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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)