Bachelor of Pharmacy. Product Management, Winwa Medical Sdn. Bhd., Bukit Mertajam, Pulau Pinang, Malaysia.
Contact for correspondence, please email: ltchan@winwamedical.com
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.
Abstract
Many drugs used in paediatric are often not available in suitable dosage forms and have to be extemporaneously prepared by pharmacists to make them suitable for the body weight, body surface area, or age of the children. Phenobarbitone is the main anti-epileptic drug (AED) for the treatment of seizure in paediatric patients. The objective of this study is to evaluate the physicochemical and microbiological stability of an extemporaneously prepared Phenobarbitone Oral Suspension using commercially available tablets and X-temp Oral Suspension System. The Phenobarbitone Oral Suspension (10mg/ml) was stored at 4oC and 30oC / 75%RH protected from light and were examined at the interval of 0, 1, 2, 3 and 6 months. The content of Phenobarbitone was determined using a validated high-performance liquid chromatography (HPLC) method. The visual appearance, odour, pH and specific gravity remained fairly unchanged throughout the study period and the content of Phenobarbitone remained above 98% of the original concentration throughout the course of the study for both temperatures. The extemporaneous preparation was not susceptible to microbial contamination. The results from the stability studies confirmed that X-temp Oral Suspension is a suitable suspending vehicle for preparing extemporaneous liquid formulation of Phenobarbitone Oral Suspension with the added advantage of alcohol-free, colourant-free and sugar-free. Based on the data collected, the shelf-life of this liquid formulation is at least 6 months when stored at 4oC (refrigeration) and 30oC / 75%RH (room temperature).
Abstract
Morphine taken by mouth is an effective analgesic for most people with moderate or severe cancer pain. Hospital pharmacists commonly prepare morphine oral liquid extemporaneously for cancer patients who require tube feeding or have difficulties in swallowing because it is not available commercially in Malaysia. This study aims to provide the physical, chemical and microbiological stability data to determine the shelf-life and storage condition for the extemporaneous preparation of morphine oral suspension (10mg/5ml) using X-Temp Oral Suspension System. The samples were divided into 2 groups and were stored at 4°C (refrigeration) and 30°C / 75%RH (room temperature) protected from light for 12 months. The physical, chemical and microbiological stability were examined at the interval of months 0, 1, 2, 3, 4, 5, 6, 9 and 12. The content of morphine was determined using HPLC-UV method. The content of morphine remained above 95% of the original concentration throughout the study period. The colour, clarity and odour remained fairly unchanged throughout the study period and the pH values were steady at around pH 4. The extemporaneous preparation was not susceptible to microbial contamination. The results from the stability studies confirmed that the new formulation of morphine oral suspension is stable for up to 12 months when packed in HDPE bottles with polypropylene caps and stored at both 4°C and 30°C / 75%RH.
Abstract
Many drugs are not available in suitable dosage forms for paediatric use and have to be extemporaneously prepared by pharmacist for the individual patient. This study is conducted to investigate the physicochemical and microbiological stability of an extemporaneous oral suspension containing 1mg/ml of folic acid. The oral suspension was prepared using commercially available tablets and vehicle from the hospital. The folic acid oral suspension was stored for 60 days at 4°C (refrigeration) and 25°C (room temperature) protected from light. The physical, chemical and microbial stability were examined at day 0, 14, 28 and 60. The content of folic acid was determined using HPLC- UV method. The analytical results showed that the content of folic acid was above 90% in all the samples tested throughout the study period. The visual appearance, colour, odour and pH remained fairly unchanged throughout the study period and the oral suspension was not susceptible to microbial contamination. The results indicated that the extemporaneous formulation was stable at both temperatures and 60 days expiration date could be recommended for this formulation.