Formulation for oral delivery of proteins, peptides and small molecules with poor permeability

A delayed release pharmaceutical dosage form comprising:

• a pharmaceutical formulation comprising:
• a dispersed powder suspended in the pharmaceutical formulation, the dispersed powder comprising an active pharmaceutical ingredient comprising a synthetic or natural poorly permeable peptide having 5 to 20 amino acids or salt or solvate thereof in an amount of 0.01-5 wt. % of the total weight of the formulation;
• a lipophilic phase comprising triglycerides of fatty acids;
• and
• at least one lipophilic surfactant comprising partial esters of polyol and fatty acids, wherein the delayed release dosage form is a coated dosage form whose release is pH dependent and the pharmaceutical formulation is free of polysaccharides and is a water-free reverse emulsion.

A method for treating a patient, comprising administering to a person in need thereof an effective amount of a pharmaceutical formulation comprising:

• a dispersed powder suspended in the pharmaceutical formulation, the dispersed powder comprising an active pharmaceutical ingredient comprising a synthetic or natural poorly permeable peptide having 5 to 20 amino acids or salt or solvate thereof in an amount of 0.01-5 wt. % of the total weight of the formulation;
• a lipophilic phase comprising triglycerides of fatty acids;
• and
• at least one lipophilic surfactant comprising partial esters of polyol and fatty acids,
• wherein the pharmaceutical formulation is free of polysaccharides and is a water-free reverse emulsion.