Mallinckrodt, Inc.

Mallinckrodt Specialty Chemicals Company

Larry E Denton

Anil M Salpekar

Anil M Salepkar

A granular pharmaceutical composition containing 85 to 99 percent ibuprofen, 0.9 to 15.0 percent binder, and 0.1 to 5.0 percent polyvinylpyrrolidone, wherein the polyvinylpyrrolidone forms a film with a portion of said binder to form agglomerates, is disclosed. Ibuprofen may be fluidized with a portion of the binder in a fluid bed apparatus and sprayed with an aqueous dispersion of polyvinylpyrrolidone and the remainder of the binder. This granulation may be subsequently blended with additional excipients and, optionally, additional active pharmaceutical ingredients for direct compression into tablets.

High ibuprofen content granulations

A granular composition containing 2-(4-isobutylphenyl)propionic acid (ibuprofen) as an active anti-inflammatory pharmaceutical ingredient as a major component, together with carboxymethylcellulose, a lubricant and water as minor components, is disclosed. Particles of ibuprofen and carboxymethylcellulose are both fluidized and coated with an aqueous disperson of a starch binder. After being dried to a moisture level of about 1-5% and blended with a lubricant and additional carboxymethylcellulose, the resulting granules can be directly molded into a pharmaceutically acceptable tablet having high hardness, short disintegration time and fast dissolution rate.

Compositions containing ibuprofen

An N-acetyl-p-aminophenol composition capable of being directly formed into a tablet having high hardness, short disintegration time and short dissolution time is disclosed. The composition includes N-acetyl-p-aminophenol, a pharmaceutically acceptable pregelatinized starch, a pharmaceutically acceptable lubricant, water and optionally an auxiliary binder such as polyvinylpyrrolidone. Also disclosed is a method for preparing the composition which includes drying a fluidized bed of the composition in a fluid bed granulator-dryer.

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Collinsville, IL, United States of America

Larry E Denton