What is discriminating media? How can u justify/select that
which media (pH etc...)is suitable for your dissolution study
of your compound?
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Answer Posted / bhupal24
A releasing medium is the one that promotes
solubilization of the drug substance from a pharmaceutical
dosage form without further qualification.
When selecting the dissolution medium, physical and
chemical data for the drug substance and drug product need
to be considered,selecting the composition of the medium,
the influence of buffers, molarity, pH, and surfactants
on the solubility and stability of the drug also need to be
evaluated,
The most common dissolution medium is dilute
hydrochloric acid, however other media commonly used
includes buffers in the physiologic pH range of 1.2 to 7.5,
simulated gastric or intestinal fluid (with or without
enzymes), water, and surfactants (with or without acids or
buffers)such as polysorbate 80, sodium lauryl sulfate, and
bile salts. The use of aqueous-organic solvent mixtures,
while generally discouraged, can also be used if justified.
Enzymes are also sometimes used in the media when testing
gelatin capsule products.
Media volumes are typically in the range of 500-1000
mL, with 900 mL the most common volume. Volumes as high as
2-4 L have been used, and as low as 100 mL for high potency
(low dosage strength) drug formulations.
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