ABSTRACT Introduction: Furosemide is a widely used loop diuretic for managing conditions such as oedema and hypertension. In paediatric patients, especially in the absence of… Read More »Stability study of an extemporaneous furosemide oral suspension prepared using commercially available tablets with X-Temp® Oral Suspension System
Introduction: Oral morphine solution is produced extemporaneously in Hospital Tengku Ampuan Afzan (HTAA). Currently, X-Temp® oral suspension system (OSS), a commercially produced drug vehicle, is used to substitute Simple Syrup in the production of oral morphine solution. Within general hospitals, particularly in HTAA, there are no published documents or official studies on the cost comparison of using Simple Syrup and X-Temp® OSS in the production of extemporaneous oral morphine solution. Materials and method: This is a retrospective study on the batches of oral morphine solution produced using Simple Syrup and X-Temp® OSS. Data were obtained from Psychotropics and Dangerous Drug Registers, Excel data and other relevant databases. All data were further analysed and presented in tables, graphs, and charts whenever applicable and necessary. Results: The median cost per batch of oral morphine with Simple Syrup is RM71.73 (IQR: RM 0.986), which is cheaper than oral morphine with X-Temp® OSS (RM547.68, IQR: RM273.84). There is a significant difference in terms of cost per batch of production between both groups (p=0.0001), where oral morphine with X-Temp® OSS has a higher median score compared to oral morphine with Simple Syrup. Oral morphine with X-Temp® OSS was produced less frequently than oral morphine with Simple Syrup. Thus, the total time spent for production per year is lesser with the use of X-Temp® OSS. The odds of disposing of oral morphine solution were significantly lower in oral morphine with X-Temp® OSS, compared to oral morphine with Simple Syrup. (OR = 43.52; 95% CI = 20.33 – 93.13; p=0.0001). Conclusion: The direct cost of X-Temp® OSS in the production of oral morphine solution is higher, but the indirect costs are lower, hence making it more beneficial in terms of reducing the use of human resources, saving time & minimizing wastage.
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.