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Related Experiment Video

Updated: Apr 30, 2026

A Soft Tooling Process Chain for Injection Molding of a 3D Component with Micro Pillars
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A small structural change resulting in improved properties for product development.

Kalle Sigfridsson1, Thomas Andersson, Veronica Berntsson

  • 1Department of Pharmaceutical Development, AstraZeneca R&D Mölndal , Mölndal , Sweden and.

Drug Development and Industrial Pharmacy
|April 24, 2014
PubMed
Summary
This summary is machine-generated.

AZD9343, a gamma-aminobutyric acid (GABA) agonist for GERD, shows improved stability over similar compounds. Its unique polar nature necessitates advanced analytical methods like capillary electrophoresis and NMR for characterization.

Keywords:
Capillary electrophoresisNMR spectroscopyformulationoral drug deliverypreformulationstability

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Area of Science:

  • Pharmaceutical Chemistry
  • Analytical Chemistry

Background:

  • AZD9343 is a novel, water-soluble gamma-aminobutyric acid (GABA) agonist developed for symptomatic relief in gastroesophageal reflux disease (GERD).
  • The compound exhibits favorable chemical stability in both aqueous and solid states, with a single observed crystal modification.
  • AZD9343 demonstrates improved hygroscopicity compared to the similar agonist lesogaberan, showing only 1.5% water uptake at 80% RH versus liquefaction at 65% RH for lesogaberan.

Purpose of the Study:

  • To characterize AZD9343 and its impurities using advanced analytical techniques due to its polar nature and lack of UV chromophore.
  • To establish robust analytical methods for assay, purity, and enantiomeric separation of AZD9343.
  • To evaluate formulation strategies for oral and intravenous solutions of AZD9343.

Main Methods:

  • Capillary electrophoresis (CE) with indirect UV detection for assay and purity determination.
  • Liquid chromatography (LC) with UV derivatization for enantiomeric separation.
  • Nuclear Magnetic Resonance (NMR) spectroscopy, including 31P-NMR, 13C-NMR, and 1H-NMR, for impurity identification.
  • Evaluation of formulation parameters including phosphate buffer concentration and EDTA addition for oral solutions.
  • Stability assessment of intravenous solutions under frozen conditions.

Main Results:

  • Developed and validated CE and LC methods suitable for the polar, non-UV-absorbing nature of AZD9343.
  • NMR techniques successfully identified and characterized impurities.
  • Optimal buffer concentrations and EDTA usage were determined for oral solutions.
  • Intravenous solutions were found unsuitable for storage at -20°C.

Conclusions:

  • AZD9343 possesses favorable physicochemical properties for pharmaceutical development, particularly its stability and reduced hygroscopicity.
  • Advanced analytical techniques, including CE, LC with derivatization, and NMR, are essential for the comprehensive characterization of AZD9343 and its impurities.
  • Specific formulation considerations are necessary for both oral and intravenous preparations to ensure stability and efficacy.