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R S Morosco

Publications and source records attributed to R S Morosco.

27 records · Page 2Linked to original sources

Stability of spironolactone in an extemporaneously prepared suspension at two temperatures.

OBJECTIVE: To determine the stability of spironolactone in an extemporaneously prepared suspension at 22 and 4 degrees C over a three-month storage period. DESIGN: Spironolactone suspension (1 mg/mL) was prepared in syrup NF, carboxymethylcellulose, and purified water USP. The suspension was stored in ten amber glass prescription bottles; five were stored at 22 degrees C and five at 4 degrees C. Samples were drawn from each bottle and analyzed in duplicate (n = 10) on days 0, 7, 14, 28, 42, 56, 70, and 91. Spironolactone concentrations were measured by a reproducible and stability-indicating HPLC method. Inspection of visual and pH changes also was performed on each study day. RESULTS: The mean concentration of spironolactone was always higher than 98 percent of its initial concentration. The pH and appearance of the suspension did not change substantially. CONCLUSIONS: Spironolactone was stable in a suspension containing syrup, carboxymethylcellulose, and purified water for three months during storage in amber glass bottles at both 22 and 4 degrees C.

Carboxymethylcellulose Sodium↗

Stability of ceftazidime (with arginine) stored in plastic syringes at three temperatures.

The stability of ceftazidime (with arginine) stored in plastic syringes at three temperatures was studied. Ceftazidime (with arginine) was reconstituted with sterile water for injection to a concentration of 100 mg/mL and transferred to plastic syringes. Syringes were stored at 22 degrees C for 24 hours; at 4 degrees C for 7 or 10 days, then at 22 degrees C for 24 hours; or at -20 degrees C for 91 days, then at 22 degrees C for 24 hours or at 4 degrees C for seven days followed by 22 degrees C for 24 hours. Ceftazidime concentration was measured at various times by using a stability-indicating high-performance liquid chromatographic method. At each sampling time, each syringe was visually inspected and the pH of each solution was measured. Mean ceftazidime concentration remained > 90% of initial concentration at all storage conditions. Although during storage the color of the solutions changed from light straw to dark yellow and the pH decreased, no precipitate was visually detected and no peaks for degradation products appeared on the chromatograms. Ceftazidime 100 mg/mL (with arginine) in sterile water for injection was stable when stored in plastic syringes for up to 24 hours at 22 degrees C, for 10 days at 4 degrees C followed by up to 24 hours at 22 degrees C, and for 91 days at -20 degrees C followed by up to 24 hours at 22 degrees C or by 7 days at 4 degrees C and up to 24 hours at 22 degrees C.

Arginine↗

Stability of amlodipine besylate in two liquid dosage forms.

OBJECTIVE: To determine the stability of amlodipine besylate in two liquid dosage forms under refrigeration and at room temperature. DESIGN: Commercially available amlodipine tablets (Norvasc-Pfizer) were used to prepare two suspensions: one in extemporaneously prepared 1% methylcellulose in syrup (1:1), and another in equal volumes of commercially available OraPlus/OraSweet. Each suspension containing amlodipine 1 mg/mL was stored in 10 plastic prescription bottles; 5 were stored at 4 degrees C and 5 at 25 degrees C. Samples were collected immediately after preparation (day 0) and on days 7, 14, 28, 42, 56, 70, and 91. Amlodipine concentration was measured by stability-indicating HPLC method (n = 15). SETTING: Research laboratory at Children's Hospital. MAIN OUTCOME MEASURES: Physical and chemical stability (> 90% of the initial concentration) of amlodipine in the two extemporaneously prepared suspensions during storage in plastic prescription bottles at 4 degrees C and 25 degrees C. RESULTS: Observed mean concentrations exceeded 90% of the initial concentrations in both suspensions for 91 days at 4 degrees C and 56 days at 25 degrees C. No noticeable change in physical appearance or odor was observed; pH changed slightly in the methylcellulose-containing formulation stored at 25 degrees C. CONCLUSION: Amlodipine was stable in two suspensions when stored in plastic prescription bottles for 91 days at 4 degrees C or 56 days at 25 degrees C. These formulations may be considered for pediatric or elderly patients who are unable to swallow tablets. The liquid dosage form would also permit accurate administration of amlodipine doses to infants and young children based on their body weight.

Amlodipine↗

Stability of dapsone in two oral liquid dosage forms.

OBJECTIVE: Dapsone use in pediatric patients is increasing; however, the currently available tablet dosage form cannot be used in young children. The objective of our study was to determine the stability of dapsone in two oral suspensions stored at two temperatures. METHODS: Commercially available dapsone tablets (25 mg) were used to prepare the suspensions: the first in simple syrup and water with citric acid, the second in 1:1 Ora Sweet:Ora Plus to yield a concentration of 2.0 mg/mL. The dosage forms were stored in 10 amber plastic prescription bottles. Five were stored at 25 degrees C and five at 4 degrees C. Three samples were taken from each of five bottles at 0, 7, 14, 28, 42, 56, 70, and 91 days (n = 15). Dapsone concentrations in each sample were measured in duplicate by a validated and stability-indicating HPLC method; the pH of each sample was also determined. The drug was considered stable if the mean concentration > or =90% of the original concentration. RESULTS: The mean concentrations of dapsone were >95% of the initial concentrations for 91 days at both 4 degrees C and 25 degrees C in each suspension. There was a slight darkening of the samples stored at 25 degrees C. CONCLUSIONS: Dapsone was stable in two suspensions prepared from commercially available tablets for at least three months at 4 degrees C and 25 degrees C.

Administration, Oral↗

Development of two stable oral suspensions of levodopa-carbidopa for children with amblyopia.

PURPOSE: To develop stable liquid dosage forms of levodopa-carbidopa for use in children with amblyopia. METHODS: Levodopa (100 mg) and carbidopa (25 mg) tablets were used to prepare the suspensions at 5 and 1.25 mg/mL, respectively. For each suspension, five bottles were stored at 25 degrees C and five at 4 degrees C. Three samples were taken from each bottle at 0, 7, 14, 28, 42, 56, 70, and 91 days (n=15). Levodopa-carbidopa concentrations for each sample were measured in duplicate by validated and stability-indicating high-performance liquid chromatographic method. RESULTS: The mean concentrations of levodopa-carbidopa in Ora Plus/Ora Sweet suspensions were 96% and 92% of the initial concentrations for 28 days at 25 degrees C, and 94% and 93% for 42 days at 4 degrees C. In the suspension containing ascorbic acid, the mean concentrations of levodopa-carbidopa were above 93% and 92% for 14 days at 25 degrees C, and 93% and 92% for 28 days at 4 degrees C. This liquid formulation was administered to 15 children (mean age: 5.6+/-1.4 years) with amblyopia. The number and type of adverse effects were similar in the levo-dopa-carbidopa versus placebo group. CONCLUSION: Levodopa-carbidopa in extemporaneous suspensions prepared in Ora Plus and Ora Sweet were stable for 28 days when stored at 25 degrees C and for 42 days at 4 degrees C. Our data suggest our liquid formulation may be used safely in children with amblyopia.

Administration, Oral↗