Comparative in Vitro Dissolution Assessment of Three Different Brands of Lansoprazole Capsules

 

J. Srinivasa Rao1*, J. Naga Mallika1, M. Sri Madhu Sri2, G. Raveendra Babu2, M. Prasada Rao2 and C. Gopinath1

1Hindu College of Pharmacy, Amravati Road, Guntur, Andhrapradesh.

2MAM College of Pharmacy, Narasaraopet, Guntur (Dt), Andhrapradesh.

 

ABSTRACT:

The present study has made an attempt to compare % release of three different brands (Lanzol, Lanzap and Lan) of lansoprazole using USP Type II (Paddle) dissolution Apparatus in three Media (phosphate buffer pH 6.0, 6.8 and 7.4).  It has been observed from the dissolution profile that more than 90% of Lansoprazole is released from each capsule at 30.0 minutes time point. The F1 and F2 values of Lanzol Vs Lanzap are 7.02% and 59.87%, Lanzol Vs Lan are 1.51% and 81.99% and Lan Vs Lanzop are 0.38% and 59.98% at pH6.0; The F1 and F2 values of Lanzol Vs Lanzap are 7.65% and 55.95%, Lanzol Vs Lan are 3.91% and 69.18%, Lan Vs Lanzop are 3.90% and 61.99% at pH 6.8.The F1 and F2 values of Lanzol Vs Lanzap are 4.12% and 67.10%, Lanzol Vs Lan 2.46%, 72.60%, Lan Vs Lanzop 1.70% and 84.53% at pH 7.4. In all three Media % Release pattern is similar; However in pH 7.4 media % Release is about 100% at 45minutes.

 

KEYWORDS: Lansoprazole, Dissolution, UV Method.

 

 

1.0 INTRODUCTION:

Dissolution test is one of the in vitro tests usually employed to assess the quality of oral drug products such as tablets and capsules. The in vitro dissolution tests can be used to guide formation developments, identify critical manufacturing variables, monitor formulation quality from batch to batch, predict in vivo performance and serve as a surrogate for bioavailability and bioequivalence1.

 

Lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole (Fig.1), a compound that inhibits gastric acid secretion. It is manufactured by a number of companies worldwide under several brand names. It was first approved by the U.S. Food and Drug Administration (FDA) in 1995.2 Lansoprazole belongs to class II drugs of the Biopharmaceutical Classification System (BCS), characterized by low solubility and high permeability3,4. Drug Absorption from a solid oral dosage form depends on the release of the drug substance from the drug product (dissolution), the solubility, and the permeability across the gastrointestinal tract. The first aspect of the tablets is determined by the manufacture of the product. The next two aspects are determined by the properties of the active pharmaceutical5.

 

2.0 EXPERIMENTAL:

Materials:

Lansoprazole active substance was obtained as a gift sample from Lee Pharma Ltd, Hyderabad, India. Three commercial brands of 30 mg lansoprazole capsules from various manufacturers coded G1-G3, were purchased from local pharmacy, Hyderabad, India.


They were well within their expiry dates. Potassium dihydrogen phosphate, Sodium hydroxide and methanol were obtained from Merck, Mumbai.

 

Figure 1: Lansoprazole Molecular structure

 

Equipments:

Balance-CP225D (Sartorius), Top Load balance-XS603S Mettler Toledo; UV-Visible Spectrophotometer-Lambda 35 UV/VIS Spectrometer (Perkin Elmer); pH Meter-780 pH Meter (Ω Metrohm); Dissolution Apparatus-Digital tablet dissolution test apparatus (DISSO-2000) LAB INDIA.

 

Buffer Preparation6:

A.      Preparation of 0.2N Potassium monobasic phosphate solution: 27.2 g of Potassium dihydrogen phosphate was dissolved in 1000mL of water.

B.       Preparation of 0.2 N NaOH solution: 8.0 g of sodium hydroxide was dissolved in 1000mL of water.

C.       Preparation of pH 6.0 phosphate buffer: 50mL of 0.2N Potassium monobasic phosphate solution was placed into a 200mL volumetric flask, 5.6mL of 0.2 N NaOH solution was added to the above solution and the volume was made up to the mark with water.

D.      Preparation of pH 6.8 Phosphate buffer: 50mL of 0.2N Potassium monobasic phosphate solution was placed into a 200mL volumetric flask, 22.4mL of 0.2 N NaOH solution was added to the above solution and the volume was made up to the mark with water.

E.       Preparation of pH 7.4 Phosphate buffer: 50mL of 0.2N Potassium monobasic phosphate solution was placed into a 200mL volumetric flask, 39.1mL of 0.2 N NaOH solution was added to the above solution and the volume was made up to the mark with water.

 

Determination of the maximum wavelength and the calibration curve of lansoprazole in pH 6.0, 6.8 and7.4 phosphate buffers:

Three Stock solutions of Lansoprazole working standard were prepared at a concentration of 60µg mL-1 in different phosphate buffers pH 6.0, 6.8 and7.4.

The above stock solutions were further diluted with corresponding buffer solution to obtain a final concentration of 6, 15, 30, 45 and 60mg mL-1.

For the determination of absorption maxima of Lansoprazole, the above solutions of lansoprazole were scanned in a range of 200-400nm. The l-max was observed at 284nm, by using respective buffer as blank.

 

Comparative Dissolution Test of Lansoprazole (USP):

Dissolution test of twelve units of each brand was performed using USP type II (Paddle) method with a medium of 900 mL of pH 6.0, pH 6.8 and pH 7.4 phosphate buffers. The test conditions were as mentioned below.

Apparatus                             : USP type II (Paddle)

RPM                                       : 75rpm

Media                                     : Phosphate buffer of pH 6.0, pH 6.8 and 7.4

Volume                                   : 900mL

Vessel temperature              : 37.0ºC

Withdrawn sample volume : 10mL

Replacement media volume                : 10mL

Time points                           : 5, 10, 15,30,45 and 60 minutes

 

The dissolution profile of each brand was plotted and data were the analyzed according to following formula.

% Release of Lansoprazole = (sample ABS/Standard ABS) x C x (900/1) x (P/100) x 100

Where P is the purity of Lansoprazole working standard

Dissolution correction factor = 10/900

Difference factor, F1 = {[St=1n (Rt – Tt)]/[St=1n Rt]} x 100

Similarity factor, F2 = 50 x log {[1+(1/n)St=1n (Rt – Tt)2]-0.5 x 100

Where Rt is % Release of Lansoprazole from Reference brand

Tt is the Release of Lansoprazole from Test brand

n is the Total number of time points used

 

3.0 RESULTS AND DISCUSSION:

The spectrometric analysis of 6, 15, 30, 45 and 60mg mL-1 of lansoprazole showed linear plots of concentration versus absorbance (Fig 2,3,4). The correlation coefficients were found to be 0.9991, 0.9991 and 0.9992 in pH 6.0, pH 6.8 and pH 7.4 phosphate buffers respectively.

 

The dissolution profile of all brands of lansoprazole capsules was obtained by plotting the percentage (%) of drug release versus time. The profile showed that all the three brands of lansoprazole gave a satisfactory release of  >90.0% at time point of 30 minutes. The profiles were shown in Fig 5, 6, 7.

 

The % release of Lansoprazole from Lansoprazole capsules of all the three brands were compared in pH 6.0, pH 6.8 and pH 7.4 phosphate buffers. The results were shown in Table 1, 2, 3, 4, 5, 6, 7, 8 and 9.

 

 

Figure 2: Linearity of Lansoprazole Standard solutions in A). pH 6.0; B) pH 6.8; C) pH 7.4 phosphate buffer.

 

Figure 3: Comparative Dissolution profile of different brands of Lansoprazole capsules 30mg in A) pH 6.0; B) pH 6.8; C) pH 7.4 phosphate buffer.

Table 1: Comparison between Lanzol (Dr Reddy's) and Lanzap (Cipla) in pH6.0

Comparative Dissolution profile for Lansoprazole capsules 30mg in pH 6.0 Media

AVERAGE (% DR)

AVERAGE (% DR)

TIME (MINS)

LANZOL

SD

Lanzap

SD

[R(t)-T(t)]

[R(t)-T(t)]2

[T(t)]

[R(t)]

5

29.51

2.02

29.51

1.67

11.13

123.80

10

37.74

3.48

37.88

4.20

0.14

0.02

15

58.82

3.15

67.48

1.66

8.66

75.06

30

90.09

0.73

94.68

0.56

4.59

21.03

45

97.16

0.52

99.87

0.96

2.71

7.34

60

97.31

0.53

100.23

0.91

2.92

8.51

SUM:

235.76

NTP:

6

LIMIT:-

50- 100 %

F2

59.87

LIMIT:-

0 - 15 %

F1

7.02

 

Table 2: Comparison between Lanzol (Dr Reddy's) and Lan (Intas Laboratories) in pH6.0

Comparative Dissolution profile for Lansoprazole capsules 30mg in pH 6.0 Media

AVERAGE (% DR)

AVERAGE (% DR)

TIME (MINS)

LANZOL

SD

Lan

SD

[R(t)-T(t)]

[R(t)-T(t)]2

[T(t)]

[R(t)]

5

29.51

2.02

29.07

2.56

-0.44

0.19

10

37.74

3.48

38.84

1.92

1.10

1.22

15

58.82

3.15

56.77

2.91

-2.05

4.19

30

90.09

0.73

92.88

0.92

2.79

7.81

45

97.16

0.52

99.36

0.92

2.20

4.82

60

97.31

0.53

100.01

0.78

2.70

7.29

SUM:

25.53

NTP:

6

LIMIT:-

50- 100 %

F2

81.99

LIMIT:-

0 - 15 %

F1

1.51

 

Table 3: Comparison between Lan (Intas Laboratories) and Lanzap (Cipla) in pH6.0.

Comparative Dissolution profile for Lansoprazole capsules 30mg in pH 6.0 Media

AVERAGE (% DR)

AVERAGE (% DR)

TIME (MINS)

Lan

SD

Lanzap

SD

[R(t)-T(t)]

[R(t)-T(t)]2

[T(t)]

[R(t)]

5

29.07

2.56

18.38

1.67

-10.69

114.20

10

38.84

1.92

37.88

4.20

-0.96

0.93

15

56.77

2.91

67.48

1.66

10.71

114.73

30

92.88

0.92

94.68

0.56

1.79

3.21

45

99.36

0.92

99.87

0.96

0.51

0.26

60

100.01

0.78

100.23

0.91

0.22

0.05

SUM:

233.38

NTP:

6

LIMIT:-

50- 100 %

F2

59.98

LIMIT:-

0 - 15 %

F1

0.38

 

Table 4: Comparison between Lanzap (Dr Reddy's) and Lanzol (Cipla) in pH6.8

Comparative Dissolution profile for Lansoprazole capsules 30mg in pH 6.8 Media

AVERAGE (% DR)

AVERAGE (% DR)

TIME (MINS)

Lanzap

SD

LANZOL

SD

[R(t)-T(t)]

[R(t)-T(t)]2

[T(t)]

[R(t)]

5

18.86

3.06

33.36

2.44

14.50

210.12

10

39.04

1.03

46.46

1.96

7.42

55.06

15

59.53

2.18

67.47

1.28

7.94

63.01

30

92.42

1.89

95.96

0.69

3.54

12.53

45

98.74

0.78

99.00

0.69

0.26

0.07

60

99.19

0.63

99.33

0.70

0.14

0.02

SUM:

340.81

NTP:

6

LIMIT:-

50- 100 %

F2

55.95

LIMIT:-

0 - 15 %

F1

7.65

 

Table 5: Comparison between Lanzep (Dr Reddy's) and Lan (Intas Laboratories) in pH6.8

Comparative Dissolution profile for Lansoprazole capsules 30mg in pH 6.8 Media

AVERAGE (% DR)

AVERAGE (% DR)

TIME (MINS)

LANZOL

SD

Lan

SD

[R(t)-T(t)]

[R(t)-T(t)]2

[T(t)]

[R(t)]

5

18.86

3.06

21.56

3.78

2.69

7.26

10

39.04

1.03

39.43

1.66

0.39

0.15

15

59.53

2.18

68.55

1.55

9.02

81.33

30

92.42

1.89

94.75

1.03

2.34

5.46

45

98.74

0.78

99.95

0.61

1.21

1.46

60

99.19

0.63

100.14

0.56

0.94

0.89

SUM:

96.54

NTP:

6

LIMIT:-

50- 100 %

F2

69.18

LIMIT:-

0 - 15 %

F1

3.91

 

Table 6: Comparison between Lan (Intas Laboratories) and Lanzap (Cipla) in pH6.8

Comparative Dissolution profile for Lansoprazole capsules 30mg in pH 6.8 Media

AVERAGE (% DR)

AVERAGE (% DR)

TIME (MINS)

Lan

SD

Lanzap

SD

[R(t)-T(t)]

[R(t)-T(t)]2

[T(t)]

[R(t)]

5

21.56

3.78

33.36

2.44

11.80

139.25

10

39.43

1.66

46.46

1.96

7.03

49.49

15

68.55

1.55

67.47

1.28

-1.08

1.17

30

94.75

1.03

95.96

0.69

1.20

1.45

45

99.95

0.61

99.00

0.69

-0.95

0.90

60

100.14

0.56

99.33

0.70

-0.80

0.64

SUM:

192.90

NTP:

6

LIMIT:-

50- 100 %

F2

61.99

LIMIT:-

0 - 15 %

F1

3.90

 

Table 7: Comparison between Lanzol (Dr Reddy's) and Lanzap (Cipla) in pH7.4

Comparative Dissolution profile for Lansoprazole capsules 30mg in pH 7.4 Media

AVERAGE (% DR)

AVERAGE (% DR)

TIME (MINS)

LANZOL

SD

Lanzap

SD

[R(t)-T(t)]

[R(t)-T(t)]2

[T(t)]

[R(t)]

5

26.32

2.43

23.48

1.25

-2.84

8.08

10

37.29

1.30

42.66

1.00

5.36

28.78

15

57.69

1.02

64.51

1.02

6.82

46.51

30

92.94

0.95

98.51

0.58

5.57

30.99

45

97.78

0.83

99.40

0.65

1.62

2.63

60

98.46

0.63

99.58

0.60

1.12

1.26

SUM:

118.25

NTP:

6

LIMIT:-

50- 100 %

F2

67.10

LIMIT:-

0 - 15 %

F1

4.12

 

Table 8: Comparison between Lanzol (Dr Reddy's) and Lan (Intas Laboratories) in pH7.4

Comparative Dissolution profile for Lansoprazole capsules 30mg in pH 7.4 Media

AVERAGE (% DR)

AVERAGE (% DR)

TIME (MINS)

LANZOL

SD

Lan

SD

[R(t)-T(t)]

[R(t)-T(t)]2

[T(t)]

[R(t)]

5

26.32

2.43

22.53

1.61

-3.79

14.39

10

37.29

1.30

38.99

1.36

1.70

2.89

15

57.69

1.02

62.44

1.08

4.75

22.54

30

92.94

0.95

97.99

0.87

5.05

25.51

45

97.78

0.83

99.23

0.52

1.45

2.10

60

98.46

0.63

99.66

0.49

1.20

1.44

SUM:

68.86

NTP:

6

LIMIT:-

50- 100 %

F2

72.60

LIMIT:-

0 - 15 %

F1

2.46

 

Table 9: Comparison between Lan (Intas Laboratories) and Lanzap (Cipla) in pH7.4

comparative Dissolution profile for Lansoprazole capsules 30mg in pH 7.4 Media

AVERAGE {% DR)

AVERAGE (% DR)

TIME (MINS)

Lan

SD

Lanzap

SD

[R(t)-T(t)]

[R(t)-T(t)]2

[T(t)]

[R(t)]

5

22.53

1.61

23.48

1.25

0.95

0.90

10

38.99

1.36

42.66

1.00

3.67

13.44

15

62.44

1.08

64.51

1.02

2.07

4.29

30

97.99

0.87

98.51

0.58

0.52

0.27

45

99.23

0.52

99.40

0.65

0.17

0.03

60

99.66

0.49

99.58

0.60

-0.08

0.01

SUM:

18.94

NTP:

6

LIMIT:-

50- 100 %

F2

84.53

LIMIT:-

0 - 15 %

F1

1.70

 

Table 10: % release of Lansoprazole for Dr Reddy's - Lanzap in phosphate buffer pH 6.0

Dr Reddy's - Lanzap (Lansoprazole capsules 30mg)

Time   (in min)

% release of Lansoprazole in pH 6.0

1

2

3

4

5

6

7

8

9

10

11

12

Avg

5

30.63

30.85

31.90

28.52

30.21

32.54

28.73

28.73

31.27

27.89

27.68

25.14

29.51+ 2.02

10

28.86

41.75

35.42

38.77

39.42

40.08

39.40

35.18

39.43

40.03

40.24

34.29

37.74+ 3.48

15

53.35

53.49

54.27

57.68

62.34

61.08

61.07

61.45

59.80

60.66

59.81

60.80

58.82+ 3.15

30

90.38

89.54

89.55

90.64

91.12

90.47

90.89

90.26

89.19

90.89

88.97

89.20

90.09+ 0.73

45

96.92

97.33

96.70

97.35

97.77

97.13

96.29

97.13

97.75

97.35

96.27

97.96

97.16+ 0.52

60

97.63

97.00

96.78

97.63

98.27

97.42

96.99

97.21

97.85

97.84

96.77

96.37

97.31+ 0.53

 

Table 11: % release of Lansoprazole for Intas Laboratories - Lan in phosphate buffer pH 6.0

Dr Reddy's - Lanzap (Lansoprazole capsules 30mg)

Time  

(in min)

% release of Lansoprazole in pH 6.0

1

2

3

4

5

6

7

8

9

10

11

12

Avg

5

27.68

28.73

26.41

27.89

28.10

31.90

28.10

29.79

36.13

28.31

29.37

26.41

29.07+ 2.56

10

38.55

41.09

39.59

40.03

36.44

39.44

41.93

40.05

38.64

37.08

38.57

34.73

38.84+ 1.92

15

57.68

58.13

57.27

60.87

57.24

59.17

57.72

57.91

59.16

52.17

52.61

51.30

56.77+ 2.91

30

93.81

94.45

94.23

93.42

93.38

92.35

91.70

91.91

92.98

91.85

92.27

92.26

92.88+ 0.92

45

100.13

98.44

98.02

98.64

100.54

97.79

99.26

99.89

100.12

100.53

99.05

99.90

99.36+ 0.92

60

100.20

100.60

98.48

98.91

100.84

99.11

99.98

100.62

100.83

100.84

99.55

100.19

100.01+ 0.92

 

Table 12: % release of Lansoprazole for Cipla - LANZOL in phosphate buffer pH 6.0

Dr Reddy's - Lanzap (Lansoprazole capsules 30mg)

Time   (in min)

% Release of Lansoprazole in pH 6.0

1

2

3

4

5

6

7

8

9

10

11

12

Avg

5

18.59

17.32

19.44

17.75

17.96

18.38

20.92

21.97

16.27

18.17

15.85

17.96

29.07+ 2.56

10

26.83

36.95

37.61

36.32

37.59

41.19

34.46

41.44

42.22

41.19

42.22

36.54

38.84+ 1.92

15

68.33

68.23

68.87

69.28

67.39

64.26

64.82

68.49

67.02

66.16

67.02

69.91

56.77+ 2.91

30

94.56

95.41

93.93

94.57

94.13

94.94

94.52

94.14

95.39

93.90

95.18

95.42

92.88+ 0.92

45

99.50

97.61

100.13

100.56

99.50

99.93

98.44

100.55

99.93

100.97

100.78

100.57

99.36+ 0.92

60

99.56

98.48

98.93

100.62

101.04

100.83

99.33

100.84

99.98

101.47

100.84

100.84

100.01+ 0.92

 

Table 13: % release of Lansoprazole for Dr Reddy's - Lanzap in phosphate buffer pH 6.8

Dr Reddy's - Lanzap (Lansoprazole capsules 30mg)

Time 

(in min)

% release of Lansoprazole in pH 6.8

1

2

3

4

5

6

7

8

9

10

11

12

Avg

5

13.90

16.10

15.28

17.75

19.40

17.06

17.34

19.54

22.16

21.33

21.88

24.63

18.86+ 3.06

10

38.82

39.26

39.53

39.00

38.06

37.48

37.90

40.54

41.26

38.91

39.33

38.39

39.04+ 1.03

15

56.58

58.51

60.44

59.88

55.61

56.29

61.11

60.45

62.52

61.81

61.26

59.88

59.53+ 2.18

30

91.18

89.96

89.85

92.32

90.21

90.63

93.29

94.39

94.69

94.40

94.95

93.14

92.42+ 1.89

45

99.41

98.57

98.84

97.63

97.88

99.81

99.16

99.86

99.58

98.48

97.80

97.92

98.74+ 0.78

60

99.77

98.94

98.94

98.10

98.24

100.33

99.22

99.92

99.78

99.08

98.93

99.07

99.19+ 0.63

 

Table 14: % release of Lansoprazole for Intas Laboratories - Lan in phosphate buffer pH 6.8

Intas Laboratories -  Lan (Lansoprazole capsules 30mg)

Time  

(in min)

% Release of Lansoprazole in pH 6.8

1

2

3

4

5

6

7

8

9

10

11

12

Avg

5

20.09

21.74

15.00

17.61

20.23

20.37

19.40

19.13

25.87

27.39

27.66

24.22

21.56+ 3.78

10

38.48

38.36

35.40

39.28

38.62

38.90

40.54

41.22

39.65

41.45

41.73

39.49

39.43+1.66

15

67.03

68.13

66.59

65.39

69.10

68.00

70.77

68.44

69.80

69.13

69.68

70.48

68.55+1.55

30

95.42

96.95

93.49

93.07

93.66

94.75

95.33

94.48

94.77

95.86

94.77

94.50

94.75+1.03

45

100.42

99.88

100.40

100.94

100.26

100.00

99.32

100.68

98.90

99.46

99.17

99.99

99.95+0.61

60

100.61

99.92

100.47

101.03

100.61

100.33

99.64

100.75

99.36

99.64

99.22

100.06

100,14+ 0.56

 

Table 15: % release of Lansoprazole for Cipla - LANZOL in phosphate buffer pH 6.8

Cipla - LANZOL (Lansoprazole capsules 30mg)

Time    (in min)

% Release of Lansoprazole in pH 6.8

 

1

2

3

4

5

6

7

8

9

10

11

12

Avg

5

30.96

31.24

36.74

28.21

31.38

32.89

33.72

34.68

36.33

34.68

35.92

33.58

33.36+ 2.44

10

45.62

43.15

46.78

45.45

44.25

44.68

45.65

47.59

49.53

48.69

49.39

46.75

46.46+ 1.96

15

68.21

66.67

68.50

68.90

69.44

66.83

66.84

67.13

65.37

69.21

66.05

66.44

67.47+ 1.28

30

94.06

95.83

95.30

95.99

96.96

96.25

96.11

96.25

95.82

96.27

96.10

96.52

95.96+ 0.69

45

98.48

98.91

97.53

99.60

100.02

99.05

98.64

99.46

98.08

99.60

99.05

99.60

99.00+ 0.69

60

99.35

99.63

97.83

99.64

100.06

99.50

98.66

99.77

98.11

99.78

99.63

100.05

99.33+ 0.70

 

Table 16: % release of Lansoprazole for Dr Reddy's - Lanzap in phosphate buffer pH 7.4

Dr Reddy's - Lanzap (Lansoprazole capsules 30mg)

Time  (in min)

% Release of Lansoprazole in pH 7.4

1

2

3

4

5

6

7

8

9

10

11

12

Avg

5

26.03

24.89

26.29

29.68

29.85

29.77

28.03

26.20

23.24

22.37

25.07

24.46

26.32+ 2.43

10

35.37

36.57

35.89

37.93

37.41

37.50

39.57

38.24

36.29

36.54

36.57

39.61

37.29+ 1.30

15

57.32

58.81

57.67

58.48

57.95

57.08

58.84

56.39

56.89

59.42

55.85

57.63

57.69+ 1.02

30

91.42

91.61

92.56

93.52

92.38

93.51

92.83

92.98

93.16

92.40

93.84

95.08

92.94+ 0.95

45

97.20

97.72

98.34

98.61

95.99

97.65

98.26

98.61

97.74

96.42

98.18

98.63

97.78+ 0.83

60

97.43

98.14

98.40

99.02

97.25

98.48

99.27

99.19

98.31

98.12

98.84

99.10

98.46+ 0.83

 

Table 17: % release of Lansoprazole for Intas Laboratories - Lan in phosphate buffer pH 7.4

Intas Laboratories -  Lan (Lansoprazole capsules 30mg)

Time   (in min)

% Release of Lansoprazole in pH 7.4

1

2

3

4

5

6

7

8

9

10

11

12

Avg

5

22.11

20.98

21.15

22.89

23.59

24.20

22.72

21.15

24.89

25.33

20.98

20.37

22.53+ 1.61

10

38.72

38.97

40.88

42.64

38.12

38.22

39.25

38.62

38.75

37.80

38.01

37.91

38.99+ 1.36

15

61.45

62.06

63.38

63.32

61.44

61.27

63.19

63.79

61.45

64.48

62.05

61.44

62.44+ 1.08

30

97.12

96.43

98.36

99.15

98.78

96.51

98.01

99.24

98.34

98.03

98.09

97.82

97.99+ 0.87

45

99.09

99.17

99.36

99.72

100.50

98.64

99.18

99.63

99.19

98.49

99.01

98.75

99.23+ 0.52

60

99.54

99.81

100.42

100.07

100.52

99.28

99.28

99.99

99.20

99.02

99.72

99.10

99.66+ 0.49

 

 

 

Table 18: % release of Lansoprazole for Cipla - LANZOL in phosphate buffer pH 7.4

Cipla - LANZOL (Lansoprazole capsules 30mg)

Time    (in min)

% Release of Lansoprazole in pH 6.8

 

1

2

3

4

5

6

7

8

9

10

11

12

Avg

5

23.15

23.41

22.72

23.68

24.20

23.59

23.94

22.28

24.46

25.07

20.28

24.98

23.48+ 1.25

10

41.34

43.61

42.21

43.00

42.66

41.87

43.00

44.12

43.97

40.93

41.74

43.45

42.66+ 1.00

15

62.69

63.50

65.31

66.28

64.19

66.09

63.84

63.94

65.16

64.95

64.26

63.94

64.51+ 1.02

30

98.53

98.02

98.91

99.18

98.81

97.87

98.89

98.98

97.43

97.68

98.63

99.15

98.51+ 0.58

45

99.10

99.79

100.41

100.07

99.54

98.66

99.28

99.37

98.31

98.48

99.54

100.24

99.40+ 0.65

60

99.54

100.07

100.95

100.08

100.25

99.02

99.28

99.55

99.19

98.93

99.11

99.03

99.58+ 0.60

 

The % drug release of lansoprazole in pH 6.0 phosphate buffer for all the three brands are more or less similar, and the % of drug release is above 90% at time point 30 min and the release is between 95 and 100 at  45 min time point. There is no remarkable difference in the release between time points 45 and 60 min. (Tables 10-12).

 

The % drug release of lansoprazole in pH 6.8 phosphate buffer for all the three brands are more or less similar, and the % of drug release is in the range of 90-95% at 30 min time point and the release is almost 100% at 45 min time point. There is no remarkable difference in the release between time points 45 and 60 min. The results were shown in Tables 13-15.

 

The % drug release of lansoprazole in pH 7.4 phosphate buffer for all the three brands are more or less similar, and the % of drug release is about 95% at time point 30 min and the % release is 100% at 45 min time point. There is no remarkable difference in the release between time points 45 and 60 min (Tables 16-18).

The % release of lansoprazole is rapid in pH 7.4 compared to the % release in pH 6.0 and pH 6.8 phosphate buffers.

 

4.0 CONCLUSION:

The % Release of Lansoprazole from all the three brands (Lanzol, Lan, and Lanzap) of was more or less similar in all the three dissolution media (Phosphate Buffer pH 6.0, pH 6.8 and pH 7.4). However the % release of Lansoprazole is comparatively more in pH 7.4 phosphate buffer.

 

5.0 REFERENCES:

1.        Akanni OO, Bioequivalence of medical products. In: Towards better quality assurance of drugs and food. Olaniyi A.A (Ed). University of Ibadan press, Ibadan, 1993; 123-135.

2.        http://www.accessdata.fda.gov accessed on 06/12/2010.

3.        FDA Guidance for Industry: SUPAC-MR: Modified Release Solid Oral Dosage forms, Food and Drug Administration, Rockville MD, 1997.

4.        FDA Guidance for Industry: Waiver of In-Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, Food and Drug Administration, Rockville MD,2000.

5.        FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms, Food and Drug Administration, Rockville MD, 1997.

6.        USP/NF-32/27; Buffer solutions; pp.861-862

 

 

 

Received on 08.12.2010

Accepted on 02.02.2011        

© A&V Publication all right reserved

Research Journal of Pharmaceutical Dosage Forms and Technology. 3(2): March-April 2011, 58-66