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Updated: Mar 14, 2026

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Baclofen Solution for Low-Volume Therapeutic Delivery.

Jay M Meythaler1, Jean D Peduzzi1

  • 1Department of Physical Medicine and Rehabilitation-Oakwood, Wayne State University School of Medicine, Detroit, MI, USA.

Neuromodulation : Journal of the International Neuromodulation Society
|October 4, 2016
PubMed
Summary

Baclofen solubility significantly increases in artificial cerebrospinal fluid (aCSF) compared to saline. This stable aCSF formulation of baclofen may offer reduced toxicity for CNS and subarachnoid administration.

Keywords:
artificial CSFbaclofenintrathecalspastic hypertoniaspasticity

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Area of Science:

  • Pharmacology
  • Neuroscience
  • Drug Delivery

Background:

  • Baclofen, a zwitterion, exhibits pH-dependent solubility.
  • Conventional formulations may present toxicity risks to the central nervous system (CNS) and subarachnoid space.
  • Improving baclofen solubility is crucial for effective administration and reduced adverse effects.

Purpose of the Study:

  • To develop a stable baclofen solution in artificial cerebrospinal fluid (aCSF).
  • To achieve baclofen concentrations between 2 mg/cc and 10 mg/cc.
  • To enhance baclofen solubility and minimize potential CNS toxicity.

Main Methods:

  • Determined baclofen solubility in aCSF across six pH levels at 37°C using HPLC analysis.
  • Assessed the stability of baclofen at 4 mg/cc in 20 cc vials stored for 18 months at 25°C/60% humidity.
  • Verified baclofen purity and stability over the 18-month period via HPLC.

Main Results:

  • Baclofen solubility exceeded 7 mg/cc between pH 6-8, though concentrations decreased over time.
  • Baclofen at 4 mg/cc in aCSF vials remained stable for 18 months, with less than 2% degradation.
  • HPLC analysis confirmed the stability and purity of the baclofen solution.

Conclusions:

  • Baclofen demonstrates superior solubility in aCSF compared to normal saline.
  • The aCSF formulation shows potential for reduced toxicity in the subarachnoid space.
  • This enhanced solubility and stability profile supports potential clinical applications of baclofen.