AA COMPARATIVE STUDY ON DISSOLUTION

PROFILES OF AMOXICILLIN IN AMOXICILLIN

CONTAINING CAPSULES AVAILABLE IN THE

KENYAN MARKET.

DONE BY: RONO KIPROTICH DONE BY: RONO KIPROTICH

VICTORVICTOR

U29/28970/2009 U29/28970/200904/19/23

INTRODUCTION

Drugs have always been subjected to periodic tests on quality and Dissolution is one of the methods used , it is a measure of bioequivalence in vitro which can as well be used to predict bioequivalence in the body

Belongs to a subgroup of β-lactam antibiotics called Penicillins which is used regularly to treat gram positive infections e.g. respiratory tract infections ,it is available in different dosage forms

JUSTIFICATION

To achieve therapeutic response, the solid pharmaceutical form has to disintegrate into active substance dissolved and absorbed into systemic circulation

This therefore means that dissolution is the rate limiting step of absorption of an active substance

This study allows the probe of capsule invivo/invitro correlation since one can argue that fast dissolution of a capsule or a tablet leads to good bioavailability of the drug in the circulating system

OBJECTIVES

The main objectives of this study was to carry out a comparative dissolution profiles of amoxicillin capsules available in the Kenya market and compare with the original brand.

METHODOLOGY

The dissolution of the five samples were done in accordance with the 2009 U.S.P requirements

Dissolution machine fitted with basket was used,100RPM, for 60 minutes

The amoxicillin standard was obtained from DARU laboratories

900ml of distilled water was used as a medium at 37o Celsius

UV-VIS Spectrophotometer from NQCL as an analytical technique

SAMPLES

Samples were purchased randomly from dispensing chemist in Nairobi (All 500mg) as follows2 locally manufactured amoxicillin capsules brands2 imported brandsAmoxil ™ from GSK as the innovator

RESULTSThe data collected on the absorbance of different amoxicillin brands selected plus that of the standard at a constant wavelength of 272nm in accordance with U.S.P 2009 were tabulated as indicated in the project ,for example

DISCUSSION

On calculation of the percentage content of each brand ,all the five tested products can be compared as follows

1.Amoxil (106%)2.Amoximed (103%)3.Penamox(101%)4.Zeemox(100%)5.Kemoxyl (93%)

CONCLUSION

Most generic brands of amoxicillin capsules available in the Kenyan market are interchangeable with the innovator brand (Amoxil™), this study supports the argument since all of the five products tested show no significant difference in dissolution

RECOMMENDATIONS

Overall, it can be recommended that drug regulatory Authorities should be reinforced and capacitated in order to address proper post marketing surveillance for sensitive medicines like antibiotics.

Further studies should be done on the tested products for better conclusion of the interchangeability with the innovator.

ACKNOWLEDGEMENT

I wish to personally acknowledge the help and assistance accorded to me by:

1. Dr J.O.Ogeto , my supervisor from the Department of Pharmaceutical chemistry

2. The technical staff in the department of pharmaceutical chemistry especially Mr.Mugo

3. The National Quality Control Laboratory for their approval of my request to use their UV machine.

THANK Y

OU ALL

FOR L

ISTE

NING