| 摘要 |
Disclosed is a solid tablet that is directly-compressed of powder, comprising meloxicam or a pharmaceutically acceptable salt thereof and one or more excipients, wherein the directly compressed powder was screened through a suitable mesh having a mesh size of 600μm to 1500μm and wherein the tablets can be broken into two, three and/or four units with each unit containing equal amounts of the active ingredient. Further disclosed is a direct compression process without any granulation step, comprising the following steps: 1) premixing of meloxicam with 10–50% of a filler/ disintegrant followed by screening through a suitable mesh having a mesh size of 600μm to 1500μm; 2) premixing of a pH adjuster and one or more colouring agents followed by screening through a suitable mesh having a mesh size of 600μm to 1500μm; 3) mixing of 90-50% of a filler/disintegrant, a second filler/disintegrant, flow regulator, lubricant and artificial flavour followed by screening through a suitable mesh having a mesh size of 600μm to 1500μm; 4) admixing the blends obtained in steps 1) and 2) followed by screening through a suitable mesh having a mesh size of 600μm to 1500μm; 5) final blending of the mixtures obtained in steps 3) and 4) followed by screening through a suitable mesh having a mesh size of 600μm to 1500μm; 6) compression of the powder mixture obtained in step 5) into a tablet, wherein the tablet can be broken into two, three and/or four units with each unit containing equal amounts of the active ingredient. |
