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The topic of drug stability
will be explored through
the fundamental importance of
drug stability in
maintaining medicine,
efficacy and safety,
including how
instability can lead to
decreased potency or
increased toxicity.
We will discuss
the major chemical
and physical
degradation pathways
and their implications
for patient health.
The lecture will outline
regulatory requirements,
essential testing methods, and
practical formulation strategies
to enhance stability.
This knowledge ensures that
pharmaceuticals remain safe,
effective, and reliable
for patient use.
Drug stability is crucial
in pharmaceutical science,
affecting both the efficacy
and safety of medicines.
It refers to a product's ability
to maintain its physical,
chemical, biological,
and microbiological qualities
throughout its shelf life.
If breakdown
products accumulate,
potency may decrease or
toxicity may increase.
Regulatory authorities require
stability data before approval.
This lecture explores
degradation pathways,
patient care implications,
testing methods, and
formulation strategies
to ensure medicines
remain effective.
Let's explore the main mechanisms
by which drugs degrade.
Chemically, drugs are
susceptible to hydrolysis,
oxidation, reduction,
photolysis, and racemization.
Reactions catalyzed by light,
heat, pH, or impurities.
Esters can hydrolyze
in moisture,
while phenolic
drugs may oxidize.
Physically, drugs may lose
stability through changes
in crystalline form,
precipitation, aggregation,
