Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • In tube‐fed patients with severe neurodevelopmental problems, omeprazole for the treatment of gastro‐oesophageal reflux disease often needs to be administered through the feeding tube. • In daily practice, various procedures are used to administer the comme...
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| Veröffentlicht in: | British journal of clinical pharmacology 2011-12, Vol.72 (6), p.990-996 |
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| container_title | British journal of clinical pharmacology |
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| creator | Boussery, Koen De Smet, Julie De Cock, Pieter Vande Velde, Saskia Mehuys, Els De Paepe, Peter Remon, Jean Paul Van Bocxlaer, Jan F. P. Van Winckel, Myriam |
| description | WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• In tube‐fed patients with severe neurodevelopmental problems, omeprazole for the treatment of gastro‐oesophageal reflux disease often needs to be administered through the feeding tube.
• In daily practice, various procedures are used to administer the commercially available, enteric‐coated omeprazole formulations through a feeding tube.
• No bioavailability data are available to support a rational choice between the available administration procedures.
WHAT THIS STUDY ADDS
• This study demonstrates a substantial interindividual variability in omeprazole pharmacokinetics after administration through the gastrostomy tube in patients with severe neurodevelopmental problems.
• In most patients, plasma concentration–time profiles seem more favourable with a suspension formulation than with a MUPS® formulation.
• Consequently, there is no apparent advantage in choosing a MUPS® formulation over the more easily administered suspension formulation.
AIMS Omeprazole is often administered through a gastrostomy tube as either (i) a Multiple Unit Pellet System (MUPS®) tablet disintegrated in water (MUPS® formulation), or (ii) a suspension in 8.4% sodium bicarbonate (suspension formulation). This bioavailability study evaluates this practice in tube‐fed patients with severe neurodevelopmental problems.
METHODS Nonblinded, two‐phase cross‐over trial.
RESULTS In seven of 10 patients, bioavailability was higher for the suspension formulation than for the MUPS® formulation. Median (90% confidence interval) area under the plasma concentration–time curve ratio (MUPS® over suspension) was 0.5 (0.06–2.37).
CONCLUSIONS In this population, omeprazole MUPS® formulation has no apparent advantage over the more easily administered suspension formulation. |
| doi_str_mv | 10.1111/j.1365-2125.2011.04038.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3244649</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1093432325</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5368-759d96e1eb174b3e341903b7bbfc8af2682e5ab48e28fe9779de091bcac24f833</originalsourceid><addsrcrecordid>eNqNkU2P0zAQhi0EYsvCX0C-IHFJ8Ec-nANIbMWXtBJ7gLPlOJPWxYmD7Wy3_Ah-M862FLjhy4w8z7wzmhchTElO03u1yymvyoxRVuaMUJqTgnCR3z1Aq3PhIVoRTqqsZCW9QE9C2BFCOa3Kx-iCpSBIw1fo581W-UFp982MEI0O2PU47h3unR9mq6Jx4_2fG2Dy6oezgFU3mNGECB46HLfezZstVnijQvQuRDcccJxbwGbEUxKAMQa8N3GLA9ymHjzC7F2XcuumIVWVxZN3rYUhPEWPemUDPDvFS_T1_bsv64_Z9ecPn9ZvrzNd8kpkddl0TQUUWloXLQde0Ibwtm7bXgvVs0owKFVbCGCih6aumw5IQ1utNCt6wfklenPUneZ2gE6nLbyycvJmUP4gnTLy38potnLjbiVnRVEVTRJ4eRLw7vsMIcrBBA3WqhHcHCRN1y0446xMqDiiOl0neOjPYyiRi51yJxfX5OKaXOyU93bKu9T6_O81z42__UvAixOggla292rUJvzhirqsmBCJe33k9sbC4b8XkFfrmyXjvwDtZ8Fn</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1093432325</pqid></control><display><type>article</type><title>Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems</title><source>MEDLINE</source><source>Wiley Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Wiley Free Content</source><source>Alma/SFX Local Collection</source><creator>Boussery, Koen ; De Smet, Julie ; De Cock, Pieter ; Vande Velde, Saskia ; Mehuys, Els ; De Paepe, Peter ; Remon, Jean Paul ; Van Bocxlaer, Jan F. P. ; Van Winckel, Myriam</creator><creatorcontrib>Boussery, Koen ; De Smet, Julie ; De Cock, Pieter ; Vande Velde, Saskia ; Mehuys, Els ; De Paepe, Peter ; Remon, Jean Paul ; Van Bocxlaer, Jan F. P. ; Van Winckel, Myriam</creatorcontrib><description>WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• In tube‐fed patients with severe neurodevelopmental problems, omeprazole for the treatment of gastro‐oesophageal reflux disease often needs to be administered through the feeding tube.
• In daily practice, various procedures are used to administer the commercially available, enteric‐coated omeprazole formulations through a feeding tube.
• No bioavailability data are available to support a rational choice between the available administration procedures.
WHAT THIS STUDY ADDS
• This study demonstrates a substantial interindividual variability in omeprazole pharmacokinetics after administration through the gastrostomy tube in patients with severe neurodevelopmental problems.
• In most patients, plasma concentration–time profiles seem more favourable with a suspension formulation than with a MUPS® formulation.
• Consequently, there is no apparent advantage in choosing a MUPS® formulation over the more easily administered suspension formulation.
AIMS Omeprazole is often administered through a gastrostomy tube as either (i) a Multiple Unit Pellet System (MUPS®) tablet disintegrated in water (MUPS® formulation), or (ii) a suspension in 8.4% sodium bicarbonate (suspension formulation). This bioavailability study evaluates this practice in tube‐fed patients with severe neurodevelopmental problems.
METHODS Nonblinded, two‐phase cross‐over trial.
RESULTS In seven of 10 patients, bioavailability was higher for the suspension formulation than for the MUPS® formulation. Median (90% confidence interval) area under the plasma concentration–time curve ratio (MUPS® over suspension) was 0.5 (0.06–2.37).
CONCLUSIONS In this population, omeprazole MUPS® formulation has no apparent advantage over the more easily administered suspension formulation.</description><identifier>ISSN: 0306-5251</identifier><identifier>EISSN: 1365-2125</identifier><identifier>DOI: 10.1111/j.1365-2125.2011.04038.x</identifier><identifier>PMID: 21658093</identifier><identifier>CODEN: BCPHBM</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adolescent ; Adult ; Anti-Ulcer Agents - administration & dosage ; Anti-Ulcer Agents - pharmacokinetics ; Bioavailability ; Biological and medical sciences ; Biological Availability ; cerebral palsy ; Child ; Cross-Over Studies ; Data processing ; Developmental Disabilities - complications ; Developmental Disabilities - physiopathology ; Enteral Nutrition ; Feeding ; feeding tube ; Female ; Gastrostomy ; Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy ; Humans ; Male ; Medical sciences ; Nervous system (semeiology, syndromes) ; neurodevelopmental problem ; Neurology ; Omeprazole ; Omeprazole - administration & dosage ; Omeprazole - pharmacokinetics ; Pharmacokinetics ; Pharmacology. Drug treatments ; proton pump inhibitor ; Severity of Illness Index ; Short Reports ; Sodium bicarbonate ; Sodium Bicarbonate - chemistry ; Suspensions ; Tablets ; Water - chemistry ; Young Adult</subject><ispartof>British journal of clinical pharmacology, 2011-12, Vol.72 (6), p.990-996</ispartof><rights>British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society. No claim to original US government works</rights><rights>2015 INIST-CNRS</rights><rights>British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society. No claim to original US government works.</rights><rights>Copyright © 2011 The British Pharmacological Society 2011</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5368-759d96e1eb174b3e341903b7bbfc8af2682e5ab48e28fe9779de091bcac24f833</citedby><cites>FETCH-LOGICAL-c5368-759d96e1eb174b3e341903b7bbfc8af2682e5ab48e28fe9779de091bcac24f833</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1365-2125.2011.04038.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2125.2011.04038.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,780,784,885,1417,1433,27924,27925,45574,45575,46409,46833</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24756288$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21658093$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Boussery, Koen</creatorcontrib><creatorcontrib>De Smet, Julie</creatorcontrib><creatorcontrib>De Cock, Pieter</creatorcontrib><creatorcontrib>Vande Velde, Saskia</creatorcontrib><creatorcontrib>Mehuys, Els</creatorcontrib><creatorcontrib>De Paepe, Peter</creatorcontrib><creatorcontrib>Remon, Jean Paul</creatorcontrib><creatorcontrib>Van Bocxlaer, Jan F. P.</creatorcontrib><creatorcontrib>Van Winckel, Myriam</creatorcontrib><title>Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems</title><title>British journal of clinical pharmacology</title><addtitle>Br J Clin Pharmacol</addtitle><description>WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• In tube‐fed patients with severe neurodevelopmental problems, omeprazole for the treatment of gastro‐oesophageal reflux disease often needs to be administered through the feeding tube.
• In daily practice, various procedures are used to administer the commercially available, enteric‐coated omeprazole formulations through a feeding tube.
• No bioavailability data are available to support a rational choice between the available administration procedures.
WHAT THIS STUDY ADDS
• This study demonstrates a substantial interindividual variability in omeprazole pharmacokinetics after administration through the gastrostomy tube in patients with severe neurodevelopmental problems.
• In most patients, plasma concentration–time profiles seem more favourable with a suspension formulation than with a MUPS® formulation.
• Consequently, there is no apparent advantage in choosing a MUPS® formulation over the more easily administered suspension formulation.
AIMS Omeprazole is often administered through a gastrostomy tube as either (i) a Multiple Unit Pellet System (MUPS®) tablet disintegrated in water (MUPS® formulation), or (ii) a suspension in 8.4% sodium bicarbonate (suspension formulation). This bioavailability study evaluates this practice in tube‐fed patients with severe neurodevelopmental problems.
METHODS Nonblinded, two‐phase cross‐over trial.
RESULTS In seven of 10 patients, bioavailability was higher for the suspension formulation than for the MUPS® formulation. Median (90% confidence interval) area under the plasma concentration–time curve ratio (MUPS® over suspension) was 0.5 (0.06–2.37).
CONCLUSIONS In this population, omeprazole MUPS® formulation has no apparent advantage over the more easily administered suspension formulation.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Anti-Ulcer Agents - administration & dosage</subject><subject>Anti-Ulcer Agents - pharmacokinetics</subject><subject>Bioavailability</subject><subject>Biological and medical sciences</subject><subject>Biological Availability</subject><subject>cerebral palsy</subject><subject>Child</subject><subject>Cross-Over Studies</subject><subject>Data processing</subject><subject>Developmental Disabilities - complications</subject><subject>Developmental Disabilities - physiopathology</subject><subject>Enteral Nutrition</subject><subject>Feeding</subject><subject>feeding tube</subject><subject>Female</subject><subject>Gastrostomy</subject><subject>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Nervous system (semeiology, syndromes)</subject><subject>neurodevelopmental problem</subject><subject>Neurology</subject><subject>Omeprazole</subject><subject>Omeprazole - administration & dosage</subject><subject>Omeprazole - pharmacokinetics</subject><subject>Pharmacokinetics</subject><subject>Pharmacology. Drug treatments</subject><subject>proton pump inhibitor</subject><subject>Severity of Illness Index</subject><subject>Short Reports</subject><subject>Sodium bicarbonate</subject><subject>Sodium Bicarbonate - chemistry</subject><subject>Suspensions</subject><subject>Tablets</subject><subject>Water - chemistry</subject><subject>Young Adult</subject><issn>0306-5251</issn><issn>1365-2125</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkU2P0zAQhi0EYsvCX0C-IHFJ8Ec-nANIbMWXtBJ7gLPlOJPWxYmD7Wy3_Ah-M862FLjhy4w8z7wzmhchTElO03u1yymvyoxRVuaMUJqTgnCR3z1Aq3PhIVoRTqqsZCW9QE9C2BFCOa3Kx-iCpSBIw1fo581W-UFp982MEI0O2PU47h3unR9mq6Jx4_2fG2Dy6oezgFU3mNGECB46HLfezZstVnijQvQuRDcccJxbwGbEUxKAMQa8N3GLA9ymHjzC7F2XcuumIVWVxZN3rYUhPEWPemUDPDvFS_T1_bsv64_Z9ecPn9ZvrzNd8kpkddl0TQUUWloXLQde0Ibwtm7bXgvVs0owKFVbCGCih6aumw5IQ1utNCt6wfklenPUneZ2gE6nLbyycvJmUP4gnTLy38potnLjbiVnRVEVTRJ4eRLw7vsMIcrBBA3WqhHcHCRN1y0446xMqDiiOl0neOjPYyiRi51yJxfX5OKaXOyU93bKu9T6_O81z42__UvAixOggla292rUJvzhirqsmBCJe33k9sbC4b8XkFfrmyXjvwDtZ8Fn</recordid><startdate>201112</startdate><enddate>201112</enddate><creator>Boussery, Koen</creator><creator>De Smet, Julie</creator><creator>De Cock, Pieter</creator><creator>Vande Velde, Saskia</creator><creator>Mehuys, Els</creator><creator>De Paepe, Peter</creator><creator>Remon, Jean Paul</creator><creator>Van Bocxlaer, Jan F. P.</creator><creator>Van Winckel, Myriam</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><general>Blackwell Science Inc</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>7TK</scope><scope>5PM</scope></search><sort><creationdate>201112</creationdate><title>Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems</title><author>Boussery, Koen ; De Smet, Julie ; De Cock, Pieter ; Vande Velde, Saskia ; Mehuys, Els ; De Paepe, Peter ; Remon, Jean Paul ; Van Bocxlaer, Jan F. P. ; Van Winckel, Myriam</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5368-759d96e1eb174b3e341903b7bbfc8af2682e5ab48e28fe9779de091bcac24f833</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Anti-Ulcer Agents - administration & dosage</topic><topic>Anti-Ulcer Agents - pharmacokinetics</topic><topic>Bioavailability</topic><topic>Biological and medical sciences</topic><topic>Biological Availability</topic><topic>cerebral palsy</topic><topic>Child</topic><topic>Cross-Over Studies</topic><topic>Data processing</topic><topic>Developmental Disabilities - complications</topic><topic>Developmental Disabilities - physiopathology</topic><topic>Enteral Nutrition</topic><topic>Feeding</topic><topic>feeding tube</topic><topic>Female</topic><topic>Gastrostomy</topic><topic>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Nervous system (semeiology, syndromes)</topic><topic>neurodevelopmental problem</topic><topic>Neurology</topic><topic>Omeprazole</topic><topic>Omeprazole - administration & dosage</topic><topic>Omeprazole - pharmacokinetics</topic><topic>Pharmacokinetics</topic><topic>Pharmacology. Drug treatments</topic><topic>proton pump inhibitor</topic><topic>Severity of Illness Index</topic><topic>Short Reports</topic><topic>Sodium bicarbonate</topic><topic>Sodium Bicarbonate - chemistry</topic><topic>Suspensions</topic><topic>Tablets</topic><topic>Water - chemistry</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Boussery, Koen</creatorcontrib><creatorcontrib>De Smet, Julie</creatorcontrib><creatorcontrib>De Cock, Pieter</creatorcontrib><creatorcontrib>Vande Velde, Saskia</creatorcontrib><creatorcontrib>Mehuys, Els</creatorcontrib><creatorcontrib>De Paepe, Peter</creatorcontrib><creatorcontrib>Remon, Jean Paul</creatorcontrib><creatorcontrib>Van Bocxlaer, Jan F. P.</creatorcontrib><creatorcontrib>Van Winckel, Myriam</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>Neurosciences Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Boussery, Koen</au><au>De Smet, Julie</au><au>De Cock, Pieter</au><au>Vande Velde, Saskia</au><au>Mehuys, Els</au><au>De Paepe, Peter</au><au>Remon, Jean Paul</au><au>Van Bocxlaer, Jan F. P.</au><au>Van Winckel, Myriam</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems</atitle><jtitle>British journal of clinical pharmacology</jtitle><addtitle>Br J Clin Pharmacol</addtitle><date>2011-12</date><risdate>2011</risdate><volume>72</volume><issue>6</issue><spage>990</spage><epage>996</epage><pages>990-996</pages><issn>0306-5251</issn><eissn>1365-2125</eissn><coden>BCPHBM</coden><abstract>WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• In tube‐fed patients with severe neurodevelopmental problems, omeprazole for the treatment of gastro‐oesophageal reflux disease often needs to be administered through the feeding tube.
• In daily practice, various procedures are used to administer the commercially available, enteric‐coated omeprazole formulations through a feeding tube.
• No bioavailability data are available to support a rational choice between the available administration procedures.
WHAT THIS STUDY ADDS
• This study demonstrates a substantial interindividual variability in omeprazole pharmacokinetics after administration through the gastrostomy tube in patients with severe neurodevelopmental problems.
• In most patients, plasma concentration–time profiles seem more favourable with a suspension formulation than with a MUPS® formulation.
• Consequently, there is no apparent advantage in choosing a MUPS® formulation over the more easily administered suspension formulation.
AIMS Omeprazole is often administered through a gastrostomy tube as either (i) a Multiple Unit Pellet System (MUPS®) tablet disintegrated in water (MUPS® formulation), or (ii) a suspension in 8.4% sodium bicarbonate (suspension formulation). This bioavailability study evaluates this practice in tube‐fed patients with severe neurodevelopmental problems.
METHODS Nonblinded, two‐phase cross‐over trial.
RESULTS In seven of 10 patients, bioavailability was higher for the suspension formulation than for the MUPS® formulation. Median (90% confidence interval) area under the plasma concentration–time curve ratio (MUPS® over suspension) was 0.5 (0.06–2.37).
CONCLUSIONS In this population, omeprazole MUPS® formulation has no apparent advantage over the more easily administered suspension formulation.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>21658093</pmid><doi>10.1111/j.1365-2125.2011.04038.x</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | British journal of clinical pharmacology, 2011-12, Vol.72 (6), p.990-996 |
| issn | 0306-5251 1365-2125 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3244649 |
| source | MEDLINE; Wiley Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Wiley Free Content; Alma/SFX Local Collection |
| subjects | Adolescent Adult Anti-Ulcer Agents - administration & dosage Anti-Ulcer Agents - pharmacokinetics Bioavailability Biological and medical sciences Biological Availability cerebral palsy Child Cross-Over Studies Data processing Developmental Disabilities - complications Developmental Disabilities - physiopathology Enteral Nutrition Feeding feeding tube Female Gastrostomy Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy Humans Male Medical sciences Nervous system (semeiology, syndromes) neurodevelopmental problem Neurology Omeprazole Omeprazole - administration & dosage Omeprazole - pharmacokinetics Pharmacokinetics Pharmacology. Drug treatments proton pump inhibitor Severity of Illness Index Short Reports Sodium bicarbonate Sodium Bicarbonate - chemistry Suspensions Tablets Water - chemistry Young Adult |
| title | Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems |
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