{"id":7662,"date":"2005-01-29T15:34:12","date_gmt":"2005-01-29T14:34:12","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=7662"},"modified":"2014-05-22T15:20:46","modified_gmt":"2014-05-22T15:20:46","slug":"limited-stability-of-lopinavirr-kaletra-above-25c","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/7662","title":{"rendered":"Limited stability of lopinavir\/r (Kaletra) above 25\u00b0C"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>Although Kaletra is generally stored in a refrigerator it retains potency for 2 months at a temperature of 25\u00b0C. This limits use for people who do not have access to refrigeration, particularly in hot countries.<\/strong><\/p>\n<p>Capparelli from University of California, Sand Diego and colleagues performed a small-scale proof of concept study in non-recommended higher temperatures, to evaluate use where refrigeration is not available, particularly in reference to Sub-Saharan Africa.<\/p>\n<p>Kaletra capsules were incubated, individually and in a group of six, in high density polythene bottles, in high humidity, at 35\u00b0C and 45\u00b0C and contents tested for capsule stability and potency at day 1, 2 and 7 and week 2, 4 and 8.<\/p>\n<p>Physical structure was maintained at 35\u00b0 for 4 weeks but capsules become distorted by week 8, increasing in weight by 3% and 11% respectively. At 45\u00b0 degrees the capsules melted together within a week. Potency compared to storage at 4\u00b0 was &gt;95% at week 4 at both 35\u00b0C and 45\u00b0C but fell below 85% by week 8.<\/p>\n<p>The study concluded, that dispensing monthly supplies of LPV\/r in climates up to 35\u00b0C where refrigeration is not available, would maintain potency, and use of this drug in wider settings than is currently available. It did not claim regulatory-standard assessment though, and highlighted the need for formulations that remain more stable at higher temperatures.<\/p>\n<h3>Comment<strong><br \/>\n<\/strong><\/h3>\n<p><strong>This was an eye opener and a great poster, and clearly there are be storage problems in tropical countries. It would be interesting if future studies also addressed potency.<\/strong><\/p>\n<p><strong>Equally interesting was the fact that the capsules gained weight \u2013 from absorbing water, in humidity. In view of this, there is a need to do bioavailability studies even when the capsules look okay, since alcohol in the caps may be lost and water gained, and this may affect absorption.<\/strong><\/p>\n<p>Reference:<\/p>\n<p>Capparelli E et al. Stability of lopinavir\/r at elevated temperatures: relevance to HIV therapy in Sub-Saharan Africa. 41st ICAAC, Washington, 2004. Abstract H-868.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base Although Kaletra is generally stored in a refrigerator it retains potency for 2 months at a temperature of 25\u00b0C. This limits use for people who do not have access to refrigeration, particularly in hot countries. Capparelli &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[99],"class_list":["post-7662","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-icaac-44th-2004"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/7662","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=7662"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/7662\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=7662"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=7662"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=7662"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}