Applicability of (SBE) 7m-β-CD in controlled-porosity osmotic pump tablets (OPTs)
The purpose of this study was to investigate the general application of a controlled-porosity osmotic pump tablet (OPT) utilizing (SBE) 7m-β-CD as both a solubilizer and an osmotic agent for drugs with varying physical properties. OPTs utilizing (SBE) 7m-β-CD were prepared for five poorly soluble an...
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Veröffentlicht in: | International journal of pharmaceutics 2004-11, Vol.286 (1), p.81-88 |
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container_title | International journal of pharmaceutics |
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creator | Okimoto, Kazuto Tokunaga, Yuji Ibuki, Rinta Irie, Tetsumi Uekama, Kaneto Rajewski, Roger A. Stella, Valentino J. |
description | The purpose of this study was to investigate the general application of a controlled-porosity osmotic pump tablet (OPT) utilizing (SBE)
7m-β-CD as both a solubilizer and an osmotic agent for drugs with varying physical properties. OPTs utilizing (SBE)
7m-β-CD were prepared for five poorly soluble and two highly water-soluble drugs. The Japanese Pharmacopoeia dissolution method was used to study the drug and (SBE)
7m-β-CD release from the OPTs. The drug concentration in the OPT core after the OPT was placed in the release medium for two hours was assayed gravimetrically and by HPLC. An appropriate composition ratio (ACR) of (SBE)
7m-β-CD to drug at which drug release from the OPT was complete and pH-independent within the physiological pH range of the GI tract was determined for each drug. The ACR values correlate to the drug concentration in the OPT core when the OPTs were placed in the release medium for two hours. The release profiles of prednisolone (a poorly water-soluble drug) and sodium chloride (a water-soluble compound) from the OPTs were almost the same as that of (SBE)
7m-β-CD. Also, the release rate of each drug per unit membrane surface area from the OPTs was similar, regardless of the differences in drug solubility. The present results confirmed that (SBE)
7m-β-CD serves as both a solubility modulator and as an osmotic pumping agent for OPTs, from which the release rate of both water-soluble and poorly water-soluble drugs can be controlled. |
doi_str_mv | 10.1016/j.ijpharm.2004.08.002 |
format | Article |
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7m-β-CD as both a solubilizer and an osmotic agent for drugs with varying physical properties. OPTs utilizing (SBE)
7m-β-CD were prepared for five poorly soluble and two highly water-soluble drugs. The Japanese Pharmacopoeia dissolution method was used to study the drug and (SBE)
7m-β-CD release from the OPTs. The drug concentration in the OPT core after the OPT was placed in the release medium for two hours was assayed gravimetrically and by HPLC. An appropriate composition ratio (ACR) of (SBE)
7m-β-CD to drug at which drug release from the OPT was complete and pH-independent within the physiological pH range of the GI tract was determined for each drug. The ACR values correlate to the drug concentration in the OPT core when the OPTs were placed in the release medium for two hours. The release profiles of prednisolone (a poorly water-soluble drug) and sodium chloride (a water-soluble compound) from the OPTs were almost the same as that of (SBE)
7m-β-CD. Also, the release rate of each drug per unit membrane surface area from the OPTs was similar, regardless of the differences in drug solubility. The present results confirmed that (SBE)
7m-β-CD serves as both a solubility modulator and as an osmotic pumping agent for OPTs, from which the release rate of both water-soluble and poorly water-soluble drugs can be controlled.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/j.ijpharm.2004.08.002</identifier><identifier>PMID: 15501004</identifier><identifier>CODEN: IJPHDE</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>(SBE) 7m-β-CD ; Adjuvants, Pharmaceutic - chemistry ; beta-Cyclodextrins - chemistry ; beta-Cyclodextrins - pharmacokinetics ; Biological and medical sciences ; Chemistry, Pharmaceutical - methods ; Chlorpromazine ; Controlled-porosity osmotic pump tablet ; Cyclodextrins ; Delayed-Action Preparations - chemistry ; Delayed-Action Preparations - pharmacokinetics ; Diltiazem hydrochloride ; Estradiol ; General pharmacology ; Indomethacin ; Medical sciences ; Naproxen ; Osmosis ; Osmotic pump ; pH-independent release ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; Porosity ; Prednisolone ; Solubility ; Sulbutamol sulfate ; Tablets</subject><ispartof>International journal of pharmaceutics, 2004-11, Vol.286 (1), p.81-88</ispartof><rights>2004 Elsevier B.V.</rights><rights>2004 INIST-CNRS</rights><rights>copyright 2004 Elsevier B.V.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c306t-7aa2da36d5bd43491bb9d2262b76cb7faa97e392a15fb999f475a3d21482d4d3</citedby><cites>FETCH-LOGICAL-c306t-7aa2da36d5bd43491bb9d2262b76cb7faa97e392a15fb999f475a3d21482d4d3</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.2004.08.002$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16222005$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15501004$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Okimoto, Kazuto</creatorcontrib><creatorcontrib>Tokunaga, Yuji</creatorcontrib><creatorcontrib>Ibuki, Rinta</creatorcontrib><creatorcontrib>Irie, Tetsumi</creatorcontrib><creatorcontrib>Uekama, Kaneto</creatorcontrib><creatorcontrib>Rajewski, Roger A.</creatorcontrib><creatorcontrib>Stella, Valentino J.</creatorcontrib><title>Applicability of (SBE) 7m-β-CD in controlled-porosity osmotic pump tablets (OPTs)</title><title>International journal of pharmaceutics</title><addtitle>Int J Pharm</addtitle><description>The purpose of this study was to investigate the general application of a controlled-porosity osmotic pump tablet (OPT) utilizing (SBE)
7m-β-CD as both a solubilizer and an osmotic agent for drugs with varying physical properties. OPTs utilizing (SBE)
7m-β-CD were prepared for five poorly soluble and two highly water-soluble drugs. The Japanese Pharmacopoeia dissolution method was used to study the drug and (SBE)
7m-β-CD release from the OPTs. The drug concentration in the OPT core after the OPT was placed in the release medium for two hours was assayed gravimetrically and by HPLC. An appropriate composition ratio (ACR) of (SBE)
7m-β-CD to drug at which drug release from the OPT was complete and pH-independent within the physiological pH range of the GI tract was determined for each drug. The ACR values correlate to the drug concentration in the OPT core when the OPTs were placed in the release medium for two hours. The release profiles of prednisolone (a poorly water-soluble drug) and sodium chloride (a water-soluble compound) from the OPTs were almost the same as that of (SBE)
7m-β-CD. Also, the release rate of each drug per unit membrane surface area from the OPTs was similar, regardless of the differences in drug solubility. The present results confirmed that (SBE)
7m-β-CD serves as both a solubility modulator and as an osmotic pumping agent for OPTs, from which the release rate of both water-soluble and poorly water-soluble drugs can be controlled.</description><subject>(SBE) 7m-β-CD</subject><subject>Adjuvants, Pharmaceutic - chemistry</subject><subject>beta-Cyclodextrins - chemistry</subject><subject>beta-Cyclodextrins - pharmacokinetics</subject><subject>Biological and medical sciences</subject><subject>Chemistry, Pharmaceutical - methods</subject><subject>Chlorpromazine</subject><subject>Controlled-porosity osmotic pump tablet</subject><subject>Cyclodextrins</subject><subject>Delayed-Action Preparations - chemistry</subject><subject>Delayed-Action Preparations - pharmacokinetics</subject><subject>Diltiazem hydrochloride</subject><subject>Estradiol</subject><subject>General pharmacology</subject><subject>Indomethacin</subject><subject>Medical sciences</subject><subject>Naproxen</subject><subject>Osmosis</subject><subject>Osmotic pump</subject><subject>pH-independent release</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Porosity</subject><subject>Prednisolone</subject><subject>Solubility</subject><subject>Sulbutamol sulfate</subject><subject>Tablets</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkM1u1DAUhS0EokPhEUDZgNpFwrWd2PEKtUOBSpWKYPaW_yI8cuJgZyr1tXgQnqkuE6lLVnfznXOPPoTeYmgwYPZx3_j9_EulsSEAbQN9A0CeoQ3uOa1py9lztAHK-7rDnJ6gVznvAYARTF-iE9x1gEtsg35czHPwRmkf_HJfxaE6-3l5dV7xsf77p95-rvxUmTgtKYbgbD3HFPM_MI9x8aaaD-NcLUoHt-Tq7Pb7Lp-_Ri8GFbJ7s95TtPtytdt-q29uv15vL25qQ4EtNVeKWEWZ7bRtaSuw1sISwojmzGg-KCW4o4Io3A1aCDG0vFPUEtz2xLaWnqIPx9o5xd8Hlxc5-mxcCGpy8ZAl4wBU9KKA3RE0ZXtObpBz8qNK9xKDfHQp93J1KR9dSuhlcVly79YHBz06-5Ra5RXg_QqobFQYkpqMz08cI6T0dYX7dORcsXHnXZLZeDcZZ31yZpE2-v9MeQCh-pQt</recordid><startdate>20041122</startdate><enddate>20041122</enddate><creator>Okimoto, Kazuto</creator><creator>Tokunaga, Yuji</creator><creator>Ibuki, Rinta</creator><creator>Irie, Tetsumi</creator><creator>Uekama, Kaneto</creator><creator>Rajewski, Roger A.</creator><creator>Stella, Valentino J.</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</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>20041122</creationdate><title>Applicability of (SBE) 7m-β-CD in controlled-porosity osmotic pump tablets (OPTs)</title><author>Okimoto, Kazuto ; Tokunaga, Yuji ; Ibuki, Rinta ; Irie, Tetsumi ; Uekama, Kaneto ; Rajewski, Roger A. ; Stella, Valentino J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c306t-7aa2da36d5bd43491bb9d2262b76cb7faa97e392a15fb999f475a3d21482d4d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>(SBE) 7m-β-CD</topic><topic>Adjuvants, Pharmaceutic - chemistry</topic><topic>beta-Cyclodextrins - chemistry</topic><topic>beta-Cyclodextrins - pharmacokinetics</topic><topic>Biological and medical sciences</topic><topic>Chemistry, Pharmaceutical - methods</topic><topic>Chlorpromazine</topic><topic>Controlled-porosity osmotic pump tablet</topic><topic>Cyclodextrins</topic><topic>Delayed-Action Preparations - chemistry</topic><topic>Delayed-Action Preparations - pharmacokinetics</topic><topic>Diltiazem hydrochloride</topic><topic>Estradiol</topic><topic>General pharmacology</topic><topic>Indomethacin</topic><topic>Medical sciences</topic><topic>Naproxen</topic><topic>Osmosis</topic><topic>Osmotic pump</topic><topic>pH-independent release</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Porosity</topic><topic>Prednisolone</topic><topic>Solubility</topic><topic>Sulbutamol sulfate</topic><topic>Tablets</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Okimoto, Kazuto</creatorcontrib><creatorcontrib>Tokunaga, Yuji</creatorcontrib><creatorcontrib>Ibuki, Rinta</creatorcontrib><creatorcontrib>Irie, Tetsumi</creatorcontrib><creatorcontrib>Uekama, Kaneto</creatorcontrib><creatorcontrib>Rajewski, Roger A.</creatorcontrib><creatorcontrib>Stella, Valentino J.</creatorcontrib><collection>Pascal-Francis</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>Okimoto, Kazuto</au><au>Tokunaga, Yuji</au><au>Ibuki, Rinta</au><au>Irie, Tetsumi</au><au>Uekama, Kaneto</au><au>Rajewski, Roger A.</au><au>Stella, Valentino J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Applicability of (SBE) 7m-β-CD in controlled-porosity osmotic pump tablets (OPTs)</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2004-11-22</date><risdate>2004</risdate><volume>286</volume><issue>1</issue><spage>81</spage><epage>88</epage><pages>81-88</pages><issn>0378-5173</issn><eissn>1873-3476</eissn><coden>IJPHDE</coden><abstract>The purpose of this study was to investigate the general application of a controlled-porosity osmotic pump tablet (OPT) utilizing (SBE)
7m-β-CD as both a solubilizer and an osmotic agent for drugs with varying physical properties. OPTs utilizing (SBE)
7m-β-CD were prepared for five poorly soluble and two highly water-soluble drugs. The Japanese Pharmacopoeia dissolution method was used to study the drug and (SBE)
7m-β-CD release from the OPTs. The drug concentration in the OPT core after the OPT was placed in the release medium for two hours was assayed gravimetrically and by HPLC. An appropriate composition ratio (ACR) of (SBE)
7m-β-CD to drug at which drug release from the OPT was complete and pH-independent within the physiological pH range of the GI tract was determined for each drug. The ACR values correlate to the drug concentration in the OPT core when the OPTs were placed in the release medium for two hours. The release profiles of prednisolone (a poorly water-soluble drug) and sodium chloride (a water-soluble compound) from the OPTs were almost the same as that of (SBE)
7m-β-CD. Also, the release rate of each drug per unit membrane surface area from the OPTs was similar, regardless of the differences in drug solubility. The present results confirmed that (SBE)
7m-β-CD serves as both a solubility modulator and as an osmotic pumping agent for OPTs, from which the release rate of both water-soluble and poorly water-soluble drugs can be controlled.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>15501004</pmid><doi>10.1016/j.ijpharm.2004.08.002</doi><tpages>8</tpages></addata></record> |
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subjects | (SBE) 7m-β-CD Adjuvants, Pharmaceutic - chemistry beta-Cyclodextrins - chemistry beta-Cyclodextrins - pharmacokinetics Biological and medical sciences Chemistry, Pharmaceutical - methods Chlorpromazine Controlled-porosity osmotic pump tablet Cyclodextrins Delayed-Action Preparations - chemistry Delayed-Action Preparations - pharmacokinetics Diltiazem hydrochloride Estradiol General pharmacology Indomethacin Medical sciences Naproxen Osmosis Osmotic pump pH-independent release Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Porosity Prednisolone Solubility Sulbutamol sulfate Tablets |
title | Applicability of (SBE) 7m-β-CD in controlled-porosity osmotic pump tablets (OPTs) |
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