Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium
Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either diclofenac potassium and diclofenac sodium. Within the biopharmaceutics classification s...
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| Veröffentlicht in: | Journal of pharmaceutical sciences 2009-04, Vol.98 (4), p.1206-1219 |
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| creator | B.Chuasuwan Binjesoh, V. Polli, J.E. Zhang, H. Amidon, G.L. Junginger, H.E. Midha, K.K. Shah, V.P. Stavchansky, S. Dressman, J.B. Barends, D.M. |
| description | Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either diclofenac potassium and diclofenac sodium. Within the biopharmaceutics classification system (BCS), diclofenac potassium and diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30min or less in 900mL buffer pH6.8, using the paddle apparatus at 75rpm or the basket apparatus at 100rpm; and (e) test product and comparator show dissolution profile similarity in pH1.2, 4.5, and 6.8. |
| doi_str_mv | 10.1002/jps.21525 |
| format | Article |
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Within the biopharmaceutics classification system (BCS), diclofenac potassium and diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30min or less in 900mL buffer pH6.8, using the paddle apparatus at 75rpm or the basket apparatus at 100rpm; and (e) test product and comparator show dissolution profile similarity in pH1.2, 4.5, and 6.8.</description><identifier>ISSN: 0022-3549</identifier><identifier>EISSN: 1520-6017</identifier><identifier>DOI: 10.1002/jps.21525</identifier><identifier>PMID: 18752289</identifier><language>eng</language><publisher>Hoboken: Elsevier Inc</publisher><subject>absorption ; Administration, Oral ; Animals ; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage ; Anti-Inflammatory Agents, Non-Steroidal - adverse effects ; Anti-Inflammatory Agents, Non-Steroidal - chemistry ; Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics ; bioequivalence ; Biological Availability ; biopharmaceutics ; biopharmaceutics classification system (BCS) ; Chemical Phenomena ; classification ; diclofenac ; Diclofenac - administration & dosage ; Diclofenac - adverse effects ; Diclofenac - chemistry ; Diclofenac - pharmacokinetics ; Excipients - chemistry ; Humans ; permeability ; regulatory science ; Solubility ; system (BCS) ; Tablets ; Therapeutic Equivalency</subject><ispartof>Journal of pharmaceutical sciences, 2009-04, Vol.98 (4), p.1206-1219</ispartof><rights>2008 Wiley-Liss, Inc.</rights><rights>Copyright © 2008 Wiley‐Liss, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4655-748e0cbc2f3ce31576040db152ae95d3e028f7d8a51bcb5ed601e1c3743fa2a73</citedby><cites>FETCH-LOGICAL-c4655-748e0cbc2f3ce31576040db152ae95d3e028f7d8a51bcb5ed601e1c3743fa2a73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjps.21525$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjps.21525$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18752289$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>B.Chuasuwan</creatorcontrib><creatorcontrib>Binjesoh, V.</creatorcontrib><creatorcontrib>Polli, J.E.</creatorcontrib><creatorcontrib>Zhang, H.</creatorcontrib><creatorcontrib>Amidon, G.L.</creatorcontrib><creatorcontrib>Junginger, H.E.</creatorcontrib><creatorcontrib>Midha, K.K.</creatorcontrib><creatorcontrib>Shah, V.P.</creatorcontrib><creatorcontrib>Stavchansky, S.</creatorcontrib><creatorcontrib>Dressman, J.B.</creatorcontrib><creatorcontrib>Barends, D.M.</creatorcontrib><title>Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium</title><title>Journal of pharmaceutical sciences</title><addtitle>J. Pharm. Sci</addtitle><description>Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either diclofenac potassium and diclofenac sodium. Within the biopharmaceutics classification system (BCS), diclofenac potassium and diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30min or less in 900mL buffer pH6.8, using the paddle apparatus at 75rpm or the basket apparatus at 100rpm; and (e) test product and comparator show dissolution profile similarity in pH1.2, 4.5, and 6.8.</description><subject>absorption</subject><subject>Administration, Oral</subject><subject>Animals</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - administration & dosage</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - adverse effects</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - chemistry</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics</subject><subject>bioequivalence</subject><subject>Biological Availability</subject><subject>biopharmaceutics</subject><subject>biopharmaceutics classification system (BCS)</subject><subject>Chemical Phenomena</subject><subject>classification</subject><subject>diclofenac</subject><subject>Diclofenac - administration & dosage</subject><subject>Diclofenac - adverse effects</subject><subject>Diclofenac - chemistry</subject><subject>Diclofenac - pharmacokinetics</subject><subject>Excipients - chemistry</subject><subject>Humans</subject><subject>permeability</subject><subject>regulatory science</subject><subject>Solubility</subject><subject>system (BCS)</subject><subject>Tablets</subject><subject>Therapeutic Equivalency</subject><issn>0022-3549</issn><issn>1520-6017</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUlPHDEQhS0UBMNyyB-IfM2hBy_tdk9ubDOAJoGEQZFysdx2NTF0t0f2LPDvMTQkOYRTSVVfPdV7hdBHSoaUEHZwN49DRgUTG2iQCskKQuUHNEgzlnGRj7bRTox3hJCCCLGFtmkpBWPlaIC6I-fX2q0g4K--87dBz39HXPuAz9sWrNMLwD-gAR0BX_vGWXwZdINPfNS3gMc-tPELPnGm8TV02iTGumWLdWf_7V75hY4xDfbQZq2bCPuvdRfdjE9nx2fZ9HJyfnw4zUxeCJHJvARiKsNqboBTIQuSE1slbxpGwnIgrKylLbWglakE2GQYqOEy57VmWvJd9LnXNcHHGKBW8-BaHR4VJeo5M5UyUy-ZJfZTz86XVbL8l3wNKQEHPbB2DTy-r6Qurq7fJLN-w8UFPPzZ0OFeFZJLoX5-mygymxyNvv-aqjLxvOchZbJyEFQ0DjqTHhDALJT17j-HPwG955fA</recordid><startdate>200904</startdate><enddate>200904</enddate><creator>B.Chuasuwan</creator><creator>Binjesoh, V.</creator><creator>Polli, J.E.</creator><creator>Zhang, H.</creator><creator>Amidon, G.L.</creator><creator>Junginger, H.E.</creator><creator>Midha, K.K.</creator><creator>Shah, V.P.</creator><creator>Stavchansky, S.</creator><creator>Dressman, J.B.</creator><creator>Barends, D.M.</creator><general>Elsevier Inc</general><general>Wiley Subscription Services, Inc., A Wiley Company</general><scope>BSCLL</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></search><sort><creationdate>200904</creationdate><title>Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium</title><author>B.Chuasuwan ; Binjesoh, V. ; Polli, J.E. ; Zhang, H. ; Amidon, G.L. ; Junginger, H.E. ; Midha, K.K. ; Shah, V.P. ; Stavchansky, S. ; Dressman, J.B. ; Barends, D.M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4655-748e0cbc2f3ce31576040db152ae95d3e028f7d8a51bcb5ed601e1c3743fa2a73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>absorption</topic><topic>Administration, Oral</topic><topic>Animals</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - administration & dosage</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - adverse effects</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - chemistry</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics</topic><topic>bioequivalence</topic><topic>Biological Availability</topic><topic>biopharmaceutics</topic><topic>biopharmaceutics classification system (BCS)</topic><topic>Chemical Phenomena</topic><topic>classification</topic><topic>diclofenac</topic><topic>Diclofenac - administration & dosage</topic><topic>Diclofenac - adverse effects</topic><topic>Diclofenac - chemistry</topic><topic>Diclofenac - pharmacokinetics</topic><topic>Excipients - chemistry</topic><topic>Humans</topic><topic>permeability</topic><topic>regulatory science</topic><topic>Solubility</topic><topic>system (BCS)</topic><topic>Tablets</topic><topic>Therapeutic Equivalency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>B.Chuasuwan</creatorcontrib><creatorcontrib>Binjesoh, V.</creatorcontrib><creatorcontrib>Polli, J.E.</creatorcontrib><creatorcontrib>Zhang, H.</creatorcontrib><creatorcontrib>Amidon, G.L.</creatorcontrib><creatorcontrib>Junginger, H.E.</creatorcontrib><creatorcontrib>Midha, K.K.</creatorcontrib><creatorcontrib>Shah, V.P.</creatorcontrib><creatorcontrib>Stavchansky, S.</creatorcontrib><creatorcontrib>Dressman, J.B.</creatorcontrib><creatorcontrib>Barends, D.M.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Journal of pharmaceutical sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>B.Chuasuwan</au><au>Binjesoh, V.</au><au>Polli, J.E.</au><au>Zhang, H.</au><au>Amidon, G.L.</au><au>Junginger, H.E.</au><au>Midha, K.K.</au><au>Shah, V.P.</au><au>Stavchansky, S.</au><au>Dressman, J.B.</au><au>Barends, D.M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium</atitle><jtitle>Journal of pharmaceutical sciences</jtitle><addtitle>J. Pharm. Sci</addtitle><date>2009-04</date><risdate>2009</risdate><volume>98</volume><issue>4</issue><spage>1206</spage><epage>1219</epage><pages>1206-1219</pages><issn>0022-3549</issn><eissn>1520-6017</eissn><abstract>Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either diclofenac potassium and diclofenac sodium. Within the biopharmaceutics classification system (BCS), diclofenac potassium and diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30min or less in 900mL buffer pH6.8, using the paddle apparatus at 75rpm or the basket apparatus at 100rpm; and (e) test product and comparator show dissolution profile similarity in pH1.2, 4.5, and 6.8.</abstract><cop>Hoboken</cop><pub>Elsevier Inc</pub><pmid>18752289</pmid><doi>10.1002/jps.21525</doi><tpages>14</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | absorption Administration, Oral Animals Anti-Inflammatory Agents, Non-Steroidal - administration & dosage Anti-Inflammatory Agents, Non-Steroidal - adverse effects Anti-Inflammatory Agents, Non-Steroidal - chemistry Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics bioequivalence Biological Availability biopharmaceutics biopharmaceutics classification system (BCS) Chemical Phenomena classification diclofenac Diclofenac - administration & dosage Diclofenac - adverse effects Diclofenac - chemistry Diclofenac - pharmacokinetics Excipients - chemistry Humans permeability regulatory science Solubility system (BCS) Tablets Therapeutic Equivalency |
| title | Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium |
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