Study Set Content:
A drug may be changed or decomposed at a molecular level by the changing of energy and the breaking at molecular level.
Inherent factors
the splitting of a drug molecule via a solvent molecule
Solvolysis
External Factors
pH
- pKa
- solubility and dissolution
- excipient interactions
temperature
s the time required for one-half of the material to degrade.
Half-life(
he resistance of the drug to the various chemical, physical, and microbiological reactions that may change the original properties of the preparations during transport, storage and use.
Drug Stability -
Quantitatively it is expressed as
shelf life.
is the period where 90% of the original Concentration is left and 10% is already degraded.
Shelf life
Shelf life
expiration dating period
s generally based on the negligible clinical consequences of such a loss
The 10% loss criterion
The time period during which a drug product is expected to remain within the approved specification for use, provided that it is stored under the conditions defined on the container label.
Shelf life
These conditions may include: A requirement that the container remains
unopened
Date placed on the container label of a drug product designating the date after which a batch of the product is not expected to remain within the approved specifications, if stored under defined conditions, and after which it must not be used.
Expiration Date
Decomposition and Stabilization of Medicinal Agents Pharmaceutical decomposition processes include:
Hydrolysis
• Dehydration
• Isomerization
• Epimerization
Oxidation
• Photolysis
May be defined as the capability of a particular formulation in a specific container/closure system to remain within its physical, chemical, microbiological, toxicological, protective and informational specifications.
Stability of Pharmaceutical Product
he extent to which a product retains, within the specified limits, throughout its period of storage and use, the same properties and characteristics possessed at the time of its
packaging
- Evaluates the effect of environmental factors on the quality of a drug substance or a formulated product which is utilized for prediction of its shelf life, determine proper storage conditions and suggest labeling instructions.
Stability Testing
The data generated during the stability testing is an important requirement for (blank) of any drug or formulation
regulatory approval
Factors Influencing the Stability of a Pharmaceutical Product: - Stability of the
active ingredients
Interaction between active ingredients and
excipients
Manufacturing process
followed
