Kinetics of generic tacrolimus in heart transplantation: A cautionary note
Tacrolimus is a core component of immunosuppressive regimens. This study compared active pharmaceutical ingredient (API) and dissolution kinetics of branded tacrolimus and formulations from three generic manufacturers (Mylan, Dr. Reddy's, Intas) including samples from patients who suffered acut...
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| Veröffentlicht in: | The Journal of heart and lung transplantation 2021-07, Vol.40 (7), p.569-572 |
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| container_title | The Journal of heart and lung transplantation |
| container_volume | 40 |
| creator | Il'Giovine, Zachary J. Williams, J. Bradley Mason, R. Preston Sherratt, Samuel C.R. Hsich, Eileen M. Lever, Harry Mehra, Mandeep R. Starling, Randall C. |
| description | Tacrolimus is a core component of immunosuppressive regimens. This study compared active pharmaceutical ingredient (API) and dissolution kinetics of branded tacrolimus and formulations from three generic manufacturers (Mylan, Dr. Reddy's, Intas) including samples from patients who suffered acute cardiac allograft rejection. Generic samples showed similar API content compared to branded samples with no major impurities. Capsules that underwent uniformity testing had consistent capsule-to-capsule API. Dissolution testing showed similar profiles between branded tacrolimus and Mylan, but notable differences with Dr. Reddy's and Intas. The approximate maximal inhibitory concentration (IC50) was highest in branded tacrolimus (29 minutes), followed by Mylan (26 minutes), Dr. Reddy's (19 minutes), and Intas (14 minutes) (Student-Newman-Keuls Multiple Comparisons Test; overall ANOVA: p = 0.0199, F = 6.469). This study suggests that the bioavailability of certain generic tacrolimus formulations peak significantly earlier than branded tacrolimus. Further study is needed to determine whether these differences are clinically relevant. |
| doi_str_mv | 10.1016/j.healun.2021.03.009 |
| format | Article |
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Bradley ; Mason, R. Preston ; Sherratt, Samuel C.R. ; Hsich, Eileen M. ; Lever, Harry ; Mehra, Mandeep R. ; Starling, Randall C.</creator><creatorcontrib>Il'Giovine, Zachary J. ; Williams, J. Bradley ; Mason, R. Preston ; Sherratt, Samuel C.R. ; Hsich, Eileen M. ; Lever, Harry ; Mehra, Mandeep R. ; Starling, Randall C.</creatorcontrib><description>Tacrolimus is a core component of immunosuppressive regimens. This study compared active pharmaceutical ingredient (API) and dissolution kinetics of branded tacrolimus and formulations from three generic manufacturers (Mylan, Dr. Reddy's, Intas) including samples from patients who suffered acute cardiac allograft rejection. Generic samples showed similar API content compared to branded samples with no major impurities. Capsules that underwent uniformity testing had consistent capsule-to-capsule API. Dissolution testing showed similar profiles between branded tacrolimus and Mylan, but notable differences with Dr. Reddy's and Intas. The approximate maximal inhibitory concentration (IC50) was highest in branded tacrolimus (29 minutes), followed by Mylan (26 minutes), Dr. Reddy's (19 minutes), and Intas (14 minutes) (Student-Newman-Keuls Multiple Comparisons Test; overall ANOVA: p = 0.0199, F = 6.469). This study suggests that the bioavailability of certain generic tacrolimus formulations peak significantly earlier than branded tacrolimus. Further study is needed to determine whether these differences are clinically relevant.</description><identifier>ISSN: 1053-2498</identifier><identifier>EISSN: 1557-3117</identifier><identifier>DOI: 10.1016/j.healun.2021.03.009</identifier><identifier>PMID: 33903017</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Drugs, Generic - pharmacokinetics ; Graft Rejection - immunology ; Graft Rejection - metabolism ; Graft Rejection - prevention & control ; Heart Transplantation ; Humans ; Immunosuppression ; Immunosuppressive Agents - pharmacokinetics ; pharmacology ; rejection ; tacrolimus ; Tacrolimus - pharmacokinetics</subject><ispartof>The Journal of heart and lung transplantation, 2021-07, Vol.40 (7), p.569-572</ispartof><rights>2021 International Society for Heart and Lung Transplantation</rights><rights>Copyright © 2021 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c464t-22e8fc0be1d0a8f8727b363afeb6b735b2056366bfa7a7034c529082e061b8873</citedby><cites>FETCH-LOGICAL-c464t-22e8fc0be1d0a8f8727b363afeb6b735b2056366bfa7a7034c529082e061b8873</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S105324982102235X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3536,27903,27904,65309</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33903017$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Il'Giovine, Zachary J.</creatorcontrib><creatorcontrib>Williams, J. Bradley</creatorcontrib><creatorcontrib>Mason, R. Preston</creatorcontrib><creatorcontrib>Sherratt, Samuel C.R.</creatorcontrib><creatorcontrib>Hsich, Eileen M.</creatorcontrib><creatorcontrib>Lever, Harry</creatorcontrib><creatorcontrib>Mehra, Mandeep R.</creatorcontrib><creatorcontrib>Starling, Randall C.</creatorcontrib><title>Kinetics of generic tacrolimus in heart transplantation: A cautionary note</title><title>The Journal of heart and lung transplantation</title><addtitle>J Heart Lung Transplant</addtitle><description>Tacrolimus is a core component of immunosuppressive regimens. This study compared active pharmaceutical ingredient (API) and dissolution kinetics of branded tacrolimus and formulations from three generic manufacturers (Mylan, Dr. Reddy's, Intas) including samples from patients who suffered acute cardiac allograft rejection. Generic samples showed similar API content compared to branded samples with no major impurities. Capsules that underwent uniformity testing had consistent capsule-to-capsule API. Dissolution testing showed similar profiles between branded tacrolimus and Mylan, but notable differences with Dr. Reddy's and Intas. The approximate maximal inhibitory concentration (IC50) was highest in branded tacrolimus (29 minutes), followed by Mylan (26 minutes), Dr. Reddy's (19 minutes), and Intas (14 minutes) (Student-Newman-Keuls Multiple Comparisons Test; overall ANOVA: p = 0.0199, F = 6.469). This study suggests that the bioavailability of certain generic tacrolimus formulations peak significantly earlier than branded tacrolimus. Further study is needed to determine whether these differences are clinically relevant.</description><subject>Drugs, Generic - pharmacokinetics</subject><subject>Graft Rejection - immunology</subject><subject>Graft Rejection - metabolism</subject><subject>Graft Rejection - prevention & control</subject><subject>Heart Transplantation</subject><subject>Humans</subject><subject>Immunosuppression</subject><subject>Immunosuppressive Agents - pharmacokinetics</subject><subject>pharmacology</subject><subject>rejection</subject><subject>tacrolimus</subject><subject>Tacrolimus - pharmacokinetics</subject><issn>1053-2498</issn><issn>1557-3117</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE1OwzAQhS0EglK4AUK-QMLYTuKEBQgh_iuxgbXluJPWVepUtovE7XFVqGDDakaaee_NfIScMcgZsOpikc9R92uXc-AsB5EDNHtkxMpSZoIxuZ96KEXGi6Y-IschLACAi5IfkiMhGhDA5Ig8v1iH0ZpAh47O0KG3hkZt_NDb5TpQ62iK8ZFGr11Y9dpFHe3gLukNNXq9abX_pG6IeEIOOt0HPP2uY_J-f_d2-5hNXh-ebm8mmSmqImacY90ZaJFNQdddLblsRSV0h23VSlG2HMpKVFXbaakliMKUvIGaI1SsrWspxuR667tat0ucGnTptl6tvF2mU9Sgrfo7cXauZsOHYsBL2ciNQ7F1SG-G4LHbiRmoDVy1UFu4agNXgVAJbpKd_w7eiX5opoWr7QKm9z8sehWMRWdwaj2aqKaD_T_hC52UjoE</recordid><startdate>20210701</startdate><enddate>20210701</enddate><creator>Il'Giovine, Zachary J.</creator><creator>Williams, J. 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Bradley</creatorcontrib><creatorcontrib>Mason, R. Preston</creatorcontrib><creatorcontrib>Sherratt, Samuel C.R.</creatorcontrib><creatorcontrib>Hsich, Eileen M.</creatorcontrib><creatorcontrib>Lever, Harry</creatorcontrib><creatorcontrib>Mehra, Mandeep R.</creatorcontrib><creatorcontrib>Starling, Randall C.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Journal of heart and lung transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Il'Giovine, Zachary J.</au><au>Williams, J. Bradley</au><au>Mason, R. Preston</au><au>Sherratt, Samuel C.R.</au><au>Hsich, Eileen M.</au><au>Lever, Harry</au><au>Mehra, Mandeep R.</au><au>Starling, Randall C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Kinetics of generic tacrolimus in heart transplantation: A cautionary note</atitle><jtitle>The Journal of heart and lung transplantation</jtitle><addtitle>J Heart Lung Transplant</addtitle><date>2021-07-01</date><risdate>2021</risdate><volume>40</volume><issue>7</issue><spage>569</spage><epage>572</epage><pages>569-572</pages><issn>1053-2498</issn><eissn>1557-3117</eissn><abstract>Tacrolimus is a core component of immunosuppressive regimens. This study compared active pharmaceutical ingredient (API) and dissolution kinetics of branded tacrolimus and formulations from three generic manufacturers (Mylan, Dr. Reddy's, Intas) including samples from patients who suffered acute cardiac allograft rejection. 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| ispartof | The Journal of heart and lung transplantation, 2021-07, Vol.40 (7), p.569-572 |
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| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Drugs, Generic - pharmacokinetics Graft Rejection - immunology Graft Rejection - metabolism Graft Rejection - prevention & control Heart Transplantation Humans Immunosuppression Immunosuppressive Agents - pharmacokinetics pharmacology rejection tacrolimus Tacrolimus - pharmacokinetics |
| title | Kinetics of generic tacrolimus in heart transplantation: A cautionary note |
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