Personalized Medicine Through Semisolid-Extrusion Based 3D Printing: Dual-Drug Loaded Gummies for Enhanced Patient Compliance

Abstract

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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Materials

Isoniazid (INH) and Pyridoxine Hydrochloride (PDX) were purchased from Cayman Chemical (Ann Arbor, MI, USA). Gelatin from porcine skin gel strength 300, Type was purchased from Sigma-Aldrich GmbH. Carrageenan was gifted by AEP Colloids. Xanthan Gum (XANATURAL 180) and Pectin type D slow set-Z were purchased from CP Kelco. Benecel™ K15M (HPMC) was gifted by Ashland (Wilmington, DE, USA). Butylated Hydroxy Anisole (BHA) and Butylated Hydroxytoluene (BHT) were purchased from MP Biomedicals, LLC. The food colors red, and blue were purchased from PCCA. Xylitol powder (Xylisorb 300) was purchased from Roquette America, Inc. Pepsin from porcine gastric mucosa, powder, 250 units/mg was purchased from Sigma-Aldrich GMBH. The reagents and solvents used were of analytical grade and were purchased from Fischer Scientific (Fair Lawn, NJ, USA). Scintillation vials and centrifuge tubes were purchased from Fischer Scientific (Hampton, NH, USA).

Holkunde, A., Karnik, I., Uttreja, P. et al. Personalized Medicine Through Semisolid-Extrusion Based 3D Printing: Dual-Drug Loaded Gummies for Enhanced Patient Compliance. Pharm Res (2025). https://doi.org/10.1007/s11095-024-03813-z