Study Set Content:
for hard crystalline powders that do not crush or triturate easily, or gummy-type; intervention/solvent
Pulverization by Intervention
Pulverization by Intervention intervention/solvent
(alcohol or acetone)
triturating/spatulating with small amount of a liquid; A paste is formed by combining the powder and a small amount of levigating agent in which the powder is insoluble.
Levigation
levigating agent
(mineral oil, glycerin)
can give information on a tablet’s porosity and its relationship to tablet hardness and disintegration time. I
Bulk density
It can also be used to check the uniformity of (blank) and to determine the proper size of (blank)
bulk chemicals, containers, mixing apparatus, and capsules for a given mass of the powder.
Angle of Repose
Critical Angle of Repose)
steepest angle of descent or dip relative to the horizontal plane to which a material can be piled w/o slumping
Angle of Repose
Angle of Repose
Ranges from 0˚C to 90˚C
Formula of Angle of Repose
Angle of repose = tan-1 (height/radius)
Methods:
Tilting Box Method
Fixed Funnel Method
Revolving Cylinder Method
What do you think are factors that may influence a sample’s angle of repose?
Morphology/ shape
- Addition of solvents
- Density
- Surface area
- Coefficient of friction
The objective of a stability study is to determine the
shelf-life
namely the time period of storage at a specified condition within which the drug product still meets its
established specifications
is an essential factor of quality, safety, and efficacy of a drug product.
Stability
A drug product, which is not of a sufficient stability, can result in changes in
physical and chemical characteristics
is a list of tests, reference to analytical procedures, and proposed acceptance criteria, including the concept of different acceptance criteria for release and shelf-life specifications.
Specification
Stability studies should include testing of those attributes of the drug product that are (blank) during storage and are likely to influence quality, safety and/or efficacy.
susceptible to change
The list of tests for each dosage form is not intended to be
exhaustive
The list of tests for each dosage form is not intended to be exhaustive, nor for every test to be
included
