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QUALITY OF CARBAMAZEPINE TABLETS IN NAIROBI COUNTY

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

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QUALITY OF CARBAMAZEPINE TABLETS IN NAIROBI COUNTY

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  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 • Interconversioncan 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

  7. RESULTS AND DISCUSSION II: ASSAY RESULTS CTD..

  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 IVDISSOLUTION : % 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?

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