RESUMO
The potential of additive manufacturing to produce architected lattice structures is remarkable, but restrictions imposed by manufacturing processes lead to practical limits on the form and dimension of structures that can be produced. In the present work, the capabilities of fused filament fabrication (FFF) to produce miniature lattices were explored, as they represent an inexpensive option for the production of polymer custom-made lattice structures. First, fused filament fabrication design guidelines were tested to assess their validity for miniature unit cells and lattice structures. The predictions were contrasted with the results of printing tests, showing some discrepancies between expected outcomes and resulting printed structures. It was possible to print functional 3D miniature open cell polymer lattice structures without support, even when some FFF guidelines were infringed, i.e., recommended minimum strut thickness and maximum overhang angle. Hence, a broad range of lattice structures with complex topologies are possible, beyond the cubic-type cell arrangements. Nevertheless, there are hard limits in 3D printing of miniature lattice structures. Strut thickness, length and orientation were identified as critical parameters in miniature lattice structures. Printed lattices that did not fully comply with FFF guidelines were capable of bearing compressive loads, even if surface quality and accuracy issues could not be fully resolved. Nevertheless, 3D printed FFF lattice structures could represent an improvement compared to other additive manufacturing processes, as they offer good control of cell geometry, and does not require additional post-processing.
RESUMO
CONTEXT: Drug polymorphism could affect drug product dissolution, manufacturability, stability and bioavailability/bioequivalence. The impact of polymorphism on the manufacturability and in vitro dissolution profiles of sulindac capsules has not been studied yet. OBJECTIVE: To evaluate the impact of polymorphism on the manufacturability and in vitro dissolution of sulindac hard gelatin capsules. MATERIALS AND METHODS: Sulindac crystal forms I and II (SLDI and SLDII, respectively) were prepared and characterized. Powder formulations containing one of the polymorphs, lactose and magnesium stearate (at three different levels) were prepared and their flow properties determined. Hard gelatin capsules were filled with the formulations and tested for fill-weight variations. Drug dissolution for SLDI- and SLDII-containing hard gelatin capsules was determined. RESULTS: Differences in flow properties for each polymorph were observed, as well as for their formulations, which in turn affected capsule weight homogeneity. Statistically significant differences in the rate and extent of drug release were observed between SLDI- and SLDII-containing capsules. DISCUSSION: Formulations containing SLDI showed a better manufacturability and a better dissolution profile than those with SLDII. CONCLUSION: Sulindac crystalline form I was the best candidate for hard gelatin capsule formulation because of its technological and in vitro dissolution properties.