Formulation Design for Orally Disintegrating Tablets Containing Enteric-Coated Particles
The purpose of this study was to investigate the applicability of our newly developed technology (RACTAB® technology) for preparing orally disintegrating tablets (ODTs) containing enteric-coated particles. Tamsulosin hydrochloride (TAM) was used as a model drug contained in the enteric-coated partic...
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| Veröffentlicht in: | Chemical & pharmaceutical bulletin 2014/05/01, Vol.62(5), pp.407-414 |
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| creator | Okuda, Yutaka Okamoto, Yasunobu Irisawa, Yosuke Okimoto, Kazuto Osawa, Takashi Yamashita, Shinji |
| description | The purpose of this study was to investigate the applicability of our newly developed technology (RACTAB® technology) for preparing orally disintegrating tablets (ODTs) containing enteric-coated particles. Tamsulosin hydrochloride (TAM) was used as a model drug contained in the enteric-coated particles. Enteric-coated particles containing TAM (ECP-T) were prepared by spray coating a mixture of TAM with controlled-release materials. ECP-T was then mixed with rapidly disintegrating granules (RDGs), which were prepared using the suspension spray-coating method, and was tableted to form ODTs (ODTRAC). ODTRAC was evaluated for its hardness, thickness, internal structure (X-ray-CT scanning), functional properties (controlled-release profile), and in vivo disintegration time. Since RDGs with micronized ethylcellulose (MEC) increased tablet hardness by increasing the contact frequency between granules, ODTRAC containing ECP-T exhibited high hardness (>50 N) and low friability ( |
| doi_str_mv | 10.1248/cpb.c13-00752 |
| format | Article |
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Tamsulosin hydrochloride (TAM) was used as a model drug contained in the enteric-coated particles. Enteric-coated particles containing TAM (ECP-T) were prepared by spray coating a mixture of TAM with controlled-release materials. ECP-T was then mixed with rapidly disintegrating granules (RDGs), which were prepared using the suspension spray-coating method, and was tableted to form ODTs (ODTRAC). ODTRAC was evaluated for its hardness, thickness, internal structure (X-ray-CT scanning), functional properties (controlled-release profile), and in vivo disintegration time. Since RDGs with micronized ethylcellulose (MEC) increased tablet hardness by increasing the contact frequency between granules, ODTRAC containing ECP-T exhibited high hardness (>50 N) and low friability (<0.5%) with a relatively low compression force. After tableting, the structure of ECP-T in ODTRAC remained intact and no damage was observed on the surface. ECP-T recovered from ODTRAC showed the same dissolution profile of TAM in Japanese Pharmacopoeia (JP) 1st and JP 2nd media as that of intact ECP-T, which indicated that the tableting process did not affect the acid-resistibility of the particle. In addition, ODTRAC rapidly disintegrated in vivo (< 30 s), even at a high compression force (at 9 kN). These findings clearly suggest that RACTAB® technology is a useful approach to prepare ODTs containing enteric-coated particles.</description><identifier>ISSN: 0009-2363</identifier><identifier>EISSN: 1347-5223</identifier><identifier>DOI: 10.1248/cpb.c13-00752</identifier><identifier>PMID: 24789923</identifier><language>eng</language><publisher>Japan: The Pharmaceutical Society of Japan</publisher><subject>Administration, Oral ; controlled release ; Drug Design ; enteric-coated particle ; orally disintegrating tablet ; Particle Size ; Sulfonamides - administration & dosage ; Sulfonamides - chemistry ; Surface Properties ; suspension spray-coating method ; Tablets, Enteric-Coated - administration & dosage ; Tablets, Enteric-Coated - chemistry ; Tamsulosin ; tamsulosin hydrochloride</subject><ispartof>Chemical and Pharmaceutical Bulletin, 2014/05/01, Vol.62(5), pp.407-414</ispartof><rights>2014 The Pharmaceutical Society of Japan</rights><rights>Copyright Japan Science and Technology Agency 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c702t-fbdb02a44ddd45797e393a8f75fddbca2109f1df20c991b196d5f5a3905c70673</citedby><cites>FETCH-LOGICAL-c702t-fbdb02a44ddd45797e393a8f75fddbca2109f1df20c991b196d5f5a3905c70673</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,1877,4010,27900,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24789923$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Okuda, Yutaka</creatorcontrib><creatorcontrib>Okamoto, Yasunobu</creatorcontrib><creatorcontrib>Irisawa, Yosuke</creatorcontrib><creatorcontrib>Okimoto, Kazuto</creatorcontrib><creatorcontrib>Osawa, Takashi</creatorcontrib><creatorcontrib>Yamashita, Shinji</creatorcontrib><creatorcontrib>Setsunan University</creatorcontrib><creatorcontrib>cFaculty of Pharmaceutical Sciences</creatorcontrib><creatorcontrib>bTowa Pharmaceutical Co</creatorcontrib><creatorcontrib>aTowa Pharmaceutical Co</creatorcontrib><creatorcontrib>Ltd</creatorcontrib><title>Formulation Design for Orally Disintegrating Tablets Containing Enteric-Coated Particles</title><title>Chemical & pharmaceutical bulletin</title><addtitle>Chem. Pharm. Bull.</addtitle><description>The purpose of this study was to investigate the applicability of our newly developed technology (RACTAB® technology) for preparing orally disintegrating tablets (ODTs) containing enteric-coated particles. Tamsulosin hydrochloride (TAM) was used as a model drug contained in the enteric-coated particles. Enteric-coated particles containing TAM (ECP-T) were prepared by spray coating a mixture of TAM with controlled-release materials. ECP-T was then mixed with rapidly disintegrating granules (RDGs), which were prepared using the suspension spray-coating method, and was tableted to form ODTs (ODTRAC). ODTRAC was evaluated for its hardness, thickness, internal structure (X-ray-CT scanning), functional properties (controlled-release profile), and in vivo disintegration time. Since RDGs with micronized ethylcellulose (MEC) increased tablet hardness by increasing the contact frequency between granules, ODTRAC containing ECP-T exhibited high hardness (>50 N) and low friability (<0.5%) with a relatively low compression force. After tableting, the structure of ECP-T in ODTRAC remained intact and no damage was observed on the surface. ECP-T recovered from ODTRAC showed the same dissolution profile of TAM in Japanese Pharmacopoeia (JP) 1st and JP 2nd media as that of intact ECP-T, which indicated that the tableting process did not affect the acid-resistibility of the particle. In addition, ODTRAC rapidly disintegrated in vivo (< 30 s), even at a high compression force (at 9 kN). These findings clearly suggest that RACTAB® technology is a useful approach to prepare ODTs containing enteric-coated particles.</description><subject>Administration, Oral</subject><subject>controlled release</subject><subject>Drug Design</subject><subject>enteric-coated particle</subject><subject>orally disintegrating tablet</subject><subject>Particle Size</subject><subject>Sulfonamides - administration & dosage</subject><subject>Sulfonamides - chemistry</subject><subject>Surface Properties</subject><subject>suspension spray-coating method</subject><subject>Tablets, Enteric-Coated - administration & dosage</subject><subject>Tablets, Enteric-Coated - chemistry</subject><subject>Tamsulosin</subject><subject>tamsulosin hydrochloride</subject><issn>0009-2363</issn><issn>1347-5223</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkM1r3DAQxU1pabZpj70WQy-9OB2NJGt1LM5HA4H0kEJvQpbkjRZZ3kr2If99tdntBnKZB_N-vBleVX0mcEGQrb-bXX9hCG0ABMc31YpQJhqOSN9WKwCQDdKWnlUfct4CIAdB31dnyMRaSqSr6s_1lMYl6NlPsb502W9iPUypvk86hKf60mcfZ7dJBYib-kH3wc257qY4ax_3q6tiJ2-abtKzs_UvnWZvgssfq3eDDtl9Oup59fv66qH72dzd39x2P-4aIwDnZuhtD6gZs9YyLqRwVFK9HgQfrO2NRgJyIHZAMFKSnsjW8oFrKoGXgFbQ8-rbIXeXpr-Ly7MafTYuBB3dtGRFOBKKnEtW0K-v0O20pFi-21Ow5sgIFKo5UCZNOSc3qF3yo05PioDaV65K5apUrp4rL_yXY-rSj86e6P8dF-DmABTXGx2mGHx0L7dNFubRjV4hEFZCWwReBBUwEGUQhshJkZLUHZK2edYbdzp17Pz5sRYV34_Tgy_uo07KRfoPgk-qrQ</recordid><startdate>2014</startdate><enddate>2014</enddate><creator>Okuda, Yutaka</creator><creator>Okamoto, Yasunobu</creator><creator>Irisawa, Yosuke</creator><creator>Okimoto, Kazuto</creator><creator>Osawa, Takashi</creator><creator>Yamashita, Shinji</creator><general>The Pharmaceutical Society of Japan</general><general>Pharmaceutical Society of Japan</general><general>Japan Science and Technology Agency</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>7TK</scope><scope>7TM</scope><scope>7U9</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>2014</creationdate><title>Formulation Design for Orally Disintegrating Tablets Containing Enteric-Coated Particles</title><author>Okuda, Yutaka ; Okamoto, Yasunobu ; Irisawa, Yosuke ; Okimoto, Kazuto ; Osawa, Takashi ; Yamashita, Shinji</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c702t-fbdb02a44ddd45797e393a8f75fddbca2109f1df20c991b196d5f5a3905c70673</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Administration, Oral</topic><topic>controlled release</topic><topic>Drug Design</topic><topic>enteric-coated particle</topic><topic>orally disintegrating tablet</topic><topic>Particle Size</topic><topic>Sulfonamides - administration & dosage</topic><topic>Sulfonamides - chemistry</topic><topic>Surface Properties</topic><topic>suspension spray-coating method</topic><topic>Tablets, Enteric-Coated - administration & dosage</topic><topic>Tablets, Enteric-Coated - chemistry</topic><topic>Tamsulosin</topic><topic>tamsulosin hydrochloride</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Okuda, Yutaka</creatorcontrib><creatorcontrib>Okamoto, Yasunobu</creatorcontrib><creatorcontrib>Irisawa, Yosuke</creatorcontrib><creatorcontrib>Okimoto, Kazuto</creatorcontrib><creatorcontrib>Osawa, Takashi</creatorcontrib><creatorcontrib>Yamashita, Shinji</creatorcontrib><creatorcontrib>Setsunan University</creatorcontrib><creatorcontrib>cFaculty of Pharmaceutical Sciences</creatorcontrib><creatorcontrib>bTowa Pharmaceutical Co</creatorcontrib><creatorcontrib>aTowa Pharmaceutical Co</creatorcontrib><creatorcontrib>Ltd</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Chemical & pharmaceutical bulletin</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Okuda, Yutaka</au><au>Okamoto, Yasunobu</au><au>Irisawa, Yosuke</au><au>Okimoto, Kazuto</au><au>Osawa, Takashi</au><au>Yamashita, Shinji</au><aucorp>Setsunan University</aucorp><aucorp>cFaculty of Pharmaceutical Sciences</aucorp><aucorp>bTowa Pharmaceutical Co</aucorp><aucorp>aTowa Pharmaceutical Co</aucorp><aucorp>Ltd</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Formulation Design for Orally Disintegrating Tablets Containing Enteric-Coated Particles</atitle><jtitle>Chemical & pharmaceutical bulletin</jtitle><addtitle>Chem. Pharm. Bull.</addtitle><date>2014</date><risdate>2014</risdate><volume>62</volume><issue>5</issue><spage>407</spage><epage>414</epage><pages>407-414</pages><issn>0009-2363</issn><eissn>1347-5223</eissn><abstract>The purpose of this study was to investigate the applicability of our newly developed technology (RACTAB® technology) for preparing orally disintegrating tablets (ODTs) containing enteric-coated particles. Tamsulosin hydrochloride (TAM) was used as a model drug contained in the enteric-coated particles. Enteric-coated particles containing TAM (ECP-T) were prepared by spray coating a mixture of TAM with controlled-release materials. ECP-T was then mixed with rapidly disintegrating granules (RDGs), which were prepared using the suspension spray-coating method, and was tableted to form ODTs (ODTRAC). ODTRAC was evaluated for its hardness, thickness, internal structure (X-ray-CT scanning), functional properties (controlled-release profile), and in vivo disintegration time. Since RDGs with micronized ethylcellulose (MEC) increased tablet hardness by increasing the contact frequency between granules, ODTRAC containing ECP-T exhibited high hardness (>50 N) and low friability (<0.5%) with a relatively low compression force. After tableting, the structure of ECP-T in ODTRAC remained intact and no damage was observed on the surface. ECP-T recovered from ODTRAC showed the same dissolution profile of TAM in Japanese Pharmacopoeia (JP) 1st and JP 2nd media as that of intact ECP-T, which indicated that the tableting process did not affect the acid-resistibility of the particle. In addition, ODTRAC rapidly disintegrated in vivo (< 30 s), even at a high compression force (at 9 kN). These findings clearly suggest that RACTAB® technology is a useful approach to prepare ODTs containing enteric-coated particles.</abstract><cop>Japan</cop><pub>The Pharmaceutical Society of Japan</pub><pmid>24789923</pmid><doi>10.1248/cpb.c13-00752</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Chemical and Pharmaceutical Bulletin, 2014/05/01, Vol.62(5), pp.407-414 |
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| language | eng |
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| source | MEDLINE; J-STAGE (Japan Science & Technology Information Aggregator, Electronic) Freely Available Titles - Japanese; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Free Full-Text Journals in Chemistry |
| subjects | Administration, Oral controlled release Drug Design enteric-coated particle orally disintegrating tablet Particle Size Sulfonamides - administration & dosage Sulfonamides - chemistry Surface Properties suspension spray-coating method Tablets, Enteric-Coated - administration & dosage Tablets, Enteric-Coated - chemistry Tamsulosin tamsulosin hydrochloride |
| title | Formulation Design for Orally Disintegrating Tablets Containing Enteric-Coated Particles |
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