Dry direct compression compositions for controlled release dosage forms

Claim 1

A dry, direct compressed product containing controlled release dosage forms of therapeutically active particulate agents and produced without heat or solvents by the steps comprising: (a) dry blending blend particles of a particle size smaller than 20 mesh and consisting essentially of from 0.01 to 95 parts by weight of biologically active particulate solids with from 5 to 99.99 weight parts of a matrix blend combination consisting essentially of from 1 to 96 parts by weight of a hydrophobic carbohydrate polymer selected from the group consisting of ethyl cellulose, propyl cellulose, cellulose acetate, cellulose propionate, cellulose acetate-butryate and cellulose acetate-propionate and from 4 to 99 parts by weight of a digestive-difficulty soluble component selected from the group consisting a wax selected from the group consisting of carnauba wax, spermceti, beeswax, candelilla wax, esparto and paraffins; a fatty acid material selected from the group consisting of fatty acids having from 12 to 28 carbon atoms, fatty monoalcohols having 12 to 28 carbon atoms, and fatty amides and amines having from 12 to 28 carbon atoms; a neutral lipid selected from the group consisting of stearin, palmitin, castorwax, phospholipids, glycolipids, glycerides, hydrogenated cottonseed oil, hydrogenated tallow and metal and organic salts of fatty acids having from 11 to 28 carbon atoms; and, mixtures thereof into a first blend; (b) compressing said first blend under a pressure of 1.5 to 20 tons per square inch; and, (c) thereafter, recovering said first blend as a compressed product having a hardness of 4 to 25 kg and excellent resistance to delamination when subjected to an external longitudinal force.