Drug Development Process Flashcards
That which hold the article and is or maybe in direct contact with the article
Containers
That which is in direct contact with the article at all times
Immediate container
The _______ is part of the container
closure
According to their ability to protect their contents from external conditions
USP Classifies container
Examples of USP Containers
Well-closed container
A tight container
Hermetic container
Single-unit container
What are some examples of Hermetic container?
- Single dose container (ampule)
- Multiple dose container (vial)
protects the contents from contamination by extraneous solids and from loss of the article under the ordinary or customary conditions of handling, shipment, storage, and distribution
well-closed container
that protects the contents from contamination by extraneous liquids, solids, or vapors; from loss of the article; and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution, and is capable of tight reclosure
tight container
that protects the contents from the effects of light by virtue of the specific properties of the material of which it is composed, including any coating applied to it. A clear and colorless or a translucent container may be made light-resistant by means of an opaque covering or by use of secondary packaging, in which case the label of the container bears a statement that the opaque covering or secondary packaging is needed until the articles are to be used or administered
Light-resistant container
impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution
Hermetic container
Example of a single dose container
ampoule
example of multiple dose container
vial
Holds a quantity of drug intended as a single dose
Single-unit container
Contain more than a single unit or dose of the medication
Multiple unit container
Official Glass Types
Type I – Highly resistant borosilicate glass
Type II – Treated soda lime glass
Type III – soda lime glass
NP – general purpose soda lime glass
Types of Plastic Container
PVC – Polyvinyl chloride = chlorine atom is added to every other carbon in polyethylene polymer
- Rigid and has good clarity
- In blister packaging of tablets and capsules
PET – polyethylene terephthalate
APET – amorphous polyethylene terephthalate glycol
PETG - polyethylene terephthalate glycol
APET & PETG – can be sterilized with gamma radiation
Problems in the use of plastics
- Permeability of the container to atmospheric oxygen and to moisture vapor
- Leaching of the constituents of the container to the internal contents
- Absorption of drugs from the contents to the container
Transmission of light through the container
Alteration of the container upon storage
