Abstract
The paper presents the unique approach to 3D printing by Selective Laser Sintering of high dose controlled release pharmaceutical dosage form, which contains almost exclusively drug substance - just crystalline paracetamol as a model drug substance and small amount of dye were used. Comprehensive printlet characterization, that included pore space analysis, drug release and subsequent dissolution modeling as well as exploratory analysis, revealed various degrees of freedom for tuning its functional properties i.e. dissolution performance. Two degrees of freedom were found substantial for the proposed approach: (1) the macro structure shaping in terms of active surface to volume ratio; (2) microstructure shaping in terms of pore space structure. The latter was found to have a great potential and can be modified by the manufacturing parameters, e.g. hatch spacing. The simplicity of the preparation and flexibility to control the dissolution performance of the pharmaceutical dosage are the advantages of the proposed approach. • Pharmaceutical high dose oral administration. • Highly drug-loaded controlled release formulations by selective laser sintering • Macro and micro structure shaping for drug dissolution tuning. • Flexible dosage form design for personalized medicine. • Simple manufacturing and simple dissolution mechanism.
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