In-vitro Evaluations of Quality Control Parameters of Paracetamol Tablets Marketed in Gondar City, Northwest Ethiopia

Abstract

Background The aim of this research was to evaluate quality control parameters of available brands of paracetamol tablets in Gondar city since standard quality parameters are essential for a better quality of the product. The different brands of paracetamol tablets were obtained from local pharmacies in Gondar town and the University of Gondar (UOG) hospital pharmacies. Methods Five brands of paracetamol, from each, 102 tablets were collected from private pharmacies, government health centers, and UOG pharmacies. The popular brands in the city, Panadol, Para-denk, Paramol, Paracetamol (EPHARM), and Cadimol, conventional tablets of 500 mg strength were chosen and the tablets were assessed for different quality parameters: weight variation, hardness, friability, disintegration, dissolution, and drug content (assay) using compendial methods. The tablets were evaluated to check if they comply with the specifications of USP (United States Pharmacopeia). Results From the results, it was observed that all the brands of paracetamol have passed the tests and met the specifications of USP. Results of weight variation, hardness, friability, and disintegration time ranged from 0.46 to 1.11%, 117.0 to 174.70 N, 0.07 to 0.63%, and 01 to 08 minutes for all the tablets, respectively. The dissolution profiles of all the brands are within the acceptable label claim. The assay results showed that the drug content of the paracetamol brands ranged from 95.04% to 106.81%. The dissolution rate was significantly different (p < 0.05) as compared to code 1 with all brands tested at 30 minutes. The disintegration time of different brands was also significantly different from the comparator (code 1) except code 2. Conclusion Based on the finding from this study, there were no significant deviations from pharmacopeia standards and specifications. The brands studied were safe enough and could be used to achieve the desired therapeutic effect.

Physical and Chemical Evaluation of Different Brands of Paracetamol Tablets

“…In this study hardness results should be acceptable and not too high to affect dissolution and disintegration of the tablets and hence release of the drug. Also, must be enough to withstand breakage, crumbling during conditions of storage, transportation and handling [8,9]. It is supposed that high values of hardness would result in high values of disintegration time which was not found in this study may be due to different formulations.…”

Evaluation of Different Methods for Dissolution Profile Similarity Comparison of Montelukast Tablets in Türkiye

“…Tablet hardness is also not a required test in pharmacopeia; however, it is stated in various sources that hardness values should be at least 50 N (5 kg) to have sufficient mechanical strength. On the other hand, if the tablet hardness is high, the disintegration time of the tablets may be delayed, which delays the onset of therapeutic effects especially for immediate-release tablets (28). All generic products had a longer disintegration time than the innovator.…”

Quality of veterinary anthelmintic drugs marketed in Gondar Zones, North West Ethiopia; presence of poor-quality medicines

“…Ten boluses from each brand of albendazole, ten boluses from each batch of ivermectin and fenbendazole were randomly taken and each bolus was then placed in the hardness tester. The tester was set to crush each tablet and the force required to crush each tablet was measured in newton [ 24 ].…”