The galenic development of a tablet with ameziniummetilsulfate

Besides the characterization of the active ingredient 4-amino-6-methoxy-1-phenmyl-pyridazinium methyl sulfate (ameziuniummetilsulfate, LU 1631, Regulton) the formulation and process development for tablets containing 10 mg active substance are described. The mixing behaviour of the ingredients and the compressing properties of the resulting directly compressible mixture are elucidated so that a reliable and reproducible manufacturing process is ensured. The quality of the active substance and tablet is described in detail and the stability for up to five years is demonstrated. The analytical specifications used are given.