STABILITIES STUDIES
• Stability of drug also can be defined as the time from the date of
manufacture and packaging of the formulation until its chemical or
predetermined level of labelled potency and its physical characteristics
have not changed appreciably.
• For a drug substance, we need to study 3 categories of stabilities-
• A. Solid state stability of drug only
• B. Compatibility studies ( drug+ excipients )
• C. Solution phase stability
Importance of stability studies
• Development of optimum formulation
(pre-formulation studies)
• Finding the optimum storage conditions
(temperature, light, humidity).
• Selecting the proper container for dispensing
(glass or plastic, clear or opaque, cap liners).
• Predicting the shelf life of the drug.
• Anticipating drug excipient interactions.
• Stabilization of the drugs against degradation
• In some cases a pharmacist may need to prepare stable compounded
preparations from existing dosage form.
• It is the responsibility of the pharmacist via the information of the
manufacture to instruct the patient in the proper storage and handling of
the drug product.
• Physical Degradation:
It is the degradation which results into the change of physical nature of drug. The
formulation is totally changed by way of appearance, organoleptic properties,
hardness, brittleness, particle size. Physical degradation includes:
• Loss of volatile components
• Loss of water
• Absorption of water
• Crystal growth
• Polymorphic changes
• Colour change
Factors affecting drug stability
1. Temperature: high temperature accelerate oxidation, reduction and
hydrolysis reaction which lead to drug degradation
2. pH:
• • Acidic and alkaline pH influence the rate of decomposition of most
drugs.
• • Many drugs are stable between pH 4 and 8.
• • Weekly acidic and basic drugs show good solubility when they are
ionized and they also decompose faster when they are ionized.
• Sometimes pH can have a very serious effect on decomposition. As little
as 1 pH unit change in pH can cause a change of ten fold in rate constant.
So when we are formulating a drug into a solution we should carefully
prepare a pH – decomposition profile
3. Moisture:
• a. Water catalyses chemical reactions as oxidation, hydrolysis and
reduction reaction
• b. Water promotes microbial growth
4. Light: affects drug stability through its energy or thermal effect which
lead to oxidation
5. Pharmaceutical dosage forms: solid dosage forms are more stable than
liquid dosage forms for presence of water.
6. Concentration: rate of drug degradation is constant for the solutions of
the same drug with different concentration. So, ratio of degraded part to
total amount of drug in diluted solution is bigger than of concentrated
solution.
• 7. Drug incompatibility: reactions between components of
pharmaceutical dosage forms it self or between these components and
cover of the container .
• 8. Oxygen: exposure of drug formulations to oxygen affects their stability
• Five stabilities of drug must be considered::
• 1. Physical
• 2. Chemical
• 3. Microbiological
• 4. Toxicological
• 5. Therapeutic
