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Characterization of Channeling Effects Applied to Extended-Release Matrix Tablets Containing Pirfenidone.

Ji-Hyun Kang1,2, Seung-Dong Yoo3, Ki-Hun Han1

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|June 26, 2023
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Channeled extended-release matrix tablets (ChMT) offer a new approach to pirfenidone (PRF) delivery. ChMT demonstrated a zero-order release pattern, potentially simplifying the complex dosing regimen for idiopathic pulmonary fibrosis treatment.

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Fibrosis Treatment

Background:

  • Pirfenidone (PRF) is FDA-approved for idiopathic pulmonary fibrosis (IPF).
  • Current PRF oral dosing is complex, requiring frequent administration and high doses.
  • There is a need for improved PRF formulations to enhance patient compliance and reduce side effects.

Purpose of the Study:

  • To develop an extended-release tablet with a zero-order release pattern for pirfenidone.
  • To compare the performance of channeled extended-release matrix tablets (ChMT) with non-channeled extended-release matrix tablets (NChMT).

Main Methods:

  • Formulation and in vitro testing of ChMT and NChMT.
  • Evaluation of drug release kinetics, swelling and erosion indices.
  • Rheology studies and X-ray microcomputed tomography (XRCT) for structural analysis.

Main Results:

  • ChMT exhibited a zero-order release pattern with a constant release rate.
  • NChMT showed a decreased release rate in the later stages of dissolution.
  • ChMT demonstrated accelerated swelling and erosion due to internal channels, confirmed by XRCT.

Conclusions:

  • The presence of channels in ChMT tablets facilitates uniform wetting and swelling, leading to zero-order drug release.
  • ChMT formulations have the potential to optimize pirfenidone dosage and mitigate adverse effects.
  • This study presents a promising strategy for improving the delivery of anti-fibrotic agents like pirfenidone.