Detection of component segregation in granules manufactured by high shear granulation with over-granulation conditions using near-infrared chemical imaging
The objective of this study was to evaluate the high shear granulation process using near-infrared (NIR) chemical imaging technique and to make the findings available for pharmaceutical development. We prepared granules and tablets made under appropriate- and over-granulation conditions with high sh...
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| Veröffentlicht in: | International journal of pharmaceutics 2013-01, Vol.441 (1-2), p.135-145 |
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| container_title | International journal of pharmaceutics |
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| creator | Koide, Tatsuo Nagato, Takuya Kanou, Yoshiyuki Matsui, Kou Natsuyama, Susumu Kawanishi, Toru Hiyama, Yukio |
| description | The objective of this study was to evaluate the high shear granulation process using near-infrared (NIR) chemical imaging technique and to make the findings available for pharmaceutical development. We prepared granules and tablets made under appropriate- and over-granulation conditions with high shear granulation and observed these granules and tablets using NIR chemical imaging system. We found an interesting phenomenon: lactose agglomeration and segregation of ingredients occurred in experimental tablets when over-granulation conditions, including greater impeller rotation speeds and longer granulation times, were employed. Granules prepared using over-granulation conditions were larger and had progressed to the consolidation stage; segregation between ethenzamide and lactose occurred within larger granules. The segregation observed here is not detectable using conventional analytical technologies such as high pressure liquid chromatography (HPLC) because the content of the granules remained uniform despite the segregation. Therefore, granule visualization using NIR chemical imaging is an effective method for investigating and evaluating the granulation process. |
| doi_str_mv | 10.1016/j.ijpharm.2012.12.005 |
| format | Article |
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We prepared granules and tablets made under appropriate- and over-granulation conditions with high shear granulation and observed these granules and tablets using NIR chemical imaging system. We found an interesting phenomenon: lactose agglomeration and segregation of ingredients occurred in experimental tablets when over-granulation conditions, including greater impeller rotation speeds and longer granulation times, were employed. Granules prepared using over-granulation conditions were larger and had progressed to the consolidation stage; segregation between ethenzamide and lactose occurred within larger granules. The segregation observed here is not detectable using conventional analytical technologies such as high pressure liquid chromatography (HPLC) because the content of the granules remained uniform despite the segregation. Therefore, granule visualization using NIR chemical imaging is an effective method for investigating and evaluating the granulation process.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/j.ijpharm.2012.12.005</identifier><identifier>PMID: 23247019</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Chromatography, High Pressure Liquid - methods ; Drug Compounding - instrumentation ; Drug Compounding - methods ; Excipients - chemistry ; Feasibility Studies ; granules ; high performance liquid chromatography ; High shear granulation ; Image analysis ; ingredients ; lactose ; Lactose - chemistry ; Near-infrared spectroscopy ; Salicylamides - administration & dosage ; Salicylamides - chemistry ; Segregation ; Spectroscopy, Near-Infrared - methods ; Tablets ; Time Factors</subject><ispartof>International journal of pharmaceutics, 2013-01, Vol.441 (1-2), p.135-145</ispartof><rights>2012 Elsevier B.V.</rights><rights>Copyright © 2012 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c389t-cc1a638d94f205fd1c5e1df6f52870f05b5517133483cd86ef8b4c13d3b0b3de3</citedby><cites>FETCH-LOGICAL-c389t-cc1a638d94f205fd1c5e1df6f52870f05b5517133483cd86ef8b4c13d3b0b3de3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ijpharm.2012.12.005$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3548,27923,27924,45994</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23247019$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Koide, Tatsuo</creatorcontrib><creatorcontrib>Nagato, Takuya</creatorcontrib><creatorcontrib>Kanou, Yoshiyuki</creatorcontrib><creatorcontrib>Matsui, Kou</creatorcontrib><creatorcontrib>Natsuyama, Susumu</creatorcontrib><creatorcontrib>Kawanishi, Toru</creatorcontrib><creatorcontrib>Hiyama, Yukio</creatorcontrib><title>Detection of component segregation in granules manufactured by high shear granulation with over-granulation conditions using near-infrared chemical imaging</title><title>International journal of pharmaceutics</title><addtitle>Int J Pharm</addtitle><description>The objective of this study was to evaluate the high shear granulation process using near-infrared (NIR) chemical imaging technique and to make the findings available for pharmaceutical development. We prepared granules and tablets made under appropriate- and over-granulation conditions with high shear granulation and observed these granules and tablets using NIR chemical imaging system. We found an interesting phenomenon: lactose agglomeration and segregation of ingredients occurred in experimental tablets when over-granulation conditions, including greater impeller rotation speeds and longer granulation times, were employed. Granules prepared using over-granulation conditions were larger and had progressed to the consolidation stage; segregation between ethenzamide and lactose occurred within larger granules. The segregation observed here is not detectable using conventional analytical technologies such as high pressure liquid chromatography (HPLC) because the content of the granules remained uniform despite the segregation. Therefore, granule visualization using NIR chemical imaging is an effective method for investigating and evaluating the granulation process.</description><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Drug Compounding - instrumentation</subject><subject>Drug Compounding - methods</subject><subject>Excipients - chemistry</subject><subject>Feasibility Studies</subject><subject>granules</subject><subject>high performance liquid chromatography</subject><subject>High shear granulation</subject><subject>Image analysis</subject><subject>ingredients</subject><subject>lactose</subject><subject>Lactose - chemistry</subject><subject>Near-infrared spectroscopy</subject><subject>Salicylamides - administration & dosage</subject><subject>Salicylamides - chemistry</subject><subject>Segregation</subject><subject>Spectroscopy, Near-Infrared - methods</subject><subject>Tablets</subject><subject>Time Factors</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc1u1DAUhS1ERaeFRwC8ZJOpf-LEs0KoQEGq1AV0bTn2deJRYg92UtRn4WXrIQNih2TpWr7fOb66B6HXlGwpoc3Vfuv3h0GnacsIZdtyCBHP0IbKlle8bpvnaEN4KytBW36OLnLeE0IaRvkLdM44q1tCdxv06yPMYGYfA44OmzgdYoAw4wx9gl7_bviA-6TDMkLGU6lOm3lJYHH3iAffDzgPoNOJWSU__Tzg-ACp-vfVxGD98Zbxkn3ocSi6ygeX9NHODDB5o0fsJ92X9kt05vSY4dWpXqL7z5--X3-pbu9uvl5_uK0Ml7u5Mobqhku7qx0jwllqBFDrGieYbIkjohNlB5TzWnJjZQNOdrWh3PKOdNwCv0TvVt9Dij8WyLOafDYwjjpAXLKiTDJS70jbFFSsqEkx5wROHVKZNj0qStQxF7VXp1zUMZeiVSWXontz-mLpJrB_VX-CKMDbFXA6Kt0nn9X9t-IgSHEpECvE-5WAsooHD0ll4yEYsD6VBJWN_j9DPAFgHq8Y</recordid><startdate>20130130</startdate><enddate>20130130</enddate><creator>Koide, Tatsuo</creator><creator>Nagato, Takuya</creator><creator>Kanou, Yoshiyuki</creator><creator>Matsui, Kou</creator><creator>Natsuyama, Susumu</creator><creator>Kawanishi, Toru</creator><creator>Hiyama, Yukio</creator><general>Elsevier B.V</general><scope>FBQ</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>20130130</creationdate><title>Detection of component segregation in granules manufactured by high shear granulation with over-granulation conditions using near-infrared chemical imaging</title><author>Koide, Tatsuo ; Nagato, Takuya ; Kanou, Yoshiyuki ; Matsui, Kou ; Natsuyama, Susumu ; Kawanishi, Toru ; Hiyama, Yukio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c389t-cc1a638d94f205fd1c5e1df6f52870f05b5517133483cd86ef8b4c13d3b0b3de3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Drug Compounding - instrumentation</topic><topic>Drug Compounding - methods</topic><topic>Excipients - chemistry</topic><topic>Feasibility Studies</topic><topic>granules</topic><topic>high performance liquid chromatography</topic><topic>High shear granulation</topic><topic>Image analysis</topic><topic>ingredients</topic><topic>lactose</topic><topic>Lactose - chemistry</topic><topic>Near-infrared spectroscopy</topic><topic>Salicylamides - administration & dosage</topic><topic>Salicylamides - chemistry</topic><topic>Segregation</topic><topic>Spectroscopy, Near-Infrared - methods</topic><topic>Tablets</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Koide, Tatsuo</creatorcontrib><creatorcontrib>Nagato, Takuya</creatorcontrib><creatorcontrib>Kanou, Yoshiyuki</creatorcontrib><creatorcontrib>Matsui, Kou</creatorcontrib><creatorcontrib>Natsuyama, Susumu</creatorcontrib><creatorcontrib>Kawanishi, Toru</creatorcontrib><creatorcontrib>Hiyama, Yukio</creatorcontrib><collection>AGRIS</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>International journal of pharmaceutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Koide, Tatsuo</au><au>Nagato, Takuya</au><au>Kanou, Yoshiyuki</au><au>Matsui, Kou</au><au>Natsuyama, Susumu</au><au>Kawanishi, Toru</au><au>Hiyama, Yukio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Detection of component segregation in granules manufactured by high shear granulation with over-granulation conditions using near-infrared chemical imaging</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2013-01-30</date><risdate>2013</risdate><volume>441</volume><issue>1-2</issue><spage>135</spage><epage>145</epage><pages>135-145</pages><issn>0378-5173</issn><eissn>1873-3476</eissn><abstract>The objective of this study was to evaluate the high shear granulation process using near-infrared (NIR) chemical imaging technique and to make the findings available for pharmaceutical development. We prepared granules and tablets made under appropriate- and over-granulation conditions with high shear granulation and observed these granules and tablets using NIR chemical imaging system. We found an interesting phenomenon: lactose agglomeration and segregation of ingredients occurred in experimental tablets when over-granulation conditions, including greater impeller rotation speeds and longer granulation times, were employed. Granules prepared using over-granulation conditions were larger and had progressed to the consolidation stage; segregation between ethenzamide and lactose occurred within larger granules. The segregation observed here is not detectable using conventional analytical technologies such as high pressure liquid chromatography (HPLC) because the content of the granules remained uniform despite the segregation. Therefore, granule visualization using NIR chemical imaging is an effective method for investigating and evaluating the granulation process.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>23247019</pmid><doi>10.1016/j.ijpharm.2012.12.005</doi><tpages>11</tpages></addata></record> |
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| ispartof | International journal of pharmaceutics, 2013-01, Vol.441 (1-2), p.135-145 |
| issn | 0378-5173 1873-3476 |
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| source | Elsevier ScienceDirect Journals Complete - AutoHoldings; MEDLINE |
| subjects | Chromatography, High Pressure Liquid - methods Drug Compounding - instrumentation Drug Compounding - methods Excipients - chemistry Feasibility Studies granules high performance liquid chromatography High shear granulation Image analysis ingredients lactose Lactose - chemistry Near-infrared spectroscopy Salicylamides - administration & dosage Salicylamides - chemistry Segregation Spectroscopy, Near-Infrared - methods Tablets Time Factors |
| title | Detection of component segregation in granules manufactured by high shear granulation with over-granulation conditions using near-infrared chemical imaging |
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