Delayed release of a drug to the colon is achieved from a delayed release formulation comprising a core and a coating for the core. The core comprises a drug and the coating comprises an outer layer and at least one layer between the core and the outer layer selected from the group consisting of an isolation layer and an inner layer. The outer layer comprises a mixture of a first polymeric material which is susceptible to attack by colonic bacteria, and a second polymeric material which has a pH threshold at about pH 5 or above. The inner layer comprises a third polymeric material which is soluble in intestinal fluid or gastrointestinal fluid, said third polymeric material being selected from an at least partially neutralised polycarboxylic acid and a non-ionic polymer. In embodiments in which the third polymeric material is a non-ionic polymer, the inner layer comprises at least one of a buffer agent and a base. The isolation layer comprises a non-ionic polymer which is soluble in intestinal fluid or gastrointestinal fluid. The outer is applied directly to the inner layer or the isolation layer using a coating preparation formed by combining the first polymeric material in an aqueous medium with a second polymeric material in an organic medium. Advantages of formulations according to the present invention include accelerated release of the drug when exposed to colonic conditions and reduction or elimination of a food and/or alcohol effect on drug release after administration.一種將藥物遞送至結腸的緩釋配方,包含核心及塗覆該核心的塗層。該核心包含藥物且該塗層包含外層及至少一介於核心與外層之間的層,該層係選自於由隔離層及內層所組成的群組。該外層包含容易被結腸內細菌攻擊的第一聚合材料與具有pH臨界值5或以上的第二聚合材料的混合物。該內層包含可溶於腸液或消化道液的第三聚合材料,該第三聚合材料係選自於由至少部分中性的多羧酸聚合物及非離子型聚合物所組成的群組。在該第三聚合材料為非離子型聚合物的實施例中,該內層包含至少一緩衝劑及鹼。該隔離層包含可溶於腸液或消化道液的非離子型聚合物。該外層係以塗層製物形式直接塗覆於該內層或該隔離層上,該塗層製物係結合在水性介質中的第一聚合材料與在有機介質中的第二聚合材料來形成。本發明配方的優點包括:當其暴露於結腸內時,會加速藥物的釋放,且降低或消除食物及/或酒精對於藥物釋放的影響。
