What is discriminating media? How can u justify/select that
which media (pH etc...)is suitable for your dissolution study
of your compound?
Answers were Sorted based on User's Feedback
Answer / mukesh patel
discriminating media is the media by which we can
diffentiate between two formulation or between innowator
and inhouse formulation.it is the media in which sink
condition is not mandatory if properly justified as per
usp.it might be official media or other than official media.
Is This Answer Correct ? | 16 Yes | 5 No |
Answer / pramod
Discriminating media is a media which shows variation in results with different formulations.I.e.Chang in excipients,excipients composition etc
Is This Answer Correct ? | 11 Yes | 0 No |
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.
Is This Answer Correct ? | 9 Yes | 2 No |
Answer / atul
which abble to differecent when we unfortunate any change
in formulation.
Is This Answer Correct ? | 5 Yes | 0 No |
Answer / bhupal24
A releasing medium is the one that promotes solubilization
of the drug substance from a pharmaceutical dosage form
without further qualification. A discriminating medium is
the one where the more subtle aspects of the pharmaceutical
dosage form can be differentiated by observing their
individual rates of dissolution. Particle size,crystal
form,salt form,presence of water of hydration,differences
in the manufacturing processes,and so forth,may all affect
the dissolution performance.The dissolution test should be
sensitive to any attribute that may affect the in vivo
performance of the product.
Is This Answer Correct ? | 4 Yes | 7 No |
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