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Preformulation stability screening of ivermectin with non-ionic emulsion excipients
N O Shaw1, M M de Villiers, A P Lötter
1Research Institute for Industrial Pharmacy, Potchefstroom University for CHE, South Africa.
Die Pharmazie
|June 16, 1999
Summary
Differential Scanning Calorimetry (DSC) and High-Performance Liquid Chromatography (HPLC) assessed ivermectin compatibility with 46 excipients. Ivermectin interacted with 21 excipients, impacting drug concentration significantly.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Formulation Development
Background:
- Preformulation studies are critical for successful drug product development.
- Non-ionic emulsions require careful selection of compatible excipients for stability and efficacy.
- Ivermectin is an antiparasitic drug with potential applications in various formulations.
Purpose of the Study:
- To evaluate the compatibility of ivermectin with commonly used excipients for non-ionic emulsion preparation.
- To identify excipients that interact with ivermectin, potentially affecting its stability and concentration.
- To provide data for informed excipient selection in ivermectin-based formulations.
Main Methods:
- Differential Scanning Calorimetry (DSC) was employed to detect thermal interactions.
- High-Performance Liquid Chromatography (HPLC) was used to quantify ivermectin concentration after interaction studies.
- Compatibility testing was performed between ivermectin and a range of non-ionic excipients.
Main Results:
- Ivermectin exhibited significant interactions with 21 out of 46 tested excipients.
- Compatibility was observed with 25 excipients.
- HPLC analysis revealed a decrease in ivermectin concentration exceeding 20% in cases of interaction.
Conclusions:
- A substantial number of common excipients are incompatible with ivermectin for non-ionic emulsion formulation.
- Excipient-drug interactions can lead to significant degradation or loss of ivermectin.
- Careful screening using DSC and HPLC is essential to select appropriate excipients for stable ivermectin formulations.