Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing
The objective of this study was to enhance tabletability of a poorly compactible drug, acetaminophen, by wet granulation using twin screw extruder at high temperature. It was desired that there would be minimum amounts of excipients used and the granules obtained after extrusion would be dry and fal...
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| Veröffentlicht in: | Journal of pharmaceutical sciences 2017-02, Vol.106 (2), p.589-600 |
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| creator | Meena, Anuprabha K. Desai, Divyakant Serajuddin, Abu T.M. |
| description | The objective of this study was to enhance tabletability of a poorly compactible drug, acetaminophen, by wet granulation using twin screw extruder at high temperature. It was desired that there would be minimum amounts of excipients used and the granules obtained after extrusion would be dry and fall within a size range suitable for tableting without any further processing. Mixtures of acetaminophen (95%) with binders (5% povidone or partially pregelatinized starch) were wet granulated through twin screw extruder at 70°C by adding 7% w/w water. The process had a short granulation time (90% granules in the size range of 125 to 1000 μm ( |
| doi_str_mv | 10.1016/j.xphs.2016.10.020 |
| format | Article |
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It was desired that there would be minimum amounts of excipients used and the granules obtained after extrusion would be dry and fall within a size range suitable for tableting without any further processing. Mixtures of acetaminophen (95%) with binders (5% povidone or partially pregelatinized starch) were wet granulated through twin screw extruder at 70°C by adding 7% w/w water. The process had a short granulation time (<1 min), and, on account of the elevated processing temperature used, no drying after extrusion was needed. By optimizing formulation and processing parameters, >90% granules in the size range of 125 to 1000 μm (<3% above 1000 μm and <7% below 125 μm) were obtained without any milling. When the granules were compressed by adding 1% disintegrant and 0.5% lubricant extragranularly, tablets produced (93.6% drug load) had good mechanical strength having hardness >1.7 MPa, which was superior to that of tablets prepared by conventional high shear wet granulation. As the granules could be extruded continuously and did not require drying and milling, the method was amenable to continuous processing.</description><identifier>ISSN: 0022-3549</identifier><identifier>EISSN: 1520-6017</identifier><identifier>DOI: 10.1016/j.xphs.2016.10.020</identifier><identifier>PMID: 27890244</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Acetaminophen - chemistry ; Analgesics, Non-Narcotic - chemistry ; compactibility ; continuous manufacturing ; Desiccation ; Drug Compounding - instrumentation ; Drug Compounding - methods ; Equipment Design ; Excipients - chemistry ; Hardness ; Hot Temperature ; Particle Size ; Povidone - chemistry ; powder technology ; Starch - analogs & derivatives ; tablet ; Tablets ; Tensile Strength ; twin-screw extruder ; Water - chemistry ; wet granulation</subject><ispartof>Journal of pharmaceutical sciences, 2017-02, Vol.106 (2), p.589-600</ispartof><rights>2017 American Pharmacists Association</rights><rights>Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-114b4ea072b10ffb2e072722969bd857d2db444125f9775b426f91888cfcbcb63</citedby><cites>FETCH-LOGICAL-c356t-114b4ea072b10ffb2e072722969bd857d2db444125f9775b426f91888cfcbcb63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27890244$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Meena, Anuprabha K.</creatorcontrib><creatorcontrib>Desai, Divyakant</creatorcontrib><creatorcontrib>Serajuddin, Abu T.M.</creatorcontrib><title>Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing</title><title>Journal of pharmaceutical sciences</title><addtitle>J Pharm Sci</addtitle><description>The objective of this study was to enhance tabletability of a poorly compactible drug, acetaminophen, by wet granulation using twin screw extruder at high temperature. It was desired that there would be minimum amounts of excipients used and the granules obtained after extrusion would be dry and fall within a size range suitable for tableting without any further processing. Mixtures of acetaminophen (95%) with binders (5% povidone or partially pregelatinized starch) were wet granulated through twin screw extruder at 70°C by adding 7% w/w water. The process had a short granulation time (<1 min), and, on account of the elevated processing temperature used, no drying after extrusion was needed. By optimizing formulation and processing parameters, >90% granules in the size range of 125 to 1000 μm (<3% above 1000 μm and <7% below 125 μm) were obtained without any milling. When the granules were compressed by adding 1% disintegrant and 0.5% lubricant extragranularly, tablets produced (93.6% drug load) had good mechanical strength having hardness >1.7 MPa, which was superior to that of tablets prepared by conventional high shear wet granulation. As the granules could be extruded continuously and did not require drying and milling, the method was amenable to continuous processing.</description><subject>Acetaminophen - chemistry</subject><subject>Analgesics, Non-Narcotic - chemistry</subject><subject>compactibility</subject><subject>continuous manufacturing</subject><subject>Desiccation</subject><subject>Drug Compounding - instrumentation</subject><subject>Drug Compounding - methods</subject><subject>Equipment Design</subject><subject>Excipients - chemistry</subject><subject>Hardness</subject><subject>Hot Temperature</subject><subject>Particle Size</subject><subject>Povidone - chemistry</subject><subject>powder technology</subject><subject>Starch - analogs & derivatives</subject><subject>tablet</subject><subject>Tablets</subject><subject>Tensile Strength</subject><subject>twin-screw extruder</subject><subject>Water - chemistry</subject><subject>wet granulation</subject><issn>0022-3549</issn><issn>1520-6017</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc1uEzEUhS0EoqHwAiyQl2wmtR17fiQ2KA2lUlErkYqlZXuui6MZe7A9acsD8Zw4pLBkda-OzneurYPQW0qWlND6bLd8mL6nJSt7EZaEkWdoQQUjVU1o8xwtCGGsWgnenaBXKe0IITUR4iU6YU3bEcb5Av06hz0MYRrBZ6x8j6-n7Eb3U2UXPA4WK_wNMr6Iys_DUbyJwUBKWGW8GWCvMvR4C-MEUeU5ArYhFuomhDg84nUYJ2Wy0wPg8zjf4dvk_B3e3juPv5oI93jzkOPcQ_zDrYPPzs9hTvhLuWgLOscCvEYvrBoSvHmap-j202a7_lxdXV9crj9eVWYl6lxRyjUHRRqmKbFWMyhrw1hXd7pvRdOzXnPOKRO2axqhOattR9u2NdZoo-vVKXp_zJ1i-DFDynJ0ycAwKA_lUZK2nK_EigtWrOxoNTGkFMHKKbpRxUdJiTz0I3fy0I889HPQSj8FeveUP-sR-n_I30KK4cPRAOWXewdRJuPAG-hdBJNlH9z_8n8D1JykmQ</recordid><startdate>201702</startdate><enddate>201702</enddate><creator>Meena, Anuprabha K.</creator><creator>Desai, Divyakant</creator><creator>Serajuddin, Abu T.M.</creator><general>Elsevier Inc</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>201702</creationdate><title>Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing</title><author>Meena, Anuprabha K. ; Desai, Divyakant ; Serajuddin, Abu T.M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-114b4ea072b10ffb2e072722969bd857d2db444125f9775b426f91888cfcbcb63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Acetaminophen - chemistry</topic><topic>Analgesics, Non-Narcotic - chemistry</topic><topic>compactibility</topic><topic>continuous manufacturing</topic><topic>Desiccation</topic><topic>Drug Compounding - instrumentation</topic><topic>Drug Compounding - methods</topic><topic>Equipment Design</topic><topic>Excipients - chemistry</topic><topic>Hardness</topic><topic>Hot Temperature</topic><topic>Particle Size</topic><topic>Povidone - chemistry</topic><topic>powder technology</topic><topic>Starch - analogs & derivatives</topic><topic>tablet</topic><topic>Tablets</topic><topic>Tensile Strength</topic><topic>twin-screw extruder</topic><topic>Water - chemistry</topic><topic>wet granulation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Meena, Anuprabha K.</creatorcontrib><creatorcontrib>Desai, Divyakant</creatorcontrib><creatorcontrib>Serajuddin, Abu T.M.</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>Journal of pharmaceutical sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Meena, Anuprabha K.</au><au>Desai, Divyakant</au><au>Serajuddin, Abu T.M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing</atitle><jtitle>Journal of pharmaceutical sciences</jtitle><addtitle>J Pharm Sci</addtitle><date>2017-02</date><risdate>2017</risdate><volume>106</volume><issue>2</issue><spage>589</spage><epage>600</epage><pages>589-600</pages><issn>0022-3549</issn><eissn>1520-6017</eissn><abstract>The objective of this study was to enhance tabletability of a poorly compactible drug, acetaminophen, by wet granulation using twin screw extruder at high temperature. It was desired that there would be minimum amounts of excipients used and the granules obtained after extrusion would be dry and fall within a size range suitable for tableting without any further processing. Mixtures of acetaminophen (95%) with binders (5% povidone or partially pregelatinized starch) were wet granulated through twin screw extruder at 70°C by adding 7% w/w water. The process had a short granulation time (<1 min), and, on account of the elevated processing temperature used, no drying after extrusion was needed. By optimizing formulation and processing parameters, >90% granules in the size range of 125 to 1000 μm (<3% above 1000 μm and <7% below 125 μm) were obtained without any milling. When the granules were compressed by adding 1% disintegrant and 0.5% lubricant extragranularly, tablets produced (93.6% drug load) had good mechanical strength having hardness >1.7 MPa, which was superior to that of tablets prepared by conventional high shear wet granulation. As the granules could be extruded continuously and did not require drying and milling, the method was amenable to continuous processing.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>27890244</pmid><doi>10.1016/j.xphs.2016.10.020</doi><tpages>12</tpages></addata></record> |
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| ispartof | Journal of pharmaceutical sciences, 2017-02, Vol.106 (2), p.589-600 |
| issn | 0022-3549 1520-6017 |
| language | eng |
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| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Acetaminophen - chemistry Analgesics, Non-Narcotic - chemistry compactibility continuous manufacturing Desiccation Drug Compounding - instrumentation Drug Compounding - methods Equipment Design Excipients - chemistry Hardness Hot Temperature Particle Size Povidone - chemistry powder technology Starch - analogs & derivatives tablet Tablets Tensile Strength twin-screw extruder Water - chemistry wet granulation |
| title | Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing |
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