Single dose and steady-state pharmacokinetics of 4 mg and 8 mg oral salbutamol controlled-release in patients with bronchial asthma
Fifteen patients with asthma were given salbutamol controlled-release (SCR) 4 mg or 8 mg twice daily for seven days, in a randomised double-blind cross-over design. Plasma salbutamol levels were measured after the first and fifteenth doses for a 12 h period following drug ingestion. At steady-state...
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| Veröffentlicht in: | European journal of clinical pharmacology 1989, Vol.37 (1), p.49-52 |
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| container_title | European journal of clinical pharmacology |
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| creator | LIPWORTH, B. J CLARK, R. A DHILLON, D. P CHARTER, M. K PALMER, J. B. D MCDEVITT, D. G |
| description | Fifteen patients with asthma were given salbutamol controlled-release (SCR) 4 mg or 8 mg twice daily for seven days, in a randomised double-blind cross-over design. Plasma salbutamol levels were measured after the first and fifteenth doses for a 12 h period following drug ingestion. At steady-state the geometric mean values for Cmax were 8.2 ng/ml for 4 mg, and 16.1 ng/ml for 8 mg. Median tmax values were 300 and 240 min respectively. The geometric mean AUC (0-12) were 4507 ng.min.ml-1 and 8980 ng.min/ml. Peak to trough fluctuation ratios were 0.577 and 0.572. There were no significant differences between 4 mg or 8 mg formulations, for any of the parameters measured, after appropriate corrections for dose. The concentration-time profiles at steady-state showed little fluctuation in plasma salbutamol levels over the twelve hour dosing interval. These results show that 4 mg and 8 mg formulations of SCR provide smooth plasma profiles at steady-state with a twice daily dosing regime. |
| doi_str_mv | 10.1007/BF00609424 |
| format | Article |
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J ; CLARK, R. A ; DHILLON, D. P ; CHARTER, M. K ; PALMER, J. B. D ; MCDEVITT, D. G</creator><creatorcontrib>LIPWORTH, B. J ; CLARK, R. A ; DHILLON, D. P ; CHARTER, M. K ; PALMER, J. B. D ; MCDEVITT, D. G</creatorcontrib><description>Fifteen patients with asthma were given salbutamol controlled-release (SCR) 4 mg or 8 mg twice daily for seven days, in a randomised double-blind cross-over design. Plasma salbutamol levels were measured after the first and fifteenth doses for a 12 h period following drug ingestion. At steady-state the geometric mean values for Cmax were 8.2 ng/ml for 4 mg, and 16.1 ng/ml for 8 mg. Median tmax values were 300 and 240 min respectively. The geometric mean AUC (0-12) were 4507 ng.min.ml-1 and 8980 ng.min/ml. Peak to trough fluctuation ratios were 0.577 and 0.572. There were no significant differences between 4 mg or 8 mg formulations, for any of the parameters measured, after appropriate corrections for dose. The concentration-time profiles at steady-state showed little fluctuation in plasma salbutamol levels over the twelve hour dosing interval. These results show that 4 mg and 8 mg formulations of SCR provide smooth plasma profiles at steady-state with a twice daily dosing regime.</description><identifier>ISSN: 0031-6970</identifier><identifier>EISSN: 1432-1041</identifier><identifier>DOI: 10.1007/BF00609424</identifier><identifier>PMID: 2687008</identifier><language>eng</language><publisher>Heidelberg: Springer</publisher><subject>Adult ; Albuterol - administration & dosage ; Albuterol - pharmacokinetics ; Albuterol - therapeutic use ; Asthma - drug therapy ; Asthma - physiopathology ; Biological and medical sciences ; Delayed-Action Preparations ; Double-Blind Method ; Female ; Forced Expiratory Volume ; Humans ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Randomized Controlled Trials as Topic ; Respiratory system ; Time Factors</subject><ispartof>European journal of clinical pharmacology, 1989, Vol.37 (1), p.49-52</ispartof><rights>1990 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c226t-f1ba8acfc5e889820f5c8edbb3ec9df5692c7f1ef5abd481a99beb11b0a848cf3</citedby><cites>FETCH-LOGICAL-c226t-f1ba8acfc5e889820f5c8edbb3ec9df5692c7f1ef5abd481a99beb11b0a848cf3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,4009,27901,27902,27903</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=6765556$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/2687008$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>LIPWORTH, B. J</creatorcontrib><creatorcontrib>CLARK, R. A</creatorcontrib><creatorcontrib>DHILLON, D. P</creatorcontrib><creatorcontrib>CHARTER, M. K</creatorcontrib><creatorcontrib>PALMER, J. B. D</creatorcontrib><creatorcontrib>MCDEVITT, D. G</creatorcontrib><title>Single dose and steady-state pharmacokinetics of 4 mg and 8 mg oral salbutamol controlled-release in patients with bronchial asthma</title><title>European journal of clinical pharmacology</title><addtitle>Eur J Clin Pharmacol</addtitle><description>Fifteen patients with asthma were given salbutamol controlled-release (SCR) 4 mg or 8 mg twice daily for seven days, in a randomised double-blind cross-over design. Plasma salbutamol levels were measured after the first and fifteenth doses for a 12 h period following drug ingestion. At steady-state the geometric mean values for Cmax were 8.2 ng/ml for 4 mg, and 16.1 ng/ml for 8 mg. Median tmax values were 300 and 240 min respectively. The geometric mean AUC (0-12) were 4507 ng.min.ml-1 and 8980 ng.min/ml. Peak to trough fluctuation ratios were 0.577 and 0.572. There were no significant differences between 4 mg or 8 mg formulations, for any of the parameters measured, after appropriate corrections for dose. The concentration-time profiles at steady-state showed little fluctuation in plasma salbutamol levels over the twelve hour dosing interval. These results show that 4 mg and 8 mg formulations of SCR provide smooth plasma profiles at steady-state with a twice daily dosing regime.</description><subject>Adult</subject><subject>Albuterol - administration & dosage</subject><subject>Albuterol - pharmacokinetics</subject><subject>Albuterol - therapeutic use</subject><subject>Asthma - drug therapy</subject><subject>Asthma - physiopathology</subject><subject>Biological and medical sciences</subject><subject>Delayed-Action Preparations</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Forced Expiratory Volume</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Respiratory system</subject><subject>Time Factors</subject><issn>0031-6970</issn><issn>1432-1041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1989</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkD1vFDEQhq0IFI4jDT2SC5QCaWG8u961S4jygRSJAqhXY-84Z_Dah-0TSs0fZ0NOoZkZ6X3mKV7GXgt4LwDGD5-uAAbQfdufsI3ou7YR0ItnbAPQiWbQI7xgL0v5ASCkhu6UnbaDGgHUhv356uNdID6nQhzjzEslnO-bUrES3-8wL2jTTx-pelt4crzny90_Uj0cKWPgBYM5VFxS4DbFmlMINDeZAuFq9ZHvsXqKtfDfvu64ySnanV8fsdTdgq_Yc4eh0Nlxb9n3q8tvFzfN7ZfrzxcfbxvbtkNtnDCo0DorSSmtWnDSKpqN6cjq2clBt3Z0gpxEM_dKoNaGjBAGUPXKum7Lzh-9-5x-HajUafHFUggYKR3KNOpO6nadW_buEbQ5lZLJTfvsF8z3k4DpofHpf-Mr_OZoPZiF5if0WPGavz3mWCwGlzFaX56wYRyklEP3F-1virw</recordid><startdate>1989</startdate><enddate>1989</enddate><creator>LIPWORTH, B. J</creator><creator>CLARK, R. A</creator><creator>DHILLON, D. P</creator><creator>CHARTER, M. K</creator><creator>PALMER, J. B. D</creator><creator>MCDEVITT, D. G</creator><general>Springer</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>1989</creationdate><title>Single dose and steady-state pharmacokinetics of 4 mg and 8 mg oral salbutamol controlled-release in patients with bronchial asthma</title><author>LIPWORTH, B. J ; CLARK, R. A ; DHILLON, D. P ; CHARTER, M. K ; PALMER, J. B. D ; MCDEVITT, D. G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c226t-f1ba8acfc5e889820f5c8edbb3ec9df5692c7f1ef5abd481a99beb11b0a848cf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1989</creationdate><topic>Adult</topic><topic>Albuterol - administration & dosage</topic><topic>Albuterol - pharmacokinetics</topic><topic>Albuterol - therapeutic use</topic><topic>Asthma - drug therapy</topic><topic>Asthma - physiopathology</topic><topic>Biological and medical sciences</topic><topic>Delayed-Action Preparations</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Forced Expiratory Volume</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Respiratory system</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>LIPWORTH, B. J</creatorcontrib><creatorcontrib>CLARK, R. A</creatorcontrib><creatorcontrib>DHILLON, D. P</creatorcontrib><creatorcontrib>CHARTER, M. K</creatorcontrib><creatorcontrib>PALMER, J. B. D</creatorcontrib><creatorcontrib>MCDEVITT, D. G</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>European journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>LIPWORTH, B. J</au><au>CLARK, R. A</au><au>DHILLON, D. P</au><au>CHARTER, M. K</au><au>PALMER, J. B. D</au><au>MCDEVITT, D. G</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Single dose and steady-state pharmacokinetics of 4 mg and 8 mg oral salbutamol controlled-release in patients with bronchial asthma</atitle><jtitle>European journal of clinical pharmacology</jtitle><addtitle>Eur J Clin Pharmacol</addtitle><date>1989</date><risdate>1989</risdate><volume>37</volume><issue>1</issue><spage>49</spage><epage>52</epage><pages>49-52</pages><issn>0031-6970</issn><eissn>1432-1041</eissn><abstract>Fifteen patients with asthma were given salbutamol controlled-release (SCR) 4 mg or 8 mg twice daily for seven days, in a randomised double-blind cross-over design. Plasma salbutamol levels were measured after the first and fifteenth doses for a 12 h period following drug ingestion. At steady-state the geometric mean values for Cmax were 8.2 ng/ml for 4 mg, and 16.1 ng/ml for 8 mg. Median tmax values were 300 and 240 min respectively. The geometric mean AUC (0-12) were 4507 ng.min.ml-1 and 8980 ng.min/ml. Peak to trough fluctuation ratios were 0.577 and 0.572. There were no significant differences between 4 mg or 8 mg formulations, for any of the parameters measured, after appropriate corrections for dose. The concentration-time profiles at steady-state showed little fluctuation in plasma salbutamol levels over the twelve hour dosing interval. These results show that 4 mg and 8 mg formulations of SCR provide smooth plasma profiles at steady-state with a twice daily dosing regime.</abstract><cop>Heidelberg</cop><cop>Berlin</cop><pub>Springer</pub><pmid>2687008</pmid><doi>10.1007/BF00609424</doi><tpages>4</tpages></addata></record> |
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| ispartof | European journal of clinical pharmacology, 1989, Vol.37 (1), p.49-52 |
| issn | 0031-6970 1432-1041 |
| language | eng |
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| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Adult Albuterol - administration & dosage Albuterol - pharmacokinetics Albuterol - therapeutic use Asthma - drug therapy Asthma - physiopathology Biological and medical sciences Delayed-Action Preparations Double-Blind Method Female Forced Expiratory Volume Humans Male Medical sciences Middle Aged Pharmacology. Drug treatments Randomized Controlled Trials as Topic Respiratory system Time Factors |
| title | Single dose and steady-state pharmacokinetics of 4 mg and 8 mg oral salbutamol controlled-release in patients with bronchial asthma |
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