Patent EA-004239-B1 (EA)
Title: Improved fast disintegrating tablet
Inventor: CHAUVEAU CHARLES
IPC: A61K47/40
Filed: 1999-11-03
Abstract: 1. An improved multiparticulate tablet consisting of particles of coated active principle which can be compressed on tablets, and on a mixture of excipients, characterized in that it disintegrates in contact with the saliva in the mouth in less than 40 seconds, and that the ratio of excipient mixture to coated active principle particles being from 0.4 to 6 parts by weight, preferably from 1 to 4 weight parts, the mixture of excipients comprising: - a disintegration agent; - a soluble diluent agent with binding properties which consists of a polyol having less than 13 carbon atoms and being either in the form of with an average particle diameter of from 100 to 500 mkm, or in the form of a powder with an average particle diameter of less than 100 mkm, wherein said polyol is selected from the group comprising mannitol, xylitol, sorbitol and maltitol; - at least one lubricant; - a permeabilizing agent; and - advantageously lubricants, sweeteners, flavourings and colours; the proportion of disintegration agent being from 1 to 15% by weight, preferably from 2 to 7 % by weight and the proportion of soluble agent being from 30 to 90% by weight, preferably from 40 to 70 % by weight, based in each case on the weight of the tablet. 2. A tablet according to claim 1, characterized in that only polyol is used as soluble diluent agent with binding properties, said polyol is selected from the group consisting of mannitol, xylitol, sorbitol and maltitol, and is used in the form of the directly compressible product. 3. A tablet according to claim 1, characterized in that the mixture of two polyols is used as soluble diluent agent with binding properties, one of them being in the form of a powder, and the other is in the form of a powder with an average particle diameter of from 100 to 500 mkm, wherein the ratio of directly compressible polyol to powder polyol is from 99/1 to 20/80, preferably from 80/20 to 20/80. 4. A tablet according to claims 1 to 3, characterized in that the active principle is selected from the group consisting of aspirin, paracetamol and ibuprofen. 5. A tablet according to any one of claims 1 to 4, characterized in that the disintegrating agent is selected from the group consisting of croscarmellose, crospovidone and mixtures thereof. 6. A tablet according to any one of claims 1 to 5, characterized in that the permeabilizing agent is selected from the group consisting of silicas with a high affinity for aqueous solvents, maltodextrins, beta-cyclodextrins and mixtures thereof. 7. A tablet according to any one of claims 1 to 6, characterized in that the permeabilizing agent is precipitated silica. 8. A tablet according to any one of claims 1 to 7, characterized in that the proportion of permeabilizing agent is from 0.1 to 10% by weight, preferably from 0.5 to 5% by weight, based on the weight of the tablet. 9. A tablet according to any one of claims 1 to 8, characterized in that the lubricant is selected from the group consisting of magnesium stearate, sodium stearyl fumarate, stearic acid, micronized polyoxyethylene glycol and mixtures thereof.