Aman W, Thoma K
Department of Pharmaceutical Technology, Ludwig-Maximilians University, Munich, Germany.
J Pharm Sci. 2004 Jul;93(7):1860-6. doi: 10.1002/jps.20033.
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.
针对对光非常敏感的莫索尼定片,介绍了不同的光稳定化方法。将光吸收剂或颜料等光稳定剂加入片剂中可显著提高光稳定性。然而,在强光照射12小时后仍检测到光降解。颜料优于着色剂或紫外线吸收剂。需要谨慎考虑使用二氧化钛。将颜料与原料药预混合对于充分发挥其光稳定性能非常有帮助。光催化活性降低的表面处理二氧化钛不如未处理的适用。这是由于颗粒团聚和粘附行为的变化,扫描电子显微镜照片证明了这一点。然而,只有通过泡罩包装或薄膜包衣对片剂进行包封,才能得到光稳定的药品。