JPWO2020032159A5 - - Google Patents

Claims (21)

A granular composition containing olopatadine or a pharmaceutically acceptable salt thereof , thaumatin and/or acesulfame potassium . 2. The granular composition according to claim 1, comprising sucrose and/or trehalose hydrate. 3. The granular composition according to claim 1, which contains dextrin and/or hydroxypropylcellulose as binder. 4. The granular composition according to any one of claims 1 to 3 , which contains DL-malic acid as a flavoring agent. The granular composition according to any one of claims 1 to 4 , containing sodium edetate hydrate and/or dibutylhydroxytoluene as stabilizers. A solid pharmaceutical formulation containing the granular composition according to any one of claims 1-5 . 7. The formulation according to claim 6 , wherein said solid pharmaceutical formulation is a granule, powder or dry syrup. (d ) A step of sieving with sieve A and sieve B is performed, and regarding the residual particles A of sieve A with a larger opening and the passing particles B of sieve B with a smaller opening, the residual particles A are the above (c) and (d), and for the passing particles B, the above steps (a) to (d) are repeated. (d ) A step of sieving with a sieve A having a mesh opening of 16 to 22 mesh and a sieve B having a mesh opening of 93 to 119 mesh, and the residual particles A of the sieve A and the sieve B Regarding the passing particles B, the steps (c) and (d) above are repeated for the remaining particles A, and the steps (a) to (d) above are repeated for the passing particles B, and the total amount is 100 weight. A method for producing a granular composition containing 85% by weight or more of a granular composition having a particle size with a lower limit of 125 to 160 μm and an upper limit of 710 to 1000 μm per %. 10. The production method according to claim 8 or 9 , further comprising a step of (a') wet mass sizing between the steps (a) and (b). 11. The production method according to claim 10 , wherein the (a') wet lump sizing is crushing sizing. The production method according to any one of claims 8 to 11 , wherein the (c) crushing and sizing is oscillator type sizing. 13. The production method according to any one of claims 8 to 12 , wherein, in the step (c), from the second time onwards, the powder is pulverized and granulated using a screen with a smaller opening. In the step (c), a screen with an opening selected from any of 12 to 18 mesh is used for the first time, and a screen with an opening smaller than the first selected from any of 18 to 30 mesh is used for the second and subsequent times. 14. The production method according to claim 13 , wherein the powder is pulverized and sized. The production method according to any one of claims 8 to 14 , wherein the binder contained as an additive is hydroxypropylcellulose and/or dextrin. A method for producing a solid pharmaceutical preparation using the granular composition produced by the production method according to any one of claims 8 to 15 . 17. The manufacturing method according to claim 16 , wherein the solid pharmaceutical preparation is granules, powders, or dry syrups. 18. The production method according to claim 16 or 17 , wherein the solid pharmaceutical formulation is a packaged product. 19. The manufacturing method according to claim 18 , wherein the packaging material for the divided package is cellopoly, glassine, aluminum laminate film, or aluminum deposition film. Use of the granular composition produced by the production method according to any one of claims 8 to 15 for producing said solid pharmaceutical formulation. 21. Use according to claim 20 , wherein said solid pharmaceutical formulation is granules, powder or dry syrup.