CONTENTS

Chapter
Title Page No.
No.

1 Introduction 1-7

2 Aim and objective 8

3 Review of literature 9-18

3.1 Drug profile 19-20

3.2 Polymers profile 21-24

3.3 Excipients profile 25-30

4 Materials and methods 31-46

4.1 Materials and equipments used 31-32

4.2 Methods 33-46

5 Results and Discussion 47-122

7 Conclusion 123-124

8 Summary 125-126

9 Bibliography 127-132
 LIST OF TABLES
Tabl
Title Page No.
e No.
1. List of raw materials used 31
2. List of equipments and instruments used. 32
3. Formulation Montelukast Sodium. 35-36
Effect of Carr’s Index and Hausner’s Ratio on flow 38
4. property.

5. Effect of Angle of repose (θ) on Flow property. 39

6. Limits for Weight Variation (IP) 40
Different drug release mechanism as per Korsmeyrs-Peppas 45
7.
Model
Standard Calibration Curve of Montelukast Sodium at 47
8.
240nm
FTIR position of characteristic bond vibrations of pure drug 55-56
9.
Montelukast Sodium and the drug with excipients.
Pre-compression parameters of Montelukast Sodium 57
10.
powder mixture.
Post-compression evaluations of Montelukast fast 58-59
11.
dissolving tablet.
63-64
12. In vitro dissolution study of Formulation (F1).
13. In vitro dissolution study of Formulation (F2) 66-67
14. In vitro dissolution study of Formulation (F3) 69-70
15. In vitro dissolution study of Formulation (F4) 72-73
16. In vitro dissolution study of Formulation (F5) 75-76
17. In vitro dissolution study of Formulation (F6) 78-79
18. In vitro dissolution study of Formulation (F7) 81-82
19. In vitro dissolution study of Formulation (F8) 84-85
20. In vitro dissolution study of Formulation (F9) 87-88
21. In vitro dissolution study of Formulation (F10) 90-91
22. In vitro dissolution study of Formulation (F11) 93-94
23. In vitro dissolution study of Formulation (F12) 96-97
24. In vitro dissolution study of Formulation (F13) 99-100
25. In vitro dissolution study of Formulation (F14) 102-103
26. In vitro dissolution study of Formulation (F15) 105-106
27. In vitro dissolution study of Formulation (F16) 108-109
28. In vitro dissolution study of Formulation (F17) 111-112
29. In vitro dissolution study of Formulation (F18) 114-115
30. Stability study of Formulation F9 at 40˚C/75% RH. 120
 121
In vitro drug release study for stability testing of
31. formulation F9 at 40˚C/75% RH.

LIST OF FIGURES

Fig. Page
Title No.
No.
19
1. Structural formula of Montelukast Sodium
21
2. Structure of Sodium starch glycolate
23
3. Structure of Crospovidone
26
4. Structure of Microcrystalline cellulose
 27
5. Structure of mannitol
49
6. FTIR of Pure Montelukast Sodium
49
7. FTIR of Pure Montelukast Sodium + crospovidone
50
8. FTIR of Pure Montelukast Sodium + Sodium starch glycolate
50
9. FTIR of Pure Montelukast Sodium + guar gum

10. FTIR of Pure Montelukast Sodium + gallen gum 51

51
11. FTIR of Pure Montelukast Sodium + sterculia gum
52
12. FTIR of Pure Montelukast Sodium + crospovidone + guar gum

13. FTIR of Pure Montelukast Sodium + crospovidone + gallen gum 52

FTIR of Pure Montelukast Sodium + crospovidone + sterculia 53
14.
gum
15. FTIR of Pure Montelukast Sodium + SSG + guar gum 53

16. FTIR of Pure Montelukast Sodium + SSG + gallen gum 54

17. FTIR of Pure Montelukast Sodium + SSG + sterculia gum 54

 LIST OF GRAPHS

Graph
Page
s Title
No.
No.
48
1. Calibration curve of Montelukast Sodium at 240 nm.
Study of dissolution data using different release kinetics models 65
2.
of formulation (F1)
Study of dissolution data using different release kinetics models 68
3.
of formulation (F2)
Study of dissolution data using different release kinetics models 71
4.
of formulation (F3)
Study of dissolution data using different release kinetics models 74
5.
of formulation (F4)
Study of dissolution data using different release kinetics models 77
6.
of formulation (F5)
Study of dissolution data using different release kinetics models 80
7.
of formulation (F6).
Study of dissolution data using different release kinetics models 83
8.
of formulation (F7).
Study of dissolution data using different release kinetics models 86
9.
of formulation (F8).
Study of dissolution data using different release kinetics models 89
10.
of formulation (F9)
Study of dissolution data using different release kinetics models 92
11.
of formulation (F10)
Study of dissolution data using different release kinetics models 95
12.
of formulation (F11)
Study of dissolution data using different release kinetics models 98
13.
of formulation (F12)
Study of dissolution data using different release kinetics models 101
14.
of formulation (F13)
Study of dissolution data using different release kinetics models 104
15.
of formulation (F14)
 Study of dissolution data using different release kinetics models 107
16.
of formulation (F15)
Study of dissolution data using different release kinetics models 110
17.
of formulation (F16)
Study of dissolution data using different release kinetics models 113
18.
of formulation (F17)
Study of dissolution data using different release kinetics models 116
19.
of formulation (F18)
118-
20. Drug release profile (F1-F18)
119