JP-2025514195-A5 -

Dates

Publication Date

20260511

Application Date

20230425

Description

While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided merely as examples. Those skilled in the art will anticipate numerous variations, modifications, and substitutions without departing from the present invention. It should be understood that various alternative forms to the embodiments of the present invention described herein may be used in the practice of the invention. The following claims define the scope of the present invention and are intended to encompass the methods and structures included in these claims, as well as their equivalents. The present invention provides, for example, the following items: (Item 1) 4% by weight or more of (Z)-endoxiphene, A drug preparation containing 1% by weight or more of croscarmellose sodium, and Enteric-coated delayed-release capsule containing the aforementioned drug formulation A composition containing the following: (Item 2) The composition according to item 1, wherein the percentage of (Z)-endoxiphene relative to total endoxiphene in the drug preparation is 95% or more, 97% or more, or 98% or more, and the total endoxiphene consists of (Z)-endoxiphene and (E)-endoxiphene. (Item 3) The composition according to item 2, wherein the percentage of (Z)-endoxiphene relative to total endoxiphene in the drug formulation is 100% or less. (Item 4) The composition according to any one of items 1 to 3, wherein the drug preparation contains 5% or more by weight, 7% or more by weight, 10% or more by weight, 12% or more by weight, or 15% or more by weight of (Z)-endoxifene. (Item 5) The composition according to any one of items 1 to 4, wherein the drug preparation contains 20% by weight or less, 22% by weight or less, 25% by weight or less, 30% by weight or less, or 40% by weight or less of (Z)-endoxifene. (Item 6) The composition according to any one of items 1 to 5, wherein the drug preparation contains 5% by weight or more and 40% by weight or less of (Z)-endoxifene. (Item 7) The composition according to any one of items 1 to 6, wherein the drug preparation contains 10% by weight or more and 25% by weight or less of (Z)-endoxifene. (Item 8) The composition according to any one of items 1 to 7, wherein the drug preparation contains 15% by weight or more and 20% by weight or less of (Z)-endoxifene. (Item 9) The composition according to any one of items 1 to 8, wherein the drug preparation contains 17% by weight or more and 19% by weight or less of (Z)-endoxifene. (Item 10) The composition according to any one of items 1 to 9, wherein the drug preparation contains 1 mg to 80 mg of (Z)-endoxifene per enteric-coated delayed-release capsule. (Item 11) The composition according to any one of items 1 to 10, wherein the drug preparation contains 10 mg to 80 mg of (Z)-endoxifene per enteric-coated delayed-release capsule. (Item 12) The composition according to any one of items 1 to 11, wherein the drug preparation contains 30 mg to 50 mg of (Z)-endoxifene per enteric-coated delayed-release capsule. (Item 13) The composition according to any one of items 1 to 12, wherein the drug formulation contains 38 mg to 42 mg of (Z)-endoxifene per enteric-coated delayed-release capsule. (Item 14) The composition according to any one of items 1 to 13, wherein the drug formulation comprises about 1 mg, about 2 mg, about 4 mg, about 10 mg, about 20 mg, about 40 mg, or about 80 mg of (Z)-endoxifene per enteric-coated delayed-release capsule. (Item 15) The composition according to any one of items 1 to 14, wherein the drug preparation contains 1.5% or more by weight, 1.7% or more by weight, 2% or more by weight, 2.2% or more by weight, 2.5% or more by weight, 2.7% or more by weight, or 2.8% or less by weight of croscarmellose sodium. (Item 16) The composition according to any one of items 1 to 15, wherein the drug preparation contains 3% by weight or less, 3.2% by weight or less, 3.5% by weight or less, 4% by weight or less, 4.5% by weight or less, or 5% by weight or less of croscarmellose sodium. (Item 17) The composition according to any one of items 1 to 16, wherein the drug preparation contains 1% by weight or more and 5% by weight or less of croscarmellose sodium. (Item 18) The composition according to any one of items 1 to 17, wherein the drug preparation contains 2% by weight or more and 4% by weight or less of croscarmellose sodium. (Item 19) The composition according to any one of items 1 to 18, wherein the drug preparation contains 2.5% by weight or more and 3% by weight or less of croscarmellose sodium. (Item 20) The composition according to any one of items 1 to 19, wherein the drug preparation contains 2.8% by weight or more and 3% by weight or less of croscarmellose sodium. (Item 21) The composition according to any one of items 1 to 20, wherein the drug formulation further comprises microcrystalline cellulose. (Item 22) The composition according to item 21, wherein