Fatty acid formulations for oral delivery of proteins and peptides, and uses thereof

A water soluble solid pharmaceutical composition formulated for oral administration by ingestion, comprising:

• (a) from about 5 to about 65% w/w of a salt of a fatty acid component, where the salt of a fatty acid component comprises saturated or unsaturated C4, C5, C6, C7, C8, C9, C10, C11, or C12 fatty acids;
• and
• (b) an insulin compound conjugate comprising an insulin protein coupled to a modifying moiety having a formula:
• —X—R1—Y-PAG-Z-R2 (Formula VI)
• where,
• X, Y and Z are independently selected linking groups and each is optionally present, and X, when present, is coupled to the insulin compound by a covalent bond, wherein the linking group is selected from —C(O)—, —O—, —S—, —C— and —N—,
• R1, if present, is a lower alkyl and may optionally include a carbonyl group;
• R2 is selected from the group consisting of a lower alkyl, optionally including a carbonyl group, and a capping group selected from the group consisting of —CH3, —H, tosylate, branched or linear C1-6 and an activating group, wherein when R1 present, R2 is a member of the capping group;
• and
• PAG is a linear or branched carbon chain incorporating one or more polyethylene glycol moieties, and optionally incorporating one or more additional moieties selected from the group consisting of —S—, —O—, —N—, and —C(O)—;
• and
• an enteric coating material for coating of the water soluble solid composition fabricated into a solid form to survive passage through the stomach without substantial loss of the insulin protein.