Formulations comprising methylthioninium chloride

摘要

Solid dosage forms of methylthioninium chloride (MTC) further comprise at least one diluent suitable for direct compression. The MTC exists in a substantially pure and stable polymorphic form. The solid dosage forms may preferably be prepared by direct compression methods.

主权项

1. A tablet pharmaceutical composition in solid dosage form comprising:
(a) substantially pure and stable polymorph Form A methylthioninium chloride (“MTC”), (b) at least one diluent suitable for direct compression selected from microcrystalline cellulose or a sugar, (c) optionally further comprising a coating and (d) optionally one or more other excipients, wherein the amount of MTC in the composition is 10-75% w/w of the weight of composition without the coating, and wherein the composition is obtained by a process comprising dry compression of an intimate powder mixture of the MTC in a substantially pure polymorphic form with the at least one diluent suitable for direct compression.