Extended stability of intravenous acetaminophen in syringes and opened vials.

PURPOSE: The stability of i.v. acetaminophen beyond the manufacturer-recommended usage limit of six hours for opened vials was evaluated. METHODS: Intravenous acetaminophen (10 mg/mL) was obtained. Three identical samples of 100 mg (10 mL in a 10-mL syringe), 250 mg (25 mL in a 30-mL syringe), 500 mg (50 mL in a 60-mL syringe), 250 mg (25 mL in the original vial), and 900 mg (90 mL in original vial) were prepared. A 0.5-mL volume of each sample was withdrawn, diluted with mobile phase to an expected concentration of 50 µg/mL, and assayed in duplicate using high-performance liquid chromatography immediately after preparation and at 24, 48, 72, and 84 hours. The samples were visually inspected for any change in color, and pH was assessed at each time of analysis. The stability of the solutions was determined by calculating the percentage of the initial acetaminophen concentration remaining at each test hour. Stability was defined as the retention of at least 90% of the initial acetaminophen concentration. RESULTS: At least 99% of the initial concentration of acetaminophen remained in the original vials and polypropylene syringes throughout the 84-hour study period. There were no detectable changes in color, pH, visible microbial growth, or visible drug precipitation. CONCLUSION: Intravenous acetaminophen (10 mg/mL) was physically and chemically stable in a range of volumes for up to 84 hours in the opened vials and in polypropylene syringes at room temperature.

Stability of an extemporaneously prepared tadalafil suspension.

PURPOSE: The stability of an extemporaneously prepared tadalafil oral suspension was studied. METHODS: An oral suspension of tadalafil 5 mg/mL was prepared by thoroughly grinding 15 20-mg tadalafil tablets in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of Ora-Sweet were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of the formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and stored at room temperature (23-25 °C). A 1-mL sample was withdrawn from each of the three bottles with a micropipette immediately after preparation and at 7, 14, 28, 57, and 91 days. After double dilution (1:10 and 0.1:5 v/v) to an expected concentration of 10 µg/mL with methanol and mobile phase, respectively, the samples were assayed in duplicate using stability-indicating high-performance liquid chromatography. The samples were visually examined for any color change and evaluated for pH changes on each day of analysis. Taste evaluation was performed at the beginning and end of the study. Stability was defined as the retention of at least 90% of the initial concentration. RESULTS: At least 99% of the initial tadalafil concentration remained throughout the 91-day study period. There were no detectable changes in color, odor, taste, and pH, and no visible microbial growth was observed in any sample. CONCLUSION: An extemporaneously prepared suspension of tadalafil 5 mg/mL in a 1:1 mixture of Ora-Plus and Ora-Sweet was stable for at least 91 days when stored in amber plastic bottles at room temperature.

Stability of an extemporaneously prepared thalidomide suspension.

PURPOSE: The short-term physical and chemical stability of an oral suspension of thalidomide 20 mg/mL was studied. METHODS: An oral suspension of thalidomide 20 mg/mL was prepared by emptying the contents of 12 100-mg thalidomide capsules into a glass mortar; 30 mL of Ora-Plus and 30 mL of Ora-Sweet were mixed and added to the thalidomide powder to make a final volume of 60 mL. Three identical samples of the formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and stored under refrigeration (3-5 °C). A 1-mL sample was withdrawn from each of the three samples with a micropipette immediately after preparation and at 7, 14, 21, 28, and 35 days. After further dilution to an expected concentration of 20 µg/mL with acetonitrile-methanol and then dilution with mobile phase, the samples were assayed in duplicate using stability-indicating high-performance liquid chromatography. Stability was determined by evaluating the percentage of the initial concentration remaining at each time point; stability was defined as the retention of at least 90% of the initial concentration of thalidomide. RESULTS: At least 92% of the initial thalidomide concentration remained throughout the 35-day study period. There were no detectable changes in color, odor, or pH and no visible microbial growth in any sample. CONCLUSION: An extemporaneously prepared suspension of thalidomide 20 mg/mL in a 1:1 mixture of Ora-Plus and Ora-Sweet was stable for at least 35 days when stored in 2-oz amber plastic bottles under refrigeration.

Stability of extemporaneously prepared glycopyrrolate oral suspensions.

PURPOSE: The stability of extemporaneously prepared glycopyrrolate 0.5-mg/mL suspensions was evaluated. METHODS: An oral suspension of glycopyrrolate 0.5 mg/mL was prepared by thoroughly grinding 30 1-mg tablets of glycopyrrolate in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of either Ora-Sweet or Ora-Sweet SF were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of the formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and stored at room temperature (23-25 °C). A 1-mL sample was withdrawn from each of the three bottles with a micropipette immediately after preparation and 7, 15, 30, 60, and 90 days afterward. After further dilution to an expected concentration of 50 µg/mL with sample diluent, the samples were assayed in duplicate by stability-indicating high-performance liquid chromatography. The samples were visually examined for any color change and evaluated for pH on each day of analysis. Taste evaluations were performed at the beginning and end of the study. Stability was defined as the retention of at least 90% of the initial concentration. RESULTS: At least 95% of the initial glycopyrrolate remained throughout the 90-day study period in both preparations. There were no detectable changes in color, odor, taste, and pH, and no visible microbial growth was observed in any sample. CONCLUSION: Extemporaneously compounded suspensions of glycopyrrolate 0.5 mg/mL in a 1:1 mixture of Ora-Plus/Ora-Sweet or Ora-Plus/Ora-Sweet SF were stable for at least 90 days when stored in amber plastic bottles at room temperature.

Stability of extemporaneously prepared oxandrolone oral suspensions.

PURPOSE: The stability of extemporaneously prepared oxandrolone oral suspensions was studied. METHODS: Oxandrolone oral suspension (1 mg/mL) was prepared using oxandrolone tablets, Ora-Plus, and either Ora-Sweet or Ora-Sweet SF. Three identical samples of each formulation were prepared and stored in 2-oz amber plastic bottles with child-resistant caps at room temperature (23-25 °C). After thorough but gentle shaking by hand to prevent foaming, a 1-mL sample was withdrawn from each of the six bottles, diluted with mobile phase to an expected concentration of 200 µg/mL, and assayed in duplicate by injecting 5 µL into the high-performance liquid chromatography system immediately after preparation and at 7, 14, 35, 60, and 90 days. The samples were examined for any change in color or pH on each day of analysis. The stability of the suspensions was determined by calculating the percentage of the initial oxandrolone concentration remaining on each test day. Stability was defined as the retention of at least 90% of the initial oxandrolone concentration. RESULTS: At least 98% of the original oxandrolone concentration remained in both formulations at the end of the 90-day study period. There was no appreciable change in odor, taste, color, or pH. Both suspensions remained white in color and sweet with no aftertaste throughout the study period. The oxandrolone was easily resuspended with gentle shaking. CONCLUSION: Extemporaneously prepared suspensions of oxandrolone 1 mg/mL in 1:1 mixtures of Ora-Plus and either Ora-Sweet or Ora-Sweet SF were stable for at least 90 days when stored in 2-oz amber plastic bottles at room temperature.

Stability of an extemporaneous alcohol-free melatonin suspension.

PURPOSE: The stability of alcohol-free oral suspensions of melatonin 1 mg/mL, extemporaneously prepared from two commercially available melatonin tablet products, was studied. METHODS: Four 1-mg/mL melatonin suspensions were prepared. Formulations A and B contained 20 crushed 3-mg tablets of melatonin combined with a 1:1 mixture of Ora-Plus and either Ora-Sweet or Ora-Sweet SF to produce a volume of 60 mL. Formulations C and D were prepared by crushing 20 combination tablets containing melatonin 3 mg and pyridoxine hydrochloride 10 mg and then combining the powder with a 1:1 mixture of Ora-Plus and either Ora-Sweet or Ora-Sweet SF to produce a 60-mL volume. The suspensions were prepared in triplicate and stored at room temperature in amber plastic prescription bottles. Immediately after preparation and on days 7, 15, 30, 60, and 90, the samples were assayed in duplicate by stability-indicating high-performance liquid chromatography (HPLC). The samples were also evaluated for any changes in color, odor, and taste. RESULTS: HPLC analysis demonstrated that at least 94% of the initial melatonin concentration in formulations A and B, and at least 98% of that in formulations C and D, remained throughout the 90-day study period. Detectable changes in color, odor, or taste occurred in all of the formulations. CONCLUSION: Extemporaneously prepared, alcohol-free, 1-mg/mL suspensions of melatonin and melatonin-pyridoxine hydrochloride in a 1:1 mixture of Ora-Plus and either Ora Sweet or Ora Sweet SF were stable for at least 90 days when stored in 2-oz amber plastic bottles at room temperature.

Stability of extemporaneously prepared acetylcysteine 1% and 10% solutions for treatment of meconium ileus.

PURPOSE: The stability of extemporaneously prepared acetylcysteine 1% and 10% solutions for treatment of meconium ileus was evaluated. METHODS: Acetylcysteine 1% (10-mg/mL) and 10% (100-mg/mL) solutions were prepared by mixing 3 and 10 mL, respectively, of commercially available 20% acetylcysteine solution with a sufficient quantity of bacteriostatic 0.9% sodium chloride for injection to make a final volume of 60 mL. Three identical samples of each concentration were prepared, placed in 2-oz amber plastic prescription bottles, and stored at 20-25 °C. Samples were assayed in duplicate using high-performance liquid chromatography and inspected for changes in color, odor, and pH immediately after preparation and at 7, 14, 30, 60, and 90 days. Stability was defined as retention of at least 90% of the initial concentration. RESULTS: At least 90% of the initial concentration of acetylcysteine was retained in both formulations for 60 days. No appreciable change from the initial pH occurred in the acetylcysteine 1% or 10% solution during the first 60 days, but there was a notable change in pH after 90 days in both formulations. Neither solution was stable at day 90. There was no detectable change in color at 90 days; however, the odor of hydrogen sulfide was more pungent than on previous study days. CONCLUSION: Extemporaneously prepared solutions of acetylcysteine 1% (10 mg/mL) and 10% (100 mg/mL) prepared with bacteriostatic 0.9% sodium chloride for injection were stable for at least 60 days when stored in plastic amber bottles at room temperature.

Airway-rehydrating agents for the treatment of cystic fibrosis: past, present, and future.

OBJECTIVE: To review and evaluate airway-rehydrating agents used for the treatment of cystic fibrosis (CF). DATA SOURCES: Literature was retrieved through MEDLINE (1977-August 2010), Cochrane Library, and International Pharmaceutical Abstracts (1977-August 2010). Search terms used included hypertonic saline, inhaled mannitol, denufosol, Moli1901, lancovutide, and cystic fibrosis. Reference citations from selected articles were reviewed. STUDY SELECTION AND DATA EXTRACTION: All articles published in English identified from the data sources were evaluated for inclusion. Clinical trials in humans and relevant review articles were evaluated for each airway-rehydrating agent. DATA SYNTHESIS: Use of airway-rehydrating agents for the treatment of CF is an expanding area. Hypertonic saline (7% NaCl) is currently the only commercially available airway-rehydrating agent recommended for chronic therapy in patients with CF and is being evaluated in younger patients. Inhaled mannitol is an investigational dry-powder inhalation agent that improves mucus clearance in a similar manner to hypertonic saline and produced a statistically significant increase in forced expiratory volume in 1 second in a Phase 3 trial. Denufosol, a P2Y(2) agonist, rehydrates the airway surface liquid bypassing the basic CF transmembrane conductance regulator (CFTR) protein defect. It produces improvement in pulmonary function and is being further evaluated in a Phase 3 trial. Lancovutide (Moli1901) is an investigational agent in early-phase trials that activates a calcium-dependent chloride channel, allowing chloride to enter the airway. CONCLUSIONS: Hypertonic saline is the primary airway-rehydrating agent used in the treatment of CF. Inhaled mannitol may become an alternative to hypertonic saline since it is faster and easier to administer. It remains unclear whether denufosol and lancovutide will be synergistic or antagonistic with hypertonic saline. Both agents have a unique mechanism of action that bypasses the basic CFTR defect.

Stability of an extemporaneously prepared clopidogrel oral suspension.

PURPOSE: The stability of an extemporaneously prepared clopidogrel oral suspension was studied. Methods Clopidogrel oral suspension (5 mg/mL) was prepared using clopidogrel bisulfate tablets, Ora-Plus, and Ora-Sweet. Six 2-oz samples were prepared; three were stored at room temperature and three under refrigeration. One milliliter was withdrawn from each sample, diluted to 10 mL with methanol, and exposed to high-frequency sound waves in a water bath to ensure complete dissolution of clopidogrel. A 300-microL sample was then withdrawn, diluted with mobile phase to an expected concentration of 15 microg/mL, and assayed in duplicate using high- performance liquid chromatography immediately after preparation and at 7, 14, 28, and 60 days. The stability of the clopidogrel suspension was determined by calculating the percentage of the initial concentration remaining on each test day. Stability was defined as retention of at least 90% of the initial concentration. RESULTS: At least 97% of the initial clopidogrel concentration remained throughout the 60-day study period, regardless of storage conditions. There were no detectable changes in color, odor, taste, or pH and no visible microbial growth in any sample. The preparation was palatable, with a slightly gritty consistency and a slightly bitter aftertaste; the bitterness intensified slightly between 28 and 60 days but remained fairly mild. CONCLUSION: Extemporaneously compounded suspensions of clopidogrel, 5 mg/mL, in a 1:1 mixture of Ora-Plus and Ora-Sweet were stable for at least 60 days when stored in amber plastic bottles at room temperature and under refrigeration.

Stability of extemporaneously prepared rifaximin oral suspensions.

PURPOSE: The stability of extemporaneously prepared rifaximin oral suspensions was studied. METHODS: An oral suspension of rifaximin 20 mg/mL was prepared by thoroughly grinding six 200-mg tablets of rifaximin in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of either Ora-Sweet or Ora-Sweet SF were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of each formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and were stored at room temperature (23-25 degrees C). A 1-mL sample was withdrawn from each of the six bottles with a micropipette immediately after preparation and at 7, 15, 30, and 60 days. After further dilution to an expected concentration of 20 microg/mL with mobile phase, the samples were assayed in duplicate using stability-indicating high-performance liquid chromatography. The samples were visually examined for any color change and pH was tested on each day of analysis. Stability was determined by evaluating the percentage of the initial concentration remaining at each time point and defined as retention of at least 90% of the initial concentration of rifaximin. RESULTS: At least 99% of the initial rifaximin remained throughout the 60-day study period in both preparations. There were no detectable changes in color, odor, taste, or pH and no visible microbial growth in any sample. CONCLUSION: Extemporaneously prepared suspensions of rifaximin 20 mg/mL in 1:1 mixtures of Ora-Plus with either Ora-Sweet or Ora-Sweet SF were stable for at least 60 days when stored in 2-oz amber plastic bottles at room temperature.

Stability of extemporaneously prepared moxifloxacin oral suspensions.

PURPOSE: The stability of extemporaneously prepared moxifloxacin oral suspensions was studied. METHODS: An oral suspension of moxifloxacin 20 mg/mL was prepared by thoroughly grinding three 400-mg tablets of moxifloxacin in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of either Ora-Sweet or Ora-Sweet SF were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of each formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and were stored at room temperature (23-25 degrees C). A 1-mL sample was withdrawn from each of the six bottles with a micropipette immediately after preparation and at 7, 14, 28, 60, and 90 days. After further dilution to an expected concentration of 8 microg/ mL with sample diluent, the samples were assayed in duplicate by stability-indicating high-performance liquid chromatography. Stability was defined as the retention of at least 90% of the initial concentration. RESULTS: At least 99% of the initial moxifloxacin remained throughout the 90-day study period in both preparations. There were no detectable changes in color, odor, taste, and pH and no visible microbial growth in any sample. CONCLUSION: Extemporaneously compounded suspensions of moxifloxacin 20 mg/mL in a 1:1 mixture of Ora-Plus and Ora-Sweet or Ora-Sweet SF were stable for at least 90 days when stored in 2-oz amber plastic bottles at room temperature.

Stability of a flavored formulation of acetylcysteine for oral administration.

PURPOSE: The chemical and physical stability of a flavored solution of acetylcysteine stored at room temperature or under refrigeration for up to 35 days in amber plastic prescription bottles were studied. METHODS: The flavored acetylcysteine solution was prepared by adding a sweetener and a strawberry creamsicle flavoring to acetylcysteine solution 10% to a final nominal acetylcysteine concentration of 86.5 mg/mL. Six identical samples of the formulation were prepared in amber plastic prescription bottles. Three bottles were stored at room temperature (23-25 degrees C) and the other three were stored in the refrigerator (3-5 degrees C). Immediately after preparation and at 7, 14, 21, 28, and 35 days, each sample was assayed in duplicate by high- performance liquid chromatography. Stability was defined as the retention of at least 90% of the initial drug concentration. RESULTS: On day 35, the refrigerated acetylcysteine samples retained 96.7% of their initial concentration. The samples stored at room temperature retained 92.5% of their initial concentration. CONCLUSION: A flavored oral formulation of acetylcysteine 86.5 mg/mL was stable for at least 35 days when stored at room temperature and in the refrigerator in amber plastic bottles.

Stability of metoprolol tartrate injection 1 mg/mL undiluted and 0.5 mg/mL in 0.9% sodium chloride injection and 5% dextrose injection.

PURPOSE: The stability of metoprolol tartrate injection 1 mg/mL undiluted and 0.5 mg/mL in 0.9% sodium chloride injection and 5% dextrose injection was studied. METHODS: Sample set A contained 50 mL of Metoprolol Tartrate Injection, USP, 1 mg/mL transferred directly from the vials. Sample set B contained 50 mL of metoprolol 0.5 mg/mL diluted with 0.9% sodium chloride injection, and sample set C contained 50 mL of metoprolol 0.5 mg/mL diluted with 5% dextrose. All samples were prepared in triplicate and stored at room temperature. The stability of the samples was analyzed in duplicate using stability-indicating high-performance liquid chromatography immediately after preparation and at 6, 12, 18, 24, and 30 hours. The samples were assessed for pH and inspected for color and visible precipitation changes. The stability of metoprolol was determined by evaluating the percentage of the initial concentration remaining at each time interval. Stability of the product was defined as retention of 90% of the initial concentration. RESULTS: The mean +/- S.D. initial concentration in sample sets A, B, and C was 1.006 +/- 0.009 mg/mL, 0.498 +/- 0.002 mg/mL, and 0.499 +/- 0.002 mg/mL, respectively. Throughout the 30-hour study period, at least 99% of the initial concentration of metoprolol tartrate remained in all three preparations at all time points. No appreciable changes in pH occurred. No changes in color and no visible precipitate or microbial growth were detected. CONCLUSION: Metoprolol tartrate injection 1 mg/mL undiluted and 0.5 mg/mL in 0.9% sodium chloride injection and 5% dextrose injection were stable at room temperature for at least 30 hours.

Stability of 70% alcohol solutions in polypropylene syringes for use in ethanol-lock therapy.

PURPOSE: The stability of 70% alcohol solutions in two diluents stored at 23-25 degrees C over 14 days in two brands of polypropylene syringes was studied. METHODS: A 70% alcohol solution was aseptically prepared by adding Dehydrated Alcohol Injection, USP, to Sterile Water for Injection, USP (SWI), in an evacuated i.v. bag. This process was repeated with Bacteriostatic Water for Injection, USP (BWI). Identical 3-mL samples of each of the two solutions were drawn into 10-and 12-mL syringes (each a different brand) and stored at 23-25 degrees C. The stability of the samples was analyzed with high-performance liquid chromatography immediately after preparation and at 3, 7, and 14 days. RESULTS: At least 96% of the initial concentration of alcohol remained throughout the 14-day study period in all syringes. There were no detectable changes in color or volume and no visible evidence of precipitation or microbial growth in any sample. CONCLUSION: Extemporaneously prepared 70% alcohol solutions in SWI or BWI were stable for at least 14 days at 23-25 degrees C in two brands of polypropylene syringes.

Stability of vecuronium in sterile water for injection stored in polypropylene syringes for 21 days.

PURPOSE: The stability of vecuronium bromide 1 mg/mL in preservative-free sterile water for injection for up to 21 days was studied. METHODS: A vecuronium bromide 1-mg/mL solution was prepared by diluting 15 vials of 10-mg Vecuronium Bromide for Injection, USP, powder with preservative-free sterile water for injection and adding the solution to an evacuated i.v. bag. Identical 10-mL volumes of the solution were prepared and stored at 23-25 or 3-5 degrees C in polypropylene syringes. The stability of vecuronium was analyzed in triplicate with stability-indicating high-performance liquid chromatography immediately after preparation of solutions and at 3, 7, 14, and 21 days. The samples were also inspected for volume and color change and for visible precipitation and microbial growth. RESULTS: The percentage of the initial vecuronium bromide concentration remaining at each time point was greater than 100% at both 23-25 and 3-5 degrees C. There were no detectable changes in volume or color and no precipitation or visible microbial growth. CONCLUSION: Vecuronium bromide in an extemporaneously prepared solution in preservative-free sterile water for injection was stable for at least 21 days at 23-25 or 3-5 degrees C.

Stability of partial doses of omeprazole-sodium bicarbonate oral suspension.

BACKGROUND: Omeprazole-sodium bicarbonate powder for oral suspension has recently been marketed. The manufacturer provides no information regarding the acceptability of using partial doses and recommends that the reconstituted suspension be administered immediately after preparation. OBJECTIVES: To determine the stability of the powder for oral suspension over 45 days, evaluate the stability of a partial dose (<20 mg) following exposure to Simulated Gastric Fluid USP (SGF) over 2 hours, and determine the feasibility of administering the suspension through neonatal and pediatric nasogastric feeding tubes compared with lansoprazole. METHODS: Three identical samples of omeprazole-sodium bicarbonate suspension 2 mg/mL were stored in the refrigerator (3-5 degrees C) and assayed by high-performance liquid chromatography immediately after preparation and at 7, 15, 30, and 45 days. Stability of a 1 mg/kg dose with an estimated volume of SGF for a simulated 12.7 kg pediatric patient was determined in triplicate over 2 hours at 37 degrees C. The ability to administer a typical dose of omeprazole suspension and lansoprazole suspension (microgranules and water compounded from lansoprazole oral disintegrating tablets) was assessed in triplicate using 3 different sizes of neonatal/pediatric nasogastric feeding tubes. RESULTS: At least 98% of the initial concentration of omeprazole remained throughout the 45 day study period in all suspensions. The suspension maintained at least 93% of the initial concentration following exposure to SGF for 2 hours. The lansoprazole bead mixture partially clogged the 6 French feeding tube and completely clogged the 5 French feeding tube. The omeprazole-sodium bicarbonate suspension was easily administered through all 3 sizes of neonatal/pediatric feeding tubes. CONCLUSIONS: Omeprazole-sodium bicarbonate suspension 2 mg/mL prepared from 20 mg packets was stable for at least 45 days when stored at 3-5 degrees C. A partial dose of 12.7 mg was stable following exposure to SGF for 2 hours at 37 degrees C. This suspension can be easily administered through 5, 6, and 8 French neonatal/pediatric feeding tubes and, when taking time and ease of preparation into account, it is cost competitive with simple omeprazole suspension.

Stability of extemporaneously prepared sodium phenylbutyrate oral suspensions.

PURPOSE: In an effort to minimize barriers to compliance and adherence and to improve the accuracy of dosage measurement, sugar-containing and sugar-free sodium phenylbutyrate suspensions were formulated, and the stability of these products over a 90-day period was determined. METHODS: An oral suspension of sodium phenylbutyrate 200 mg/mL was prepared by thoroughly grinding 12 g of Sodium Phenylbutyrate Powder, USP, in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of either Ora-Sweet or Ora-Sweet SF were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of each formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and were stored at room temperature. A 500-microL sample was withdrawn from each of the six bottles with a micropipette immediately after preparation and at 7, 14, 28, 60, and 90 days. After further dilution to an expected concentration of 100 microg/mL with the mobile phase, the samples were assayed by high-performance liquid chromatography. Stability was defined as the retention of at least 90% of the initial concentration. RESULTS: At least 95% of the initial sodium phenylbutyrate concentration remained throughout the 90-day study period in both preparations. There were no detectable changes in color, odor, taste, and pH and no visible microbial growth in any sample. CONCLUSION: Extemporaneously compounded suspensions of sodium phenylbutyrate, 200 mg/mL, in a 1:1 mixture of Ora-Plus and Ora-Sweet or Ora-Sweet SF were stable for at least 90 days when stored in 2-oz amber plastic bottles at room temperature.

Stability of an extemporaneously prepared alcohol-free phenobarbital suspension.

PURPOSE: The physical and chemical short-term stability of alcohol-free, oral suspensions of phenobarbital 10 mg/mL prepared from commercially available tablets in both a sugar and a sugar-free vehicle was assessed at room temperature. METHODS: Phenobarbital oral suspension 10 mg/mL was prepared by crushing 10 60-mg tablets of phenobarbital with a mortar and pestle. A small amount of Ora-Plus was added to the phenobarbital powder to sufficiently wet the particles. A 1:1 mixture of Ora-Plus and either Ora-Sweet or Ora-Sweet SF was combined with the phenobarbital powder to produce a final volume of 60 mL. Three identical samples of each of the two different formulations were prepared and stored at room temperature in 2-oz amber plastic bottles. Immediately after preparation and at 15, 30, 60, and 115 days, the samples were assayed in duplicate by stability-indicating high-performance liquid chromatography. The samples were tasted and inspected for color and odor changes. The percent of the initial concentration remaining at each study time for each phenobarbital suspension was determined. Stability was defined as the retention of at least 90% of the initial concentration. RESULTS: There were no detectable changes in color, odor, and taste and no visible microbial growth in any sample. At least 98% of the initial phenobarbital concentration remained throughout the 115-day study period in both preparations. CONCLUSION: An extemporaneously prepared alcohol-free suspension of phenobarbital 10 mg/mL in a 1:1 mixture of Ora-Plus and Ora-Sweet or Ora-Sweet SF was stable for at least 115 days when stored in 2-oz amber plastic bottles at room temperature.

Influence of an interactive computer-based inhaler technique tutorial on patient knowledge and inhaler technique.

BACKGROUND: Patient knowledge of correct inhaler technique is essential in the treatment of pulmonary disease. Computer delivery of educational content may augment existing teaching efforts. OBJECTIVE: To determine whether a computer-based tutorial on inhaler technique could improve patients' knowledge and ability to correctly demonstrate inhaler technique. METHODS: A total of 34 adults with pulmonary disease and experience using inhalers were randomized into the control or intervention groups. The intervention group viewed the tutorial, after which they demonstrated their inhaler technique and completed an Inhaler Technique Knowledge Test. Control group patients, who did not view the tutorial, were also evaluated on their demonstrated inhaler technique and technique knowledge. Additional information obtained included demographics, illness and treatment history, and patients' use of computers. Lastly, all patients who viewed the tutorial completed a brief questionnaire eliciting tutorial feedback. Control group patients were invited to view the tutorial after other data collection was complete. The 2 principal outcomes were the observed inhaler technique score and the inhaler technique knowledge test score. Comparisons between groups were conducted using Student's t-test and chi(2) test, with a p value less than 0.05 considered statistically significant. RESULTS: Eighteen subjects were enrolled in the computer group; 16 were in the control group. The intervention group demonstrated significantly better inhaler technique, with a mean Observed Inhaler Technique Score of 88.3 +/- 12.3 compared with 67.4 +/- 19.2 for the control group (p = 0.001). The intervention group also scored significantly higher on the Inhaler Technique Knowledge Test, with a score of 80.9 +/- 17.0 versus 67.4 +/- 11.8 for the control group (p = 0.01). Overall, the program appeared acceptable to patients. CONCLUSIONS: Patients in the tutorial group demonstrated better inhaler technique and scored higher on the Inhaler Technique Knowledge Test compared with those in a control group. This tutorial may be a useful educational tool to enhance patient education regarding inhaler technique.