Abstract: The present invention relates to an oral complex formulation comprising omega-3 fatty acid or its derivatives encapsulated in a hard or soft capsule containing sorbitol and sorbitan, as well as an HMG-CoA reductase inhibitor. The formulation of the present invention comprising omega-3 fatty acid encapsulated with sorbitol and sorbitan provides better prevention related materials from being formed, leading to improved long-term storage stability. The oral complex formulation of the present invention also can raise the serum HDL-cholesterol level, while reducing both LDL-cholesterol and TG levels. The oral complex formulation of the present invention is useful for treatment of hyperlipidemia.

Abstract: An oral complex composition comprising omega-3 fatty acid esters and HMG-CoA reductase inhibitor, can effectively raise serum HDL level while reducing serum LDL and TG levels and can be used to treat hyperlipidemia owing to its good drug dissolution rate and storage stability with showing no delayed release behavior even after 6 months of accelerated storage.