Pharmaceutical composition
AssigneeKowa Company, Ltd.
InventorAkito Minamizono
Life of this patent
Estimating the term…
Abstract
Provided is a pharmaceutical composition which contains pemafibrate, a salt thereof or a solvate thereof and one or more selected from the group consisting of a metal oxide, a dihydric alcohol, an ester species and a silicic acid compound and which has excellent storage stability. The pharmaceutical composition includes the following components (A) and (B):(A) pemafibrate, a salt thereof or a solvate thereof; and (B) one or more selected from the group consisting of the following components (B-1) to (B-4):(B-1) a metal oxide; (B-2) a dihydric alcohol; (B-3) an ester species; and (B-4) a silicic acid compound, with component (A) and component (B) being substantially in non-contact with each other.
Claims20
A solid pharmaceutical composition, comprising:
- an active component comprising pemafibrate, a salt thereof or a solvate thereof;
- and
- at least one ester species selected from the group consisting of acetyltriethyl citrate, acetyltributyl citrate, triethyl citrate, tributyl citrate and triacetin,
- wherein the active component and the at least one ester species are formulated substantially in non-contact with each other such that the pemafibrate is substantially in non-contact with the at least one ester species, and
- wherein a total content of the at least one ester species with respect to 1 part by mass of a free form of pemafibrate is from 1 to 10 parts by mass.
A pharmaceutical composition, comprising:
- a film-coated tablet comprising a core tablet and a film coating layer,
- wherein the core tablet comprising an active component comprising pemafibrate, a salt thereof or a solvate thereof, and the film coating layer comprising at least one ester species selected from the group consisting of acetyltriethyl citrate, acetyltributyl citrate, triethyl citrate, tributyl citrate and triacetin are formulated such that the pemafibrate in the core tablet is substantially in non-contact with the at least one ester species, and
- wherein a total content of the at least one ester species with respect to 1 part by mass of a free form of pemafibrate is from 1 to 10 parts by mass.
A pharmaceutical composition, comprising:
- a film-coated tablet comprising a core tablet and a film coating layer,
- wherein the core tablet comprising an active component comprising pemafibrate, a salt thereof or a solvate thereof, and the film coating layer comprising at least one of a metal oxide, a dihydric alcohol and a silicic acid compound, and at least one ester species selected from the group consisting of acetyltriethyl citrate, acetyltributyl citrate, triethyl citrate, tributyl citrate and triacetin are formulated such that the pemafibrate is not in contact with the at least one of the metal oxide, the dihydric alcohol and the silicic acid compound, and the at least one ester species, and
- wherein a total content of the at least one ester species with respect to 1 part by mass of a free form of pemafibrate is from 1 to 10 parts by mass.
A method for stabilizing pemafibrate, a salt thereof or a solvate thereof in a pharmaceutical composition, comprising:
- incorporating an active component comprising pemafibrate, a salt thereof or a solvate thereof, and at least one ester species selected from the group consisting of acetyltriethyl citrate, acetyltributyl citrate, triethyl citrate, tributyl citrate and triacetin such that the active component and the at least one ester species are formulated substantially in non-contact with each other such that the pemafibrate is substantially in non-contact with the at least one ester species, and
- wherein a total content of the at least one ester species with respect to 1 part by mass of a free form of pemafibrate is from 1 to 10 parts by mass.
Dependencies are inferred from the claim text.