Dissolution Profile and Similarity Factor for Tablet Dissolution

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

Profile points (Hrs) 0 10 20 30 45

FEBUXOSTAT F/C TABLETS 80 mg. B.NO :-PTA(695)031 MFG DATE:- MAR-2009

Mfg by.:by.:- TAKEDA

EXP.DATE:-

FEB-2011

PHARMACEUTICALS % Drug Release 0.0 91.5 99.7 98.9 98.4

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

91.5

91.0

98.9

91.3

99.7

98.4

80.7

   d   e   v    l   o   s   s    i    d   g   u   r    D    %

80.0

60.0

40.0

20.0 0.0

0.0

0.0 0

5

10

15

20

25 Time in mins.

30

35

40

ULORIC 80, 40199AF27, TAKEDA PHARMA. FEBUXOSTAT FEBUXOST AT 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 Mf b .:- 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 Mf b .: 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

10.80 8.40 7.90 1.00 28.10

7.23

COMPARATIVE DISSOLUTION PROFILE OF NIFEDIPINE ER TABLETS 20 MG

Nifedipine ER capsule 30mg B.NO :- NB2008

Nefidipine ER Tablets 30 mg. B.NO :-PTA(025)089 MFG DATE:-

(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

% Drug Release (%Cummulative) 3 Hrs 6 Hrs 12 Hrs

1

6.5

29.3

73.2

1

22.0

46.6

93.1

2

6.8

36.0

81.0

2

13.8

34.8

75.4

3

7.7

36.2

81.5

3

19.8

41.5

86.4

4

7.8

32.1

83.7

4

21.5

46.8

89.6

5

6.5

29.4

73.3

5

6

7.0

36.1

81.7

6

Mean %

7.0

33.2

79.1

#DIV/0!

Mean %

19.3

42.4

86.1

#DIV/0!

Min Max.

6.5 7.8

29.3 36.2

73.2 83.7

0.0 0.0

Min Max.

13.8 22.0

34.8 46.8

75.4 93.1

0.0 0.0

%RSD

7.9

10.1

5.8

#DIV/0!

%RSD

19.7

13.3

8.9

#DIV/0!

Dissolution Parameters:-

Medium:- Phosphate buffer pH 6.8 (900 ml) Apparatus:- Paddle with sinker  RPM:- 50 Time points:- 3,6 & 12 hrs