How to prevent cross-linking reaction in gelatin capsules?

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      1. Select the excipients that are not easy to produce aldehydes or to promote the cross-linking reaction.In the preparation of the auxiliary materials, plasticizers, preservatives, fats, polyethylene compounds such as PEG, aliphatic alcohols, aliphatic phenols, polyethylene glycerides are easy to produce aldehydes.Non-ionic surfactant tween 80, because the molecule contains polyoxyethylene, prone to oxidative degradation, the formation of formaldehyde.

      2. For drugs prone to cross-linking reaction, it is inappropriate to develop into hard capsules, soft capsules and other dosage forms.For example, the dissolution of gefebeczyl, etonoic acid, chloramphenicol, furantoin, paracetamol, digoxin, vitamin and ibuprofen all decreased significantly in the loaning process.Drugs containing an aldehyde group react with gelatin residues to cross-link the gelatin.

      3. Control the influence of temperature, humidity, light and other factors in the external environment.The occurrence of crosslinking reaction is influenced by the temperature, humidity and light in the external environment.The capsules should be stored in a cool, dry and dark place with a temperature of 15~25℃C and a relative humidity of 30 ~40%.Cross-linking reaction is less likely to occur at room temperature.

      Amino acid residues in gelatin molecules stored at high temperature for a long time are prone to self-oxidation to form an aldehyde group. The formed aldehyde group can cross-link with amino acid residues on the surrounding gelatin molecules.And with the increase of temperature, the degree of cross-linking reaction is more intense.It can catalyze the formation of imine intermediates, catalyze the degradation of excipients into degradation products that facilitate cross-linking reactions, and make it easier for oxygen to penetrate gelatin molecules, thus accelerating its oxidation.The interaction of uv-vis with high temperature and humidity also promoted the occurrence of cross-linking reaction and the autooxidation of gelatin.

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            Avenue 17

              What excellent question

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