Influence of Excipients and Pressing Force on the Impurity Content of N-(4-aminobenzoyl)-L-glutamic Acid in Folic Acid Drugs During Storage

Introduction. Excipients, impurities contained in them, and sorbed water are one of the reasons for degradation active pharmaceutical substance (API). Excipients effect should be especially evaluated moisture-sensitive APIs. Folic acid (FA) is an important vitamin humans. It hydrolyze under action UV irradiation main decomposition product N-(p-aminobenzoyl)glutamic (impurity A). We found increase content impurity A during FA film-coated tablets storage PVC-film aluminum foil packaging absence irradiation. Aim. Investigate excipients parameters production process on drugs. Materials methods. The containing 1.0 mg API produced by direct compression technology were objects study. pressing force (PF) was varied from 5 to 15 kN. Results discussion. that 93.0 % lactose monohydrate obtained with PF above 10 kN exceeded limit value 300 days. Probably simultaneously acts both as a source free catalyst hydrolysis. Since interaction occurs solid phase, accelerates hydrolysis increasing contact area substances mobility molecules. Conclusion. probably cause Independently mechanism its action, leads rate This due molecules between excipient API. have selected optimum pressure range (5–10 kN) tablet mix FA.