Stability of Extemporaneously Prepared Hydroxycarbamide Oral Suspensions.

Hydroxycarbamide, available as tablets, is a pharmacological agent for fetal hemoglobin induction such as sickle cell anemia. The need for alternative dosage form options for patients unable to take tablets led hospital pharmacies to prepare solutions and suspensions. The objective of this study was to determine the stability of hydroxycarbamide in Ora-Plus in combination with either Ora-Sweet or Ora-Sweet SF, Ora-Blend, or Ora-Blend SF suspending agents. The studied samples were compounded into 100-mg/mL suspensions and stored in 60-mL amber glass bottles at room (22°C to 25°C) or refrigerated (4°C to 8°C) temperature. Samples were assayed at each time point out to 120 days by a stability-indicating high-performance liquid chromatography method. The samples were examined for any change in color, odor, visual microbiology, and pH on initial and final day of analysis. At least 90% of hydroxycarbamide concentration remained in all suspensions at the end of the 120-day study period in both conditions. There was no appreciable change in color, odor, or taste. The pH values of suspensions stored at 25°C changed by at least 1 unit at the end of the study period. Based on the data collected, the beyond-use date of these suspensions is 120 days when stored in 60-mL amber glass bottles at both temperature storage conditions.

Stability study of oral pediatric idebenone suspensions.

Adapted forms for administration to infants are limited. The proposed study was performed to propose oral liquid formulations of idebenone in Ora-Plus and either Ora-Sweet or Ora-Sweet SF, Ora-Blend, Ora-Blend SF and Inorpha. Each formulation was stored in 30 ml amber glass bottle at 5 or 25 °C for 90 days. Idebenone contents in these suspensions, determined by a stability-indicating high-performance liquid chromatography method, remained stable at least 90 days in Inorpha when stored at the two temperatures. In Ora-Blend, the stability was estimated at 14 days and in other suspensions at 20 days at the two temperatures. After 90 days storage, the pH of Ora-Plus and Ora-Sweet or Ora-Sweet SF changed between -0.10 and -0.25 units. For others suspensions, the pH changes were not significant (< -0.09 unit). No change was observed in color, odor or visual microbiology. To conclude, we recommended the use of idebenone in Inorpha vehicle stable for at least 90 days at 25 °C.

Stability-Indicating High-Performance Liquid Chromatography Assay for the Determination of Sulthiame in Pharmaceutical Dosage Forms.

A stability-indicating assay by reversed-phase high performance liquid chromatography method was developed and validated for the determination of sulthiame (STM). The chromatographic separation was achieved on a reversed-phase NovaPack C18 column and an isocratic mobile phase consisting of deionized water:methanol (70:30, v/v). The flow rate was 1.0 mL/min (ultraviolet detection at 210 nm). The STM was separated within 2.83 min. The linearity of the method was demonstrated in the range of 20.0-200.0 µg/mL and a coefficient of determination of r (2) = 0.9999. The limits of detection and quantification were 4.2 and 9.5 µg/mL, respectively. The intraday and interday precisions were less than 1%. Accuracy of the method ranged from 98.3% to 101.7%, with a relative standard deviation of <1%. STM was degraded by accelerated breakdown in alkaline, acidic, or oxidative stress conditions. This method allows accurate and reliable determination of STM for drug stability assay in pharmaceutical studies.

An Observational Study of the Impact of a Computerized Physician Order Entry System on the Rate of Medication Errors in an Orthopaedic Surgery Unit.

AIM: To assess the impact of the implementation of a Computerized Physician Order Entry (CPOE) associated with a pharmaceutical checking of medication orders on medication errors in the 3 stages of drug management (i.e. prescription, dispensing and administration) in an orthopaedic surgery unit. METHODS: A before-after observational study was conducted in the 66-bed orthopaedic surgery unit of a teaching hospital (700 beds) in Paris France. Direct disguised observation was used to detect errors in prescription, dispensing and administration of drugs, before and after the introduction of computerized prescriptions. Compliance between dispensing and administration on the one hand and the medical prescription on the other hand was studied. The frequencies and types of errors in prescribing, dispensing and administration were investigated. RESULTS: During the pre and post-CPOE period (two days for each period) 111 and 86 patients were observed, respectively, with corresponding 1,593 and 1,388 prescribed drugs. The use of electronic prescribing led to a significant 92% decrease in prescribing errors (479/1593 prescribed drugs (30.1%) vs 33/1388 (2.4%), p < 0.0001) and to a 17.5% significant decrease in administration errors (209/1222 opportunities (17.1%) vs 200/1413 (14.2%), p < 0.05). No significant difference was found in regards to dispensing errors (430/1219 opportunities (35.3%) vs 449/1407 (31.9%), p = 0.07). CONCLUSION: The use of CPOE and a pharmacist checking medication orders in an orthopaedic surgery unit reduced the incidence of medication errors in the prescribing and administration stages. The study results suggest that CPOE is a convenient system for improving the quality and safety of drug management.