Table of Contents

1. Introduction ................................................................................................................ 5
1.1 Introduction to solubility and dissolution enhancement ...................................... 5
1.1.1 Introduction to oral dosage form ................................................................... 5
1.1.2 Introduction to poorly water-soluble drug and need to improve their
solubility and dissolution characteristics ................................................................ 6
1.2 Introduction to Solid Dispersion ..................................................................... 8
1.2.1 Advantages of Solid Dispersion............................................................... 9
1.2.2 Method for preparation of Solid Dispersion ............................................ 9
1.3 Introduction to Nitazoxanide............................................................................ 10
1.4 Introduction to Urea: ........................................................................................ 13
1.5 Introduction to PEG 4000 ................................................................................ 13
2. Literature Review................................................................................................... 15
2.1 Literature review on Solid Dispersion: ............................................................ 15
2.2 Review of work done on Nitazoxanide ............................................................ 20
3. Aim & Objectives .................................................................................................... 23
3.1 AIM: ................................................................................................................. 23
3.2 OBJECTIVES: ................................................................................................. 23
4. Experimental Work Done ........................................................................................ 24
4.1 List of Material and Instruments used: ............................................................. 24
4.2 Experimental methodology: ............................................................................... 24
4.2.1 Identification of Drug: ............................................................................... 24
4.2.2 Preparation of Standard Calibration Curve of Nitazoxanide in
Dimethylformamide and phosphate buffer pH 7.5. .............................................. 25
4.2.4 Drug-Excipient compatibility studies ........................................................ 25
4.3 Method used for Preparation of Solid Dispersion: ........................................... 25
4.4 Preparation of Solid Dispersion: ...................................................................... 25
4.5 Evaluation Parameters ...................................................................................... 26
6. In vitro drug release study .............................................................................. 28
7. SEM study ...................................................................................................... 28
5. Result and Discussion ............................................................................................ 29
5.1 Identification of Drug: ...................................................................................... 29
5.1.1 FT-IR study: ................................................................................................ 29
 5.1.2 DSC study:................................................................................................... 30
5.1.3 Calibration curve DMF and Phosphate buffer (pH 7.5): ............................. 31
5.2 Drug-Excipient Compatibility study: ............................................................... 32
5.3 Evaluation of Solid Dispersion batches: .......................................................... 36
5.3.1 Drug Content: ............................................................................................. 36
5.3.2 Flow property of Solid Dispersion ............................................................ 37
5.3.3 In-vitro dissolution study:........................................................................... 37
5.4 Batch Optimization: ............................................................................................. 39
5.5 Evaluation of Optimized Batch: ....................................................................... 39
List of Figure
 

Figure 1. Distribution of drug delivery system in market 5

Figure:2 Nitazoxanide FTIR spectra 19
Figure3: Reported FT-IR spectra of Nitazoxanide 19
Figure 4: Structure of Nitazoxanide 20
Figure 5: Lutein Nitazoxanide graph 20
Figure 6: calibration curve of NTZ in DMF 21
Figure 7: calibration curve in Phosphate buffer pH 7.5 22
Figure 8: FT-IR spectrum of Nitazoxanide 22
Figure 9: FT-IR spectrum of Urea 23
Figure 9: FT-IR spectrum of PEG 4000 23
Figure 10: FT-IR spectrum of Physical Mixture 24
Figure 11: DSC of Nitazoxanide 24
Figure 12: DSC of Urea 25
Figure 13: DSC of PEG 4000 26
Figure 14: DSC of Physical Mixture 27
Figure 15: Graphical representation of in-vitro dissolution profile of Batch F1-F3 38
Figure 16: Graphical representation of in-vitro dissolution profile of Batch F4-F6 38
Figure 17: Graphical representation of in-vitro dissolution profile of Batch F7-F9 39
Figure 18: % CPR of Optimized batch 40
figure 19: % CPR of Pure Nitazoxanide 40
List of Table
Table 1: USP and BP solubility criteria. ____________________________________ 8
Table 2: List of Materials ______________________________________________ 24
Table 3: List of Instruments ____________________________________________ 24
Table 4: solid dispersion batch __________________________________________ 26
Table 5: Calibration curve of Nitazoxanide ________________________________ 23
Table 6: drug content of all batch _______________________________________ 29
Table 7: flow property of Batch F1 to F9 _________________________________ 29
Table 8: In vitro Dissolution profile of Nitazoxanide _________________________ 29
Table 9: dissolution od Optimized batch and pure drug _______________________ 39
Table 10: Evaluation of Optimized batch compare with pure drug ______________ 40