Pharmaceutical Type III – Regular Soda-Lime Glass · Type

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:

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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
package system:

·        
Includes cartons, corrugated
shippers & pallets.

Packaging must meet the following Requirements: ideal
requirements

·        
Protect the preparation from
environmental conditions.

·        
Non-reactive with the
product and so does not alter the identity of the product.

·        
Does not impart tastes or
odors to the product.

·        
Nontoxic.

·        
FDA approved.

·        
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:

·        
Ampoules,

·        
Vials,

·        
Syringes,

·        
Cartridges,

·        
Bottles, and

·        
Bags 2.

TYPES OF GLASS

·        
Type I – Borosilicate Glass

·        
Type II – Treated Soda-Lime
Glass

·        
Type III – Regular Soda-Lime
Glass

·        
Type NP – General Purpose
Soda-Lime Glass

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
surface alkali.

·        
The de-alkalizing process is
known as “sulfur treatment” and virtually prevents “weathering” of empty
bottles.

·        
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
chemical resistance.

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.

PLASTIC CONTAINERS:

Advantages:

·        
Ease of manufacturing

·        
Available in various types
of quality

·        
Freedom of design to which
they lend themselves

·        
Extremely resistant to
breakage

Dosage Form – Plastic Interactions / Limitations of Plastic
Materials:

·        
Permeation

·        
Leaching

·        
Sorption

·        
Chemical modification

·        
Alteration on the properties
of plastics or product 1.

 

 

TYPES OF CONTAINERS

Injections are placed either in single-dose containers or in
multiple-dose containers. 

o   Single-dose
container:

·        
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.

o   Multiple-dose
container:

·        
A hermetic container that
permits withdrawal of successive portions of the contents without changing the strength,
quality, or purity of the remaining portion 3.

Ampoules

·        
Small-volume parenteral
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.

Advantages

·        
Glass ampoules are low
cost and

·        
Very little interaction
between the container and the product (if Type I glass is used).

Disadvantages

·        
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

·        
Vials are containers
usually made of Type I borosilicate glass.

·        
With a re-usable synthetic
rubber closure.

·        
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
a vial.

·        
Products packaged in vials
for multiple use will therefore incorporate a preservative to prevent any
microorganisms accidentally introduced into the product during use from
proliferating.

Advantage:

·        
The glass is inert and
does not interact with the drug.

Disadvantage:

·        
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
plastic bottles.

·        
These products range in
size from 100 mL up to 1000 mL.

·        
Collapsible bag
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
infusion fluid.

·        
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.

Advantages:

·        
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.

Disadvantages:

·        
PVC bags is that drugs may
become adsorbed onto the plastic (e.g. insulin) or react with the plastic (e.g.
etoposide).

·        
Components can leach out
of the plastic such as monomers and phthalate plasticizers which may be toxic
in long-term exposure.

Syringes

·        
Nowadays, parenteral
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.