Patent ID: 8263126

Claim:
A process for preparing a bilayered orodispersible tablet, comprising the following steps: a) preparation of two types of particles of optionally coated active substances; b) preparation of two dry mixtures each comprising tableting excipients and one of the two types of particles; c) precompression of a first of the two dry mixtures obtained above to obtain a first precompressed dry mixture, wherein a stress exerted ranges from 0.5 kN to 15 kN; d) application of a second of the two dry mixtures to the first precompressed dry mixture; e) precompression of the second of the two dry mixtures applied to the first precompressed dry mixture to provide preformed layers, wherein a stress exerted ranges from 0.5 kN to 15 kN; and f) final compression on the preformed layers provided by the foregoing steps, wherein the stress exerted ranges from 5 kN to 15 kN, and wherein said tablet has a hardness of 1 kp (9.8 N) to 6 kp (58.8 N) and comprises two superimposed and integral layers, each of the layers comprising: (i) one active substance; (ii) at least one soluble agent selected from the group consisting of sugars, polyols with less than 13 carbon atoms, and mixtures thereof; (iii) at least one disintegrant selected from the group consisting of croscarmellose, crospovidone and mixtures thereof; and (iv) at least one swelling agent.