Drug Stability

Drug Stability

Done by: Pharm.D Zeinab Salman

Index

1. Definition of drug stability

2. Types of drug stability

3. Importance of stability testing

4. Consequences of drug instability

5. Factors affecting drug stability

Drug Stability

It is the ability of drugs to maintain their physical, chemical, microbial, therapeutic and toxicological properties during the time of storage and usage by the patient. Stability studies are performed on drug substances and drug products.

Chemical

Types of Drug Stability

Each ingredient retains its chemical integrity

There are five important types of drug stability that must be insured.

Physical

The original physical properties are retained

Microbiological

Therapeutic

Sterility or resistance to microbial growth is retained

The therapeutic effect remains unchanged

Toxicological

No significant increase in toxicity occurs

Importance of Stability Testing

1. To ensure patients' well-being.
2. To protect the reputation of the manufacturer.
3. To provide a database that can be used in the development of new products.
4. To determine shelf life and storage conditions.

Consequences of Drug Instability

• Loss of vehicles (evaporation of water from o/w creams, evaporation of alcohol from alcoholic mixtures)
• Loss of content uniformity (impaction of suspensions)
• Loss of elegance (change in color)

• Loss of activity (aspirin hydrolysis, adrenaline oxidation)

• Reduction in bioavailability
• Loss of safety (production of toxic substances)

Factors Affecting Drug Stability

Temperature

pH

Moisture

Dosage Form

Light

Concentration

Drug Incompatability

Oxygen

Thank you for your attention!