Mcneil-ppc, Inc.

Mcneil-pcc, Inc.

James T Walter

David H Rogers

Sunanda R Kulkarni

Robert T McFadden

Christopher Szymczak

The present invention provides a composition for forming a compressed solid dosage form that is a free-flowing compressible admixture of simethicone, an adsorbant, and an optional active agent, wherein the weight ratio of simethicone to adsorbent is at least 1:2.22. Also included are solid dosage forms made from a free-flowing compressible admixture of simethicone, an adsorbant, and an optional active agent, wherein the weight ratio of simethicone to adsorbent is at least 1:2.22.

Simethicone solid oral dosage form

A preblend for making lactase tablets is prepared containing about 1-99% (preferably about 200-60%) by weight lactase and about 1-99% (preferably about 40-80%) by weight microcrystalline cellulose. Lactase used in the preblend may be in combination with up to about 4 parts (preferably about 0.5-2 parts) by weight cutting agent such as sugars, starches, cellulose, and inorganic salts for each part by weight lactase. About 0.5-4% by weight lubricant such as magnesium stearate may be present in the preblend. A preferred preblend contains about 9.6 weight percent lactase and about 90 weight percent microcrystalline cellulose, or about 2000 to about 9000 FCC lactase units and from about 40 to about 80 weight percent microcrystalline cellulose. Another preferred preblend contains about 9.6 weight percent lactase, about 30.0 weight percent microcrystalline cellulose and about 59.4 weight percent mannitol. Each preblend may also contain magnesium stearate. A preferred lactase is fromand the microcrystalline cellulose preferably has an average particle size of about 10-200 &#x3bc;m.

Preblend of microcrystalline cellulose and lactase for making tablets

Stable lactase tablets

A preblend for making lactase tablets is prepared containing about 1-99% (preferably about 20-60%) by weight lactase and about 1-99% (preferably about 40-80%) by weight microcrystalline cellulose. Lactase used in the preblend may be in combination with up to about 4 parts (preferably about 0.5-2 parts) by weight cutting agent such as sugars, starches, cellulose, and inorganic salts for each part by weight lactase. About 0.5-4% by weight lubricant such as magnesium stearate may be present in the preblend. A preferred preblend contains about 9.6 weight percent lactase and about 90 weight percent microcrystalline cellulose. Another preferred preblend contains about 9.6 weight percent lactase, about 30.0 weight percent microcrystalline cellulose and about 59.4 weight percent mannitol. Each preblend may also contain magnesium stearate. A preferred lactase is from Aspergillus oryzae and the microcrystalline cellulose preferably has an average particle size of about 20-200 .mu.m.

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Ambler, PA, United States of America

James T Walter