Gelatin capsule brittleness effect of capsule color and gelatin origin on moisture related brittleness

A. Al-Maaieh

, Eli Lilly & Co

Gelatin capsule brittleness effect of capsule color and gelatin origin on moisture related brittleness Ahmad Al-Maaieh Purpose. To investigate the effect of gelatin origin (bovine, porcine or porcine/bovine blend) and capsule shell color (white, blue or red) on moisture related capsule brittleness using capsules from two different manufacturers. Methods. Empty capsule shells were stored inside a glove box and dried using dry air. At appropriate time points, samples were removed and immediately stored in aluminum foil bags. Capsule moisture content was determined using a loss-ondrying instrument (Computrac Max-2000). Capsule brittleness was determined using 100 capsules at each time point by subjecting the shells to a pressure of ~ 55 psi for 10 seconds using a piston. Results. Data indicate that there are significant differences among different gelatin capsule shells with regard to their sensitivity to moisture related breakage. Effect of gelatin source and shell color for capsule shells obtained from two vendors can be seen in the attached Figure. Overall, red porcine/bovine blend shells from vendor 2 were the most sensitive to moisture loss. On the other hand, the most resistant gelatin shell to breakage induced by moisture loss was the blue bovine shell from vendor 1. The effect of dye on breakage can be seen where red porcine/bovine blend capsules were found more sensitive to moisture loss than blue porcine/bovine blend capsules (both shells made by vendor 2). Also, white bovine shells were more sensitive than blue bovine shells (both made by vendor 1). On the other hand, the effect of gelatin origin can also be seen. For example, red porcine/bovine blend capsules were more sensitive than red porcine shells from vendor 2. For comparison, non-gelatin white capsule shells from vendor 2 were tested and did not show any significant breakage even after losing 35% of their initial moisture content.

Conclusions. Different gelatin capsule shells are different in their sensitivity to moisture related breakage. All investigated gelatin shells show tremendous increase in brittleness with moisture loss. However, this effect is different in shells of different gelatin origin or color. Non-gelatin capsule shells are superior to all gelatin capsules with regard to moisture related breakage.