chemical stability 1

What is stability?

• Ability to retain original characteristics

• During manufacture

• During transport

• During storage

• During use

What does product stability refer to?

• Ability of a product to remain stable

• Maintains quality, safety, and effectiveness over time

Product stability issues where the observed problem is not the root cause

• If a surfactant breaks down (chemically or by microbes), the emulsion can crack (separate).

• If an antimicrobial agent breaks down by hydrolysis, it won’t protect the product anymore, so microorganisms can grow. I

• f the active ingredient sticks to the container, it looks like the active agent is lost, even though it’s just adsorbed onto the container.

What is physical instability in pharmaceutical products?

• Physical changes in a product

• No chemical degradation

• Affects bioavailability, dosage form, and patient acceptability

How does physical instability affect bioavailability?

• Alteration of drug solubility

• Loss of API through evaporation

• Non-uniform drug distribution

What physical changes can occur in liquid dosage forms?

• Separation of liquid phases in emulsions

• Settling of solids in suspensions

• Alteration of viscosity

How does physical instability affect patient acceptability?

• Change in colour

• Change in taste

• Change in odour