Taste masked pharmaceutical composition

A method of using

• (i) poly(meth)acrylate or
• (ii) a mixture comprising 60-90% (w/w) EC and 10-40% (w/w) hydroxypropyl methylcellulose (HPMC),
• for the assembly of an outer coating layer (final or taste masking coating) free from a low molecular weight water-soluble ionic compound for a multi-layered particle, the multi-layered particle comprising:
• a) an inert core,
• b) one or more coating layer(s), wherein at least one coating layer comprises a pharmaceutically active ingredient and a binder,
• c) an intermediate coating layer (seal coating) free from a low molecular weight water-soluble ionic compound and comprising a water-soluble pharmaceutical film-forming compound, selected from the group consisting of hydroxypropyl methylcellulose (HPMC), polyethylene glycol (PEG) poly(1-vinylpyrrolidin-2-one) (PVP), and any combination thereof, and
• d) the outer coating layer (final or taste masking coating) free from a low molecular weight water-soluble ionic compound and comprising
• (i) a poly(meth)acrylate or
• (ii) a mixture comprising 60-90% (w/w) ethylcellulose (EC) and 10-40% (w/w) hydroxypropyl methylcellulose (HPMC),
• wherein the pharmaceutically active ingredient is water-soluble and comprises either at least one basic group and/or a bitter taste.

A method of using a pharmaceutical composition comprising a multi-layered particle, the multi-layered particle comprising:

• a) an inert core,
• b) one or more coating layer(s), wherein at least one coating layer comprises a pharmaceutically active ingredient and a binder,
• c) the intermediate coating layer (seal coating) free from a low molecular weight water-soluble ionic compound and comprising a water-soluble pharmaceutical film-forming compound, selected from the group consisting of hydroxypropyl methylcellulose (HPMC), polyethylene glycol (PEG) poly(1-vinylpyrrolidin-2-one) (PVP), and any combination thereof, and
• d) an outer coating layer (final or taste masking coating) free from a low molecular weight water-soluble ionic compound and comprising
• (i) a poly(meth)acrylate or
• (ii) a mixture comprising 60-90% (w/w) ethylcellulose (EC) and 10-40% (w/w) hydroxypropyl methylcellulose (HPMC),
• wherein the pharmaceutically active ingredient is water-soluble and comprises either at least one basic group and/or a bitter taste;
• wherein the pharmaceutical composition is used for treating
• α) a metabolic disease, via DPP IV as target,
• β) a heart disease, via the if-channel as target,
• γ) a heart disease, via phosphodiesterase III as target,
• δ) an inflammatory disease via cyclooxygenase 2 as target, or
• ε) a disease of the central nervous system via the benzodiazepine receptor as target.

A pharmaceutical composition comprising a taste masked multi-layered particle, the multi-layered particle comprising:

• a) an inert core,
• b) one or more coating layer(s), wherein at least one coating layer comprises a pharmaceutically active ingredient and a binder,
• c) the intermediate coating layer (seal coating) free from a low molecular weight water-soluble ionic compound and comprising a water-soluble pharmaceutical film-forming compound, selected from the group consisting of hydroxypropyl methylcellulose (HPMC), polyethylene glycol (PEG) poly(1-vinylpyrrolidin-2-one) (PVP), and any combination thereof, and
• d) an outer coating layer (final or taste masking coating) free from a low molecular weight water-soluble ionic compound and comprising
• (i) a poly(meth)acrylate or
• (ii) a mixture comprising 60-90% (w/w) ethylcellulose (EC) and 10-40% (w/w) hydroxypropyl methylcellulose (HPMC),
• wherein the pharmaceutically active ingredient is water-soluble and comprises either at least one basic group and/or a bitter taste;
• wherein the pharmaceutical composition is in solid form, preferably a capsule or tablet with a mass of 20 to 4000 mg per unit, more preferred 20 to 500 mg per unit, even more preferred 30 to 400 mg per unit, most preferred 40 to 300 mg per unit.