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Claims for Patent: 6,183,778

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Claims for Patent: 6,183,778

Title: Pharmaceutical tablet capable of liberating one or more drugs at different release rates
Abstract:Pharmaceutical tablet consisting of a first layer containing one or more drugs with immediate or controlled release formulation, a second layer containing one or more drugs, either equal to or different from the first layer, with slow release formulation, and a low-permeability barrier-type layer coating said second layer or, alternatively, placed between the first and second layer and, if necessary, containing a drug.
Inventor(s): Conte; Ubaldo (Busto Arisizio, IT), LaManna; Aldo (Pavia, IT), Maggi; Lauretta (Pavia, IT)
Assignee: Jagotec AG (Hergiswil, CH)
Application Number:09/009,672
Patent Claims: 1. An oral dosage form in the form of a tablet, capable of providing one or more pharmaceutically active substances in two or more different releases, the dosage form comprising at least three layers of specific geometric shape, wherein the dosage form comprises:

a) a first layer, from which there occurs a first release of at least one pharmaceutically active substance, wherein the release is characterized as an immediate release or a controlled release, the layer comprising substances which swell or solubilize when contacted with aqueous liquids;

b) a second layer from which there occurs a second release of at least one pharmaceutically active substance, wherein the at least one pharmaceutically active substance is the same as or different from the at least one pharmaceutically active substance released from the first layer in the first release, wherein the second release is characterized as a controlled release, the second layer comprising substances that swell, or erode, or are gellable when contacted with aqueous liquids; and

c) a third layer at least partially coating one or more free surfaces of the second layer, the third layer comprising substances that swell, or erode, or are gellable when contacted with aqueous liquids, and wherein at least two layers of the dosage form are formed by the compression of a mixture of granular components.

2. The oral dosage form of claim 1, wherein the third layer functions as a barrier to release of at least one pharmaceutically active substance from the layer adjacent to the third layer, the third layer effective to control release of the at least one pharmaceutically active substance for a period of at least about three to four hours.

3. The oral dosage form of claim 1, wherein the dosage form further comprises at least one intermediate layer interspersed between any two adjacent layers of the dosage form, wherein the at least one intermediate layer either contains or does not contain at least one pharmaceutically active substance, and wherein, where the intermediate layer contains the at least one pharmaceutically active substance, release of the substance from the intermediate layer is characterized as an immediate or a controlled release.

4. The oral dosage form of claim 1, wherein the dosage form further comprises a film coating layer at least partially covering the surface of the dosage form.

5. The oral dosage form of claim 4, wherein the coating layer dissolves in aqueous fluids with a pH greater than about 5.

6. The oral dosage form of claim 4, wherein the coating layer comprises a sugar.
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