Pharmaceutical composition comprising dabigatran etexilate, and preparation method, solid preparation and use thereof

A pharmaceutical composition of dabigatran etexilate suitable for oral administration, characterized in that the pharmaceutical composition is a multi-granule preparation in which each granule comprises a spherical or substantially spherical acidic core including Vitamin C, a separation layer comprising a water-soluble polymer layer and a semipermeable film layer, a dabigatran etexilate layer, and an optional coating layer surrounding the dabigatran etexilate layer,

• wherein the separation layer separates the acidic core including Vitamin C and the dabigatran etexilate layer,
• wherein the separation layer is surrounded by the dabigatran etexilate layer having the same spherical shape,
• wherein the water-soluble polymer layer is located between the acidic core and the semipermeable film layer,
• wherein the semipermeable film layer comprises a water-soluble compound, a water-insoluble compound, and an optional anti-sticking agent and/or plasticizer, the water-soluble compound being lactose, the water-insoluble compound being selected from the group consisting of ethylcellulose and hydroxypropylmethylcellulose acetate succinate (HPMCAS),
• wherein the weight ratio of the dabigatran etexilate layer to the acidic core including Vitamin C is 1:0.6 to 1:1.1,
• wherein the weight gain ratio of the water-soluble polymer layer to the semipermeable film layer is 1:0.1 to 1:10,
• wherein the pharmaceutical composition is in the form of capsules comprising the multi-granule preparation.