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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Dissolution of fluconazole from 3D-printed prolonged-release tablets: a quantitative evaluation.

Jolanta Pyteraf1, Witold Jamróz1, Mateusz Kurek1

  • 1Chair of Pharmaceutical Technology and Biopharmaceutics, Jagiellonian University Medical College, Medyczna 9, 30-688 Kraków, Poland.

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Fused Deposition Modeling (FDM) and Vat Photopolymerization (VPP) 3D printing methods influence fluconazole release mechanisms. FDM tablets rely on polymer relaxation, while VPP tablets utilize diffusion through a cross-linked matrix for prolonged drug delivery.

Keywords:
Drug releaseFluconazoleFused deposition modelingIntrinsic dissolution rateKinetic ModelsLiquid crystal displaySurface dissolution imaging

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Area of Science:

  • Pharmaceutical Technology
  • Additive Manufacturing
  • Drug Delivery Systems

Background:

  • Additive technologies, particularly 3D printing, are increasingly utilized in pharmaceutical manufacturing for creating customized dosage forms.
  • Understanding the impact of different 3D printing techniques on drug release kinetics is crucial for developing effective modified-release formulations.
  • Fluconazole, an antifungal agent, is often formulated for prolonged release to improve patient compliance and therapeutic outcomes.

Purpose of the Study:

  • To investigate and compare the drug release mechanisms of fluconazole from prolonged-release tablets manufactured using two distinct 3D printing methods: Fused Deposition Modeling (FDM) and Vat Photopolymerization (VPP).
  • To elucidate how the differences in FDM and VPP fabrication processes and associated excipients affect the drug release profile and underlying mechanism.

Main Methods:

  • Tablets containing 50 mg of fluconazole were fabricated using Fused Deposition Modeling (FDM) with poly(vinyl alcohol) and Liquid Crystal Display (LCD)-based Vat Photopolymerization (VPP) utilizing cross-linked polyethylene glycol diacrylate.
  • Drug release studies were conducted to characterize the prolonged release of fluconazole from both types of 3D-printed tablets.
  • Surface dissolution imaging and kinetic modeling were employed to analyze and differentiate the drug release mechanisms.

Main Results:

  • Both FDM and VPP methods successfully produced fluconazole tablets exhibiting prolonged drug release.
  • For FDM-printed tablets, drug release was primarily governed by the dissolution and relaxation of the water-soluble poly(vinyl alcohol) matrix.
  • In VPP-printed tablets, drug release was predominantly controlled by the diffusion of fluconazole through the stable, water-insoluble cross-linked polyethylene glycol diacrylate matrix, with minimal matrix erosion.

Conclusions:

  • The choice of 3D printing technology significantly dictates the drug release mechanism in prolonged-release formulations.
  • FDM printing facilitates drug release through polymer swelling and erosion, suitable for water-soluble polymers, while VPP printing enables diffusion-controlled release from robust, insoluble matrices.
  • These findings highlight the importance of selecting appropriate 3D printing techniques and excipients to achieve desired drug release profiles for specific therapeutic needs.