Highly stable compositions of orally active nucleotide analogues or orally active nucleotide analogue prodrugs

Abstract

Disclosed are highly stable compositions having outstanding storage stability and/or demonstrating exceptional resistance to aqueous solution degradation, the composition including an orally active nucleotide analog or an orally active nucleotide analog prodrug, which is orally bioavailable, such as adefovir dipivoxil and tenofovir disoproxil. For example, when a composition of the invention is stored for 1 month or for 18 months at 25° C. and 60% relative humidity, its orally active nucleotide analog or orally active nucleotide analog prodrug degrades to provide a composition containing no more than 0.2% or no more than 0.7% by weight of a less orally bioavailable impurity, respectively. Also disclosed are a container/closure package system including the composition and a package insert and methods of manufacturing the composition and treating a patient for a disease or condition, for example, a viral disease or cancer, with the use of the composition.