How to photostabilize molsidomine tablets.
Different methods of photostabilization are presented for the very light sensitive molsidomine tablets. The incorporation of photostabilizers such as light absorber or pigments into the tablets considerably improved the photostability. Nevertheless, photodegradation was still detected after 12 h of intense light stress. Pigments are superior to colorants or ultraviolet absorbers. The use of titanium dioxide needs to be considered carefully. Preblending the pigment with the drug substance is very helpful for taking full advantage of its photostabilizing properties. Surface-treated titanium dioxide with reduced photocatalytic activity was less suitable than untreated. That was due to a change of particle agglomeration and adhesion behavior, which was demonstrated by scanning electron microscopy pictures. However, only the protection of the tablets by a cover, either by blistering or film coating, gave a photostable drug product.
Aman
W
W
Department of Pharmaceutical Technology, Ludwig-Maximilians University, Munich, Germany. wolfgang.aman@gx.novartis.com
Thoma
K
K
D004355:Drug Stability; D008029:Lighting; D008981:Molsidomine / Q000138:chemical synthesis* / Q000493:pharmacokinetics / Q000528:radiation effects*; D010777:Photochemistry; D013608:Tablets, Enteric-Coated; D014466:Ultraviolet Rays
D013608:Tablets, Enteric-Coated; D008981:Molsidomine