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
The objective of this study is to look into the stability of Chloral Hydrate 40 mg per ml formulated as oral solution in X-temp Oral Suspension System in order to select proper storage conditions and establish beyond-use date. X-temp is a novel oral, flavoured sugar-free extemporaneous compounding vehicle to assist in the preparation of extemporaneous dosage forms.
The compounded solution of 40 mg/ml was prepared by dissolving chloral hydrate powder in X-temp vehicle. The solution was then packed in amber HDPE containers, and were stored at refrigeration 5 ± 3°C and room temperature 30°C. Physical, chemical and microbiological parameters were evaluated at predetermined time-points up to 180 days. Samples were tested using a validated stability–indicating assay. Chloral hydrate concentration was assayed by high-performance liquid chromatography (HPLC).
The stability results indicated that the solution remained unchanged in visual appearance or pH at both refrigeration and room temperature for up to 180 days. The HPLC results showed that all the stability studies maintained 90 – 100% of initial drug concentration. There was no substantial changes in the microbiological stability.
Chloral hydrate solution prepared in X-temp Oral Suspension System was stable for up to 180 days when stored at room temperature and refrigeration conditions. These results demonstrated that X-temp is a suitable vehicle for extemporaneous compounding for chloral hydrate.
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).
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.
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.