An enteric-coated pharmaceutical composition suitable for an acid labile high drug load medicament that is sensitive to a pH of less than 3

摘要

Provided is a high drug load enteric coated pharmaceutical composition that includes a core comprised of a medicament which is sensitive to a low pH environment of less than 3, such as ddl (also known as didanosine or 2',3'-dideoxyinosine, and marketed by Bristol-Myers Squibb Co. under the brand name Videx® and is an acid labile drug that has been shown to be effective in the treatment of patients with the HIV virus). The composition is preferably in the form of beadlets having an enteric coating formed of methacrylic acid copolymer, plasticizer and an additional coat comprising an anti-adherent. The so-called beadlets have excellent resistance to disintegration at pH less than 3 but have excellent drug release properties at pH greater than 4.5. A method of making said pharmaceutical composition is also disclosed.