Stability of an extemporaneously prepared tadalafil suspension from freemexy's blog
The stability of an extemporaneously prepared tadalafil oral suspension
was studied. An oral suspension of tadalafil 5 mg/mL was prepared by
thoroughly grinding 15 20-mg Cialis powder
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 A 1-mL sample was withdrawn from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.
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. 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.
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