Pharmaceutical or nutraceutical composition with sustained release characteristic and with resistance against the influence of ethanol

2:

• The pharmaceutical or nutraceutical composition, according to claim 1, wherein the total amount of the inner coating layer is in the range of 10 to 100% by weight in relation to the total amount of the core by weight.

3:

• The pharmaceutical or nutraceutical composition, according to claim 1, wherein the composition does not comprise, except for the inner coating layer and the outer coating layer, any further controlling layer present which controls the release of the pharmaceutical or the nutraceutical active ingredient.

4:

• The pharmaceutical or nutraceutical composition, according to claim 1, wherein the one or more salts of alginic acid have a viscosity of 30 to 720 cP in a 1% aqueous solution (weight/weight).

5:

• The pharmaceutical or nutraceutical composition, according to claim 1, wherein the inner coating layer further comprises up to 70% by weight of one or more pharmaceutically or nutraceutically acceptable excipients relative to the total weight of the inner coating layer.

6:

• The pharmaceutical or nutraceutical composition, according to claim 1, wherein the release of the pharmaceutical or nutraceutical active ingredient in % under in-vitro conditions in a pH 1.2 medium without ethanol for 2 hours and subsequent change to a buffered pH 6.8 medium does not differ by more than plus/minus 20% (absolute percentage) relative to the release of the pharmaceutical or nutraceutical active ingredient in % under in-vitro conditions in a pH 1.2 medium with 40% (v/v) ethanol for 2 hours and subsequent change to a buffered pH 6.8 medium.

7:

• The pharmaceutical or nutraceutical composition, according to claim 1, wherein the release in % of the pharmaceutical or nutraceutical active ingredient under in-vitro conditions in a pH 1.2 medium without calcium ions for 2 hours and subsequent change to a buffered pH 6.0 medium does not differ by more than plus/minus 20% (absolute percentage) relative to the release in % of the pharmaceutical or nutraceutical active ingredient under in-vitro conditions in a pH 1.2 medium with 1.25 mM calcium ions for 2 hours and subsequent change to a buffered pH 6.0 medium.

8:

• The pharmaceutical or nutraceutical composition according to claim 1, wherein the release of the pharmaceutical or nutraceutical active ingredient under in-vitro conditions after 2 hours in a pH 1.2 medium according to USP and subsequent change of the medium to a buffered medium of pH 6.8 according to USP is 30 to 100% in a total time from 4 to 16 hours.

9:

• The pharmaceutical or nutraceutical composition according to claim 1, wherein the one or more water-insoluble polymers or copolymers comprise (meth)acrylate copolymers.

10:

• The pharmaceutical or nutraceutical composition according to claim 1, wherein the one or more water-insoluble polymers or copolymers comprise a copolymer comprising free-radical polymerized units of more than 95 and up to 100% by weight C1- to C4-alkyl esters of acrylic or of methacrylic acid relative to the total weight of the copolymer and less than 5% by weight of acrylic or methacrylic acid relative to the total weight of the copolymer.

11:

• The pharmaceutical or nutraceutical composition according to claim 1, wherein the one or more water-insoluble polymers or copolymers are selected from the group consisting of vinyl polymers or copolymers, water-insoluble celluloses, and mixtures thereof.

12:

• The pharmaceutical or nutraceutical composition according to claim 1, wherein the one or more water-soluble polymers comprise water-soluble celluloses are selected from the group consisting of methyl-, ethyl or propyl-ethers of cellulose and mixtures thereof.

13:

• The pharmaceutical or nutraceutical composition according to claim 1, wherein the outer coating layer further comprises an emulsifier.

14:

• A process for producing the pharmaceutical or nutraceutical composition according to claim 1, the process comprising:
• forming the core comprising the active ingredient by direct compression, compression of dry, wet or sintered granules, extrusion and subsequent rounding off, wet or dry granulation, direct pelleting or by binding powders onto active ingredient-free beads, neutral cores or active ingredient-containing particles and
• applying the inner coating layer and the outer coating layer in the form of aqueous dispersions or organic solutions in spray processes or by fluidized bed spray granulation onto the core.

15:

• The pharmaceutical or nutraceutical composition according to claim 1, wherein a release of the pharmaceutical or nutraceutical active ingredient is a sustained release with resistance against the influence of ethanol, resistance against the influence of calcium ions, or both.

17:

• A method for the sustained release of a pharmaceutical or nutraceutical active ingredient, comprising:
• exposing the pharmaceutical or nutraceutical composition according to claim 1 to a medium;
• wherein the release of the pharmaceutical or nutraceutical active ingredient in % under in-vitro conditions in a pH 1.2 medium without ethanol or calcium ions for 2 hours and subsequent change of the medium to a buffered medium of pH 6.8 differs by less than plus/minus 20% (absolute percentage) relative to the release of the pharmaceutical or nutraceutical active ingredient in % under in-vitro conditions in a pH 1.2 medium comprising 40% (v/v) ethanol, 1.25 mM calcium ions, or both for 2 hours and subsequent change of the medium to a buffered pH 6.8 medium.

18:

• The pharmaceutical or nutraceutical composition, according to claim 7, wherein the release in % of the pharmaceutical or nutraceutical active ingredient under in-vitro conditions in a pH 1.2 medium without calcium ions for 2 hours and subsequent change to a buffered pH 6.0 medium does not differ by more than plus/minus 20% (absolute percentage) relative to the release in % of the pharmaceutical or nutraceutical active ingredient under in-vitro conditions in a pH 1.2 medium with 1.25 mM calcium ions for 2 hours and subsequent change to a buffered pH 6.0 medium with 1.25 mM calcium ions.

19:

• The pharmaceutical or nutraceutical composition according claim 1, wherein the outer coating layer further comprises up to 20% by weight relative to the total weight of the outer coating layer of a non-ionic emulsifier selected from the group consisting of a polyoxyethylene derivative of a sorbitan ester, a sorbitan ether, and mixtures thereof.