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Pharmaceutical Lauryl Sulfate Salts: Prevalence, Formation Rules, and Formulation Implications
Yiwang Guo1, Changquan Calvin Sun1
1Department of Pharmaceutics, College of Pharmacy, University of Minnesota, 308 Harvard Street SE, Minneapolis, Minnesota 55455, United States.
Sodium lauryl sulfate (SLS) frequently causes drug precipitation by forming insoluble salts. This study highlights the widespread nature of this issue, urging proactive mitigation strategies in drug development to ensure consistent drug dissolution.
Area of Science:
- Pharmaceutical Sciences
- Physical Chemistry
Background:
- Anionic surfactant sodium lauryl sulfate (SLS) can negatively impact drug dissolution by forming poorly soluble lauryl sulfate (LS) salts.
- This phenomenon is often overlooked in drug development due to a perceived low incidence.
Purpose of the Study:
- To investigate the prevalence of drug precipitation caused by SLS.
- To understand the thermodynamic and kinetic factors influencing LS salt formation and precipitation.
Main Methods:
- Tested 18 diverse compounds for precipitation upon mixing with SLS.
- Utilized Fourier-transform infrared (FTIR) spectroscopy to detect intermolecular interactions.
- Reviewed literature for additional examples of SLS-induced precipitation.
Main Results:
- 14 out of 18 tested compounds precipitated when mixed with SLS.
- FTIR indicated intermolecular interactions between SLS and 3 additional compounds.
- Combined with literature data, this confirms the widespread occurrence of SLS-induced precipitation.
Conclusions:
- Drug precipitation with SLS is a prevalent issue across various chemical structures.
- Precipitation is governed by thermodynamic solubility products and influenced by SLS surfactant properties affecting kinetics.
- Proactive identification and mitigation of LS salt formation are crucial for drug development to prevent dissolution issues.
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