Abstract: The manufacture of compositions containing montelukast and to stable tablet compositions resulting thereof are disclosed, which include a first compaction step of a dry blend including, montelukast or a pharmaceutically acceptable salt thereof, and microcrystalline cellulose, and a further compression step into tablets.
Abstract: The invention provides a sustained release composition free of food effect comprising a core comprising an active agent except for carbamazepine or verapamil, and a coating comprising, based on the weight of the coating, from 30 to 80% of a gastroresistant polymer and from 10 to 40% of a hydrophilic silicon dioxide. The invention also provides a method of alleviating food effect in a pharmaceutical composition. The invention also provides a dispersion useful thereof.
Abstract: The invention provides a delayed release tablet, comprising: (i) a core comprising an active ingredient selected from the group consisting of oxybutynin hydrochloride, propranolol hydrochloride, buspiron hydrochloride, niacin, cetirizin hydrochloride, cerivastin sodium, metoprolol fumarate, and alendronate sodium., and conventional excipients; and (ii) a coating consisting essentially of a water-insoluble, water-permeable film- forming polymer, a plasticizer and a water-soluble polymer.
Abstract: The invention provides a solid composition comprising glipizide which is not in an amorphous form; polyethylene oxide; the balance consisting of conventional additives; and a functional coating; exhibiting a dissolution profile such that after 4 hours, from 10 to 30% of the glipizide is released, after 8 hours, from 40 to 60% of the glipizide is released, after 12 hours, from 80 to 100% of the glipizide is released.
Abstract: The invention provides a sustained release composition free of food effect comprising:
(c) a core comprising carbamazepine; and
(d) a functional coating comprising, based on the weight of the coating, from 30 to 80% of a gastroresistant polymer and from 10 to 40% of a hydrophilic silicon dioxide.
The invention also provides a method for alleviating food effect in a carbamazepine pharmaceutical composition.
Abstract: The present invention relates to a composition, particularly adapted to oral administration, substantially free of alkaline-reacting compounds. The composition comprises (a) a core containing an acid-labile benzimidazole active principle, where the core comprises a plurality of nuclei and the active principle mixed together and then compressed together, and where the active principle is not in the form of an alkaline salt; (b) an intermediate layer; and (c) an enteric layer; provided that omeprazole is not the benzimidazole active principle. A process for preparing the composition is also disclosed.
Abstract: The invention provides a delayed release coated tablet, free of stabilizer and free of pore-forming agent comprising: (i) a core consisting essentially of bupropion hydrochloride, a binder and a lubricant; and (ii) a first coating consisting essentially of a water-insoluble, water-permeable film-forming polymer, a plasticizer and a water-soluble polymer; and (iii) a second coating consisting essentially of a methacrylic polymer and a plasticizer therefor.
Abstract: The invention provides a controlled release tablet, free of stabilizer and free of pore-forming agent comprising: (i) a core consisting essentially of bupropion hydrochloride, a binder and a lubricant; and (ii) a coating consisting essentially of a water-insoluble, water-permeable film-forming polymer, a plasticizer and a water-soluble polymer.
Abstract: The invention provides a controlled release tablet, free of stabilizer and free of pore-forming agent comprising: (i) a core consisting essentially of bupropion hydrochloride, a binder and a lubricant; and (ii) a coating consisting essentially of a water-insoluble, water-permeable film-forming polymer, a plasticizer and a water-soluble polymer.