Development of Platform Technology for Gastro-resistant Soft Gel Capsules by Using Cross-linking Technique

Abstract

Introduction: Conventional enteric coating is very challenging in soft gel capsules because of their shell nature (smooth surfaces and elasticity). Soft gelatin capsules are highly sensitive to temperature, humidity and they can lose their tensile strength during the conventional coating process. Materials and Methods: Enteric soft gel capsules were prepared by the addition of enteric polymer in the gelatin shell composition by inducing the cross-linking of gelatin through chemical treatment. Results: This dual approach makes the soft gelatin capsules resist the drug release in the stomach and reliably release their contents in the intestine within a predetermined time without affecting the physical properties of soft gel capsules. Conclusions: Enteric effects of soft gel capsules are brought by a specialized synergetic technique, which is unique for the molecules, requiring intestinal drug release.