Coated solid preparation
The present disclosure provides a pharmaceutical solid preparation containing at least one pharmaceutically active ingredient, wherein the surface of the solid preparation is coated with a light shielding agent or a metal oxide, and a process for producing a solid preparation containing at least one pharmaceutically active ingredient, comprising a step of coating a light shielding agent or a metal oxide.
1 . A pharmaceutical solid preparation containing at least one pharmaceutically active ingredient, wherein the solid preparation has a coating layer having a thickness from 1 nm to less than 500 nm, consisting of physically deposited metal oxide particles on a surface of the solid preparation, wherein a total amount of the metal oxide particles is from 5×10 −6 mg/mm 2 to 3×10 −3 mg/mm 2 .
2 . The pharmaceutical solid preparation according to claim 1 , wherein the coating layer comprises no polymer compound.
3 . The pharmaceutical solid preparation according to claim 1 , wherein the metal oxide particles are physically deposited on the surface of the solid preparation by sputtering.
4 . The pharmaceutical solid preparation according to claim 1 , wherein the metal oxide particles comprise iron oxide particles.
5 . The pharmaceutical solid preparation according to claim 1 , wherein the solid preparation is a tablet.
6 . The pharmaceutical solid preparation according to claim 5 , of which a disintegration time is substantially the same as that of the tablet before the coating.
7 . A process for producing the pharmaceutical solid preparation of claim 1 , comprising sputtering the metal oxide particles on the surface of the solid preparation in an amount of 5×10 −6 mg/mm 2 to 3×10 −3 mg/mm 2 to form the coating layer.
8 . The process for producing a pharmaceutical solid preparation according to claim 7 , wherein the metal oxide particles comprise iron oxide particles and/or titanium oxide particles.
9 . The process for producing a pharmaceutical solid preparation according to claim 7 , wherein the solid preparation is a tablet.
10 . The process for producing a pharmaceutical solid preparation according to claim 9 , of which a disintegration time is substantially the same as that of the tablet before the coating.
11 . A method for photostabilizing the pharmaceutical solid preparation of claim 1 , comprising sputtering the metal oxide particles on the surface of the solid preparation in an amount of 5×10 −6 mg/mm 2 to 3×10 −3 mg/mm 2 to form the coating layer.
12 . The method for photostabilizing a pharmaceutical solid preparation according to claim 11 , wherein the metal oxide particles comprise iron oxide particles and/or titanium oxide particles.
13 . The method for photostabilizing a pharmaceutical solid preparation according to claim 11 , wherein the solid preparation is a tablet.
14 . The pharmaceutical solid preparation according to claim 1 , wherein the metal oxide particles comprise red ferric oxide particles.
15 . The pharmaceutical solid preparation according to claim 1 , wherein the metal oxide particles comprise titanium oxide particles.
16 . The pharmaceutical solid preparation according to claim 1 , wherein the coating layer has a thickness from 10 nm to 400 nm.
17 . The pharmaceutical solid preparation according to claim 1 , wherein the thickness is from 100 nm to 300 nm.
18 . The pharmaceutical solid preparation according to claim 1 , wherein the metal oxide particles comprise at least one metal oxide selected from the group consisting of iron oxide, titanium dioxide, and silicon dioxide.
19 . The pharmaceutical solid preparation according to claim 1 , wherein the at least one pharmaceutically active ingredient comprises a photolabile pharmaceutically active ingredient.
20 . The pharmaceutical solid preparation according to claim 1 , wherein the metal oxide particles are physically deposited on the surface of the solid preparation by sputtering; wherein the metal oxide particles comprise iron oxide particles; wherein the thickness is from 10 nm to less than 500 nm; and wherein the at least one pharmaceutically active ingredient comprises a photolabile pharmaceutically active ingredient.