| abstract |
A pharmaceutical composition in a solid dosage form which is a tablet comprising, as an active ingredient, methylthioninium chloride (MTC), said composition additionally comprising at least one diluent suitable for direct compression which is microcrystalline cellulose or a sugar, in the that the MTC exists in a substantially pure and stable polymorphic form, which is the Form A polymorph in which the amount of MTC in the composition is more than 10% w / w, and in which the composition is obtained by a process comprising dry compression of a mixture of intimate powders of the MTC in a substantially pure polymorphic form with the at least one diluent suitable for direct compression and, optionally, one or more other excipients. |