Pharmaceuticals for Oral Delivery

摘要

The present invention provides pharmaceutical compositions suitable for oral delivery and methods of treating subjects in need thereof. The pharmaceutical compositions of the present invention enhance bioavailability of at least one compound classified as BCS Class II, BCS Class III or BCS Class IV.

主权项

1. A solid oral dosage form comprising:
a mixture comprising:
a therapeutically effective amount of at least one active pharmaceutical compound classified as BCS Class III, wherein the compound does not include a peptide bond in the molecular structure of the compound;an absorption enhancer; andfrom 100 mg to 500 mg of coated citric acid particles, wherein the citric acid particles are coated with a water soluble coat that separates the citric acid from the active pharmaceutical compound, wherein, if the dosage form was added to ten milliliters of 0.1 M aqueous sodium bicarbonate solution, the pH of the solution would be acidified to a pH no higher than 5.5; an enteric coating; and a water soluble barrier positioned between the mixture and the enteric coating, thereby separating the mixture from the enteric coating, wherein oral administration results in a synergistic increase in systemic bioavailability of the active pharmaceutical compound when compared to the systemic bioavailability provided by administration of a solid dosage form containing an equal dose of the active pharmaceutical compound without the absorption enhancer and the citric acid.