Bioequivalence evaluation of new microparticulate capsule and marketed tablet dosage forms of lornoxicam in healthy volunteers
Purpose: To compare oral bioavailability and pharmacokinetic parameters of different lornoxicam formulations and to assess similarity in plasma level profiles by statistical techniques. Methods: An open-label, two-period crossover trial was followed in 24 healthy Pakistani volunteers (22 males, 2 fe...
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| Veröffentlicht in: | Tropical journal of pharmaceutical research 2016-04, Vol.15 (4), p.877 |
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| creator | Shah, Pervaiz Akhtar Bashir, Sajid Ahsan, Muhammad Abbas, Nasir Malik, Muhammad Zubair Nazar, Hafiz Muhammad Irfan |
| description | Purpose: To compare oral bioavailability and pharmacokinetic
parameters of different lornoxicam formulations and to assess
similarity in plasma level profiles by statistical techniques.
Methods: An open-label, two-period crossover trial was followed in 24
healthy Pakistani volunteers (22 males, 2 females). Each participant
received a single dose of lornoxicam controlled release (CR)
microparticles and two doses (morning and evening) of conventional
lornoxicam immediate release (IR) tablet formulation. The
microparticles were prepared by spray drying method. The formulations
were administered again in an alternate manner after a washout period
of one week. Pharmacokinetic parameters were determined by Kinetica 4.0
software using plasma concentration-time data. Moreover, data were
statistically analyzed at 90 % confidence interval (CI) and
Schuirmann's two one-sided t-test procedure. Results: Peak
plasma concentration (Cmax) was 20.2 % lower for CR formulation
compared to IR formulation (270.90 ng/ml vs 339.44 ng/ml, respectively)
while time taken to attain Cmax (tmax) was 5.25 and 2.08 h,
respectively. Area under the plasma drug level versus time (AUC) curve
was comparable for both CR and IR formulations. The 90 % confidence
interval (CI) values computed for Cmax, AUC0-24, and AUC0-∞ ,
after log transformation, were 87.21, 108.51 and 102.74 %,
respectively, and were within predefined bioequivalence range (80 - 125
%). Conclusion: The findings suggest that CR formulation of
lornoxicam did not change the overall pharmacokinetic properties of
lornoxicam in terms of extent and rate of lornoxicam absorption. |
| doi_str_mv | 10.4314/tjpr.v15i4.30 |
| format | Article |
| fullrecord | <record><control><sourceid>bioline_cross</sourceid><recordid>TN_cdi_crossref_primary_10_4314_tjpr_v15i4_30</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>cria_bioline_pr_pr16118</sourcerecordid><originalsourceid>FETCH-LOGICAL-b315t-cb40911418d275aa0aac1d5bceccd03b147b8f9d47a2a98ed766889571b9f5a13</originalsourceid><addsrcrecordid>eNpFkM1OwzAQhCMEEqVw5O4XSPA2cRIfoeJPqsQFztHG2VAXJw62U-iFZyeFCqSVdrT6NNqZKLoEnmQpZFdhM7hkC0JnScqPohkImceyXBTHBy2kzE-jM-83nItcSphFXzfa0vuot2ioV8RoEiMGbXtmW9bTB-u0cnZAF7QaDQZiCgc_GmLYN6xD90aBGhawNhRYYz2-Emut6_zewFjX20-tsGO6Z2tCE9Y7trVm7AOR8-fRSYvG08Vhz6OXu9vn5UO8erp_XF6v4joFEWJVZ1wCZFA2i0IgckQFjagVKdXwtIasqMtWNlmBC5QlNUWel6UUBdSyFQjpPIp_facs3jtqq8Hp6fldBbzal1fty6t-yqtSPvHJL19ra3RPf7hyGqv_4zSQA5TpNyFSeY8</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Bioequivalence evaluation of new microparticulate capsule and marketed tablet dosage forms of lornoxicam in healthy volunteers</title><source>African Journals Online (Open Access)</source><source>Bioline International</source><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Free Full-Text Journals in Chemistry</source><creator>Shah, Pervaiz Akhtar ; Bashir, Sajid ; Ahsan, Muhammad ; Abbas, Nasir ; Malik, Muhammad Zubair ; Nazar, Hafiz Muhammad Irfan</creator><creatorcontrib>Shah, Pervaiz Akhtar ; Bashir, Sajid ; Ahsan, Muhammad ; Abbas, Nasir ; Malik, Muhammad Zubair ; Nazar, Hafiz Muhammad Irfan</creatorcontrib><description>Purpose: To compare oral bioavailability and pharmacokinetic
parameters of different lornoxicam formulations and to assess
similarity in plasma level profiles by statistical techniques.
Methods: An open-label, two-period crossover trial was followed in 24
healthy Pakistani volunteers (22 males, 2 females). Each participant
received a single dose of lornoxicam controlled release (CR)
microparticles and two doses (morning and evening) of conventional
lornoxicam immediate release (IR) tablet formulation. The
microparticles were prepared by spray drying method. The formulations
were administered again in an alternate manner after a washout period
of one week. Pharmacokinetic parameters were determined by Kinetica 4.0
software using plasma concentration-time data. Moreover, data were
statistically analyzed at 90 % confidence interval (CI) and
Schuirmann's two one-sided t-test procedure. Results: Peak
plasma concentration (Cmax) was 20.2 % lower for CR formulation
compared to IR formulation (270.90 ng/ml vs 339.44 ng/ml, respectively)
while time taken to attain Cmax (tmax) was 5.25 and 2.08 h,
respectively. Area under the plasma drug level versus time (AUC) curve
was comparable for both CR and IR formulations. The 90 % confidence
interval (CI) values computed for Cmax, AUC0-24, and AUC0-∞ ,
after log transformation, were 87.21, 108.51 and 102.74 %,
respectively, and were within predefined bioequivalence range (80 - 125
%). Conclusion: The findings suggest that CR formulation of
lornoxicam did not change the overall pharmacokinetic properties of
lornoxicam in terms of extent and rate of lornoxicam absorption.</description><identifier>ISSN: 1596-5996</identifier><identifier>EISSN: 1596-9827</identifier><identifier>DOI: 10.4314/tjpr.v15i4.30</identifier><language>eng</language><publisher>Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria</publisher><subject>Analgesic ; Controlled release ; Lornoxicam ; Microparticles ; NSAIDs ; Pharmacokinetics</subject><ispartof>Tropical journal of pharmaceutical research, 2016-04, Vol.15 (4), p.877</ispartof><rights>Copyright 2016 - Tropical Journal of Pharmaceutical Research</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b315t-cb40911418d275aa0aac1d5bceccd03b147b8f9d47a2a98ed766889571b9f5a13</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,860,27901,27902,79168</link.rule.ids></links><search><creatorcontrib>Shah, Pervaiz Akhtar</creatorcontrib><creatorcontrib>Bashir, Sajid</creatorcontrib><creatorcontrib>Ahsan, Muhammad</creatorcontrib><creatorcontrib>Abbas, Nasir</creatorcontrib><creatorcontrib>Malik, Muhammad Zubair</creatorcontrib><creatorcontrib>Nazar, Hafiz Muhammad Irfan</creatorcontrib><title>Bioequivalence evaluation of new microparticulate capsule and marketed tablet dosage forms of lornoxicam in healthy volunteers</title><title>Tropical journal of pharmaceutical research</title><description>Purpose: To compare oral bioavailability and pharmacokinetic
parameters of different lornoxicam formulations and to assess
similarity in plasma level profiles by statistical techniques.
Methods: An open-label, two-period crossover trial was followed in 24
healthy Pakistani volunteers (22 males, 2 females). Each participant
received a single dose of lornoxicam controlled release (CR)
microparticles and two doses (morning and evening) of conventional
lornoxicam immediate release (IR) tablet formulation. The
microparticles were prepared by spray drying method. The formulations
were administered again in an alternate manner after a washout period
of one week. Pharmacokinetic parameters were determined by Kinetica 4.0
software using plasma concentration-time data. Moreover, data were
statistically analyzed at 90 % confidence interval (CI) and
Schuirmann's two one-sided t-test procedure. Results: Peak
plasma concentration (Cmax) was 20.2 % lower for CR formulation
compared to IR formulation (270.90 ng/ml vs 339.44 ng/ml, respectively)
while time taken to attain Cmax (tmax) was 5.25 and 2.08 h,
respectively. Area under the plasma drug level versus time (AUC) curve
was comparable for both CR and IR formulations. The 90 % confidence
interval (CI) values computed for Cmax, AUC0-24, and AUC0-∞ ,
after log transformation, were 87.21, 108.51 and 102.74 %,
respectively, and were within predefined bioequivalence range (80 - 125
%). Conclusion: The findings suggest that CR formulation of
lornoxicam did not change the overall pharmacokinetic properties of
lornoxicam in terms of extent and rate of lornoxicam absorption.</description><subject>Analgesic</subject><subject>Controlled release</subject><subject>Lornoxicam</subject><subject>Microparticles</subject><subject>NSAIDs</subject><subject>Pharmacokinetics</subject><issn>1596-5996</issn><issn>1596-9827</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>RBI</sourceid><recordid>eNpFkM1OwzAQhCMEEqVw5O4XSPA2cRIfoeJPqsQFztHG2VAXJw62U-iFZyeFCqSVdrT6NNqZKLoEnmQpZFdhM7hkC0JnScqPohkImceyXBTHBy2kzE-jM-83nItcSphFXzfa0vuot2ioV8RoEiMGbXtmW9bTB-u0cnZAF7QaDQZiCgc_GmLYN6xD90aBGhawNhRYYz2-Emut6_zewFjX20-tsGO6Z2tCE9Y7trVm7AOR8-fRSYvG08Vhz6OXu9vn5UO8erp_XF6v4joFEWJVZ1wCZFA2i0IgckQFjagVKdXwtIasqMtWNlmBC5QlNUWel6UUBdSyFQjpPIp_facs3jtqq8Hp6fldBbzal1fty6t-yqtSPvHJL19ra3RPf7hyGqv_4zSQA5TpNyFSeY8</recordid><startdate>20160401</startdate><enddate>20160401</enddate><creator>Shah, Pervaiz Akhtar</creator><creator>Bashir, Sajid</creator><creator>Ahsan, Muhammad</creator><creator>Abbas, Nasir</creator><creator>Malik, Muhammad Zubair</creator><creator>Nazar, Hafiz Muhammad Irfan</creator><general>Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria</general><scope>RBI</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20160401</creationdate><title>Bioequivalence evaluation of new microparticulate capsule and marketed tablet dosage forms of lornoxicam in healthy volunteers</title><author>Shah, Pervaiz Akhtar ; Bashir, Sajid ; Ahsan, Muhammad ; Abbas, Nasir ; Malik, Muhammad Zubair ; Nazar, Hafiz Muhammad Irfan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b315t-cb40911418d275aa0aac1d5bceccd03b147b8f9d47a2a98ed766889571b9f5a13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Analgesic</topic><topic>Controlled release</topic><topic>Lornoxicam</topic><topic>Microparticles</topic><topic>NSAIDs</topic><topic>Pharmacokinetics</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shah, Pervaiz Akhtar</creatorcontrib><creatorcontrib>Bashir, Sajid</creatorcontrib><creatorcontrib>Ahsan, Muhammad</creatorcontrib><creatorcontrib>Abbas, Nasir</creatorcontrib><creatorcontrib>Malik, Muhammad Zubair</creatorcontrib><creatorcontrib>Nazar, Hafiz Muhammad Irfan</creatorcontrib><collection>Bioline International</collection><collection>CrossRef</collection><jtitle>Tropical journal of pharmaceutical research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shah, Pervaiz Akhtar</au><au>Bashir, Sajid</au><au>Ahsan, Muhammad</au><au>Abbas, Nasir</au><au>Malik, Muhammad Zubair</au><au>Nazar, Hafiz Muhammad Irfan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bioequivalence evaluation of new microparticulate capsule and marketed tablet dosage forms of lornoxicam in healthy volunteers</atitle><jtitle>Tropical journal of pharmaceutical research</jtitle><date>2016-04-01</date><risdate>2016</risdate><volume>15</volume><issue>4</issue><spage>877</spage><pages>877-</pages><issn>1596-5996</issn><eissn>1596-9827</eissn><abstract>Purpose: To compare oral bioavailability and pharmacokinetic
parameters of different lornoxicam formulations and to assess
similarity in plasma level profiles by statistical techniques.
Methods: An open-label, two-period crossover trial was followed in 24
healthy Pakistani volunteers (22 males, 2 females). Each participant
received a single dose of lornoxicam controlled release (CR)
microparticles and two doses (morning and evening) of conventional
lornoxicam immediate release (IR) tablet formulation. The
microparticles were prepared by spray drying method. The formulations
were administered again in an alternate manner after a washout period
of one week. Pharmacokinetic parameters were determined by Kinetica 4.0
software using plasma concentration-time data. Moreover, data were
statistically analyzed at 90 % confidence interval (CI) and
Schuirmann's two one-sided t-test procedure. Results: Peak
plasma concentration (Cmax) was 20.2 % lower for CR formulation
compared to IR formulation (270.90 ng/ml vs 339.44 ng/ml, respectively)
while time taken to attain Cmax (tmax) was 5.25 and 2.08 h,
respectively. Area under the plasma drug level versus time (AUC) curve
was comparable for both CR and IR formulations. The 90 % confidence
interval (CI) values computed for Cmax, AUC0-24, and AUC0-∞ ,
after log transformation, were 87.21, 108.51 and 102.74 %,
respectively, and were within predefined bioequivalence range (80 - 125
%). Conclusion: The findings suggest that CR formulation of
lornoxicam did not change the overall pharmacokinetic properties of
lornoxicam in terms of extent and rate of lornoxicam absorption.</abstract><pub>Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria</pub><doi>10.4314/tjpr.v15i4.30</doi><oa>free_for_read</oa></addata></record> |
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| source | African Journals Online (Open Access); Bioline International; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Free Full-Text Journals in Chemistry |
| subjects | Analgesic Controlled release Lornoxicam Microparticles NSAIDs Pharmacokinetics |
| title | Bioequivalence evaluation of new microparticulate capsule and marketed tablet dosage forms of lornoxicam in healthy volunteers |
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