Pharmaceutical Approach to HIV Protease Inhibitor Atazanavir for Bioavailability Enhancement Based on Solid Dispersion System
Atazanavir (ATV) is a low oral bioavailability (BA) compound and, clinically, is generally coadministrated with ritonavir (RTV), which boosts the oral BA of ATV by inhibiting cytochrome P450 (CYP) 3A, and P-glycoprotein (Pgp) via the same metabolic pathway. However, depending on pharmacokinetic inte...
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| Veröffentlicht in: | Biological & Pharmaceutical Bulletin 2007, Vol.30(4), pp.733-738 |
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| creator | Fukushima, Keizo Terasaka, Shuichi Haraya, Kenta Kodera, Satoshi Seki, Yuichiro Wada, Ayako Ito, Yukako Shibata, Nobuhito Sugioka, Nobuyuki Takada, Kanji |
| description | Atazanavir (ATV) is a low oral bioavailability (BA) compound and, clinically, is generally coadministrated with ritonavir (RTV), which boosts the oral BA of ATV by inhibiting cytochrome P450 (CYP) 3A, and P-glycoprotein (Pgp) via the same metabolic pathway. However, depending on pharmacokinetic interaction, RTV-boosted ATV has great potential for other comedication. In this study we demonstrated the pharmaceutical approach to BA improvement of ATV without RTV in rats, based on the solid dispersion system using sodium lauryl sulfate (SLS) as a carrier and Gelucire® 50/13 as an absorption enhancer. ATV solid dispersions in SLS were prepared by a conventional solvent method and, at ratios of ATV to SLS of 1 : 2 and 1 : 3, were demonstrated to form an amorphous state in powder X-ray diffraction (PXRD) analysis and exhibited 2.26- and 2.36-fold improvement in a dissolution test in comparison to bulk ATV, respectively. After oral administration to rats, ATV solid dispersion in SLS at a ratio of 1 : 2 showed a 3.5-fold increase in BA compared with bulk ATV. Moreover, the addition of Gelucire 50/13 to ATV solid dispersion, at a total ratio of Gelucire 50/13, ATV and SLS 1 : 1 : 2 gave 7.0- and 4.7-fold increase in Cmax and BA compared with bulk ATV, respectively, when the relative BA to RTV-boosted ATV reached 93%. The results in this study proved that a pharmaceutical approach could improve the bioavailability of ATV without pharmacokinetic interaction with RTV. |
| doi_str_mv | 10.1248/bpb.30.733 |
| format | Article |
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However, depending on pharmacokinetic interaction, RTV-boosted ATV has great potential for other comedication. In this study we demonstrated the pharmaceutical approach to BA improvement of ATV without RTV in rats, based on the solid dispersion system using sodium lauryl sulfate (SLS) as a carrier and Gelucire® 50/13 as an absorption enhancer. ATV solid dispersions in SLS were prepared by a conventional solvent method and, at ratios of ATV to SLS of 1 : 2 and 1 : 3, were demonstrated to form an amorphous state in powder X-ray diffraction (PXRD) analysis and exhibited 2.26- and 2.36-fold improvement in a dissolution test in comparison to bulk ATV, respectively. After oral administration to rats, ATV solid dispersion in SLS at a ratio of 1 : 2 showed a 3.5-fold increase in BA compared with bulk ATV. Moreover, the addition of Gelucire 50/13 to ATV solid dispersion, at a total ratio of Gelucire 50/13, ATV and SLS 1 : 1 : 2 gave 7.0- and 4.7-fold increase in Cmax and BA compared with bulk ATV, respectively, when the relative BA to RTV-boosted ATV reached 93%. The results in this study proved that a pharmaceutical approach could improve the bioavailability of ATV without pharmacokinetic interaction with RTV.</description><identifier>ISSN: 0918-6158</identifier><identifier>EISSN: 1347-5215</identifier><identifier>DOI: 10.1248/bpb.30.733</identifier><identifier>PMID: 17409512</identifier><language>eng</language><publisher>Japan: The Pharmaceutical Society of Japan</publisher><subject>Administration, Oral ; Animals ; atazanavir ; Atazanavir Sulfate ; Biological Availability ; Drug Carriers - chemistry ; Excipients - chemistry ; Fats - chemistry ; gelucire 50/13 ; HIV Infections - blood ; HIV Infections - drug therapy ; HIV Infections - virology ; HIV Protease Inhibitors - administration & dosage ; HIV Protease Inhibitors - blood ; HIV Protease Inhibitors - pharmacokinetics ; HIV Protease Inhibitors - therapeutic use ; Human immunodeficiency virus ; Male ; Oils - chemistry ; Oligopeptides - administration & dosage ; Oligopeptides - blood ; Oligopeptides - pharmacokinetics ; Oligopeptides - therapeutic use ; powder X-ray diffraction ; Powders ; Pyridines - administration & dosage ; Pyridines - blood ; Pyridines - pharmacokinetics ; Pyridines - therapeutic use ; Rats ; Rats, Wistar ; ritonavir ; Sodium Dodecyl Sulfate - chemistry ; sodium lauryl sulfate ; solid dispersion ; X-Ray Diffraction</subject><ispartof>Biological and Pharmaceutical Bulletin, 2007, Vol.30(4), pp.733-738</ispartof><rights>2007 The Pharmaceutical Society of Japan</rights><rights>Copyright Japan Science and Technology Agency 2007</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c691t-930c18040e8c96ecfed356c9b78fe1ad4b15139877b45ae634667829e11d24463</citedby><cites>FETCH-LOGICAL-c691t-930c18040e8c96ecfed356c9b78fe1ad4b15139877b45ae634667829e11d24463</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,1877,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17409512$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fukushima, Keizo</creatorcontrib><creatorcontrib>Terasaka, Shuichi</creatorcontrib><creatorcontrib>Haraya, Kenta</creatorcontrib><creatorcontrib>Kodera, Satoshi</creatorcontrib><creatorcontrib>Seki, Yuichiro</creatorcontrib><creatorcontrib>Wada, Ayako</creatorcontrib><creatorcontrib>Ito, Yukako</creatorcontrib><creatorcontrib>Shibata, Nobuhito</creatorcontrib><creatorcontrib>Sugioka, Nobuyuki</creatorcontrib><creatorcontrib>Takada, Kanji</creatorcontrib><creatorcontrib>Kyoto Pharmaceutical University</creatorcontrib><creatorcontrib>Faculty of Pharmaceutical Sciences</creatorcontrib><creatorcontrib>bDepartment of Biopharmaceutics</creatorcontrib><creatorcontrib>aDepartment of Pharmacokinetics</creatorcontrib><creatorcontrib>Doshisha Women's College of Liberal Arts</creatorcontrib><title>Pharmaceutical Approach to HIV Protease Inhibitor Atazanavir for Bioavailability Enhancement Based on Solid Dispersion System</title><title>Biological & Pharmaceutical Bulletin</title><addtitle>Biol Pharm Bull</addtitle><description>Atazanavir (ATV) is a low oral bioavailability (BA) compound and, clinically, is generally coadministrated with ritonavir (RTV), which boosts the oral BA of ATV by inhibiting cytochrome P450 (CYP) 3A, and P-glycoprotein (Pgp) via the same metabolic pathway. However, depending on pharmacokinetic interaction, RTV-boosted ATV has great potential for other comedication. In this study we demonstrated the pharmaceutical approach to BA improvement of ATV without RTV in rats, based on the solid dispersion system using sodium lauryl sulfate (SLS) as a carrier and Gelucire® 50/13 as an absorption enhancer. ATV solid dispersions in SLS were prepared by a conventional solvent method and, at ratios of ATV to SLS of 1 : 2 and 1 : 3, were demonstrated to form an amorphous state in powder X-ray diffraction (PXRD) analysis and exhibited 2.26- and 2.36-fold improvement in a dissolution test in comparison to bulk ATV, respectively. After oral administration to rats, ATV solid dispersion in SLS at a ratio of 1 : 2 showed a 3.5-fold increase in BA compared with bulk ATV. Moreover, the addition of Gelucire 50/13 to ATV solid dispersion, at a total ratio of Gelucire 50/13, ATV and SLS 1 : 1 : 2 gave 7.0- and 4.7-fold increase in Cmax and BA compared with bulk ATV, respectively, when the relative BA to RTV-boosted ATV reached 93%. The results in this study proved that a pharmaceutical approach could improve the bioavailability of ATV without pharmacokinetic interaction with RTV.</description><subject>Administration, Oral</subject><subject>Animals</subject><subject>atazanavir</subject><subject>Atazanavir Sulfate</subject><subject>Biological Availability</subject><subject>Drug Carriers - chemistry</subject><subject>Excipients - chemistry</subject><subject>Fats - chemistry</subject><subject>gelucire 50/13</subject><subject>HIV Infections - blood</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - virology</subject><subject>HIV Protease Inhibitors - administration & dosage</subject><subject>HIV Protease Inhibitors - blood</subject><subject>HIV Protease Inhibitors - pharmacokinetics</subject><subject>HIV Protease Inhibitors - therapeutic use</subject><subject>Human immunodeficiency virus</subject><subject>Male</subject><subject>Oils - chemistry</subject><subject>Oligopeptides - administration & dosage</subject><subject>Oligopeptides - blood</subject><subject>Oligopeptides - pharmacokinetics</subject><subject>Oligopeptides - therapeutic use</subject><subject>powder X-ray diffraction</subject><subject>Powders</subject><subject>Pyridines - administration & dosage</subject><subject>Pyridines - blood</subject><subject>Pyridines - pharmacokinetics</subject><subject>Pyridines - therapeutic use</subject><subject>Rats</subject><subject>Rats, Wistar</subject><subject>ritonavir</subject><subject>Sodium Dodecyl Sulfate - chemistry</subject><subject>sodium lauryl sulfate</subject><subject>solid dispersion</subject><subject>X-Ray Diffraction</subject><issn>0918-6158</issn><issn>1347-5215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkt9rFDEQxxdR7Fl98Q-QgOCDsOdkk91snuRaW3tQsOCP15DNzno5dpNrkiuc4P9urne14IsvCcl85jszfKcoXlOY04q3H7pNN2cwF4w9KWaUcVHWFa2fFjOQtC0bWrcnxYsY1wAgoGLPixMqOMiaVrPi981Kh0kb3CZr9EgWm03w2qxI8uRq-YPcBJ9QRyRLt7KdTT6QRdK_tNN3NpAhP8-s13fajrqzo007cuFW2hmc0CVyljN74h356kfbk082bjBEu__YxYTTy-LZoMeIr473afH98uLb-VV5_eXz8nxxXZpG0lRKBoa2wAFbIxs0A_asbozsRDsg1T3vaE2ZbIXoeK2xYbxpRFtJpLSvOG_YafHuoJuHu91iTGqy0eA4aod-G5WAnCLo_8EKeM34Pfj2H3Dtt8HlIRTlXLIGasYy9f5AmeBjDDioTbCTDjtFQe29U9k7xUCJe_jNUXLbTdg_okezMnB5AHJ0b5Z3o3X4WNhE0Vk_-twlCAXAALjKhivI8vujlZxXTGahjwehdUz6J_6tpENeghEfmuKHY5_8EDF5WxQ69gcTksFR</recordid><startdate>20070401</startdate><enddate>20070401</enddate><creator>Fukushima, Keizo</creator><creator>Terasaka, Shuichi</creator><creator>Haraya, Kenta</creator><creator>Kodera, Satoshi</creator><creator>Seki, Yuichiro</creator><creator>Wada, Ayako</creator><creator>Ito, Yukako</creator><creator>Shibata, Nobuhito</creator><creator>Sugioka, Nobuyuki</creator><creator>Takada, Kanji</creator><general>The Pharmaceutical Society of Japan</general><general>Pharmaceutical Society of Japan</general><general>Japan Science and Technology Agency</general><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>7QP</scope><scope>7QR</scope><scope>7TK</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20070401</creationdate><title>Pharmaceutical Approach to HIV Protease Inhibitor Atazanavir for Bioavailability Enhancement Based on Solid Dispersion System</title><author>Fukushima, Keizo ; 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However, depending on pharmacokinetic interaction, RTV-boosted ATV has great potential for other comedication. In this study we demonstrated the pharmaceutical approach to BA improvement of ATV without RTV in rats, based on the solid dispersion system using sodium lauryl sulfate (SLS) as a carrier and Gelucire® 50/13 as an absorption enhancer. ATV solid dispersions in SLS were prepared by a conventional solvent method and, at ratios of ATV to SLS of 1 : 2 and 1 : 3, were demonstrated to form an amorphous state in powder X-ray diffraction (PXRD) analysis and exhibited 2.26- and 2.36-fold improvement in a dissolution test in comparison to bulk ATV, respectively. After oral administration to rats, ATV solid dispersion in SLS at a ratio of 1 : 2 showed a 3.5-fold increase in BA compared with bulk ATV. Moreover, the addition of Gelucire 50/13 to ATV solid dispersion, at a total ratio of Gelucire 50/13, ATV and SLS 1 : 1 : 2 gave 7.0- and 4.7-fold increase in Cmax and BA compared with bulk ATV, respectively, when the relative BA to RTV-boosted ATV reached 93%. The results in this study proved that a pharmaceutical approach could improve the bioavailability of ATV without pharmacokinetic interaction with RTV.</abstract><cop>Japan</cop><pub>The Pharmaceutical Society of Japan</pub><pmid>17409512</pmid><doi>10.1248/bpb.30.733</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Administration, Oral Animals atazanavir Atazanavir Sulfate Biological Availability Drug Carriers - chemistry Excipients - chemistry Fats - chemistry gelucire 50/13 HIV Infections - blood HIV Infections - drug therapy HIV Infections - virology HIV Protease Inhibitors - administration & dosage HIV Protease Inhibitors - blood HIV Protease Inhibitors - pharmacokinetics HIV Protease Inhibitors - therapeutic use Human immunodeficiency virus Male Oils - chemistry Oligopeptides - administration & dosage Oligopeptides - blood Oligopeptides - pharmacokinetics Oligopeptides - therapeutic use powder X-ray diffraction Powders Pyridines - administration & dosage Pyridines - blood Pyridines - pharmacokinetics Pyridines - therapeutic use Rats Rats, Wistar ritonavir Sodium Dodecyl Sulfate - chemistry sodium lauryl sulfate solid dispersion X-Ray Diffraction |
| title | Pharmaceutical Approach to HIV Protease Inhibitor Atazanavir for Bioavailability Enhancement Based on Solid Dispersion System |
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