Pharmaceutical Packaging: “Pharmaceutical
packaging means the combination of components necessary to contain, preserve,
protect & deliver a safe, efficacious drug product, such that at any time
point before expiration date of the drug product, a safe & efficacious
dosage form is available”.
Types of Packaging Systems:
Primary package system:
Made up of those package
components & subcomponents that come into direct contact with the product,
or those that may have a direct effect on the product shelf life.
Secondary or tertiary
Includes cartons, corrugated
shippers & pallets.
Packaging must meet the following Requirements: ideal
Protect the preparation from
Non-reactive with the
product and so does not alter the identity of the product.
Does not impart tastes or
odors to the product.
Protect the dosage form from
damage or breakage.
Meet tamper-resistance requirements,
wherever applicable 1.
Packaging materials & closures:
lnjectable formulations are packaged into containers made of glass
or plastic. Container systems include:
TYPES OF GLASS
Type I – Borosilicate Glass
Type II – Treated Soda-Lime
Type III – Regular Soda-Lime
Type NP – General Purpose
Type I: Borosilicate Glass
Highly resistant glass
A substantial part of the
alkali & earth cations are replaced by boron and/or aluminum & zinc.
It is more chemically inert
than the soda-lime glass.
It is used to contain strong
acids & alkalies as well as all types of solvents.
The addition of approx 6%
boron to form type I glass reduces the leaching action.
Type II: Treated Soda-Lime Glass
Type II containers are made
of commercial soda-lime glass that has been de-alkalized or treated to remove
The de-alkalizing process is
known as “sulfur treatment” and virtually prevents “weathering” of empty
Thus sulfur treatment
neutralizes the alkaline oxides on the surface & thus rendering the glass more chemically resistant.
Type III – Regular Soda-Lime Glass
Containers are untreated
& made up of commercial soda-lime glass of average or better than-average
Type NP – General Purpose Soda-Lime Glass
Containers made up of
soda-lime glass are supplied for non-parenteral products, those intended for
oral or topical use.
Ease of manufacturing
Available in various types
Freedom of design to which
they lend themselves
Extremely resistant to
Dosage Form – Plastic Interactions / Limitations of Plastic
Alteration on the properties
of plastics or product 1.
TYPES OF CONTAINERS
Injections are placed either in single-dose containers or in
A hermetic container holding
a quantity of sterile drug intended for parenteral administration as a single dose;
when opened, it cannot be resealed with assurance that sterility has been maintained.
A hermetic container that
permits withdrawal of successive portions of the contents without changing the strength,
quality, or purity of the remaining portion 3.
products are often packaged in glass or plastic ampoules.
Ampoules are used for single
use, unpreserved products.
Glass ampoules range in size
typically from 1 mL up to 10 mL in volume, though larger sizes are available.
The glass chosen is referred
to as Type I or borosilicate glass.
Ampoules are supplied as open
necked containers that are sealed by fusion of the narrow glass neck after filling.
Usually the neck of the
ampoule has a painted ceramic ring on it. Due to the baking process required to
fuse the ceramic to the glass, this acts as a weak point at which the ampoule
can be easily snapped open by hand.
Glass ampoules are low
Very little interaction
between the container and the product (if Type I glass is used).
Fragility glass container.
Potential for deposition of
glass particles into the drug product on opening.
Potential for injury to the fingers
of the person opening the ampoule. .
Vials are containers
usually made of Type I borosilicate glass.
With a re-usable synthetic
Vials have advantages as
containers as they permit multiple withdrawals.
Made in sizes usually ranging
from 5 mL to 100 mL.
Vials are sealed with a bromobutyl or chlorobutyl synthetic rubber closure held in place by an aluminium
seal crimped around the neck of the glass vial.
Rubber closure (or septum)
is usually protected by a plastic flip-off cap.
Rubber septum is
self-sealing to a high degree and so more than one withdrawal can be made from
Products packaged in vials
for multiple use will therefore incorporate a preservative to prevent any
microorganisms accidentally introduced into the product during use from
The glass is inert and
does not interact with the drug.
Puncturing the rubber
closure can cause large rubber particles to be introduced into the drug product.
Infusion bags and bottles
Large volume parenteral
products are packaged in glass bottles, collapsible plastic bags and semi-rigid
These products range in
size from 100 mL up to 1000 mL.
presentations are the most common form of container.
They are manufactured from
PVC or more increasingly polyolefin plastic.
Collapsible bags usually
have an additive port to allow other injectable drugs to be added to the
Polyolefin is much less
reactive and is now replacing PVC for this reason in infusion bags.
Large volume glass bottles
are essentially the same as glass vials, but on a larger scale.
All large volume
parenteral products are meant for single-use only.
Collapsible bags is that they
collapse under atmospheric pressure as the contents are removed from them.
Therefore they do not
require an air inlet system to equilibrate air pressure between the outside and
inside of the container, as do rigid glass bottles.
PVC bags is that drugs may
become adsorbed onto the plastic (e.g. insulin) or react with the plastic (e.g.
Components can leach out
of the plastic such as monomers and phthalate plasticizers which may be toxic
in long-term exposure.
products may be packaged in syringes.
Thus be presented to the
healthcare professional or patient in a ready to use format.
This requires aseptic filling
using specialist equipment.
Drug can be administered
from the syringe using an infusion device 4.