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Table 1 In-vitro quality of a reference and seven generic enteric-coated 50 mg diclofenac sodium tablet formulations available on the Saudi market

From: Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation

Code Weight n = 20 Active substance contentb n = 20 Hardnessc n = 10 Friabilityd n = 20 Disintegratione (phosphate buffer) n = 6 Dissolutionf (phosphate buffer) n = 8
Mean (SD) mg Rangea % from mean Mean (SD) mg Mean (SD) % of label Mean (SD) kg %Loss Range
Minute: second
Mean (range) release at 45 min% of label
R 212.9 (3.6) 97–103 51.0 (1.7) 102.0 (3.4) 15.4 (1.1) 0.24 15:00–15:00 100 (99–103)
G1 203.7 (3.0) 97–102 55.7 (0.9) 111.3 (1.7) 20.1 (1.7) 1.10 14:09–14:09 81(69–90)
G2 208.9 (4.3) 95–103 53.8 (2.0) 107.6 (4.0) 16.6 (1.2) 0.00 17:23–19:19 106 ( 102–109)
G3 192.5 (3.5) 96–103 49.3 (2.0) 98.6 (4.0) 12.8 (0.4) 0.00 13:29–13:29 101 (94–113)
G4 283.6 (4.0) 97–103 50.9 (1.7) 101.9 (3.4) 11.9 (0.9) 0.16 20:37–20:37 108 (102–112)
G5 232.1 (3.3) 98–103 51.7 (2.2) 103.3 (4.4) 16.8 (1.3) 0.00 18:00–18:00 102 (101–103)
G6 243.9 (2.2) 99–103 54.9 (0.9) 109.9 (1.8) 18.3 (0.8) 0.75 9:00–9:00 109 (107–112)
G7 219.9 (2.8) 98–102 52.0 (2.0) 104.0 (4.0) 14.4 (0.7) 0.20 8:53–8:53 104 (100–107)
  1. aAcceptable variation limits ≤ ±7.5% for tablets ˃  80 and < 250 mg and ≤ ±5% for tablets ≥ 250 mg; to pass, no more than 2/20 tablet differ by more than the percentage permitted and no one tablet differ by more than double the percentage. b Acceptable limits, mean content 90–110% of label. cOptimum hardness for coated tablets 10–20 kg. dAcceptable limit ≤ 1%. eNone disintegrated in 0.1 N HCl for 2 h. Acceptable limits, no disintegration in 0.1 N HCl for 2 h and complete disintegration in phosphate buffer (pH 6.8) within 60 min. f0 to 0.1% release was observed in 0.1 N HCL for 2 h. Acceptable limits, release of ≤ 10% of label in 0.1 N HCl and ≥ 75 + 5% in phosphate buffer (pH 6.8)