Abstract: A directly compressed orodispersible tablet comprises 0.1 to 50% of a ungranulated active agent (w/w), 10 to 80% of a sugar-based direct compression base, and 10 to 80% of a microcrystalline cellulose (MCC) direct compression base, and has a hardness of at least 60N, and a disintegration time of less than 40 seconds. The sugar-based direct compression base is a DC sugar alcohol, especially direct compression mannitol, and the MCC base is a silicified MCC, especially a Prosolv. The active is a hydrophobic active, typically a high-dose active. Also disclosed is a method of producing an orodispersible tablet comprising the steps of directly compressing a mixture of components at a compression force of at least 5 k N to form the tablet, wherein the mixture of components comprises 0.1 to 50% of an active agent (w/w), 10 to 80% of a sugar-based direct compression base (w/w); and 10 to 80% of a microcrystalline cellulose (MCC) direct compression base (w/w).

Abstract: Self-emulsifying microemulsion or emulsion preconcentrate pharmaceutical compositions containing an omega-3 fatty acid oil such as a fish oil and a poorly water soluble therapeutic agent such as cyclosporin are formulated for administration, particularly oral administration to a human. The preconcentrates, which are substantially free of or contain only minor amounts of a hydrophilic solvent system, contain a pharmaceutically effective amount of an omega-3 fatty acid oil; a therapeutically effective amount of a poorly water soluble therapeutic agent that is substantially soluble in the omega-3 fatty acid oil; and a surfactant system comprising at least one surfactant. Microemulsions or emulsions formed by diluting the self-emulsifying preconcentrate with an aqueous solution are also provided.