Crosslinking Of Gelatin Capsules

~emistry of the crosslinking of gelatin is a complex phenomenon. the nature of which is dependent on several factors. The present manuscript represents an attempt to answer some specific basic science issues. Two "stress" conditions are commonly known in connection with gelatin capsules. The first condition is induced by exposure to formaldehyde. The second stress condition is created by exposing the gelatin capsules to high moisture and elevated temperatures (Le., stressed storage conditions) . The adverse effect of prolonged storage on in vi tro disintegration and on subsequent drug release from gelatin capsules has long been known . Changes in in vitro dissolution due to exposure to high humidity have been observed in capsules containing chloramphenicol, tetracycline. nitrofurantoin, and either water insoluble or relatively water soluble agents. The principal concern is to detemline the effect of stressed conditions on the bioavai lability andlor the clinical efficacy of a drug from gelatin capsules or gelatin coated tablets. It has been shown recently that hard gelatin capsules tested in a dissolution The chemi.try of the cro •• linking of gelatin is a comple. phenomenon. the neture of which i. d.pendent on •• veral factors. Th. pre.ent manuscript repre.ent. an attempt to answer some specific ba.ic science I •• ue •.