The use of citric acid to prolong the in vivo gastro-retention of a floating dosage form in the fasted state
Gastro-retentive dosage forms have the potential to improve local therapy and decrease the variation in bioavailability that is observed with a number of commercially available immediate and modified release preparations. In this study, a dosage form has been developed, utilising freeze-dried calciu...
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| Veröffentlicht in: | International journal of pharmaceutics 2006-02, Vol.308 (1), p.8-13 |
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| container_title | International journal of pharmaceutics |
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| creator | Stops, Frances Fell, John T. Collett, John H. Martini, Luigi G. Sharma, Harbans L. Smith, Anne-Marie |
| description | Gastro-retentive dosage forms have the potential to improve local therapy and decrease the variation in bioavailability that is observed with a number of commercially available immediate and modified release preparations. In this study, a dosage form has been developed, utilising freeze-dried calcium alginate beads, designed to float on the surface of the stomach contents thus prolonging the retention time.
The aim of the study was to also assess the in vivo behaviour of the radio-labelled calcium alginate beads when they were administered under fasting conditions with either water or an aqueous solution of citric acid, a potential gut transit delaying substance. The study was performed in healthy male volunteers who swallowed the radio-labelled calcium alginate beads after a 10
h overnight fast. Gamma scintigraphy was selected as the method to monitor the movement of the calcium alginate beads. The volunteers consumed no further food or drink until gastric emptying of the calcium alginate beads was complete.
The results indicated that prolonged gastric retention was achieved when the dosage form was administered with the citric acid solution when compared to retention in the absence of citric acid. Citric acid, therefore, has the potential to delay the gastric emptying of the calcium alginate beads when administered to fasted volunteers. |
| doi_str_mv | 10.1016/j.ijpharm.2005.09.036 |
| format | Article |
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The aim of the study was to also assess the in vivo behaviour of the radio-labelled calcium alginate beads when they were administered under fasting conditions with either water or an aqueous solution of citric acid, a potential gut transit delaying substance. The study was performed in healthy male volunteers who swallowed the radio-labelled calcium alginate beads after a 10
h overnight fast. Gamma scintigraphy was selected as the method to monitor the movement of the calcium alginate beads. The volunteers consumed no further food or drink until gastric emptying of the calcium alginate beads was complete.
The results indicated that prolonged gastric retention was achieved when the dosage form was administered with the citric acid solution when compared to retention in the absence of citric acid. Citric acid, therefore, has the potential to delay the gastric emptying of the calcium alginate beads when administered to fasted volunteers.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/j.ijpharm.2005.09.036</identifier><identifier>PMID: 16338108</identifier><identifier>CODEN: IJPHDE</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Adult ; Alginate ; Alginates - administration & dosage ; Alginates - chemistry ; Beads ; Biological and medical sciences ; Citric acid ; Citric Acid - pharmacology ; Delayed-Action Preparations ; Drug Carriers - administration & dosage ; Fasting ; Floating dosage forms ; Gastric Emptying - drug effects ; Gastric retention ; Gastrointestinal Tract - diagnostic imaging ; Gastrointestinal Transit - drug effects ; General pharmacology ; Glucuronic Acid - administration & dosage ; Glucuronic Acid - chemistry ; Hexuronic Acids - administration & dosage ; Hexuronic Acids - chemistry ; Humans ; Hydrogen-Ion Concentration ; Male ; Medical sciences ; Middle Aged ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; Radionuclide Imaging ; Radiopharmaceuticals ; Scintigraphy ; Sodium Pertechnetate Tc 99m ; Solubility ; Surface Properties</subject><ispartof>International journal of pharmaceutics, 2006-02, Vol.308 (1), p.8-13</ispartof><rights>2005 Elsevier B.V.</rights><rights>2006 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c459t-45b6dc02e00ea1702749e9545325587ff0e1e1f9f33e48ff5b3828446b2cbb3f3</citedby><cites>FETCH-LOGICAL-c459t-45b6dc02e00ea1702749e9545325587ff0e1e1f9f33e48ff5b3828446b2cbb3f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0378517305007088$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,65309</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17439600$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16338108$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Stops, Frances</creatorcontrib><creatorcontrib>Fell, John T.</creatorcontrib><creatorcontrib>Collett, John H.</creatorcontrib><creatorcontrib>Martini, Luigi G.</creatorcontrib><creatorcontrib>Sharma, Harbans L.</creatorcontrib><creatorcontrib>Smith, Anne-Marie</creatorcontrib><title>The use of citric acid to prolong the in vivo gastro-retention of a floating dosage form in the fasted state</title><title>International journal of pharmaceutics</title><addtitle>Int J Pharm</addtitle><description>Gastro-retentive dosage forms have the potential to improve local therapy and decrease the variation in bioavailability that is observed with a number of commercially available immediate and modified release preparations. In this study, a dosage form has been developed, utilising freeze-dried calcium alginate beads, designed to float on the surface of the stomach contents thus prolonging the retention time.
The aim of the study was to also assess the in vivo behaviour of the radio-labelled calcium alginate beads when they were administered under fasting conditions with either water or an aqueous solution of citric acid, a potential gut transit delaying substance. The study was performed in healthy male volunteers who swallowed the radio-labelled calcium alginate beads after a 10
h overnight fast. Gamma scintigraphy was selected as the method to monitor the movement of the calcium alginate beads. The volunteers consumed no further food or drink until gastric emptying of the calcium alginate beads was complete.
The results indicated that prolonged gastric retention was achieved when the dosage form was administered with the citric acid solution when compared to retention in the absence of citric acid. Citric acid, therefore, has the potential to delay the gastric emptying of the calcium alginate beads when administered to fasted volunteers.</description><subject>Adult</subject><subject>Alginate</subject><subject>Alginates - administration & dosage</subject><subject>Alginates - chemistry</subject><subject>Beads</subject><subject>Biological and medical sciences</subject><subject>Citric acid</subject><subject>Citric Acid - pharmacology</subject><subject>Delayed-Action Preparations</subject><subject>Drug Carriers - administration & dosage</subject><subject>Fasting</subject><subject>Floating dosage forms</subject><subject>Gastric Emptying - drug effects</subject><subject>Gastric retention</subject><subject>Gastrointestinal Tract - diagnostic imaging</subject><subject>Gastrointestinal Transit - drug effects</subject><subject>General pharmacology</subject><subject>Glucuronic Acid - administration & dosage</subject><subject>Glucuronic Acid - chemistry</subject><subject>Hexuronic Acids - administration & dosage</subject><subject>Hexuronic Acids - chemistry</subject><subject>Humans</subject><subject>Hydrogen-Ion Concentration</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Radionuclide Imaging</subject><subject>Radiopharmaceuticals</subject><subject>Scintigraphy</subject><subject>Sodium Pertechnetate Tc 99m</subject><subject>Solubility</subject><subject>Surface Properties</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkD2P1DAQQC0E4paDnwByA13COP6IUyF04ks6ieaoLccZ73mVjRfbuxL__hxtpCup3Lw3M36EvGfQMmDq86ENh9OjTce2A5AtDC1w9YLsmO55w0WvXpId8F43kvX8hrzJ-QAAqmP8NblhinPNQO_I_PCI9JyRRk9dKCk4al2YaIn0lOIclz0tlQgLvYRLpHubS4pNwoJLCXFZNUv9HG0JFZ1itnukPqbjqqymrwZONBdb8C155e2c8d323pI_37893P1s7n__-HX39b5xQg6lEXJUk4MOAdCyHrpeDDhIIXknpe69B2TI_OA5R6G9lyPXnRZCjZ0bR-75Lfl0nVu_8PeMuZhjyA7n2S4Yz9n0oLRiQldQXkGXYs4JvTmlcLTpn2Fg1szmYLbMZs1sYDA1c_U-bAvO4xGnZ2vrWoGPG2Czs7NPdnEhP3O94IMCqNyXK4c1xyVgMtkFXBxOIaErZorhP6c8ARAOngs</recordid><startdate>20060203</startdate><enddate>20060203</enddate><creator>Stops, Frances</creator><creator>Fell, John T.</creator><creator>Collett, John H.</creator><creator>Martini, Luigi G.</creator><creator>Sharma, Harbans L.</creator><creator>Smith, Anne-Marie</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>20060203</creationdate><title>The use of citric acid to prolong the in vivo gastro-retention of a floating dosage form in the fasted state</title><author>Stops, Frances ; Fell, John T. ; Collett, John H. ; Martini, Luigi G. ; Sharma, Harbans L. ; Smith, Anne-Marie</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c459t-45b6dc02e00ea1702749e9545325587ff0e1e1f9f33e48ff5b3828446b2cbb3f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adult</topic><topic>Alginate</topic><topic>Alginates - administration & dosage</topic><topic>Alginates - chemistry</topic><topic>Beads</topic><topic>Biological and medical sciences</topic><topic>Citric acid</topic><topic>Citric Acid - pharmacology</topic><topic>Delayed-Action Preparations</topic><topic>Drug Carriers - administration & dosage</topic><topic>Fasting</topic><topic>Floating dosage forms</topic><topic>Gastric Emptying - drug effects</topic><topic>Gastric retention</topic><topic>Gastrointestinal Tract - diagnostic imaging</topic><topic>Gastrointestinal Transit - drug effects</topic><topic>General pharmacology</topic><topic>Glucuronic Acid - administration & dosage</topic><topic>Glucuronic Acid - chemistry</topic><topic>Hexuronic Acids - administration & dosage</topic><topic>Hexuronic Acids - chemistry</topic><topic>Humans</topic><topic>Hydrogen-Ion Concentration</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Radionuclide Imaging</topic><topic>Radiopharmaceuticals</topic><topic>Scintigraphy</topic><topic>Sodium Pertechnetate Tc 99m</topic><topic>Solubility</topic><topic>Surface Properties</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Stops, Frances</creatorcontrib><creatorcontrib>Fell, John T.</creatorcontrib><creatorcontrib>Collett, John H.</creatorcontrib><creatorcontrib>Martini, Luigi G.</creatorcontrib><creatorcontrib>Sharma, Harbans L.</creatorcontrib><creatorcontrib>Smith, Anne-Marie</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>Stops, Frances</au><au>Fell, John T.</au><au>Collett, John H.</au><au>Martini, Luigi G.</au><au>Sharma, Harbans L.</au><au>Smith, Anne-Marie</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The use of citric acid to prolong the in vivo gastro-retention of a floating dosage form in the fasted state</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2006-02-03</date><risdate>2006</risdate><volume>308</volume><issue>1</issue><spage>8</spage><epage>13</epage><pages>8-13</pages><issn>0378-5173</issn><eissn>1873-3476</eissn><coden>IJPHDE</coden><abstract>Gastro-retentive dosage forms have the potential to improve local therapy and decrease the variation in bioavailability that is observed with a number of commercially available immediate and modified release preparations. In this study, a dosage form has been developed, utilising freeze-dried calcium alginate beads, designed to float on the surface of the stomach contents thus prolonging the retention time.
The aim of the study was to also assess the in vivo behaviour of the radio-labelled calcium alginate beads when they were administered under fasting conditions with either water or an aqueous solution of citric acid, a potential gut transit delaying substance. The study was performed in healthy male volunteers who swallowed the radio-labelled calcium alginate beads after a 10
h overnight fast. Gamma scintigraphy was selected as the method to monitor the movement of the calcium alginate beads. The volunteers consumed no further food or drink until gastric emptying of the calcium alginate beads was complete.
The results indicated that prolonged gastric retention was achieved when the dosage form was administered with the citric acid solution when compared to retention in the absence of citric acid. Citric acid, therefore, has the potential to delay the gastric emptying of the calcium alginate beads when administered to fasted volunteers.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>16338108</pmid><doi>10.1016/j.ijpharm.2005.09.036</doi><tpages>6</tpages></addata></record> |
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| ispartof | International journal of pharmaceutics, 2006-02, Vol.308 (1), p.8-13 |
| issn | 0378-5173 1873-3476 |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adult Alginate Alginates - administration & dosage Alginates - chemistry Beads Biological and medical sciences Citric acid Citric Acid - pharmacology Delayed-Action Preparations Drug Carriers - administration & dosage Fasting Floating dosage forms Gastric Emptying - drug effects Gastric retention Gastrointestinal Tract - diagnostic imaging Gastrointestinal Transit - drug effects General pharmacology Glucuronic Acid - administration & dosage Glucuronic Acid - chemistry Hexuronic Acids - administration & dosage Hexuronic Acids - chemistry Humans Hydrogen-Ion Concentration Male Medical sciences Middle Aged Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Radionuclide Imaging Radiopharmaceuticals Scintigraphy Sodium Pertechnetate Tc 99m Solubility Surface Properties |
| title | The use of citric acid to prolong the in vivo gastro-retention of a floating dosage form in the fasted state |
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