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Quality Assessment of Carbamazepine Tablets in Nairobi County

This study assesses the quality of Carbamazepine tablets in Nairobi County, focusing on assay results, dissolution profiles, and overall compliance with USP specifications. The findings highlight the importance of quality control in ensuring effective treatment for epilepsy patients.

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Quality Assessment 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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