QUALITY OF CARBAMAZEPINE TABLETS IN NAIROBI COUNTY

BY: KAINGU WINNIE MSINDA

U29/2014/2010

SUPERVISOR: DR. K.O. ABUGA

OCTOBER 2014

INTRODUCTION

• Epilepsy: Brain disorder - recurrent seizures due to disturbed brain activity

• Seizures accompanied by loss of the functions

• Treatment: phenobarbitone, phenytoin, ethosuximide, carbamazepine, gabapentin

• Carbamazepine - commonest drug in Kenya

• Quality assessment parameters: Dissolution, content, friability

STUDY JUSTIFICATION

• Quality medicines – pillar in health care

• Need for continuous PMS of medicines

• Carbamazepine occurs as 4 polymorphs with variable solubilities

• Previous studies: dissolution problems – effect on oral bioavailability

• Interconversion can occur during storage and manufacture

OBJECTIVES

• General objective: To carry out quality control of carbamazepine tablets in Nairobi County

• Specific objectives:

• To sample carbamazepine 200 mg tablets from pharmacies in Nairobi County

• To carry out assay and dissolution on the samples as per USP specifications

METHODOLOGY• Sampling - done in Nairobi County, 9 brands

purchased

• Reference standard donated by NQCL, potency 99.5%

• Assay- USP (2009) HPLC method

• Dissolution- USP (2009) method

• Modifications made on both methods

RESULTS AND DISCUSSION I: ASSAY RESULTS

SAMPLE CODE

NRB001

NRB 002

NRB 003

NRB 004

NRB 005

%LC 119.7 103.5 113.8 100.9 122.5

S/D 1.24 1.39 0.59 0.19 0.45

n= 6 4 3 3 3

RESULTS AND DISCUSSION II: ASSAY RESULTS CTD..

SAMPLECODE

NRB 006 NRB 007 NRB 008 NRB 009

%LC 112.67 104.67 107.31 110.78

S/D 1.19 0.78 0.56 0.57

n= 3 3 3 6

RESULTS AND DISCUSSION III:

ASSAY CTD....• Four samples passed: NRB 002, NRB 004NRB

007 and NRB 008

• Five samples failed :NRB 001, NRB 003, NRB

005, NRB 006 and NRB 009

• Samples that failed contained high % LCS

RESULTS AND DISCUSSION IV DISSOLUTION : % OF DRUG

RELEASED.

RESULTS AND DISCUSSION V: DISSOLUTION PROFILES

RESULTS AND DISCUSSION VI: DISSOLUTION CONT...

• Products attained efficient release of carbamazepine.

• At least 45% of the dose was released within 15 min

• At least 75% of the dose within 60 min

• Carbamazepine is insoluble in pure water but soluble in SLS

CONCLUSION

• 44% of samples complied with assay

• > 55% products contained high %LC

• Products had good dissolution attributes

• Variations in dissolution among samples observed

• Bioavailability investigation could explain effects in vivo

RECOMMENDATIONS

• Analyse all nine samples

• Further studies

QUESTIONS?