Plasticizers Affect Softgel Stability

Effect of Plasticizer Type on Long-Term Stability of Enteric-Coated Softgels

Authors: I. McGuffy1 , K. Zhuang2, S. Tindal1 , N. Langley2

This study evaluated the effect of two plasticizer types on the stability of enteric-coated softgels at 25 C/60%RH and 40C/75%RH in HDPE bottles. Stability was measured by changes in coating film appearance, hardness, brittleness, and/or acid resistance. Conclusion: As both plasticizers are capable of producing robust enteric-coated softgels, the choice of plasticizer seems straightforward. But stability studies show that the differences between the two plasticizers may be due to plasticizer and/or moisture migration. To develop a robust stable softgel enteric coating, take into consideration plasticizer type, plasticizer level, and the potential for plasticizer migration from the coating into the softgel shell.

1. Catalent
2. BASF Corporation