Evaluation of the Stability of Mercaptopurine Suspension Compounded in a Commercial Vehicle and the Determination of an Appropriate Beyond-use Date.

Mercaptopurine is commonly used to treat acute lymphoblastic leukemia and has historically been commercially available only in tablet form. Since tablets may be difficult for children and elderly patients to swallow, many pharmacists have compounded mercaptopurine suspensions. The U.S. Food and Drug Administration recently approved a commercial suspension, but it is not widely available at this time. Therefore, pharmacists may still need to compound mercaptopurine suspension for use in areas where it is not available or if the commercial suspension is in short supply. Stability studies must be conducted in order to assign appropriate beyond-use dates for compounded preparations. The objective of this study was to evaluate the stability of extemporaneously compounded suspensions using commercially available mercaptopurine tablets, as well as active pharmaceutical ingredient in a vehicle of Ora-Sweet and Ora-Plus (1:1) stored in plastic and glass containers at room temperature. Each mercaptopurine preparation was analyzed using a validated stability-indicating high-performance liquid chromatography method at the following time points: 0, 7, 14, 21, 30, 60, and 90 days. Suspensions were also observed for changes in appearance or odor, and pH was tested at each time point. The suspension compounded from Roxane generic tablets was extremely viscous and was therefore eliminated from the study. All other suspensions showed no observed physical changes and maintained greater than 93% of initial concentration of mercaptopurine for the entire study period.

Evaluation of the stability of promethazine hydrochloride in pluronic lecithin organogel and the determination of an appropriate beyond-use date.

Previous reports indicate that pharmacists are assigning a wide variety of beyond-use dates to extemporaneously compounded medications in topical Pluronic lecithin organogel. The objective of this study was to evaluate the stability of promethazine in Pluronic lecithin organogel over a period of six months and to determine an appropriate beyond-use date. A stability-indicating high-performance liquid chromatography method for promethazine in Pluronic lecithin organogel was validated in our laboratory. Samples of each formulation were analyzed by high- performance liquid chromatography at 0, 7, 14, 21, 28, 45, 60, 90, and 180 days. At each time point, the average concentration and average percent of initial concentration were calculated. The beyond-use date was determined at the time period that the samples were physically stable and maintained at least 90% of the initial concentration. Promethazine hydrochloride was chemically stable in Pluronic lecithin organogel for the period of six months. However, the formulation was physically stable only up to 60 days, and the gel matrix showed signs of physical instability at 90 days, therefore, a 60-day beyond-use date is appropriate for this formulation.

Evaluation of the stability of ketoprofen in pluronic lecithin organogel and the determination of an appropriate beyond-use date.

Previous reports indicate that pharmacists are assigning a wide variety of beyond-use dates to extemporaneously compounded medications in topical Pluronic lecithin organogel. The objective of this study was to evaluate the stability of ketoprofen in Pluronic lecithin organogel over a period of six months and to determine an appropriate beyond-use date for this formulation. A stability-indicating high-performance liquid chromatography method for ketoprofen in Pluronic lecithin organogel was validated in our laboratory. Samples of the formulation were analyzed by high-performance liquid chromatography at 0, 7, 14, 21, 28, 45, 60, 90, and 180 days. At each time point, the average concentration and average percent of initial concentration were calculated. The beyond-use date was determined as the time period that the samples were physically stable and maintained at least 90% of the initial concentration. Ketoprofen in Pluronic lecithin organogel was chemically and physically stable for six months when stored at room temperature and protected from light. Therefore, a beyond-use date of six months is appropriate for this preparation.

Evaluation of the stability of fluoxetine in pluronic lecithin organogel and the determination of an appropriate beyond-use date.

Fluoxetine is a commonly prescribed psychotropic medication for a variety of behavioral diagnoses in veterinary practice, and fluoxetine in Pluronic lecithin organogel has been used successfully in treating inappropriate urine spraying in felines. Historically, pharmacists have assigned a variety of beyond-use dates to extemporaneously compound drugs in Pluronic lecithin organogel. The objective of this study was to evaluate the stability of fluoxetine in Pluronic lecithin organogel over a period of six months and to determine an appropriate beyond-use date. A stability-indicating high-performance liquid chromatography method for fluoxetine in Pluronic lecithin organogel was validated in our laboratory. Fluoxetine-Pluronic lecithin organogel 50 mg/mL was prepared by a local compounding pharmacy and analyzed by high-performance liquid chromatograph at 0, 7, 14, 21, 28, 45, 60, 90, and 180 days. Physical stability was also assessed by visual observation. At each time point percent of initial concentration was calculated. The beyond-use date was determined as the time period that the samples maintained at least 90 percent of the initial concentration. At 180 days, the mean percent of initial concentration was 99 +/- 1.5 and, visually, the fluoxetine-Pluronic lecithin organogel retained the original color and consistency, without detectable separation of the different phases of Pluronic lecithin organogel. Since fluoxetine was physically stable and retained greater than 90 percent of initial concentration in Pluronic lecithin organogel for 180 days when stored at room temperature and protected from light, a beyond-use date of 180 days is appropriate.

Evaluation of the stability of acetaminophen in pluronic lecithin organogel and the determination of an appropriate beyond-use date.

Transdermal acetaminophen in Pluronic lecithin organogel (APAP-PLO) has been anecdotally reported as beneficial when used in cancer patients in the hospice setting. However, there is currently no published information regarding the stability of APAP-PLO. The objective of this study was to identify an appropriate formulation of APAP-PLO and to evaluate the stability of that formulation in order to determine an appropriate beyond-use date. APAP-PLO 50% was prepared by a local compounding pharmacy and analyzed at 0, 7, 14, 28, 45, 60, 90, and 180 days using a stability-indicating high-performance liquid chromatographic method. The mean concentrations and standard deviations were determined for each time point. Physical stability was also assessed by visual observation at each time point. The beyond-use date was determined as the time period that the samples maintained at least 90 percent of the initial concentration. At 180 days, the APAP-PLO was physically stable as noted by visual observation, and the concentration was 102 +/- 4.8 percent of initial concentration indicating that a beyond-use date of 180 days would be appropriate for this formulation.

Pharmacist-implemented pharmaceutical manufacturers' assistance programs: effects on health outcomes for seniors.

In the environment of rapidly mounting medication costs, pharmaceutical manufacturers' assistance programs (PMAPs) have become increasingly important in supplying medications to financially vulnerable patients. At Shenandoah Valley Compassionate Pharmacy, Winchester, Virginia, a nonprofit facility serving low-income seniors, a pharmacist and a patient advocate implement PMAPs by helping to enroll patients, dispensing medications, and providing patient counseling. To examine the effects of the program, we compared patients' clinical indicators before and after a 42-month intervention. Statistical analysis evaluated changes in clinical variables, such as systolic and diastolic blood pressure, glycosylated hemoglobin A1c, lipid panel (total cholesterol, low-density lipoprotein [LDL], highdensity lipoprotein [HDL], and triglycerides [TG]) for 84 seniors diagnosed with one or more chronic conditions. Results show statistically significant improvement in total cholesterol, LDL, and mean arterial pressure (calculated). TGs and A1c did not change significantly. In addition to dispensing free medications, the pharmacist provides counseling to enhance the efficacy of geriatric pharmacotherapy.