{"id":2681,"date":"2007-04-04T13:02:25","date_gmt":"2007-04-04T12:02:25","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=2681"},"modified":"2013-09-20T17:18:10","modified_gmt":"2013-09-20T17:18:10","slug":"pk-results-from-heat-stable-formulation-of-ritonavir","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/2681","title":{"rendered":"PK results from heat-stable formulation of ritonavir"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>Pharmocokinetic data for three prototypes of a heat-stable, meltrex formulation of ritonavir, was presented by George Hanna from Abbott Laboratories. When the development of meltrex formulation lopinavir\/r was underway, many clinicians and advocates were equally keen to see the same approach applied to ritonavir.<\/strong><\/p>\n<p>Long-term stability evaluations under a variety of temperature and humidity conditions and additional bioavailability studies are ongoing to guide selection of a formulation suitable for registration.<\/p>\n<p>Although equivalence results presented at the meeting looked impressive, no one was lead to believe that there would be a short approval time for this formulation.<\/p>\n<p>Scale up to commercial batches, FDA approval based on the 600mg once-daily original ritonavir approval, and then stability assessments which commonly test commercial batches for up to a year prior to approval, are some of the hurdles that need to be achieved.<\/p>\n<p>This makes the timeline for possible approval still several years away.<\/p>\n<p class=\"ref\">Reference:<\/p>\n<p class=\"ref\">Cai Y, Klein C, Roggatz U et al. Bioequivalence of pilot tablet formulations of ritonavir to the marketed soft gel capsule at a dose of 100 mg. Oral abstract 52LB.<br \/>\n<a href=\"http:\/\/www.retroconference.org\/2007\/Abstracts\/30518.htm\">http:\/\/www.retroconference.org\/2007\/Abstracts\/30518.htm<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base Pharmocokinetic data for three prototypes of a heat-stable, meltrex formulation of ritonavir, was presented by George Hanna from Abbott Laboratories. When the development of meltrex formulation lopinavir\/r was underway, many clinicians and advocates were equally keen &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[61],"class_list":["post-2681","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-croi-2007"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/2681","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=2681"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/2681\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=2681"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=2681"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=2681"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}