Pharmacokinetics of two generic co-formulations of lopinavir/ritonavir for HIV-infected children: a pilot study of paediatric Lopimune versus the branded product in healthy adult volunteers
Objectives To determine the pharmacokinetic profiles of lopinavir and ritonavir in two newly developed generic co-formulations for HIV-infected children (Lopimune paediatric tablets and granules, 100/25 mg of lopinavir/ritonavir, Cipla Pharmaceuticals), and to compare these with the branded product...
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description | Objectives To determine the pharmacokinetic profiles of lopinavir and ritonavir in two newly developed generic co-formulations for HIV-infected children (Lopimune paediatric tablets and granules, 100/25 mg of lopinavir/ritonavir, Cipla Pharmaceuticals), and to compare these with the branded product (Kaletra). Methods This Phase I, comparative, open-label, three-period, single-dose, crossover study was designed as a pilot study to exclude large (>40%) differences in the exposure to lopinavir. Single doses of medication, normalized to 400 mg of lopinavir, were administered on an empty stomach, 1 week apart. A 32 h pharmacokinetic curve was recorded. In an additional part of the study, in five of the same volunteers, a pharmacokinetic curve was recorded after administration of the Lopimune granules and Kaletra oral solution, both with food. Results Twelve healthy subjects were enrolled (four females). The median (range) age, height and body weight were 24 (21–55) years, 1.79 (1.63–1.95) m and 72 (51–87) kg, respectively. The median [interquartile range (IQR)] AUC0–t of lopinavir was 71.8 (48.8–93.5), 38.7 (28.7–52.2) and 58.7 (42.5–79.4) mg·h/L with Kaletra tablets, Lopimune granules and Lopimune paediatric tablets, all taken on an empty stomach, respectively. The respective Cmax values were 7.2 (5.8–8.3), 4.6 (4.1–5.2) and 6.5 (5.0–7.1) mg/L after intake of the different formulations. When comparing the Lopimune formulations with the reference product Kaletra, for all parameters the differences were statistically significant (P ≤ 0.015). Ritonavir exposure was also lower after intake of the generic formulations versus Kaletra. When the five subjects took the Lopimune granules or Kaletra solution with food, the median (IQR) AUC0–t of lopinavir was 58.5 (55.4–77.6) and 49.6 (39.1–58.1) mg·h/L, respectively. Conclusions Large differences in pharmacokinetic parameters can be excluded for Lopimune paediatric tablets when compared with the branded product and taken on an empty stomach, and also for Lopimune granules when these are taken with food. |
doi_str_mv | 10.1093/jac/dkp472 |
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T. M. M. ; Colbers, E. P. H. ; Fillekes, Q. ; Hoitsma, A. ; Burger, D. M.</creator><creatorcontrib>de Kanter, C. T. M. M. ; Colbers, E. P. H. ; Fillekes, Q. ; Hoitsma, A. ; Burger, D. M.</creatorcontrib><description>Objectives To determine the pharmacokinetic profiles of lopinavir and ritonavir in two newly developed generic co-formulations for HIV-infected children (Lopimune paediatric tablets and granules, 100/25 mg of lopinavir/ritonavir, Cipla Pharmaceuticals), and to compare these with the branded product (Kaletra). Methods This Phase I, comparative, open-label, three-period, single-dose, crossover study was designed as a pilot study to exclude large (>40%) differences in the exposure to lopinavir. Single doses of medication, normalized to 400 mg of lopinavir, were administered on an empty stomach, 1 week apart. A 32 h pharmacokinetic curve was recorded. In an additional part of the study, in five of the same volunteers, a pharmacokinetic curve was recorded after administration of the Lopimune granules and Kaletra oral solution, both with food. Results Twelve healthy subjects were enrolled (four females). The median (range) age, height and body weight were 24 (21–55) years, 1.79 (1.63–1.95) m and 72 (51–87) kg, respectively. The median [interquartile range (IQR)] AUC0–t of lopinavir was 71.8 (48.8–93.5), 38.7 (28.7–52.2) and 58.7 (42.5–79.4) mg·h/L with Kaletra tablets, Lopimune granules and Lopimune paediatric tablets, all taken on an empty stomach, respectively. The respective Cmax values were 7.2 (5.8–8.3), 4.6 (4.1–5.2) and 6.5 (5.0–7.1) mg/L after intake of the different formulations. When comparing the Lopimune formulations with the reference product Kaletra, for all parameters the differences were statistically significant (P ≤ 0.015). Ritonavir exposure was also lower after intake of the generic formulations versus Kaletra. When the five subjects took the Lopimune granules or Kaletra solution with food, the median (IQR) AUC0–t of lopinavir was 58.5 (55.4–77.6) and 49.6 (39.1–58.1) mg·h/L, respectively. Conclusions Large differences in pharmacokinetic parameters can be excluded for Lopimune paediatric tablets when compared with the branded product and taken on an empty stomach, and also for Lopimune granules when these are taken with food.</description><identifier>ISSN: 0305-7453</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dkp472</identifier><identifier>PMID: 20056686</identifier><identifier>CODEN: JACHDX</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Adult ; Age ; Anti-HIV Agents - administration & dosage ; Anti-HIV Agents - pharmacokinetics ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiretroviral drugs ; Biological and medical sciences ; Body weight ; Children ; Cross-Over Studies ; Drug therapy ; Female ; Food ; Generic drugs ; generics ; Granules ; HIV ; Human Experimentation ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunopathology ; Infectious diseases ; Lopinavir ; Male ; Medical sciences ; Middle Aged ; Pediatrics ; Pharmaceuticals ; Pharmacokinetics ; Pharmacology ; Pharmacology. Drug treatments ; Pilot Projects ; Plasma - chemistry ; Pyrimidinones - administration & dosage ; Pyrimidinones - pharmacokinetics ; Ritonavir ; Ritonavir - administration & dosage ; Ritonavir - pharmacokinetics ; Statistical analysis ; Stomach ; Tablets ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Viral infections ; Young Adult</subject><ispartof>Journal of antimicrobial chemotherapy, 2010-03, Vol.65 (3), p.538-542</ispartof><rights>The Author 2010. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org 2010</rights><rights>2015 INIST-CNRS</rights><rights>Copyright Oxford Publishing Limited(England) Mar 2010</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c479t-f70e94794c2e36016bfbf31938700e3309fe8bdbc6d383a8664c044d69697a1d3</citedby><cites>FETCH-LOGICAL-c479t-f70e94794c2e36016bfbf31938700e3309fe8bdbc6d383a8664c044d69697a1d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1584,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22581557$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20056686$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>de Kanter, C. T. M. M.</creatorcontrib><creatorcontrib>Colbers, E. P. H.</creatorcontrib><creatorcontrib>Fillekes, Q.</creatorcontrib><creatorcontrib>Hoitsma, A.</creatorcontrib><creatorcontrib>Burger, D. M.</creatorcontrib><title>Pharmacokinetics of two generic co-formulations of lopinavir/ritonavir for HIV-infected children: a pilot study of paediatric Lopimune versus the branded product in healthy adult volunteers</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>Objectives To determine the pharmacokinetic profiles of lopinavir and ritonavir in two newly developed generic co-formulations for HIV-infected children (Lopimune paediatric tablets and granules, 100/25 mg of lopinavir/ritonavir, Cipla Pharmaceuticals), and to compare these with the branded product (Kaletra). Methods This Phase I, comparative, open-label, three-period, single-dose, crossover study was designed as a pilot study to exclude large (>40%) differences in the exposure to lopinavir. Single doses of medication, normalized to 400 mg of lopinavir, were administered on an empty stomach, 1 week apart. A 32 h pharmacokinetic curve was recorded. In an additional part of the study, in five of the same volunteers, a pharmacokinetic curve was recorded after administration of the Lopimune granules and Kaletra oral solution, both with food. Results Twelve healthy subjects were enrolled (four females). The median (range) age, height and body weight were 24 (21–55) years, 1.79 (1.63–1.95) m and 72 (51–87) kg, respectively. The median [interquartile range (IQR)] AUC0–t of lopinavir was 71.8 (48.8–93.5), 38.7 (28.7–52.2) and 58.7 (42.5–79.4) mg·h/L with Kaletra tablets, Lopimune granules and Lopimune paediatric tablets, all taken on an empty stomach, respectively. The respective Cmax values were 7.2 (5.8–8.3), 4.6 (4.1–5.2) and 6.5 (5.0–7.1) mg/L after intake of the different formulations. When comparing the Lopimune formulations with the reference product Kaletra, for all parameters the differences were statistically significant (P ≤ 0.015). Ritonavir exposure was also lower after intake of the generic formulations versus Kaletra. When the five subjects took the Lopimune granules or Kaletra solution with food, the median (IQR) AUC0–t of lopinavir was 58.5 (55.4–77.6) and 49.6 (39.1–58.1) mg·h/L, respectively. Conclusions Large differences in pharmacokinetic parameters can be excluded for Lopimune paediatric tablets when compared with the branded product and taken on an empty stomach, and also for Lopimune granules when these are taken with food.</description><subject>Adult</subject><subject>Age</subject><subject>Anti-HIV Agents - administration & dosage</subject><subject>Anti-HIV Agents - pharmacokinetics</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiretroviral drugs</subject><subject>Biological and medical sciences</subject><subject>Body weight</subject><subject>Children</subject><subject>Cross-Over Studies</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Food</subject><subject>Generic drugs</subject><subject>generics</subject><subject>Granules</subject><subject>HIV</subject><subject>Human Experimentation</subject><subject>Human immunodeficiency virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunodeficiencies</subject><subject>Immunodeficiencies. Immunoglobulinopathies</subject><subject>Immunopathology</subject><subject>Infectious diseases</subject><subject>Lopinavir</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pediatrics</subject><subject>Pharmaceuticals</subject><subject>Pharmacokinetics</subject><subject>Pharmacology</subject><subject>Pharmacology. Drug treatments</subject><subject>Pilot Projects</subject><subject>Plasma - chemistry</subject><subject>Pyrimidinones - administration & dosage</subject><subject>Pyrimidinones - pharmacokinetics</subject><subject>Ritonavir</subject><subject>Ritonavir - administration & dosage</subject><subject>Ritonavir - pharmacokinetics</subject><subject>Statistical analysis</subject><subject>Stomach</subject><subject>Tablets</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Viral infections</subject><subject>Young Adult</subject><issn>0305-7453</issn><issn>1460-2091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0d2K1DAUB_Aiiruu3vgAEgQRhDpp0yatdzKrOwsDLqKLeBPS5NTJTJvUfIzOw_luZnbGXfBCr3Igv_PPx8mypwV-XeCWzNZCztRmqlh5LzstKorzErfF_ewUE1znrKrJSfbI-zXGmNa0eZidlBjXlDb0NPt1tRJuFNJutIGgpUe2R-GHRd_AgNMSSZv31o1xEEFbc7M92EkbsdVu5nSwNxVKBi0ur3NtepABFJIrPSgH5g0SaNKDDciHqHb7_kmA0iLs05cpaowG0Bacjx6FFaDOCaNSwuSsijIgbdAKxBBWOyRUHALa2iGaAKnjcfagF4OHJ8f1LPv8_t2n-SJffri4nL9d5rJibch7hqFNVSVLIBQXtOu7nhQtaRjGQAhue2g61UmqSENEQ2klcVUp2tKWiUKRs-zlITfd6XsEH_iovYRhEAZs9JxVFS2LmlX_l4Q0bToYJ_n8L7m20Zn0DF4WjNK6ITShVwcknfXeQc8np0fhdrzAfD98nobPD8NP-NkxMXYjqFv6Z9oJvDgC4aUY-vTRUvs7V9ZNUdfsztk4_fvA_OC0D_DzVgq34ZQRVvPFl6_8_Gp-XZ9ffOQl-Q16Atd2</recordid><startdate>20100301</startdate><enddate>20100301</enddate><creator>de Kanter, C. T. M. M.</creator><creator>Colbers, E. P. H.</creator><creator>Fillekes, Q.</creator><creator>Hoitsma, A.</creator><creator>Burger, D. M.</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>BSCLL</scope><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>7QL</scope><scope>7QO</scope><scope>7T7</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20100301</creationdate><title>Pharmacokinetics of two generic co-formulations of lopinavir/ritonavir for HIV-infected children: a pilot study of paediatric Lopimune versus the branded product in healthy adult volunteers</title><author>de Kanter, C. T. M. M. ; Colbers, E. P. H. ; Fillekes, Q. ; Hoitsma, A. ; Burger, D. M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c479t-f70e94794c2e36016bfbf31938700e3309fe8bdbc6d383a8664c044d69697a1d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Age</topic><topic>Anti-HIV Agents - administration & dosage</topic><topic>Anti-HIV Agents - pharmacokinetics</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiretroviral drugs</topic><topic>Biological and medical sciences</topic><topic>Body weight</topic><topic>Children</topic><topic>Cross-Over Studies</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Food</topic><topic>Generic drugs</topic><topic>generics</topic><topic>Granules</topic><topic>HIV</topic><topic>Human Experimentation</topic><topic>Human immunodeficiency virus</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immunodeficiencies</topic><topic>Immunodeficiencies. Immunoglobulinopathies</topic><topic>Immunopathology</topic><topic>Infectious diseases</topic><topic>Lopinavir</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pediatrics</topic><topic>Pharmaceuticals</topic><topic>Pharmacokinetics</topic><topic>Pharmacology</topic><topic>Pharmacology. Drug treatments</topic><topic>Pilot Projects</topic><topic>Plasma - chemistry</topic><topic>Pyrimidinones - administration & dosage</topic><topic>Pyrimidinones - pharmacokinetics</topic><topic>Ritonavir</topic><topic>Ritonavir - administration & dosage</topic><topic>Ritonavir - pharmacokinetics</topic><topic>Statistical analysis</topic><topic>Stomach</topic><topic>Tablets</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><topic>Viral infections</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>de Kanter, C. T. M. M.</creatorcontrib><creatorcontrib>Colbers, E. P. H.</creatorcontrib><creatorcontrib>Fillekes, Q.</creatorcontrib><creatorcontrib>Hoitsma, A.</creatorcontrib><creatorcontrib>Burger, D. M.</creatorcontrib><collection>Istex</collection><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>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of antimicrobial chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>de Kanter, C. T. M. M.</au><au>Colbers, E. P. H.</au><au>Fillekes, Q.</au><au>Hoitsma, A.</au><au>Burger, D. M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetics of two generic co-formulations of lopinavir/ritonavir for HIV-infected children: a pilot study of paediatric Lopimune versus the branded product in healthy adult volunteers</atitle><jtitle>Journal of antimicrobial chemotherapy</jtitle><addtitle>J Antimicrob Chemother</addtitle><date>2010-03-01</date><risdate>2010</risdate><volume>65</volume><issue>3</issue><spage>538</spage><epage>542</epage><pages>538-542</pages><issn>0305-7453</issn><eissn>1460-2091</eissn><coden>JACHDX</coden><abstract>Objectives To determine the pharmacokinetic profiles of lopinavir and ritonavir in two newly developed generic co-formulations for HIV-infected children (Lopimune paediatric tablets and granules, 100/25 mg of lopinavir/ritonavir, Cipla Pharmaceuticals), and to compare these with the branded product (Kaletra). Methods This Phase I, comparative, open-label, three-period, single-dose, crossover study was designed as a pilot study to exclude large (>40%) differences in the exposure to lopinavir. Single doses of medication, normalized to 400 mg of lopinavir, were administered on an empty stomach, 1 week apart. A 32 h pharmacokinetic curve was recorded. In an additional part of the study, in five of the same volunteers, a pharmacokinetic curve was recorded after administration of the Lopimune granules and Kaletra oral solution, both with food. Results Twelve healthy subjects were enrolled (four females). The median (range) age, height and body weight were 24 (21–55) years, 1.79 (1.63–1.95) m and 72 (51–87) kg, respectively. The median [interquartile range (IQR)] AUC0–t of lopinavir was 71.8 (48.8–93.5), 38.7 (28.7–52.2) and 58.7 (42.5–79.4) mg·h/L with Kaletra tablets, Lopimune granules and Lopimune paediatric tablets, all taken on an empty stomach, respectively. The respective Cmax values were 7.2 (5.8–8.3), 4.6 (4.1–5.2) and 6.5 (5.0–7.1) mg/L after intake of the different formulations. When comparing the Lopimune formulations with the reference product Kaletra, for all parameters the differences were statistically significant (P ≤ 0.015). Ritonavir exposure was also lower after intake of the generic formulations versus Kaletra. When the five subjects took the Lopimune granules or Kaletra solution with food, the median (IQR) AUC0–t of lopinavir was 58.5 (55.4–77.6) and 49.6 (39.1–58.1) mg·h/L, respectively. Conclusions Large differences in pharmacokinetic parameters can be excluded for Lopimune paediatric tablets when compared with the branded product and taken on an empty stomach, and also for Lopimune granules when these are taken with food.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>20056686</pmid><doi>10.1093/jac/dkp472</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection; Free Full-Text Journals in Chemistry |
subjects | Adult Age Anti-HIV Agents - administration & dosage Anti-HIV Agents - pharmacokinetics Antibiotics. Antiinfectious agents. Antiparasitic agents Antiretroviral drugs Biological and medical sciences Body weight Children Cross-Over Studies Drug therapy Female Food Generic drugs generics Granules HIV Human Experimentation Human immunodeficiency virus Human viral diseases Humans Immunodeficiencies Immunodeficiencies. Immunoglobulinopathies Immunopathology Infectious diseases Lopinavir Male Medical sciences Middle Aged Pediatrics Pharmaceuticals Pharmacokinetics Pharmacology Pharmacology. Drug treatments Pilot Projects Plasma - chemistry Pyrimidinones - administration & dosage Pyrimidinones - pharmacokinetics Ritonavir Ritonavir - administration & dosage Ritonavir - pharmacokinetics Statistical analysis Stomach Tablets Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Viral infections Young Adult |
title | Pharmacokinetics of two generic co-formulations of lopinavir/ritonavir for HIV-infected children: a pilot study of paediatric Lopimune versus the branded product in healthy adult volunteers |
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