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Published on: September 20, 2017
Compatibility study between acetylcysteine and some commonly used tablet excipients.
1Department of Research and Development, Lek Pharmaceutical and Chemical Works, Ljubljana, Slovenia, Yugoslavia.
The Journal of Pharmacy and Pharmacology
|June 1, 1992
Summary
This study examined acetylcysteine interactions with common pharmaceutical excipients. Acetylcysteine showed compatibility with most, but degraded with polyethylene glycol (PEG), glycine, and saccharin sodium under humid, high-temperature conditions.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Analytical Chemistry
Background:
- Acetylcysteine is a widely used mucolytic agent.
- Understanding drug-excipient interactions is crucial for stable pharmaceutical formulations.
- Excipients can affect the stability and efficacy of active pharmaceutical ingredients.
Purpose of the Study:
- To investigate the compatibility and interactions between acetylcysteine and common tablet/capsule excipients.
- To identify excipients that may compromise acetylcysteine stability.
- To provide data for developing stable acetylcysteine formulations.
Main Methods:
- Differential Scanning Calorimetry (DSC) for thermal analysis.
- Fourier Transform Infrared Spectroscopy (FT-IR) for chemical interaction analysis.
- High-Performance Liquid Chromatography (HPLC) and Thin-Layer Chromatography (TLC) for degradation studies.
Main Results:
- Acetylcysteine demonstrated compatibility with microcrystalline cellulose, sodium carboxymethylcellulose, amorphous silicon dioxide, PVP, cross-linked PVP, corn starch, saccharose, and magnesium stearate.
- Decreased thermal stability of acetylcysteine was observed with corn starch, magnesium stearate, saccharose, and lactose.
- Significant interactions and degradation of acetylcysteine were identified with lactose, PEG 4000/6000, glycine, adipic acid, and saccharin sodium, particularly under high temperature and humidity.
Conclusions:
- Most common excipients are compatible with acetylcysteine.
- Excipients such as polyethylene glycol (PEG), glycine, and saccharin sodium can lead to acetylcysteine degradation.
- Formulation strategies should consider these interactions to ensure the long-term stability of acetylcysteine medications.
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