Pharmaceutical cyclosporin compositions

An oral cyclosporin formulation comprising a cyclosporin, another active entity and at least one pharmaceutically acceptable excipient and adapted to release cyclosporin in the ileum and/or colon, wherein the formulation is selected from:

• a formulation comprising solid-, semi-solid or liquid filled seamless minicapsules comprising one or more layers, the minicapsules having a release profile to release the cyclosporin in the ileum and/or colon;
• or
• a formulation comprising minispheres comprising (i) a hydrophobic solution or suspension comprising cyclosporin and (ii) gelatin in which the hydrophobic solution is encapsulated.

An oral composition comprising minicapsules having a core comprising a cyclosporin in a solubilised form in combination with another active entity, wherein the non-cyclosporin active entity is selected from a live or live attenuated organism;

• a live or live-attenuated virus;
• or a combination thereof.

A pharmaceutical formulation comprising cyclosporin and another active pharmaceutical ingredient, with release of the cyclosporin and another active pharmaceutical ingredient targeted to the GI tract, the other active pharmaceutical ingredient being selected from:

• a live or live attenuated organism;
• a live or live-attenuated virus;
• or a combination thereof.

A multiple minicapsule modified release composition comprising at least two populations of different active ingredient-containing minicapsules;

• wherein a first active ingredient is cyclosporin in a solubilised liquid form;
• and a second active ingredient is selected from a live or live attenuated organism and/or a live or live-attenuated virus.

A method of treating or preventing HIV replication in a subject, the method comprising orally administering to the subject an effective amount of cyclosporin in a solubilised liquid form included in an oral formulation which permits targeted release of the solubilised cyclosporin at least in the colon.

A method of inhibiting T-cell mitosis in a subject, the method comprising orally administering to the subject an effective amount of cyclosporin in a solubilised liquid form included in an oral formulation which permits targeted release of the solubilised cyclosporin at least in the colon.