Oral administration form for difficulty soluble basic active ingredients

摘要

Composition (C) for oral administration of a drug having pH-dependent solubility and a dose number above 1 at a pH above 5, comprises pellets consisting of: (a) a core comprising an organic acid with a water-solubility above 1 g/250 ml at 20[deg]C, optionally together with binders or other additives; (b) an optional insulating layer; (c) a drug-containing layer; and (d) an optional coating. An independent claim is also included for the production of (C) comprising: (i) forming the cores by granulation, pelletization or extrusion/spheronization; (ii) applying an insulating layer comprising a water-soluble polymer and optionally plasticizer, release agent and/or pigment; (iii) applying a dispersion containing the drug, binder and optionally release agent; (iv) drying the dispersion; (v) optionally applying a coating of film former, plasticizer and optionally pigment; and (vi) filling hard capsules with the resulting pellets.