Stability of extemporaneously prepared oxandrolone oral suspensions.

Title

Stability of extemporaneously prepared oxandrolone oral suspensions.

Creator

Johnson Cary E; Cober Mary Petrea; Hawkins Katherine A; Julian Justin D

Publisher

American Journal of Health-System Pharmacy

Date

2011
2011-03-15

Description

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 After thorough but gentle shaking by hand to prevent foaming, a 1-mL sample was withdrawn from each of the six bottles, diluted with mobile phase to an expected concentration of 200 µg/mL, and assayed in duplicate by injecting 5 µL into the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.

Subject

Human; Descriptive Statistics; Administration; Oral; Drug Compounding; Suspensions; Acid-Base Equilibrium; Androgens – Administration and Dosage; Weight Gain – Chemically Induced

Identifier

Rights

Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).

Pages

519–521

Issue

6

Volume

68

Citation

Johnson Cary E; Cober Mary Petrea; Hawkins Katherine A; Julian Justin D, “Stability of extemporaneously prepared oxandrolone oral suspensions.,” NEOMED Bibliography Database, accessed September 17, 2021, https://neomed.omeka.net/items/show/6005.

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