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Development of a multiple unit pellet formulation for a weakly basic drug.

C Guthmann1, R Lipp, T Wagner

  • 1Pharmaceutical Development, Schering AG, Berlin, D-13342, Germany.

Drug Development and Industrial Pharmacy
|April 25, 2007
PubMed
Summary
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This study aimed to achieve pH-independent drug release for SAG/ZK, a potential oral treatment for inflammatory diseases. Incorporating fumaric acid into extended-release pellets successfully resulted in pH-independent drug release.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems

Background:

  • SAG/ZK, an oral anti-inflammatory drug candidate, exhibits pH-dependent solubility, impacting its release from conventional formulations.
  • Drug release from standard pellet formulations decreases as the dissolution medium's pH increases.

Purpose of the Study:

  • To develop extended-release pellets for SAG/ZK with pH-independent drug release.
  • To overcome the challenge of pH-dependent solubility and ensure consistent drug delivery.

Main Methods:

  • Extended-release pellets were prepared using extrusion/spheronization and film coating.
  • Organic acids (fumaric, tartaric, adipic acid) were incorporated into the pellet cores.
  • X-ray diffraction studies were conducted to assess recrystallization and salt formation.

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Main Results:

  • Pellets containing fumaric acid demonstrated a localized decrease in pH within the core, leading to increased SAG/ZK release at higher pH values (pH 6.8).
  • This resulted in pH-independent drug release for fumaric acid-containing pellets.
  • Pellets with tartaric and adipic acid showed continued pH-dependent release due to their lower acidity and higher solubility.

Conclusions:

  • Incorporation of fumaric acid is an effective strategy for achieving pH-independent drug release of SAG/ZK.
  • The localized pH modification within the pellet core is crucial for overcoming pH-dependent solubility issues.
  • No adverse recrystallization or salt formation was observed with the tested organic acids.