry Biomedical and Life Sciences Biomedicine Biotechnology Cellulose - chemistry Chemistry, Pharmaceutical - methods Drug Compounding - methods Drug Liberation Ethylene Glycols Excipients - chemistry Ibuprofen - chemistry Particle Size Pharmacology/Toxicology Pharmacy Polymers - chemistry Powders - chemistry Research Article Solubility Solvents - chemistry Technology, Pharmaceutical - methods Water - chemistry |
| title | An Advanced Twin-Screw Granulation Technology: The use of Non-Volatile Solvents with High Solubilizing Capacity |
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