Stability-study-of-an-extemporaneous-isoniazid-oral-suspension-prepared-using-commercially-available-tablets-with-x-temp-oral-suspension-system

Abstract

Isoniazid (INH) is a hydrazine derivative that is routinely used for the treatment of pulmonary and extrapulmonary tuberculosis. It is used with other anti-tuberculosis drugs usually in regimes including rifampicin, ethambutol, and pyrazinamide. As there is no access to commercial oral solution in Malaysia, there is a requirement to prepare this product by extemporaneous compounding. This study is initiated to identify an easy-to-prepare formulation for compounding and to select product storage condition and establish beyond-use date. INH tablets were used to mix into X-Temp® Oral Suspension System to compound the 10 mg per mL and 40 mg per mL solution. For the stability studies, the finished products were packed into amber HDPE bottles and stored at refrigeration (5°C ± 3°C) or room temperature (30°C ± 2°C) for up to 90 days. The samples were evaluated by visual inspection, pH measurement, high-performance liquid chromatography (HPLC) assay at predetermined testing intervals for 90 days. The samples were submitted for microbiology testing at each time point. An HPLC method validation was also carried out to ensure that the system provides accurate, precise and reliable analytical data. The results showed that INH suspension at concentration of 10mg/mL and 40mg/mL remained unchanged in physical, chemical and microbiological evaluations for up to 90 days. The HPLC results demonstrated that all the samples retained the drug concentration within the specification. It could be suggested that INH tablet can be extemporaneously compounded in X-Temp® Oral Suspension System at a concentration of between 10mg/mL to 40mg/mL with the resulting product stable for up to 90 days when packed in HDPE bottles and stored at either refrigeration or room temperature.