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[Galenic quality of test substances]
1Alfred-Marchionini-Institut, Gesellschaft für Forschung und experimentelle Dermatologie mbH, Reinbek.
Zeitschrift Fur Hautkrankheiten
|December 15, 1987
Summary
The Standard-Epicutantest-HERMAL substances show no detectable inhomogeneity. This ensures consistent grain size, active substance content, and homogeneous spreading for reliable allergy testing results.
Area of Science:
- Dermatology
- Allergen testing
- Pharmacology
Background:
- Standardized allergen testing is crucial for accurate diagnosis.
- The Standard-Epicutantest-HERMAL is a widely used diagnostic tool.
- Ensuring the quality and consistency of test substances is paramount.
Purpose of the Study:
- To experimentally verify the homogeneity and quality of the 20 test substances in the Standard-Epicutantest-HERMAL.
- To confirm that the test substances meet the criteria for reproducible and relevant results in epicutaneous testing.
Main Methods:
- Microscopy for grain size analysis.
- Analytical determination of active substance content.
- Agar diffusion and spreading tests on human skin.
- Evaluation of active substance release from vaseline base.
Main Results:
- No inhomogeneity was detected among the 20 test substances.
- Consistent grain size spectrum and equivalent active substance content were confirmed.
- Good active substance release from vaseline and homogeneous spreading on skin were demonstrated using Finn Chambers on Scanpor and Epiquick plasters.
Conclusions:
- The Standard-Epicutantest-HERMAL substances meet all required criteria for homogeneity and quality.
- These findings support the reliability and reproducibility of results obtained from this epicutaneous test system.