عنوان المقالة: In-Use Stability Study of Paracetamol Original Brand of Oral Suspension: Simulated In-Home Storage Conditions
د. عادل أحمد محمد سعيد | Dr. Adel Ahmed Mohammed Seaad | 13933
- Publication Type
- Journal
- Arabic Authors
- English Authors
- Olfat Saleh Ahmed Mohammed, Abdul Rahman Alawi Bin Yahia and Adel AM Saeed
- Abstract
- Background: In-use stability refers to products in multi-dose containers that are at risk of losing their contents because of repetitive opening and closure. Objectives: To determine the duration that multi-dose paracetamol (PCM) oral suspension may be used after the first dosage has been removed without affecting the product’s integrity. Method: Original PCM samples (Panadol®) were chosen and stored in six different storage conditions that represent in-home storage conditions. The study was designed to simulate as closely as possible a real usage of the multi-dose container products for in-use stability assessment. Visual inspection and a pH meter were used to track the change in colour and pH values respectively. The stability was assessed using the UV spectroscopic method. The HPLC method was used to determine the presence of PCM impurities. Results: The odor of all samples appeared to be acidic strawberry at the end of the study however, the pH values of all samples remained within the USP acceptable limit. Samples stored under refrigeration and kept within the outer carton experienced the least degradation. Calculated T90% was about 5.3 months in the most stable storage condition (condition A) and just (3.45 months) in the least stable one (condition F). PCM impurity, p-aminophenol (PAP), appeared in amounts exceeding the allowable BP limits (0.1%) in all samples except condition A. Conclusion: The maximum in-use shelf life of the original brand PCM suspension was 5.5 months hence the use of PCM after that should be avoided
- Publication Date
- 9/28/2022
- Publisher
- American Journal of Biomedical Science & Research
- Volume No
- 7
- Issue No
- 2
- ISSN/ISBN
- 2642-1747
- DOI
- 10.34297/AJBSR.2022.17.002324
- Pages
- 18-31
- File Link
- تحميل (1 مرات التحميل)
- External Link
- https://www.researchgate.net/publication/364050219_In-Use_Stability_Study_of_Paracetamol_Original_Brand_of_Oral_Suspension_Simulated_In-Home_Storage_Conditions
- Keywords
- In-use stability, Storage conditions, Shelf life, Impurities, Paracetamol suspension