Sustained release tablet formulations
First Claim
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1. A two-layer tablet comprising:
- a first layer containing one or more antacid substances and therapeutically inert pharmaceutically acceptable adjunct materials free of sustained release ingredients; and
a second layer containing as the active ingredient, one or more antacid compounds, said tablet being hydrodynamically balanced so that, upon contact with gastric fluid, said second layer acquires and maintains a bulk density of less than one thereby being buoyant in said fluid and remaining buoyant in the gastric fluid of the stomach until substantially all of the antacid compounds contained therein have been released therefrom, said second layer comprising a homogeneous mixture of said antacid compounds, from about 0% to about 80% by weight of therapeutically inert, pharmaceutically acceptable adjunct materials, and from about 20% by weight to about 75% by weight of one or a mixture of hydrocolloids selected from the group consisting of methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose and sodium carboxymethylcellulose to provide, upon contact with gastric fluid, a water impermeable barrier on the surface of said second layer, said tablet being compressed to a hardness of from about 12 to about 14 S.C.U.
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Abstract
A novel sustained release formulation for the preparation of tablets for oral administration is disclosed. The formulation is hydrodynamically balanced to be buoyant in gastric juice thereby remaining in the stomach for an extended period of time.
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Citations
1 Claim
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1. A two-layer tablet comprising:
a first layer containing one or more antacid substances and therapeutically inert pharmaceutically acceptable adjunct materials free of sustained release ingredients; and a second layer containing as the active ingredient, one or more antacid compounds, said tablet being hydrodynamically balanced so that, upon contact with gastric fluid, said second layer acquires and maintains a bulk density of less than one thereby being buoyant in said fluid and remaining buoyant in the gastric fluid of the stomach until substantially all of the antacid compounds contained therein have been released therefrom, said second layer comprising a homogeneous mixture of said antacid compounds, from about 0% to about 80% by weight of therapeutically inert, pharmaceutically acceptable adjunct materials, and from about 20% by weight to about 75% by weight of one or a mixture of hydrocolloids selected from the group consisting of methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose and sodium carboxymethylcellulose to provide, upon contact with gastric fluid, a water impermeable barrier on the surface of said second layer, said tablet being compressed to a hardness of from about 12 to about 14 S.C.U.
Specification
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Current AssigneeHoffmann-La Roche Incorporated (Roche Holding AG)
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Original AssigneeHoffmann-La Roche Incorporated (Roche Holding AG)
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InventorsSheth, Prabhakar R., Tossounian, Jacques L.
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Primary Examiner(s)Rose, Shep K.
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Application NumberUS05/872,181Time in Patent Office391 DaysField of Search424/14-38US Class Current424/472CPC Class CodesA61K 9/0065 Forms with gastric retentio...
