By Don Wetherhold, SVP Business Development, Lauren Beach, Ph.D., Senior Product Development Scientist, Kelly Caputo, Ph.D., Senior Product Development Scientist, Aprecia Pharmaceuticals
Adults and children alike often struggle with compliance and acceptance of medication regimens due to the sizes and shape of prescribed tablets. One pharmaceutical manufacturer sought to create a convenient, easy-to-swallow dosage form by taking an alternative approach: three-dimensional printing (3DP). This white paper outlines their approach to creating an FDA validated manufacturing process for rapidly disintegrating dosage forms.
An online survey conducted in the United States found that 50% of surveyed American adults (N = 1002) reported difficulty swallowing tablets and capsules.1 These numbers are even higher in pediatric and geriatric populations. Concerned that physical characteristics (e.g., size and shape) of many tablets and capsules affect patient compliance and acceptance of prescribed medication regimens, Aprecia Pharmaceuticals set out to create a convenient and easy-to-swallow dosage form. The goal was to accommodate formulation designs that could deliver higher drug loads with taste masking or a modified release profile as required. Such formulation designs are often difficult to achieve using conventional fast melt (ODTs, Thin Films) technology platforms. To accomplish this goal, Aprecia developed a commercially viable, FDA validated manufacturing process for rapidly disintegrating dosage forms that utilizes three-dimensional printing (3DP).