Patent ID: 8734849

Claim:
An oral multiparticulate pharmaceutical form comprising pellets having a size in the range from 50 to 2,500 which comprise: a) a mucoadhesive inner matrix layer consisting essentially of a mucoadhesive polymer having a mucoadhesive effect and an active substance which is a peptide or a protein, which may include non-natural amino acid residue(s), embedded in the mucoadhesive polymer, and b) an outer film coating consisting essentially of an anionic polymer or copolymer, wherein the mucoadhesive inner matrix layer does not contain gelatin, wherein said multiparticulate pharmaceutical form is formulated so that the contained pellets are released in the pH range of the stomach, wherein the outer coatings of the pellets are adjusted through the choice of the anionic polymer or copolymer or its formulation with excipients and its layer thickness such that the coating dissolves in pH ranges from 4.0 to 8.0 in the intestine within 15 to 60 min, so that the active substance-containing, mucoadhesive inner matrix layer is exposed and binds to the intestinal mucosa, protects the active substance from physical, chemical, and enzymatic inactivation and releases the active substance there, wherein the active substance content embedded in the mucoadhesive polymer of the mucoadhesive inner matrix layer is a maximum of 40% by weight based on the weight of the mucoadhesive polymer having a mucoadhesive effect, and wherein the mucoadhesive polymer having a mucoadhesive effect exhibits a mucoadhesive effect of η b =150 to 1000 mPa·s and a water uptake of from 10 to 750% in 15 min in a range of +/−0.5 pH units relative to the pH at which the outer coating starts to dissolve and is selected from the group consisting of at least one of chitosan, a (meth)acrylate copolymer consisting of 20-40% by weight methyl methacrylate and 60 to 80% by weight methacrylic acid, a crosslinked polyacrylic acid, an uncrosslinked polyacrylic acid, an Na alginate, and a pectin.