1. QUALITY OF CARBAMAZEPINE TABLETS IN NAIROBI COUNTY BY: KAINGU WINNIE MSINDA U29/2014/2010 SUPERVISOR: DR. K.O. ABUGA OCTOBER 2014

2. 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

3. 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

4. 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

5. 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

6. RESULTS AND DISCUSSION I: ASSAY RESULTS SAMPLE CODE NRB 001 NRB 002 NRB 003 NRB 004 NRB 005 %LC119.7103.5113.8100.9122.5 S/D1.241.390.590.190.45 n=64333

7. RESULTS AND DISCUSSION II: ASSAY RESULTS CTD.. SAMPLE CODE NRB 006NRB 007NRB 008NRB 009 %LC112.67104.67107.31110.78 S/D1.190.780.560.57 n=3336

8. 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

9. RESULTS AND DISCUSSION IV DISSOLUTION : % OF DRUG RELEASED.

10. RESULTS AND DISCUSSION V: DISSOLUTION PROFILES

11. 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

12. 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

13. RECOMMENDATIONS Analyse all nine samples Further studies

14. QUESTIONS?