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Text
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URL Address
<a href="http://doi.org/10.2146/ajhp100225" target="_blank" rel="noreferrer noopener">http://doi.org/10.2146/ajhp100225</a>
Pages
519–521
Issue
6
Volume
68
Dublin Core
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Title
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Stability of extemporaneously prepared oxandrolone oral suspensions.
Publisher
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American Journal of Health-System Pharmacy
Date
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2011
2011-03-15
Subject
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Human; Descriptive Statistics; Administration; Oral; Drug Compounding; Suspensions; Acid-Base Equilibrium; Androgens – Administration and Dosage; Weight Gain – Chemically Induced
Creator
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Johnson Cary E; Cober Mary Petrea; Hawkins Katherine A; Julian Justin D
Description
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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 After thorough but gentle shaking by hand to prevent foaming, a 1-mL sample was withdrawn from each of the six bottles, diluted with mobile phase to an expected concentration of 200 µg/mL, and assayed in duplicate by injecting 5 µL into the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.
Identifier
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<a href="http://doi.org/10.2146/ajhp100225" target="_blank" rel="noreferrer noopener">10.2146/ajhp100225</a>
Rights
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Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2011
Acid-Base Equilibrium
Administration
American Journal of Health-System Pharmacy
Androgens – Administration and Dosage
Cober Mary Petrea
Department of Pharmaceutical Sciences
Department of Pharmacy Practice
Descriptive Statistics
Drug Compounding
Hawkins Katherine A
Human
Johnson Cary E
Julian Justin D
NEOMED College of Pharmacy
Oral
Suspensions
Weight Gain – Chemically Induced