Patent ID: 8314058

Claim:
A solid pharmaceutical composition comprising a mixture of: (a) an active macromolecular principle which is a polypeptide or protein, polynucleotide or polysaccharide; (b) a non-conjugated bile acid or salt; and (c) an additive chosen from (i) propyl gallate or a linear or branched chain C 1-12 alkyl, C 1-12 alkyloxy, C 1-12 alkylthio or C 2-12 alkenyl ester of gallic acid which is optionally substituted with one or more groups which are the same or different and are selected from halogen and linear or branched chain C 1-12 alkyl, C 1-12 alkyloxy, C 1-12 alkylthio or C 2-12 alkenyl; (ii) butyl hydroxy anisole, or hydroxy anisole wherein the methoxy group linked to the aromatic ring and/or the hydrogen ortho to the hydroxyl group is/are replaced by one or more groups which are the same or different and are selected from linear or branched chain C 1-12 alkyl, C 1-12 alkyloxy, C 1-12 alkylthio and C 2-12 alkenyl, either unsubstituted or substituted in any position by one or more halogen atoms; and (iii) a mixture of (i) and (ii) wherein the mixture comprises at least 1% by weight of the additive (c), wherein the ratio by weight of the non-conjugated bile salt+additive (b+c) to the active macromolecular principle is at least 3:1 and wherein the composition, when introduced into the intestine, does not raise the pH of the intestinal fluid above pH 7.0.