ASSESSMENT OF QUALITY OF METRONIDAZOLE TABLET BRANDS SOLD IN ISHAKA TOWN PHARMACIES.

TABLE OF CONTENT

DECLARATION .......................................................................................................................................... ii

APPROVAL ................................................................................................................................................. iii

DEDICATION ............................................................................................................................................. iv

ACKNOWLEDGMENT ............................................................................................................................... v

LIST OF ABBREVIATIONS ...................................................................................................................... vi

CHAPTER ONE ........................................................................................................................................... 1

1.0 INTRODUCTION ................................................................................................................................... 1

1.1 Background .............................................................................................................................................. 1

1.2 Problem statement ............................................................................................................................ 2

1.3 Justification of the study .................................................................................................................... 2

1.4 Objectives of the study ..................................................................................................................... 3

1.4.1 General objective ............................................................................................................................ 3

1.4.2 Specific objectives ........................................................................................................................... 3

1.5 Research questions ................................................................................................................................. 3

CHAPTER TWO .......................................................................................................................................... 4

2.0 LITERATURE REVIEW ........................................................................................................................ 4

2.1 Overview of tablets ................................................................................................................................ 4

2.2 Metronidazole tablets ............................................................................................................................. 4

2.3 Methods for In-Vitro Evaluation Studies ................................................................................................ 7

2.3.1 Weight variation ................................................................................................................................... 7

2.3 .2 Disintegration time ............................................................................................................................... 8

2.3.3 Friability of tablets testing ................................................................................................................... 8

2.3 .4 Hardness testing ................................................................................................................................... 8

CHAPTER THREE ....................................................................................................................................... 9

3.0 MATERIALS AND METHOD ............................................................................................................. 9

3 .I Study design ........................................................................................................................................... 9

3.2 Area of study .......................................................................................................................................... 9

3.3 Determination of sample size .................................................................................................................. 9

3.4 Selection criteria ...................................................................................................................................... 9

3.4.1 Inclusion criteria ................................................................................................................................... 9

3.4.2 Exclusion criteria ................................................................................................................................ 9

3.5 Laboratory analysis ....................................................................................................................... 9

3.5.1 Weight variation test ........................................................................................................................... 9

3.5 .2 Disintegration time test ...................................................................................................................... 10

3.5.4 Hardness test ...................................................................................................................................... 10

3.5.5 Friability ............................................................................................................................................. 10

3.5.6 Assay of Metronidazole tablets by Titration method ....................................................................... 10

3.6 Data analysis ...................................................................................................................................... 11

3.7 Ethical considerations ........................................................................................................................... 11

3.8 Limitations ............................................................................................................................................ 11

CHAPTER FOUR ....................................................................................................................................... 12

4.0 RESULTS ............................................................................................................................................. 12

4.1 Friability ................................................................................................................................................ 12

4.2 Weight variation .................................................................................................................................. 12

4.3 Disintegration time ............................................................................................................................... 13

4.4 Crushing strength ................................................................................................................................. 14

4.5 Assay .................................................................................................................................................... 15

CHAPTER FIVE ......................................................................................................................................... 16

5.1 DISCUSSION ........................................................................................................................................... 16

5.1.1 Friability .............................................................................................................................................. 16

5.1.2 Hardness ............................................................................................................................................. 16

5 .1.3 Disintegration time ............................................................................................................................. 17

5.1.5 Weight variation ................................................................................................................................. 18

5.2 CONCLUSION ..................................................................................................................................... 18

5.3 RECOMMENDATIONS ...................................................................................................................... 19

REFERENCES ............................................................................................................................................ 30

Abstract 

In Uganda, there are different brands of metronidazole, each brand has its own formulation which affects the release and delivery of drug and produce variable clinical responses. So, there is a need for In-vitro analysis of different brands of metronidazole tablets. In this study, eight brands containing 200mg of metronidazole were purchased from ishaka town pharmacies. The main objective of this research was to evaluate the quality of the different brands of metronidazole sold in Ishaka town pharmacies. The eight brands of metronidazole were tested for friability, weight variation, hardness/crushing strength, disintegration time and finally percentage assay. All tablet brands MET!, MET2, MET3, MET4, MET5, MET6, MET7 and MET8 passed the friability test, hardness test , weight variation test and assay. All brands passed the disintegration test except MET4. This study showed the importance of evaluating quality of metronidazole brands in the country.