Abstract: The invention pertains to a co-processed excipient composition suitable for tableting, said composition comprising at least one filler-binder, at least one disintegrant, and at least one lubricant which have been subjected to granulation together, and said composition partially or completely coated with lactose, preferably in crystalline form. The inventors have overcome the prejudice against the use of lubricants in tableting excipient compositions early in the tableting process. It was found that the alleged detrimental affects of the lubricant in terms of binding and disintegration could readily be controlled in a excipient composition wherein the lubricant is co-processed in the matrix, and the composition is provided with a lactose coat.

Abstract: A controlled release excipient composition suitable in formulation of a slow or extended release tablet, contains a synergistic mixture of substantially uncross-linked carboxymethyl starch, or sodium starch glycolate (SSG), and a hydrophilic, non-ionic cellulose ether, preferably hydroxypropylmethylcellulose. Whether or not a SSG in the mixture is sufficiently uncross-linked in the context of the invention can be determined by sedimentation: 0.25 g of the formulation in 100 ml deionized water after 24 hours at 25° C., if subjected to centrifugation at 6080 G at 25° C. for 15 minutes, should exhibit a sedimentation volume of more than 60 ml.

Abstract: The invention pertains to a co-processed excipient composition suitable for tableting, said composition comprising at least one filler-binder, at least one disintegrant, and at least one lubricant which have been subjected to granulation together, and said composition partially or completely coated with lactose, preferably in crystalline form. The inventors have overcome the prejudice against the use of lubricants in tableting excipient compositions early in the tableting process. It was found that the alleged detrimental affects of the lubricant in terms of binding and disintegration could readily be controlled in a excipient composition wherein the lubricant is co-processed in the matrix, and the composition is provided with a lactose coat.

Abstract: A controlled release excipient composition suitable in formulation of a slow or extended release tablet, contains a synergistic mixture of substantially uncross-linked carboxymethyl starch, or sodium starch glycolate (SSG), and a hydrophilic, non-ionic cellulose ether, preferably hydroxypropylmethylcellulose. Whether or not a SSG in the mixture is sufficiently uncross-linked in the context of the invention can be determined by sedimentation: 0.25 g of the formulation in 100 ml deionized water after 24 hours at 25° C., if subjected to centrifugation at 6080 G at 25° C. for 15 minutes, should exhibit a sedimentation volume of more than 60 ml.