Stability behaviour of molsidomine-containing pellet formulations.
Molsidomine in mixtures with different inactive ingredients has been subjected to a stability test. The fingerprint chromatogram obtained by HPLC with diode-array detection of mixtures of molsidomine with povidone 25 revealed decomposition products; the detection wavelength of 210 nm resulted in easy detection of the degradation products. Molsidomine-containing pellets were manufactured according to a compact procedure and by applying the active ingredient to placebo pellets. Compared with the nonpareil pellet formulations, compact pellets have a considerably higher water content and undergo decomposition of the active ingredient after storage for 50 months under different conditions. It is assumed that the decomposition of molsidomine is accelerated by the peroxide found in povidone.
Laicher
A
A
Klinge Pharma GmbH, Munich, Germany.
Jünger
H
H
Klemm
F H
FH
D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006813:Humidity; D008981:Molsidomine / Q000737:chemistry*; D013607:Tablets; D013696:Temperature; D014665:Vasodilator Agents / Q000737:chemistry*
D013607:Tablets; D014665:Vasodilator Agents; D008981:Molsidomine