Stability of reconstituted fluconazole oral suspension in plastic bottles and oral syringes.

BACKGROUND: Fluconazole for oral suspension is a dry powder with a beyond-use date of 14 days after being reconstituted. Dispensing fluconazole liquid in the inpatient setting would be much more efficient if prefilled oral syringes containing standard doses were readily available. In addition, if the beyond-use date could be extended, the resulting decreased waste would be economically beneficial. OBJECTIVE: To determine the stability of reconstituted fluconazole oral suspension using high-performance liquid chromatography (HPLC). METHODS: Diflucan lyophilized powder was reconstituted to fluconazole 40 mg/mL using Sterile Water for Irrigation, USP. Samples were stored at room temperature in both the original Diflucan plastic bottles and in amber polyethylene oral syringes with silicon elastomer plunger tips that were sealed with high-density polyethylene caps. Samples were analyzed immediately and at 14, 28, 42, 56, and 70 days. Fluconazole concentrations were measured using a modified stability-indicating HPLC method. At each test interval, the density of the suspension was determined gravimetrically and then used to calculate the exact volume of sample used for each analysis. Excessive degradation was defined as greater than 10% loss of the initial concentration. RESULTS: The stock internal standard was stable for at least 77 days when stored in the dark at room temperature. The stock and working fluconazole standard solutions were prepared fresh at each test interval. Reconstituted oral suspension retained more than 90% of the initial fluconazole concentration for at least 70 days at 22-25 degrees C. No changes in color, odor, or visible microbiological growth were observed in any sample. The pH of the suspension was initially 4.2 and remained essentially unchanged throughout the study. CONCLUSIONS: Reconstituted fluconazole oral suspension is stable in both the product's original plastic bottles and in amber polyethylene oral syringes for at least 70 days when stored at 22-25 degrees C.

Stability of codeine phosphate in an extemporaneously compounded syrup.

PURPOSE: The stability of codeine phosphate in an extemporaneously compounded syrup is described. METHODS: Codeine phosphate 3-mg/mL syrup was prepared using commercially available Codeine Phosphate, USP, Sterile Water for Irrigation, USP, and Ora-Sweet syrup vehicle. Samples were stored in amber polyethylene terephthalate bottles with child-resistant caps. A second batch of codeine phosphate 3-mg/mL syrup was prepared and drawn into amber polyethylene oral syringes with silicon elastomer tips. All samples were stored at room temperature and in the dark. Samples were analyzed immediately and at 7, 14, 28, 42, 56, 70, and 98 days. Codeine phosphate concentrations were measured using a modified stability-indicating high-performance liquid chromatographic method. At each test interval, the density of the syrup was determined gravimetrically using a 10-mL amber oral syringe. Excessive degradation was defined as a greater than 7% loss of the initial concentration. RESULTS: The stock internal standard was stable for at least 98 days at room temperature. The compounded syrup retained more than 93% of the initial codeine phosphate concentration for at least 98 days at 22-25 degrees C. No changes in color, clarity, or odor and no visible solids or microbial growth were observed in any sample. The pH of the syrup was initially 4.2 and remained unchanged throughout the study. CONCLUSION: Codeine phosphate 3 mg/mL in Ora-Sweet syrup vehicle was stable in both amber polyethylene terephthalate bottles and amber polyethylene oral syringes for at least 98 days when stored at 22-25 degrees C and protected from light.

Stability of nifedipine in an extemporaneously compounded oral solution.

The stability of nifedipine in an extemporaneously compounded oral solution is described. A solution of nifedipine 10 mg/mL was prepared from commercially available nifedipine powder with polyethylene glycol 400, glycerin, and peppermint oil. Four samples were stored in amber glass bottles at room temperature under fluorescent lighting and analyzed in duplicate. Samples were analyzed immediately and at 7, 14, 23, and 35 days. Eight samples were stored in amber oral syringes and eight in amber oral syringes wrapped in aluminum foil; all were stored at room temperature under fluorescent lighting. Samples from foil-wrapped syringes were analyzed at 7 and 14 days; samples not wrapped in foil were analyzed after 7 days. Nifedipine concentrations were measured with a modified stability-indicating high-performance liquid chromatographic method. Excessive degradation was defined as a greater than 10% loss of initial drug concentration. There were no detectable changes in color or odor and no visible solids or microbial growth was observed in any sample. Samples in amber glass bottles and amber oral syringes wrapped in aluminum foil retained more than 90% of the initial nifedipine for 35 and 14 days, respectively. Samples packaged in amber oral syringes not wrapped in foil lost over 20% of the initial nifedipine concentration within 7 days. Nifedipine 10 mg/mL was stable in an oral solution prepared from commercially available powder in a peppermint-flavored vehicle for at least 35 days when stored at 22-25 degrees C in amber glass bottles and for at least 14 days when stored in amber oral syringes wrapped in aluminum foil.