Compatibility and stability studies involving polymers used in fused deposition modeling 3D printing of medicines

One of the challenges for developing three-dimensional printed medicines is related to their stability due to the manufacturing conditions involving high temperatures. This work proposed a new protocol for preformulation studies simulating thermal processing and aging of the printed medicines, tested regarding their morphology and thermal, crystallographic, and spectroscopic profiles.

Highlights

Preformulation protocol was proposed to guide the development of 3D-printed medicines.

Drug models were able to support thermal processing equivalent to FDM/3D printing.

Soluplus showed a protective effect for metoprolol after double heating and aging.

Paracetamol and PVA mixture demonstrated incompatibility under heating processing.

Generally, despite the strong drug-polymer interactions observed, the chemical stability of the model drugs was preserved under such conditions. In fact, in the metoprolol and Soluplus® composition, the drug’s solubilization in the polymer produced a delay in the drug decomposition, suggesting a protective effect of the matrix. Paracetamol and polyvinyl alcohol mixture, in turn, showed unmistakable signs of thermal instability and chemical decomposition, in addition to physical changes.

In the presented context, establishing protocols that simulate processing and storage conditions may be decisive for obtaining stable pharmaceutical dosage forms using three-dimensional printing technology.

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Materials: PCM (lot 1511337) was purchased by Purifarma (São Paulo, Brazil), and MTL (lot FN 81700006) was provided by Purifarma (Anápolis, Brazil). Plasdone® K-29/32 (poly (vinylpyrrolidone-co-vinyl acetate) (PVPVA), lot 002177615) was donated by Ashland Specialty Ingredients (Covington, LA, USA), Eudragit® L100 (EUL, methacrylic acid-methyl methacrylate copolymer, lot B111003013) was provided by Evonik (Essen, Germany), Soluplus® (SOL, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol copolymer, lot 84414368E0) was a gift from BASF (Ludwigshafen, Germany), and Parteck® MXP (PVA, polyvinyl alcohol, lot F1952064) was donated by Merck (Darmstadt, Germany).

Article information: Ihatanderson A. Silva, Ana Luiza Lima, Tais Gratieri, Guilherme M. Gelfuso, Livia L. Sa-Barreto, Marcilio Cunha-Filho, Compatibility and stability studies involving polymers used in fused deposition modeling 3D printing of medicines, Journal of Pharmaceutical Analysis, 2021. https://doi.org/10.1016/j.jpha.2021.09.010.