Related Experiment Videos
[Photostability of nifedipine]
Acta Pharmaceutica Hungarica
|January 1, 1996
Summary
Nifedipine (Cordaflex) tablets show excellent stability under light protection, meeting strict pharmaceutical standards over 48 months. Photodegradation products were identified, confirming drug substance and product integrity.
Area of Science:
- Photochemistry
- Pharmaceutical Chemistry
- Drug Stability
Context:
- Nifedipine, a 1,4-dihydropyridine calcium channel blocker, is susceptible to photodegradation.
- The Cordaflex product family includes various Nifedipine formulations.
- Light protection is crucial for maintaining the efficacy and safety of Nifedipine dosage forms.
Purpose:
- To investigate the photochemical degradation pathways of Nifedipine.
- To characterize the chemical structures of Nifedipine decomposition products.
- To evaluate the effectiveness of light protection strategies for Nifedipine tablets (Cordaflex retard 20 mg) over extended periods.
Summary:
- Photochemical degradation reactions and decomposition product structures were analyzed for Nifedipine and its Cordaflex formulations.
- Long-term stability trials (48 months) assessed light protection for Cordaflex retard 20 mg tablets.
- High-Performance Liquid Chromatography (HPLC) was used to monitor impurity levels and dissolution profiles.
Impact:
- The study confirms that implemented light protection measures ensure Nifedipine drug products meet stringent compendial requirements.
- Findings support the long-term stability and quality of Nifedipine formulations under recommended storage conditions.
- This research provides valuable data for pharmaceutical manufacturers regarding drug stability and light protection efficacy.