MACLEODS PHARMACEUTICALS LTD.

RESEARCH & DEVELOPMENT CENTER

G-2 MIDC Industrial Estate, Mahakali Caves Road,
Andheri (East) Mumbai 400 093.

COMPARATIVE DISSOLUTION PROFILE OF FEBUXOSTAT F/C TABLETS 80 MG

Time in min.

ULORIC 80 (FEBUXOSTAT 80mg)

B.NO :- 40199AF27
MFG DATE:- Not available
EXP.DATE:- MAR 2011
Mfg by.:- TAKEDA
PHARMACEUTICALS
Profile points (Hrs)
% Drug Release
0
0.0
10
91.5
20
99.7
30
98.9
45
98.4

FEBUXOSTAT F/C TABLETS 80 mg.

B.NO :-PTA(695)031
MFG DATE:- MAR-2009
EXP.DATE:- FEB-2011
Mfg by.: Macleods Pharmaceutical Ltd.
% Drug Release
0.0
80.7
91.3
91.0
99.4

DISSOLUTION PROFILE OF FEBUXOSTAT F/C TABLETS

80 MG

120.0

99.4
100.0

91.0
98.9

91.3
99.7

91.5

98.4

80.7

% Drug dissolved

80.0

60.0

40.0

20.0
0.0

0.0

0.0
0

10

15

20

25
Time in mins.

30

35

40

ULORIC 80, 40199AF27, TAKEDA PHARMA.

FEBUXOSTAT F/C Tablets 80mg, PTA(695)031, Macleods Pharmaceutical Ltd.

Dissolution Parameters:Medium:- Phosphate buffer pH 6.8 (900 ml)

Apparatus:- Paddle with sinker
RPM:- 50
Time points:- 3,6 & 12 hrs
Conclusion :

Similarity factor (f2) =

54.90

45

50

COMPARATIVE DISSOLUTION PROFILE OF FEBUXOSTAT F/C TABLETS 80 MG

Sr. No.

1
2
3
4

ULORIC 80 (FEBUXOSTAT
80mg)
B.NO :- 40199AF27
MFG DATE:- Not available
Time
EXP.DATE:- MAR 2011
intervals Mfg by.:- TAKEDA
10
91.5
20
99.7
30
98.9
45
98.4

FEBUXOSTAT F/C TABLETS

80 mg.
B.NO :-PTA(695)031
MFG DATE:- MAR-2009
EXP.DATE:- FEB-2011
Mfg by.: Macleods
80.7
91.3
91.0
99.4
SUM
[SQ (Rt-Tt)]/n
1+(SQ (Rt-Tt)/n)
SQRT(1+[SQ (Rt-Tt)/n])
100/SQRT(1+n/SQ (Rt-Tt))
LOG100/SQRT(1+n/SQ (Rt-Tt))
Similarity factor (f2) =

Difference Factor (f1) =

(Rt-Tt)

10.80
8.40
7.90
-1.00

(Rt-Tt)x(RtTt)
(Rt-Tt)

116.64
70.56
62.41
1.00
250.61
62.6525
63.6525
7.9782517
12.534074
1.0980923
54.90

7.23

10.80
8.40
7.90
1.00
28.10

(Rt)

91.50
99.70
98.90
98.40
388.50

COMPARATIVE DISSOLUTION PROFILE OF NIFEDIPINE ER TABLETS 20 MG

Nefidipine ER Tablets 30 mg.

B.NO :-PTA(025)089
MFG DATE:EXP.DATE:Mfg by.: Macleods
Pharmaceutical Ltd.

Nifedipine ER capsule 30mg

B.NO :- NB2008
MFG DATE:- Not available
EXP.DATE:Mfg by.:No.of
Units

% Drug Release (%Cummulative)

3 Hrs
6 Hrs 12 Hrs

No.of
Units

6.5

29.3

73.2

6.8

36.0

81.0

7.7

36.2

81.5

7.8

32.1

83.7

5
6

6.5

29.4

73.3

7.0

36.1

81.7

5
6

Mean %
Min
Max.
%RSD

7.0

33.2

79.1

#DIV/0!

6.5
7.8

29.3
36.2

73.2
83.7

0.0
0.0

7.9

10.1

5.8

#DIV/0!

Dissolution Parameters:-

Medium:- Phosphate buffer pH 6.8 (900 ml)

Apparatus:- Paddle with sinker
RPM:- 50
Time points:- 3,6 & 12 hrs

% Drug Release (%Cummulative)

3 Hrs 6 Hrs 12 Hrs

22.0

46.6

93.1

13.8

34.8

75.4

19.8

41.5

86.4

21.5

46.8

89.6

19.3

42.4

86.1

#DIV/0!

13.8
22.0

34.8
46.8

75.4
93.1

0.0
0.0

19.7

13.3

8.9

#DIV/0!

Mean %
Min
Max.
%RSD