Pharmaceutical quality of Lamotrigine Tablets
  • 1.04.2019
  • 1,080
Pharmaceutical quality of Lamotrigine Tablets
Owner / Producer Owner / Producer
Suthana Pai-sin, Sasida Yoosook
Year Year

Lamotrigine tablets is an antiepilepsy drugs, which is used as a monotherapy or with other medications to prevent and control seizures. It is also used as a mood stabilizers in bipolar disorders. Lamotrigine tablets formulations are available in the strength of 25, 50 and 100 mg. In the fiscal year 2018, Bureau of Drug and Narcotic cooperated with Thai Food and Drug Administration surveyed the quality of lamotrigine tablets by randomly collected samples from public hospitals, importers and local manufacturers under Quality Assurance of Medicine Program. The total of 31 samples, from 1 importer (3 registration numbers) and 2 manufacturers (6 registration numbers) were evaluated according to the United States Pharmacopeia specification (USP 40) for identification, assay, weight variation and organic impurities. The analytical method was verified prior to sample testing. The results showed that all samples (100%) complied with pharmacopeia specification. It can be concluded that lamotrigine tablets in Thailand have satisfactory pharmaceutical characteristics which will be used for drug procurement in hospitals.

Key words : Lamotrigine tablets, Antiepilepsy drugs, Seizures, Mood stabilizers, Bipolar disorders