Opening up the pharmaceutical formulation space for Additive Manufacturing

Prasad, Elke and Halbert, Gavin and Robertson, John (2021) Opening up the pharmaceutical formulation space for Additive Manufacturing. In: EUPAT 10 (2021) pan-European Science Conference on QbD & PAT, 2021-10-04 - 2021-10-06, Virtual Conference.

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3D printing (3DP) of pharmaceutical formulations via commercially available FDM printers has gained interested in recent years, enabling personalisation of medicines. It also facilitates advanced control of the micro-structure of the tablet core, permitting fine tuning of product release characteristics with a single formulation. In addition, the technology also offers a platform for Dose escalation studies employing a single formulation and single manufacturing step. FDM printers utilise filament feedstock material of specific diameter, which is conveyed by a drive gear and molten in the hot end and extruded via the nozzle of the printer. Suitable mechanical properties of the filament and physical properties of the formulation are paramount in this process. Print failure can be associated with (brittle) filament breaking in the drive gear or soft (ductile) filaments buckling in the drive gear or hot end [1, 2]. The formulation space for pharmaceutical additive manufacturing is therefore very limited, since most immediate release polymers are very brittle. In this study a novel, integrated HME-3DP (Intellectual Property Office UK, patent application number 2101534.2) was used to directly print oral dosage forms using a pharmaceutical immediate release polymer (Soluplus®) without the need for an intermediate feedstock filament. Different tablet microstructures were printed for a formulation containing 50% w/w Mefenamic acid (MFA) in a polymer matrix of 35% w/w Soluplus and 15% w/w D-Sorbitol. The 3DP dose forms showed different drug release profiles, based on the microstructure design and increased consistency compared to a commercially available MFA containing capsule [3]. This study demonstrates how an integrated HME-3DP opens up the pharmaceutical formulation space for additive manufacturing and allows for fine tuning of drug release profiles based on micro-structure design of a tablet.