Light induced fluorescence for predicting API content in tablets: Sampling and error
The use of a light induced fluorescence (LIF) instrument to estimate the total content of fluorescent active pharmaceutical ingredient in a tablet from surface sampling was demonstrated. Different LIF sampling strategies were compared to a total tablet ultraviolet (UV) absorbance test for each table...
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Veröffentlicht in: | International journal of pharmaceutics 2010-05, Vol.391 (1), p.13-20 |
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description | The use of a light induced fluorescence (LIF) instrument to estimate the total content of fluorescent active pharmaceutical ingredient in a tablet from surface sampling was demonstrated. Different LIF sampling strategies were compared to a total tablet ultraviolet (UV) absorbance test for each tablet. Testing was completed on tablets with triamterene as the active ingredient and on tablets with caffeine as the active ingredient, each with a range of concentrations. The LIF instrument accurately estimated the active ingredient within 10% of total tablet test greater than 95% of the time. The largest error amongst all of the tablets tested was 13%. The RMSEP between the techniques was in the range of 4.4–7.9%. Theory of the error associated with the surface sampling was developed and found to accurately predict the experimental error. This theory uses one empirically determined parameter: the deviation of estimations at different locations on the tablet surface. As this empirical parameter can be found rapidly, correct use of this prediction of error may reduce the effort required for calibration and validation studies of non-destructive surface measurement techniques, and thereby rapidly determine appropriate analytical techniques for estimating content uniformity in tablets. |
doi_str_mv | 10.1016/j.ijpharm.2010.02.009 |
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As this empirical parameter can be found rapidly, correct use of this prediction of error may reduce the effort required for calibration and validation studies of non-destructive surface measurement techniques, and thereby rapidly determine appropriate analytical techniques for estimating content uniformity in tablets.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/j.ijpharm.2010.02.009</identifier><identifier>PMID: 20156535</identifier><identifier>CODEN: IJPHDE</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Biological and medical sciences ; Caffeine - analysis ; Chemistry, Pharmaceutical - instrumentation ; Content uniformity ; Drug Compounding - methods ; Fluorescence ; General pharmacology ; Light ; Medical sciences ; PAT ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. 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Different LIF sampling strategies were compared to a total tablet ultraviolet (UV) absorbance test for each tablet. Testing was completed on tablets with triamterene as the active ingredient and on tablets with caffeine as the active ingredient, each with a range of concentrations. The LIF instrument accurately estimated the active ingredient within 10% of total tablet test greater than 95% of the time. The largest error amongst all of the tablets tested was 13%. The RMSEP between the techniques was in the range of 4.4–7.9%. Theory of the error associated with the surface sampling was developed and found to accurately predict the experimental error. This theory uses one empirically determined parameter: the deviation of estimations at different locations on the tablet surface. As this empirical parameter can be found rapidly, correct use of this prediction of error may reduce the effort required for calibration and validation studies of non-destructive surface measurement techniques, and thereby rapidly determine appropriate analytical techniques for estimating content uniformity in tablets.</description><subject>Biological and medical sciences</subject><subject>Caffeine - analysis</subject><subject>Chemistry, Pharmaceutical - instrumentation</subject><subject>Content uniformity</subject><subject>Drug Compounding - methods</subject><subject>Fluorescence</subject><subject>General pharmacology</subject><subject>Light</subject><subject>Medical sciences</subject><subject>PAT</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Selection Bias</subject><subject>Spectrophotometry, Ultraviolet - methods</subject><subject>Surface analysis</subject><subject>Surface Properties</subject><subject>Tablets</subject><subject>Tablets - chemistry</subject><subject>Triamterene - analysis</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkE1rGzEQhkVIqR23PyFBl5DTuvpYrXZzCSG0qcHQQt2z0EojW2a_Iu0W8u-rxU567Gng5Xlnhgeha0rWlNDiy3Htj8NBh3bNSMoIWxNSXaAlLSXPeC6LS7QkXJaZoJIv0FWMR0JIwSj_iBapIgrBxRLttn5_GLHv7GTAYtdMfYBooDOAXR_wEMB6M_pujx9_brDpuxG6mcejrhsY4z3-pduhmQHdWQwh9OET-uB0E-Hzea7Q729fd0_fs-2P583T4zYzvMrHzFaVY5rXFQNa1pI4Q3NiSyNSVlqXVwkDrYWhtZaSV7oua0dcWfCC21I4vkJ3p71D6F8miKNqffq9aXQH_RSV5DlhggmZSHEiTehjDODUEHyrw6uiRM0-1VGdfarZpyJMJZ-pd3O-MNUt2PfWm8AE3J4BHY1uXNCd8fEfx6TgBc0T93DiIPn44yGoaPxs2foAZlS29_955S_IvpbF</recordid><startdate>20100531</startdate><enddate>20100531</enddate><creator>Domike, Reuben</creator><creator>Ngai, Samuel</creator><creator>Cooney, Charles L.</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>20100531</creationdate><title>Light induced fluorescence for predicting API content in tablets: Sampling and error</title><author>Domike, Reuben ; Ngai, Samuel ; Cooney, Charles L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c394t-d99f2a3b92e18b70fc140d8c5a3b8df49c39eaa5c1ba7739ab8bf0f86363d85f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Biological and medical sciences</topic><topic>Caffeine - analysis</topic><topic>Chemistry, Pharmaceutical - instrumentation</topic><topic>Content uniformity</topic><topic>Drug Compounding - methods</topic><topic>Fluorescence</topic><topic>General pharmacology</topic><topic>Light</topic><topic>Medical sciences</topic><topic>PAT</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Selection Bias</topic><topic>Spectrophotometry, Ultraviolet - methods</topic><topic>Surface analysis</topic><topic>Surface Properties</topic><topic>Tablets</topic><topic>Tablets - chemistry</topic><topic>Triamterene - analysis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Domike, Reuben</creatorcontrib><creatorcontrib>Ngai, Samuel</creatorcontrib><creatorcontrib>Cooney, Charles L.</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>Domike, Reuben</au><au>Ngai, Samuel</au><au>Cooney, Charles L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Light induced fluorescence for predicting API content in tablets: Sampling and error</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2010-05-31</date><risdate>2010</risdate><volume>391</volume><issue>1</issue><spage>13</spage><epage>20</epage><pages>13-20</pages><issn>0378-5173</issn><eissn>1873-3476</eissn><coden>IJPHDE</coden><abstract>The use of a light induced fluorescence (LIF) instrument to estimate the total content of fluorescent active pharmaceutical ingredient in a tablet from surface sampling was demonstrated. Different LIF sampling strategies were compared to a total tablet ultraviolet (UV) absorbance test for each tablet. Testing was completed on tablets with triamterene as the active ingredient and on tablets with caffeine as the active ingredient, each with a range of concentrations. The LIF instrument accurately estimated the active ingredient within 10% of total tablet test greater than 95% of the time. The largest error amongst all of the tablets tested was 13%. The RMSEP between the techniques was in the range of 4.4–7.9%. Theory of the error associated with the surface sampling was developed and found to accurately predict the experimental error. This theory uses one empirically determined parameter: the deviation of estimations at different locations on the tablet surface. 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subjects | Biological and medical sciences Caffeine - analysis Chemistry, Pharmaceutical - instrumentation Content uniformity Drug Compounding - methods Fluorescence General pharmacology Light Medical sciences PAT Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Selection Bias Spectrophotometry, Ultraviolet - methods Surface analysis Surface Properties Tablets Tablets - chemistry Triamterene - analysis |
title | Light induced fluorescence for predicting API content in tablets: Sampling and error |
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