A DONE BY: RONO KIPROTICH VICTOR U29/28970/2009 A COMPARATIVE STUDY ON DISSOLUTION PROFILES OF AMOXICILLIN IN AMOXICILLIN CONTAINING CAPSULES AVAILABLE IN THE KENYAN MARKET. DONE BY: RONO KIPROTICH VICTOR U29/28970/ /14/2015

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 37 o Celsius UV-VIS Spectrophotometer from NQCL as an analytical technique

SAMPLES Samples were purchased randomly from dispensing chemist in Nairobi (All 500mg) as follows 2 locally manufactured amoxicillin capsules brands 2 imported brands Amoxil ™ from GSK as the innovator

RESULTS The 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.

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