ENTERIC COATED PHARMACEUTICAL COMPOSITIONS

摘要

The present invention relates to an enteric coated pharmaceutical composition comprisinga core in the from of pellets comprising a therapeutically effective amount of duloxetine or its pharmaceutically acceptable salt, the pellets having a size between 700 to 1000µm;a separating layer surrounding the core, comprising one or more pharmaceutically acceptable film-forming polymers and pharmaceutically acceptable excipient(s), the separating layer being present in an amount ranging from about 5% to about 20% by weight of the composition, andan enteric layer surrounding the separating layer comprising about 8% to about 25% by weight of the composition of poly(methacrylic acid, ethyl acrylate) ( 1 : 1 ) neutralized to a pH of about 5.0, wherein the enteric coated pharmaceutical composition, when administered orally to human subjects on an empty stomach, provides a maximum plasma concentration of duloxetine ranging from about 25 ng/ml to about 45 ng/ml, occurring from about 5 to 7 hours.