A PHARMACEUTICAL EQUIVALENCE STUDY OF THE SELECTED AZITHROMYCIN 500 mg BRANDS ON THE UGANDAN MARKET

TABLE OF CONTENTS

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

DDEDICATION ............................................................................................................................................. iii

ACKNOWLEDGEMENT ........................................................................................................................... iv

ABBREVIATIONS ..................................................................................................................... vii

ABSTRACT ............................................................................................................................................... viii

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

I I INTRODUCT!ON ............................................................................................................................... 1

1.11 Background ................................................................................................................................... 1

1.2 Problem statement ........................................................................................................................... 3

1.3 Aim of' the study .............................................................................................................................. 3

1.4 Significance of the study ................................................................................................................. 3

1.5 Objectives of the study .................................................................................................................... 4

I .5 I General objective ...................................................................................................................... .4

I.S:2 Spccilic objeetivcs .................................................................................................................... .4

1.6 Research qucstion ............................................................................................................................ 4

1.7 Inclusion procedure ........................................................................................................................ .4

CHAPTER TWO .......................................................................................................................................... 5

LITERATURE REVIEW .................................................................................................................... 5

2.1\zithromycin ................................................................................................................................... S

2.2 Pharmaceutical equivalence ............................................................................................................ 5

2.3 Friability test ................................................................................................................................... 6

2.4 Weight variation .............................................................................................................................. 6

2.5 liard ness test ................................................................................................................................... 7

2.6 Disintegration test. ........................................................................................................................... ?

CHAPTER THREE ...................................................................................................................................... 8

MATERIALS ND METHODS .................................................................................................. 8

Equipment: I lard ness tester, Friabilator, Disintegration machine, Electronic balance, UV-Vis

spectrophotometer, Mmtar and pestles ................................................................................................. 8

3 .2 Study area ......................................................................................................................................... 8

3.3S tudy design ..................................................................................................................................... 8

3.'11 Inclusion criteria ............................................................................................................................ 8

3.2 Exclusion criteria ........................................................................................................................... 8

3.5 l.aboratory analysis ......................................................................................................................... 8

3.51 Weight variation ............................................................................................................................ 9

3.52 Disintegration tcs\. ....................................................................................................................... 10

3.53 Reliability test ............................................................................................................................... 10

3.5~ llardcst tcs\ .................................................................................................................................. 10

3.55 Assay of the active ingredient ..................................................................................................... 10

3.551 Preparation of standard calibration curvc .............................................................................. 10

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

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

1.1 RESULTS .......................................................................................................................................... 12

1,.11 Weight variation .......................................................................................................................... 12

Table 4: Hardness, friability, and disintegration ........................................................................... 12

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

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

5.2 Weight variation .......................................................................................................................... 16

5.12 Hardness ...................................................................................................................................... 16

S.IJ Disintegration .............................................................................................................................. 16

5.14 Friability ..................................................................................................................................... 17

5.15 Assay ........................................................................................................................................... 17

5.2 CONCLUSION ................................................................................................................................. 17

5.3 RECOMMENDATIONS .................................................................................................................. 17

REFERENCES ............................................................................................................................................ 18 

ABSTRACT 

Azithromycin, being a very important antibiotic, is manufactured by different pharmaceutical companies and available in numerous brands. Therefore, it requires a quantitative evaluation and assessment of tablets' chemical, and physical properties to determine their pharmaceutical equivalence. In this study, three brands of 500mg azithromycin on the Ugandan market that is: brand X from lJ .K, Y from Egypt, and Z from U.S .A were tested for pharmaceutical equivalence irrespective of their large differences in cost. The physicochemical quality parameters tested included: weight variation, size, hardness, friability and disintegration time of three brands of