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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 °C) and the other three were stored in the refrigerator (3-5 °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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 mg/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. [ABSTRACT FROM AUTHOR]

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 mg/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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 °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 mg/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. [ABSTRACT FROM AUTHOR]

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 °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 μg/ 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose. The stability of 70% alcohol solutions in two diluents stored at 23-25 °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 °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 °C in two brands of polypropylene syringes. [ABSTRACT FROM AUTHOR]

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 °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 °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 °C. [ABSTRACT FROM AUTHOR]

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-μL 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 μg/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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The stability of dolasetron 10 mg/mL over 90 days when prepared as an oral liquid formulation from commercially available tablets in both strawberry syrup and a sugar-free vehicle was studied. A liquid suspension of dolasetron mesy- late 10 mg/mL was prepared from commercially available dolasetron tablets, Ora-Plus, and Ora-Sweet or strawberry syrup. Six samples of each formulation were prepared and stored in amber plastic bottles. Three samples of each formulation were refrigerated (3-5 °C) and three were stored at room temperature (23-25 °C). A 1-mL sample was withdrawn from each of the 12 bottles immediately and after 7, 14, 30, 60, and 90 days. After further dilution to an expected concentration of 10 μg/mL with sample diluent, the solutions were assayed in duplicate using high-performance liquid chromatography. The samples were also inspected for color and odor changes, and the pH of each sample was determined. The stabilityindicating capability of the dolasetron assay was determined by forced degradation of four separate 10-mg/mL samples exposed to direct sunlight for 90 days. There were no detectable changes in color, odor, or taste and no visible microbial growth in any sample. At least 98% of the initial dolasetron concentration remained throughout the 90-day study period for all samples. An extemporaneously compounded oral liquid preparation of dolasetron mesylate 10 mg/mL in a 1:1 mixture of Ora-Plus and strawberry syrup or Ora-Sweet was stable for at least 90 days when stored at 3-5 or 23-25 °C. [ABSTRACT FROM AUTHOR]

Purpose. The stability of an extemporaneouslyprepared clopidogrel oral suspensionwas studied.Methods. Clopidogrel oral suspension (5mg/mL) was prepared using clopidogrelbisulfate tablets, Ora-Plus, and Ora-Sweet.Six 2-oz samples were prepared; threewere stored at room temperature andthree under refrigeration. One milliliterwas withdrawn from each sample, dilutedto 10 mL with methanol, and exposed tohigh-frequency sound waves in a waterbath to ensure complete dissolution ofclopidogrel. A 300-mL sample was thenwithdrawn, diluted with mobile phaseto an expected concentration of 15 mg/mL, and assayed in duplicate using highperformance liquid chromatographyimmediately after preparation and at 7,14, 28, and 60 days. The stability of theclopidogrel suspension was determinedby calculating the percentage of the initialconcentration remaining on each test day.Stability was defined as retention of atleast 90% of the initial concentration.Results. At least 97% of the initial clopidogrelconcentration remained throughoutthe 60-day study period, regardless of storageconditions. There were no detectablechanges in color, odor, taste, or pH and novisible microbial growth in any sample. Thepreparation was palatable, with a slightlygritty consistency and a slightly bitter aftertaste;the bitterness intensified slightlybetween 28 and 60 days but remainedfairly mild.Conclusion. Extemporaneously compoundedsuspensions of clopidogrel, 5 mg/mL, in a 1:1 mixture of Ora-Plus and Ora-Sweet were stable for at least 60 days whenstored in amber plastic bottles at roomtemperature and under refrigeration. [ABSTRACT FROM AUTHOR]