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Published on: August 9, 2022
Stability of paracetamol in packaged tablet formulations
1Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Karachi, Karachi-75270, Pakistan.
Pakistan Journal of Pharmaceutical Sciences
|July 1, 1993
Summary
This study assessed paracetamol tablet stability under various temperature and humidity conditions over six months. Results show packaging type significantly impacts paracetamol shelf-life, with PVC/PVDC/Al foil and polycoated paper offering superior protection.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability
- Formulation Development
Background:
- Paracetamol is a widely used analgesic and antipyretic.
- Understanding drug stability is crucial for ensuring therapeutic efficacy and patient safety.
- Environmental factors like temperature and humidity can significantly affect pharmaceutical product shelf-life.
Purpose of the Study:
- To investigate the impact of varying temperature and humidity on the stability of commercial paracetamol tablet formulations.
- To determine the degradation kinetics and shelf-life of paracetamol tablets under different storage conditions.
- To compare the protective efficacy of different packaging materials for paracetamol tablets.
Main Methods:
- Commercial paracetamol tablet formulations were stored under controlled, varied temperature and humidity conditions for six months.
- Paracetamol degradation was monitored over time.
- Degradation kinetics were analyzed using apparent first-order kinetics.
- Shelf-life (t(90)) was calculated for each formulation and packaging type.
Main Results:
- Paracetamol degradation in tablets followed apparent first-order kinetics.
- Calculated shelf-lives (t(90)) ranged from 9.8 to 23.0 months.
- PVC/PVDC/Aluminum foil and polycoated paper packaging provided significantly better protection against degradation compared to viscose film packaging.
Conclusions:
- Environmental conditions and packaging materials are critical factors influencing paracetamol tablet stability.
- PVC/PVDC/Al foil and polycoated paper are recommended as superior packaging options for enhancing paracetamol tablet shelf-life.
- The study provides valuable data for optimizing paracetamol formulation and packaging strategies to ensure product quality and longevity.
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