Shell Materials for Chewable Capsules, From Design of Experiments to Optimal Dosage Form Manufacturing

Abstract Innovations in chewable dosage forms provide solutions for swallowing difficulties faced by certain patient populations. Chewable softgel capsules (SGC) offer opportunities to expand the benefits of SGC, excelling in the delivery of lipid‐based formulations by optimizing the mechanical properties of the shell material without compromising industrial‐scale manufacturing. This study employs an original approach, with a target product profile that aims to combine processability and chewability, to develop optimized chewable dosage forms. Through a mixture design of experiments, key factors such as plasticizer content and the addition of acid‐modified thin‐boiling corn starch are explored, focusing on response parameters critical to achieving the desired properties of the capsule shell material. Optimal shell compositions—one starch‐free and another containing 9% w/w starch, with respective gelatin/non‐volatile plasticizer ratios of 0.81 and 0.67 are determined and evaluated by manufacturing chewable SGC at pilot scale using rotary die technology. The successful manufacturing and resulting capsules, which exhibit the intended properties, highlight the efficiency of this approach in striking the right balance between processability, soft texture, and quick disintegration time.