Quality Control Assessments of Different Brands of Diclofenac Tablets

ABSTRACT
Quality control Assessment of four different brands of Diclofenac 50mg tablets were carried out on diclofenac tablets. The aim of the work is to check the quality parameters of diclofenac tablets through systematic assessment of their pharmaceutical properties ensures safety, efficacy and compliance with regulatory standards. Results: the weight variation, for tablet with a strength of 50mg, weight variation test may not be carried out if the formulation and manufacturing process are well controlled and validated. If the production process is reliable and the formulation is stable, the weight variation might be considered negligible, especially if the active ingredient is uniformly distributed. Additionally, regulatory guidelines may specify that weight variation testing is not necessarily certain strength or type of formulations, depending on the intended used and the risk associated with variability. Friability indicates the tablet's ability to withstand mechanical stress. Lower friability (2% for Brand A) suggests better mechanical integrity, while higher friability (0%,1% for Brand B and C) might indicate a lack of robustness, which could lead to tablet breakage during handling. Friability should be less than 1% according to BP Pharmacopoeia for good quality tablets. The hardness for Brand B is 4.87kg, and Brand C is 4.04kg which is generally considered to be acceptable for tablet integrity. Brand A lower hardness (3.00kg) raises concerns regarding its mechanical strength, potentially leading to disintegration during transportation or handling. For hardness to be acceptable according to US Pharmacopoeia should be from 4 - 10 kg respectively. Disintegration Brand B and C has the quickest disintegration time while Brand A takes the longest time. Quick disintegration is preferable as it may enhance drug release and absorption, thus influencing therapeutic effectiveness. Variations in disintegration times could also hint at differences in formulation and excipient properties. Dissolution Brand B and C shows the highest dissolution, indicating better bioavailability, while Brand A has the lowest. Effective dissolution is crucial for ensuring that the drug reaches circulation in adequate amounts. Adequate dissolution rates are typically expected to be above 70% for therapeutic effectiveness. Assay potency all brands fall within acceptable limits of assay, proving their efficacy. Brand A has the lowest potency (90%), which raises concerns over its effectiveness in delivering the required dose compared to others. Statistical Significance although statistical differences exist in other parameters (except for weight variation), which weight variation is not conducted for the brands due to the strength of the tablets.