Mcneil-ppc, Inc.

Other

David H Rogers

James T Walter

Sunanda R Kulkarni

Robert T McFadden

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.

Under full flow conditions circulated water is conducted for heating through an elongated vertical chamber by a pump along a down-flow path from an upper lateral inlet to a lower outlet and in surrounding relationship to a vertically disposed electrical heating element in the chamber. The chamber is defined by a housing dimensioned to conduct flow with substantially no storage of water therein in order to progressively elevate the water temperature as the water is circulated through the chamber. The heating element extends upwardly from the lower axial end of the housing and terminates substantially at the level of the bottom of the inlet. Operation of the heating element is controlled by a thermostat and a flow responsive control both mounted on the upper axial end of the housing so that the heating element is energized only during periods of flow at a predetermined flow rate when the liquid is below a predetermined temperature. In this manner the internal temperature can be maintained at a relatively low value thus enabling the use of synthetic resins and other inexpensive components.

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Ambler, PA, United States of America

David H Rogers