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Ethinylestradiol and levonorgestrel preparations on the Belgian market: a comparative study
V Vanheusden1, K De Braekeleer, J Corthout
1APB, Service de Contrôle des Médicaments, Bruxelles.
Journal De Pharmacie De Belgique
|April 28, 2012
Summary
This study evaluated coated tablets containing levonorgestrel and ethinylestradiol/levonorgestrel. All tested products met quality standards for dissolution, assay, and content uniformity.
Area of Science:
- Pharmaceutical Sciences
- Drug Formulation
- Analytical Chemistry
Background:
- Levonorgestrel and ethinylestradiol/levonorgestrel are key components in hormonal contraceptives.
- Quality control of oral contraceptives is crucial for patient safety and efficacy.
- Coated and film-coated tablet formulations require specific analytical evaluations.
Purpose of the Study:
- To conduct a comparative evaluation of pharmaceutical preparations containing levonorgestrel.
- To assess the quality of ethinylestradiol/levonorgestrel combination tablets.
- To verify compliance with established quality standards for coated oral contraceptive tablets.
Main Methods:
- In vitro dissolution testing to assess drug release profiles.
- Assay testing to determine active pharmaceutical ingredient content.
- Content uniformity analysis to ensure consistent dosing across tablets.
- Utilized validated analytical methods adhering to international guidelines.
Main Results:
- All evaluated coated and film-coated tablet preparations met the required quality specifications.
- In vitro dissolution results were consistent with expected performance.
- Assay and content uniformity tests confirmed the integrity and consistency of the formulations.
Conclusions:
- The evaluated levonorgestrel and ethinylestradiol/levonorgestrel tablets demonstrate acceptable quality.
- The analytical methods employed provide reliable assessment of these oral contraceptive formulations.
- Compliance with postulated requirements ensures product quality and therapeutic reliability.
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