The influence of formulation and manufacturing process on the photostability of tablets.
The formulation and the manufacturing process can significantly influence the photostability of tablets. Investigations of various formulation and manufacturing parameters were done with tablets containing nifedipine and molsidomine as highly light sensitive drugs. The effect of relevant formulation factors are stated. Whereas the particle size of the drug substance and the choice of the lubricant had no effect, the drug content, the compression diluent and geometric alterations significantly affected the photoinstability. Depending on the formulation drug losses varied between 30 and 55% after 12 h irradiation in a light testing cabinet (Suntest CPS+). Manufacturing parameters like compression force and direct compression versus granulation showed less serious influences. Nevertheless, photostability changes up to 10% were registered.
Aman
W
W
Department of Pharmaceutical Technology, Ludwig-Maximilians-Universität München, Butenandtstr. 5, 81377 Munich, Germany.
Thoma
Karl
K
D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004339:Drug Compounding / Q000379:methods; D004355:Drug Stability; D005079:Excipients; D008027:Light; D008153:Lubrication; D008981:Molsidomine / Q000737:chemistry / Q000528:radiation effects; D009543:Nifedipine / Q000737:chemistry / Q000528:radiation effects; D010316:Particle Size; D010777:Photochemistry; D013607:Tablets / Q000528:radiation effects*; D014665:Vasodilator Agents / Q000737:chemistry / Q000528:radiation effects
D005079:Excipients; D013607:Tablets; D014665:Vasodilator Agents; D008981:Molsidomine; D009543:Nifedipine