Patent ID: 6395303
Filing Date: 2002-05-28
Classification: A61K,Y10S

Abstract:
A process for the preparation of an agglomerated material solid dosage form, comprising preparing an aqueous slurry comprising:(a) microcrystalline cellulose; (b) a microcrystalline cellulose compressibility augmenting agent comprising a highly polar dye selected from the group consisting of 3,3â€²-[[1,1â€²Biphenyl]- 4,4â€²-diylbis-(azo)]bis[4-amino-1-naphthalenesulfonic acid] disodium salt; disodium salt of 6-hydroxy-5[(2-4-sulfophenyl) azo]-2-naphthalenesulfonic acid); 5-oxo-1-(p- sulfophenyl)-4-[(p-sulfophenyl)azo]-2-pyrazoline-3-carboxylic acid, trisodium salt); disodium salt of 1-p-sulphophenylazo-2-naphthol-6-sulfonic acid); trisodium-2-hydroxy- 1-(4-sulfonato-1-naphthylazo) naphthalene-6, 8-disulfonate); disodium 4,4â€²-(2,4- dihydroxy-5-hydroxymethyl-3, 3-phenylene bisazo)di(napthalene-1-sulfonate)); tetrasodium 4-acetamido-5-hyroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1- naphthylazo]naphthalene-1,7-disulfonate); disodium 4-hydroxy-3-(4-sulfanato-1- naphythylazo) Naphthalene-1-sulfonate); trisodium 2-hydroxy-1-(4-sulfonato-1- naphthylazo) naphthalene-3, 6-disulfonate) and mixtures thereof which inhibits interactions between cellulose surfaces via the creation of a hydrophobic boundary at cellulose surfaces; and (c) an active agent; and thereafter drying the resultant aqueous slurry utilizing a spray drying technique to obtain an agglomerated material which is then directly compressed into a tablet.