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Details for Patent: 7,547,451

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Details for Patent: 7,547,451

Title:Pellet formulation for the treatment of the intestinal tract
Abstract: An orally adminsterable 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)
Assignee: Dr. Falk Pharma GmbH (Freiburg, DE)
Filing Date:Feb 07, 2003
Application Number:10/360,410
Claims:1. A process for preparing an orally administrable pharmaceutical pellet formulation having a controlled release profile for the treatment of the intestinal tract, which pellet comprises a core including an aminosalicyclic acid as a pharmaceutically active compound or a pharmaceutically acceptable salt thereof and optionally pharmaceutically tolerable additives, wherein the active compound is present in the core in a non gel-forming polymer matrix which matrix is essentially insoluble in the intestinal tract and permeable to intestinal fluids and the active compound, the matrix-forming polymer making up at least 1% by weight of the total weight of the core, wherein the process comprises: mixing the 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.

2. The process of claim 1, wherein the matrix-forming polymer comprises co-poly(ethyl acrylate, methyl methacrylate) or ter-poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride).

3. The process of claim 1 or 2, wherein the matrix-forming polymer comprises 4 to 10% by weight of the total weight of the core.

4. The process of claim 1, wherein the aminosalicyclic acid comprises 5-aminosalicyclic acid.

5. The process of claim 1, further comprising applying an enteric coating to a pellet formed from the moist mass.

6. The process of claim 5, wherein the enteric coating comprises a methacrylic acid containing copolymer or methylhydroxypropyl cellulose phthalate.

7. The process of claim 6, wherein the methacrylic acid containing copolymer comprises co-poly(methacrylic acid, methyl methacrylate), wherein the co-polymer comprises free carboxylic acid functional groups.

8. A process for preparing an orally administrable pharmaceutical pellet formulation having a controlled release profile, which pellet comprises a core comprising 5-aminosalicylic acid (5-ASA) or a pharmaceutically acceptable salt thereof, wherein the 5-ASA is present in the core in a non gel-forming polymer matrix, wherein the matrix is essentially insoluble in the intestinal tract and permeable to intestinal fluids, the process comprises: mixing the 5-ASA and the non gel-forming polymer matrix; scattering in magnesium sterate; and extruding a moist mass.

9. The process of claim 8, further comprising applying an enteric coating to a pellet formed from the moist mass.

10. The process of claim 9, wherein the enteric coating comprises a methacrylic acid containing copolymer or methylhydroxypropyl cellulose phthalate.

11. The process of claim 10, wherein the methacrylic acid containing copolymer comprises co-poly(methacrylic acid, methyl methacrylate), wherein the co-polymer comprises free carboxylic acid functional groups.

12. The process of claims 1 or 8, further comprising cutting the moist mass into pieces.

13. The process of claim 12, wherein the pieces are about 1 mm long.

14. The process of claim 12, further comprising rounding the pieces in a spheronizer.

15. The process of claim 14, further comprising drying the pieces.

16. The process of claim 15, wherein the pieced are dried at about 60.degree. C.

17. The process of claim 15, further comprising: dissolving poly(methacrylic acid, methylmethacrylate) 1:1 in an ethanol/water mixture; suspending triethyl citrate, talc, titanium dioxide and magnesium state in the mixture; and coating the pieces with the suspended mixture.

18. The process of any of claims 7, 8, 9, 10, or 11, further comprising applying a single coating layer to a pellet formed from the moist mass.
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