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Claims for Patent: 8,940,328

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Claims for Patent: 8,940,328

Title:Pellet formulation for the treatment of the intestinal tract
Abstract: An orally administrable pharmaceutical pellet formulation for the treatment of the intestinal tract is disclosed, which comprises a core and an enteric coating, the core including, as a pharmaceutical active compound, aminosalicylic acid or a pharmaceutically tolerable salt or a derivative thereof.
Inventor(s): Otterbeck; Norbert (Uberlingen, DE), Gruber; Peter (Merzhausen, DE)
Assignee: Dr. Falk Pharma GmbH (Freiburg, DE)
Application Number:13/790,809
Patent Claims: 1. An orally administrable pharmaceutical pellet formulation having a controlled release profile for the treatment of the intestinal tract, which comprises a core and an enteric coating, the core including aminosalicylic acid or a pharmaceutically acceptable salt thereof, wherein the aminosalicylic acid or pharmaceutically acceptable salt thereof is present in the core and homogenously dispersed in a non gel-forming polymer matrix which is essentially insoluble in the intestinal tract and permeable to intestinal fluids and the aminosalicylic acid, the matrix-forming polymer making up at least 1% and up to approximately 21% by weight of the total weight of the core.

2. The pellet formulation as claimed in claim 1, wherein the pellet formulation is a capsule.

3. The pellet formulation as claimed in claim 1, wherein the pellets formulation is a tablet.

4. The pellet formulation as claimed in claim 1, wherein the pellets have a size of 0.1 to 3 mm.

5. An orally administrable pharmaceutical pellet formulation having a controlled release profile for the treatment of the intestinal tract, which comprises a core and an enteric coating, the core including aminosalicylic acid or a pharmaceutically acceptable salt thereof, wherein the aminosalicylic acid or pharmaceutically acceptable salt thereof is present in the core and homogenously dispersed in a polymer matrix which is essentially insoluble in the intestinal tract and permeable to intestinal fluids and the aminosalicylic acid, the matrix-forming polymer making up at least 1% and up to approximately 21% by weight of the total weight of the core.

6. The pellet formulation of claim 5, wherein the polymer matrix comprises a non gel-forming polymer.

7. The pellet formulation of claim 5, wherein the matrix forming polymer makes up 10% by weight of the total weight of the core.

8. An orally administrable pharmaceutical pellet formulation having a controlled release profile for the treatment of the intestinal tract, which comprises a core and an enteric coating, the core including aminosalicylic acid or a pharmaceutically acceptable salt thereof, wherein the aminosalicylic acid or pharmaceutically acceptable salt thereof is present in the core and homogenously dispersed in a polymer matrix which is essentially insoluble in the intestinal tract and permeable to intestinal fluids and the aminosalicylic acid, the matrix-forming polymer making up at least 1% by weight of the total weight of the core, and wherein the pellets have a size of 0.1 to 3 mm.

9. The pellet formulation of claim 8, wherein the polymer matrix comprises a non gel-forming polymer.

10. The pellet formulation as claimed in claim 8, wherein the pellets have a size of 0.5 to 1 mm.

11. The pellet formulation as claimed in claim 5, wherein the pellet formulation is a capsule.

12. The pellet formulation as claimed in claim 5, wherein the pellet formulation is a tablet.

13. The pellet formulation as claimed in claim 5, wherein the pellets have a size of 0.1 to 3 mm.

14. A controlled release pellet formulation for treatment of the intestinal tract, said formulation comprising: 1) a core comprising a homogeneously dispersed pharmaceutically active compound in a non gel-forming polymer matrix, and 2) an enteric coating, wherein the non gel-forming polymer matrix is essentially insoluble in the intestinal tract and permeable to intestinal fluid made by the process comprising: mixing the pharmaceutically active compound and the non gel-forming polymer matrix; scattering in a pharmaceutically tolerable additive; and extruding a moist mass of the matrix-forming polymer and the active compound.

15. The pellet formulation of claim 1, wherein the polymer matrix is water-insoluble in the intestinal tract.

16. The pellet formulation of claim 5, wherein the polymer matrix is water-insoluble in the intestinal tract.

17. The pellet formulation of claim 8, wherein the polymer matrix is water-insoluble in the intestinal tract.

18. The pellet formulation of claim 1, wherein the polymer is present in an amount which guarantees a delayed release of the aminosalicylic acid.

19. The pellet formulation of claim 5, wherein the polymer is present in an amount which guarantees a delayed release of the aminosalicylic acid.

20. The pellet formulation of claim 8, wherein the polymer is present in an amount which guarantees a delayed release of the aminosalicylic acid.

21. A controlled release pellet formulation for treatment of the intestinal tract, said formulation comprising: 1) a core comprising a homogeneously dispersed pharmaceutically active compound in a polymer matrix, and 2) an enteric coating, wherein the polymer matrix wherein the polymer is present in an amount which guarantees a delayed release of the aminosalicylic acid, is essentially insoluble in the intestinal tract and permeable to intestinal fluid made by the process comprising: mixing the pharmaceutically active compound and the non gel-forming polymer matrix; scattering in a pharmaceutically tolerable additive; and extruding a moist mass of the matrix-forming polymer and the active compound.
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