Mallinckrodt, Inc.

Particle Dynamics International, LLC.

Steven R Freebersyser

Donald F Loncrini

Thomas E Haag

R Saul Levinson

Anil M Salpekar

Denis Stotler

Douglas A Robinson

Compositions comprising calcium carbonate and processes for making such compositions are provided. The invention provides a granulation comprising about 95% to about 99% by weight calcium carbonate, about 0.5% to about 5% by weight of a binder and about 0.03% to about 3% by weight of a porosity increasing agent. A pharmaceutical or nutritional composition prepared from such a granulation comprises about 90% to about 99% by weight calcium carbonate, about 0.03% to about 3% by weight of a porosity increasing agent, and about 1% to about 10% by weight of other excipients. The composition provides a smaller tablet than conventional calcium carbonate compositions, for improved ease of swallowing.

Calcium compositions

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 partially gelatinized starch, a pharmaceutically acceptable lubricant, water and optionally an auxiliary binder, an auxiliary disintegrant or both of these optional components. Also disclosed is a method for preparing the essential components (and optional components if desired) and spray drying the slurry.

N-acetyl-p-aminophenol compositions containing partially gelatinized

A composition having broad spectrum antimicrobial activity and being freeze and heat stable is comprised of a clear solution containing up to approximately 90% by weight of a eutectic mixture of three or more lower alkyl esters of p-hydroxybenzoic acid such as isopropyl p-hydroxybenzoate, isobutyl p-hydroxybenzoate and n-butyl p-hydroxybenzoate in a ratio between approximately 1:1:1 to 4:2:2, respectively, approximately 10% to 90% by weight of a 'Glydant' solution (composed of 55% 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin and 45% water) and at least approximately 0.5% by weight based on the weight of the eutectic mixture and the 'Glydant' solution of an anionic surfactant. The latter, for example, may be dioctyl sodium sulfosuccinate, sodium lauryl sulfate or the ammonium or sodium salt of sulfated nonylphenoxypoly(ethyleneoxy) ethanol.

Compositions of p-hydroxybenzoic acid esters and methods of preparation

A heat and freeze-thaw stable, oil-in-water emulsion is comprised of from approximately 10% to 60% by weight of a eutectic oil containing a mixture of three or more lower alkyl esters of p-hydroxybenzoic acid, from approximately 1.5% to 5.0% by weight of an emulsifying agent which may be gelatin, casein, collagen, glyceryl oleate, the ammonium or sodium salt of sulfated nonylphenoxypoly(ethyleneoxy) ethanol or mixtures thereof, from approximately 3% to 10% by weight of sorbitol and the balance water. The method of preparing such emulsions is also disclosed.

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Florissant, MO, United States of America

Steven R Freebersyser