Evaluation of Dissolution of Osmotic-Controlled Release Paliperidone Tablets Using the Reciprocating Cylinder Method
The dissolution profiles of paliperidone from INVEGA® 3-mg tablets, osmotic-controlled release tablets, were evaluated by using the reciprocating cylinder method (RC method). We used 4 different compositions of the dissolution fluids, by considering the environment of the tablet in the gastrointesti...
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| Veröffentlicht in: | YAKUGAKU ZASSHI 2013/03/01, Vol.133(3), pp.405-410 |
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| container_title | YAKUGAKU ZASSHI |
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| creator | Nagata, Shunji Jin-nai, Aya Hirai, Ken-ichi Baba, Mikako Higashi, Kousuke Tanaka, Yusuke |
| description | The dissolution profiles of paliperidone from INVEGA® 3-mg tablets, osmotic-controlled release tablets, were evaluated by using the reciprocating cylinder method (RC method). We used 4 different compositions of the dissolution fluids, by considering the environment of the tablet in the gastrointestinal tract. After a lag time of 2 to 4 h, paliperidone was approximately dissolved to 24 h by zero-order release. The dissolution characteristics of paliperidone were not affected by the kind of the test medium, pH, and surfactant. In addition, the dissolution of the tablets was evaluated using the paddle method in distilled water, Japanese Pharmacopeia (JP) 1st test fluid, and JP 2nd test fluid. The dissolution profiles of paliperidone obtained using the RC method and the paddle method were very similar. Further, the dispersion of the percentage of the dissolved paliperidone obtained using the RC method and the paddle method was small. |
| doi_str_mv | 10.1248/yakushi.12-00259 |
| format | Article |
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We used 4 different compositions of the dissolution fluids, by considering the environment of the tablet in the gastrointestinal tract. After a lag time of 2 to 4 h, paliperidone was approximately dissolved to 24 h by zero-order release. The dissolution characteristics of paliperidone were not affected by the kind of the test medium, pH, and surfactant. In addition, the dissolution of the tablets was evaluated using the paddle method in distilled water, Japanese Pharmacopeia (JP) 1st test fluid, and JP 2nd test fluid. The dissolution profiles of paliperidone obtained using the RC method and the paddle method were very similar. Further, the dispersion of the percentage of the dissolved paliperidone obtained using the RC method and the paddle method was small.</description><identifier>ISSN: 0031-6903</identifier><identifier>EISSN: 1347-5231</identifier><identifier>DOI: 10.1248/yakushi.12-00259</identifier><identifier>PMID: 23257415</identifier><language>eng ; jpn</language><publisher>Japan: The Pharmaceutical Society of Japan</publisher><subject>dissolution test ; Isoxazoles - administration & dosage ; Osmosis ; osmotic-controlled release ; paliperidone ; Paliperidone Palmitate ; Pyrimidines - administration & dosage ; reciprocating cylinder method ; Solubility ; Tablets</subject><ispartof>YAKUGAKU ZASSHI, 2013/03/01, Vol.133(3), pp.405-410</ispartof><rights>2013 by the PHARMACEUTICAL SOCIETY OF JAPAN</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c476t-e4fe0f96e534b4d562e93f97362682cb8d1aeed76304ce5dfcd0f96de5914dc73</citedby><cites>FETCH-LOGICAL-c476t-e4fe0f96e534b4d562e93f97362682cb8d1aeed76304ce5dfcd0f96de5914dc73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1883,4024,27923,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23257415$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nagata, Shunji</creatorcontrib><creatorcontrib>Jin-nai, Aya</creatorcontrib><creatorcontrib>Hirai, Ken-ichi</creatorcontrib><creatorcontrib>Baba, Mikako</creatorcontrib><creatorcontrib>Higashi, Kousuke</creatorcontrib><creatorcontrib>Tanaka, Yusuke</creatorcontrib><title>Evaluation of Dissolution of Osmotic-Controlled Release Paliperidone Tablets Using the Reciprocating Cylinder Method</title><title>YAKUGAKU ZASSHI</title><addtitle>YAKUGAKU ZASSHI</addtitle><description>The dissolution profiles of paliperidone from INVEGA® 3-mg tablets, osmotic-controlled release tablets, were evaluated by using the reciprocating cylinder method (RC method). We used 4 different compositions of the dissolution fluids, by considering the environment of the tablet in the gastrointestinal tract. After a lag time of 2 to 4 h, paliperidone was approximately dissolved to 24 h by zero-order release. The dissolution characteristics of paliperidone were not affected by the kind of the test medium, pH, and surfactant. In addition, the dissolution of the tablets was evaluated using the paddle method in distilled water, Japanese Pharmacopeia (JP) 1st test fluid, and JP 2nd test fluid. The dissolution profiles of paliperidone obtained using the RC method and the paddle method were very similar. Further, the dispersion of the percentage of the dissolved paliperidone obtained using the RC method and the paddle method was small.</description><subject>dissolution test</subject><subject>Isoxazoles - administration & dosage</subject><subject>Osmosis</subject><subject>osmotic-controlled release</subject><subject>paliperidone</subject><subject>Paliperidone Palmitate</subject><subject>Pyrimidines - administration & dosage</subject><subject>reciprocating cylinder method</subject><subject>Solubility</subject><subject>Tablets</subject><issn>0031-6903</issn><issn>1347-5231</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkE1P7CAUhonR6ETduzJduqkXeqCdLs34mXjjjdE1oXDqoEwZgZrMvxedj8sC8pLnvDl5CDlj9JJVfPpnpT7GOLc5lJRWot0jEwa8KUUFbJ9MKAVW1i2FI3Iao-0yk49g00NyVEElGs7EhKSbL-VGlawfCt8X1zZG78ZtfIoLn6wuZ35IwTuHpnhGhypi8U85u8RgjR-weFGdwxSL12iHtyLNMWPaLoPXuTn_zFbODgZD8RfT3JsTctArF_F08x6T19ubl9l9-fh09zC7eiw1b-pUIu-R9m2NAnjHjagrbKFvG6irelrpbmqYQjRNDZRrFKbX5gc3KFrGjW7gmFyse_MmnyPGJBc2anRODejHKBkwDsBZwzNK16gOPsaAvVwGu1BhJRmVP7rlRncO8ld3HjnftI_dAs1uYCs3A_dr4D0m9YY7QIXs1OH_RgAJv_e2e4fouQoSB_gGMUiZIA</recordid><startdate>2013</startdate><enddate>2013</enddate><creator>Nagata, Shunji</creator><creator>Jin-nai, Aya</creator><creator>Hirai, Ken-ichi</creator><creator>Baba, Mikako</creator><creator>Higashi, Kousuke</creator><creator>Tanaka, Yusuke</creator><general>The Pharmaceutical Society of Japan</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>2013</creationdate><title>Evaluation of Dissolution of Osmotic-Controlled Release Paliperidone Tablets Using the Reciprocating Cylinder Method</title><author>Nagata, Shunji ; Jin-nai, Aya ; Hirai, Ken-ichi ; Baba, Mikako ; Higashi, Kousuke ; Tanaka, Yusuke</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c476t-e4fe0f96e534b4d562e93f97362682cb8d1aeed76304ce5dfcd0f96de5914dc73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng ; jpn</language><creationdate>2013</creationdate><topic>dissolution test</topic><topic>Isoxazoles - administration & dosage</topic><topic>Osmosis</topic><topic>osmotic-controlled release</topic><topic>paliperidone</topic><topic>Paliperidone Palmitate</topic><topic>Pyrimidines - administration & dosage</topic><topic>reciprocating cylinder method</topic><topic>Solubility</topic><topic>Tablets</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nagata, Shunji</creatorcontrib><creatorcontrib>Jin-nai, Aya</creatorcontrib><creatorcontrib>Hirai, Ken-ichi</creatorcontrib><creatorcontrib>Baba, Mikako</creatorcontrib><creatorcontrib>Higashi, Kousuke</creatorcontrib><creatorcontrib>Tanaka, Yusuke</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>YAKUGAKU ZASSHI</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nagata, Shunji</au><au>Jin-nai, Aya</au><au>Hirai, Ken-ichi</au><au>Baba, Mikako</au><au>Higashi, Kousuke</au><au>Tanaka, Yusuke</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of Dissolution of Osmotic-Controlled Release Paliperidone Tablets Using the Reciprocating Cylinder Method</atitle><jtitle>YAKUGAKU ZASSHI</jtitle><addtitle>YAKUGAKU ZASSHI</addtitle><date>2013</date><risdate>2013</risdate><volume>133</volume><issue>3</issue><spage>405</spage><epage>410</epage><pages>405-410</pages><issn>0031-6903</issn><eissn>1347-5231</eissn><abstract>The dissolution profiles of paliperidone from INVEGA® 3-mg tablets, osmotic-controlled release tablets, were evaluated by using the reciprocating cylinder method (RC method). We used 4 different compositions of the dissolution fluids, by considering the environment of the tablet in the gastrointestinal tract. After a lag time of 2 to 4 h, paliperidone was approximately dissolved to 24 h by zero-order release. The dissolution characteristics of paliperidone were not affected by the kind of the test medium, pH, and surfactant. In addition, the dissolution of the tablets was evaluated using the paddle method in distilled water, Japanese Pharmacopeia (JP) 1st test fluid, and JP 2nd test fluid. The dissolution profiles of paliperidone obtained using the RC method and the paddle method were very similar. Further, the dispersion of the percentage of the dissolved paliperidone obtained using the RC method and the paddle method was small.</abstract><cop>Japan</cop><pub>The Pharmaceutical Society of Japan</pub><pmid>23257415</pmid><doi>10.1248/yakushi.12-00259</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0031-6903 |
| ispartof | YAKUGAKU ZASSHI, 2013/03/01, Vol.133(3), pp.405-410 |
| issn | 0031-6903 1347-5231 |
| language | eng ; jpn |
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| source | J-STAGE Free; MEDLINE; Alma/SFX Local Collection |
| subjects | dissolution test Isoxazoles - administration & dosage Osmosis osmotic-controlled release paliperidone Paliperidone Palmitate Pyrimidines - administration & dosage reciprocating cylinder method Solubility Tablets |
| title | Evaluation of Dissolution of Osmotic-Controlled Release Paliperidone Tablets Using the Reciprocating Cylinder Method |
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