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QbD guided development of immediate release FDM-3D printed tablets with customizable API doses
[Display omitted] •Proper tablet designs enable fast API release from PVA-based 3D printed structures.•Tablet size scaling guided by predictive models allows API dose customization.•The API release from honeycomb designs is less affected by varied printing settings.•Personalized medications are obta...
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| Published in: | International journal of pharmaceutics 2022-02, Vol.613, p.121411-121411, Article 121411 |
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| Main Authors: | , , , , , , , , , |
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| Language: | English |
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| cites | cdi_FETCH-LOGICAL-c365t-d1fe34732e23e3d2154c61b45c99f0fa7b9eba0ec02f4c5e13f16a2b2b18e6543 |
| container_end_page | 121411 |
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| container_start_page | 121411 |
| container_title | International journal of pharmaceutics |
| container_volume | 613 |
| creator | Crișan, Andrea Gabriela Iurian, Sonia Porfire, Alina Rus, Lucia Maria Bogdan, Cătălina Casian, Tibor Lucacel, Raluca Ciceo Turza, Alexandru Porav, Sebastian Tomuță, Ioan |
| description | [Display omitted]
•Proper tablet designs enable fast API release from PVA-based 3D printed structures.•Tablet size scaling guided by predictive models allows API dose customization.•The API release from honeycomb designs is less affected by varied printing settings.•Personalized medications are obtainable via rational choice of printing parameters.
The objective of this work was to develop a fused deposition modeling (FDM) 3D printed immediate release (IR) tablet with flexibility in adjusting the dose of the active pharmaceutical ingredient (API) by scaling the size of the dosage form and appropriate drug release profile steadiness to the variation of dimensions or thickness of the deposited layers throughout the printing process. Polyvinyl alcohol-based filaments with elevated API content (50% w/w) were prepared by hot melt extrusion (HME), through systematic screening of polymeric formulations with different drug loadings, and their printability was evaluated by means of mechanical characterization. For the tablet fabrication step by 3D printing (3DP), the Quality by Design (QbD) approach was implemented by employing risk management strategies and Design of Experiments (DoE). The effects of the tablet design, tablet size and the layer height settings on the drug release and the API content were investigated. Between the two proposed original tablet architectures, the honeycomb configuration was found to be a suitable candidate for the preparation of IR dosage forms with readily customizable API doses. Also, a predictive model was obtained, which assists the optimization of variables involved in the printing phase and thereby facilitates the tailoring process. |
| doi_str_mv | 10.1016/j.ijpharm.2021.121411 |
| format | article |
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•Proper tablet designs enable fast API release from PVA-based 3D printed structures.•Tablet size scaling guided by predictive models allows API dose customization.•The API release from honeycomb designs is less affected by varied printing settings.•Personalized medications are obtainable via rational choice of printing parameters.
The objective of this work was to develop a fused deposition modeling (FDM) 3D printed immediate release (IR) tablet with flexibility in adjusting the dose of the active pharmaceutical ingredient (API) by scaling the size of the dosage form and appropriate drug release profile steadiness to the variation of dimensions or thickness of the deposited layers throughout the printing process. Polyvinyl alcohol-based filaments with elevated API content (50% w/w) were prepared by hot melt extrusion (HME), through systematic screening of polymeric formulations with different drug loadings, and their printability was evaluated by means of mechanical characterization. For the tablet fabrication step by 3D printing (3DP), the Quality by Design (QbD) approach was implemented by employing risk management strategies and Design of Experiments (DoE). The effects of the tablet design, tablet size and the layer height settings on the drug release and the API content were investigated. Between the two proposed original tablet architectures, the honeycomb configuration was found to be a suitable candidate for the preparation of IR dosage forms with readily customizable API doses. Also, a predictive model was obtained, which assists the optimization of variables involved in the printing phase and thereby facilitates the tailoring process.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/j.ijpharm.2021.121411</identifier><identifier>PMID: 34954001</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>3D Printing ; Customization ; Design space ; Drug Compounding ; Drug Liberation ; Fused deposition modeling ; Immediate release ; Polyvinyl alcohol ; Printing, Three-Dimensional ; Quality by Design ; Tablets ; Technology, Pharmaceutical</subject><ispartof>International journal of pharmaceutics, 2022-02, Vol.613, p.121411-121411, Article 121411</ispartof><rights>2021 Elsevier B.V.</rights><rights>Copyright © 2021 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c365t-d1fe34732e23e3d2154c61b45c99f0fa7b9eba0ec02f4c5e13f16a2b2b18e6543</citedby><cites>FETCH-LOGICAL-c365t-d1fe34732e23e3d2154c61b45c99f0fa7b9eba0ec02f4c5e13f16a2b2b18e6543</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34954001$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Crișan, Andrea Gabriela</creatorcontrib><creatorcontrib>Iurian, Sonia</creatorcontrib><creatorcontrib>Porfire, Alina</creatorcontrib><creatorcontrib>Rus, Lucia Maria</creatorcontrib><creatorcontrib>Bogdan, Cătălina</creatorcontrib><creatorcontrib>Casian, Tibor</creatorcontrib><creatorcontrib>Lucacel, Raluca Ciceo</creatorcontrib><creatorcontrib>Turza, Alexandru</creatorcontrib><creatorcontrib>Porav, Sebastian</creatorcontrib><creatorcontrib>Tomuță, Ioan</creatorcontrib><title>QbD guided development of immediate release FDM-3D printed tablets with customizable API doses</title><title>International journal of pharmaceutics</title><addtitle>Int J Pharm</addtitle><description>[Display omitted]
•Proper tablet designs enable fast API release from PVA-based 3D printed structures.•Tablet size scaling guided by predictive models allows API dose customization.•The API release from honeycomb designs is less affected by varied printing settings.•Personalized medications are obtainable via rational choice of printing parameters.
The objective of this work was to develop a fused deposition modeling (FDM) 3D printed immediate release (IR) tablet with flexibility in adjusting the dose of the active pharmaceutical ingredient (API) by scaling the size of the dosage form and appropriate drug release profile steadiness to the variation of dimensions or thickness of the deposited layers throughout the printing process. Polyvinyl alcohol-based filaments with elevated API content (50% w/w) were prepared by hot melt extrusion (HME), through systematic screening of polymeric formulations with different drug loadings, and their printability was evaluated by means of mechanical characterization. For the tablet fabrication step by 3D printing (3DP), the Quality by Design (QbD) approach was implemented by employing risk management strategies and Design of Experiments (DoE). The effects of the tablet design, tablet size and the layer height settings on the drug release and the API content were investigated. Between the two proposed original tablet architectures, the honeycomb configuration was found to be a suitable candidate for the preparation of IR dosage forms with readily customizable API doses. Also, a predictive model was obtained, which assists the optimization of variables involved in the printing phase and thereby facilitates the tailoring process.</description><subject>3D Printing</subject><subject>Customization</subject><subject>Design space</subject><subject>Drug Compounding</subject><subject>Drug Liberation</subject><subject>Fused deposition modeling</subject><subject>Immediate release</subject><subject>Polyvinyl alcohol</subject><subject>Printing, Three-Dimensional</subject><subject>Quality by Design</subject><subject>Tablets</subject><subject>Technology, Pharmaceutical</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNqFkMlOwzAQhi0EgrI8AshHLikeL0l6QhVlqVQESHDFcpwJuEqaYjtF8PSkauHKaaTR98_yEXIKbAgM0ov50M2X78Y3Q844DIGDBNghA8gzkQiZpbtkwESWJwoycUAOQ5gzxlIOYp8cCDlSkjEYkNenYkLfOldiSUtcYd0uG1xE2lbUNQ2WzkSkHms0AenN5D4RE7r0bhF7Ppqixhjop4vv1HYhto37Xvfo-HFKyzZgOCZ7lakDnmzrEXm5uX6-uktmD7fTq_EssSJVMSmhwv5mwZELFCUHJW0KhVR2NKpYZbJihIVhaBmvpFUIooLU8IIXkGOqpDgi55u5S99-dBiiblywWNdmgW0XNE9BZipX-RpVG9T6NgSPle7_aYz_0sD0Wq2e661avVarN2r73Nl2RVf0Yv5Svy574HIDYP_oyqHXwTpc2F6iRxt12bp_VvwAom2MgQ</recordid><startdate>20220205</startdate><enddate>20220205</enddate><creator>Crișan, Andrea Gabriela</creator><creator>Iurian, Sonia</creator><creator>Porfire, Alina</creator><creator>Rus, Lucia Maria</creator><creator>Bogdan, Cătălina</creator><creator>Casian, Tibor</creator><creator>Lucacel, Raluca Ciceo</creator><creator>Turza, Alexandru</creator><creator>Porav, Sebastian</creator><creator>Tomuță, Ioan</creator><general>Elsevier B.V</general><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>20220205</creationdate><title>QbD guided development of immediate release FDM-3D printed tablets with customizable API doses</title><author>Crișan, Andrea Gabriela ; Iurian, Sonia ; Porfire, Alina ; Rus, Lucia Maria ; Bogdan, Cătălina ; Casian, Tibor ; Lucacel, Raluca Ciceo ; Turza, Alexandru ; Porav, Sebastian ; Tomuță, Ioan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c365t-d1fe34732e23e3d2154c61b45c99f0fa7b9eba0ec02f4c5e13f16a2b2b18e6543</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>3D Printing</topic><topic>Customization</topic><topic>Design space</topic><topic>Drug Compounding</topic><topic>Drug Liberation</topic><topic>Fused deposition modeling</topic><topic>Immediate release</topic><topic>Polyvinyl alcohol</topic><topic>Printing, Three-Dimensional</topic><topic>Quality by Design</topic><topic>Tablets</topic><topic>Technology, Pharmaceutical</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Crișan, Andrea Gabriela</creatorcontrib><creatorcontrib>Iurian, Sonia</creatorcontrib><creatorcontrib>Porfire, Alina</creatorcontrib><creatorcontrib>Rus, Lucia Maria</creatorcontrib><creatorcontrib>Bogdan, Cătălina</creatorcontrib><creatorcontrib>Casian, Tibor</creatorcontrib><creatorcontrib>Lucacel, Raluca Ciceo</creatorcontrib><creatorcontrib>Turza, Alexandru</creatorcontrib><creatorcontrib>Porav, Sebastian</creatorcontrib><creatorcontrib>Tomuță, Ioan</creatorcontrib><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>International journal of pharmaceutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Crișan, Andrea Gabriela</au><au>Iurian, Sonia</au><au>Porfire, Alina</au><au>Rus, Lucia Maria</au><au>Bogdan, Cătălina</au><au>Casian, Tibor</au><au>Lucacel, Raluca Ciceo</au><au>Turza, Alexandru</au><au>Porav, Sebastian</au><au>Tomuță, Ioan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>QbD guided development of immediate release FDM-3D printed tablets with customizable API doses</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2022-02-05</date><risdate>2022</risdate><volume>613</volume><spage>121411</spage><epage>121411</epage><pages>121411-121411</pages><artnum>121411</artnum><issn>0378-5173</issn><eissn>1873-3476</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><abstract>[Display omitted]
•Proper tablet designs enable fast API release from PVA-based 3D printed structures.•Tablet size scaling guided by predictive models allows API dose customization.•The API release from honeycomb designs is less affected by varied printing settings.•Personalized medications are obtainable via rational choice of printing parameters.
The objective of this work was to develop a fused deposition modeling (FDM) 3D printed immediate release (IR) tablet with flexibility in adjusting the dose of the active pharmaceutical ingredient (API) by scaling the size of the dosage form and appropriate drug release profile steadiness to the variation of dimensions or thickness of the deposited layers throughout the printing process. Polyvinyl alcohol-based filaments with elevated API content (50% w/w) were prepared by hot melt extrusion (HME), through systematic screening of polymeric formulations with different drug loadings, and their printability was evaluated by means of mechanical characterization. For the tablet fabrication step by 3D printing (3DP), the Quality by Design (QbD) approach was implemented by employing risk management strategies and Design of Experiments (DoE). The effects of the tablet design, tablet size and the layer height settings on the drug release and the API content were investigated. Between the two proposed original tablet architectures, the honeycomb configuration was found to be a suitable candidate for the preparation of IR dosage forms with readily customizable API doses. Also, a predictive model was obtained, which assists the optimization of variables involved in the printing phase and thereby facilitates the tailoring process.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>34954001</pmid><doi>10.1016/j.ijpharm.2021.121411</doi><tpages>1</tpages></addata></record> |
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| ispartof | International journal of pharmaceutics, 2022-02, Vol.613, p.121411-121411, Article 121411 |
| issn | 0378-5173 1873-3476 |
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| source | ScienceDirect Freedom Collection |
| subjects | 3D Printing Customization Design space Drug Compounding Drug Liberation Fused deposition modeling Immediate release Polyvinyl alcohol Printing, Three-Dimensional Quality by Design Tablets Technology, Pharmaceutical |
| title | QbD guided development of immediate release FDM-3D printed tablets with customizable API doses |
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