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1037656 
Journal Article 
Stability of an extemporaneously prepared tadalafil suspension 
Pettit, RS; Johnson, CE; Caruthers, RL 
2012 
Yes 
American Journal of Health-System Pharmacy
ISSN: 1079-2082
EISSN: 1535-2900 
69 
7 
592-594 
English 
22441791 
WOS:000304124000016 
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 A 1-mL sample was withdrawn from each of the three bottles with a micropipette immediately after preparation and at 7, 14, 28, 57, and 91 days.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. 
Chromatography, liquid; Color; Compounding; Concentration; Hydrogen ion concentration; Odors; Stability; Storage; Suspensions; Tadalafil; Taste; Temperature; Vasodilator agents; Vehicles 
IRIS
• Methanol (Non-Cancer)
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