Purpose: The purpose of this research was to develop and characterize dual-drug Isoniazid-Pyridoxine gummies using Semisolid Extrusion (SSE) 3D printing technology, aimed at personalized dosing for a broad patient demographic, from pediatric to geriatric. This study leverages SSE 3D printing, an innovative approach in personalized medicine, to enable precise dose customization and improve patient adherence. By formulating dual drug-loaded gummies, the research addresses the challenges of pill burden and poor palatability associated with traditional tuberculosis regimens, ultimately enhancing the therapeutic experience and effectiveness for patients across various age groups.

Methods: Gummies were formulated using varying ratios of gelatin, carrageenan, and xylitol, and printed using the BIO X 3D printer. Rheological properties were evaluated to confirm printability, shear-thinning behavior, and viscosity recovery. In vitro drug release and stability were assessed under refrigerated (5 ± 3°C) and ambient (25 ± 2°C) storage conditions. FT-IR spectroscopy was used to examine drug-excipient interactions.

Results: The optimized F3 formulation, containing 900 mg Isoniazid and 30 mg Pyridoxine, demonstrated successful printability and structural integrity. Over 80% of both drugs were released within 30 min. Rheological testing confirmed ideal shear-thinning and viscoelastic properties for extrusion-based printing. Suitable textural properties for pediatric patient compliance were observed. Stability studies showed that both drug content and release profiles remained consistent for 30 days under refrigerated storage.

Conclusions: This study determines the potential of SSE 3D printing in fabricating personalized Isoniazid-Pyridoxine-loaded gummies, offering a novel, patient-friendly dosage form for tuberculosis treatment. The optimized formulation exhibited excellent printability, stability, and rapid drug release, positioning 3D-printed gummies as a promising alternative to conventional oral dosage forms in enhancing patient adherence.

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Source
http://dx.doi.org/10.1007/s11095-024-03813-zDOI Listing

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