College Papers

Packaging the combination of components necessary to contain,

Packaging
of Parenterals

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”.

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Types of Packaging Systems:

Primary package system:

·        
Those components and
subcomponents that come into direct contact with the product, and these
components having direct effect on the shelf life of the product.

Secondary or tertiary
package system:

·        
Such packaging includes
cartons, corrugated shippers and pallets.

Packaging must meet the following Requirements: ideal
requirements

·        
It protect the component of preparation
from environmental conditions.

·        
It should be non-reactive with
content of container.

·        
It should maintain identity
of the product intact.

·        
It does not impart any
tastes or odors to the content of the product.

·        
It should be non toxic.

·        
It should be FDA approved.

·        
It should provide mechanical
support to damage or breakage.

·        
It must meet FDA
requirements for tamper-resistance requirements, whenever it is applicable 1.

Packaging materials & closures: 

Injectable formulations are usually packaged into glass or plastic
containers. Container systems for parenteral include:

·        
Ampoules,

·        
Vials,

·        
Syringes,

·        
Cartridges,

·        
Bottles, and

·        
Bags 2.

FOUR TYPES OF GLASS  

·        
Type I  is called as  Borosilicate Glass

·        
Type II is called as Treated
Soda-Lime Glass

·        
Type III is called as
Regular Soda-Lime Glass

·        
Type NP  is also called as General Purpose Soda-Lime
Glass

Type I: Borosilicate Glass 

·        
Type 1 glass is Highly
resistant glass.

·        
In this type of glass usually
the alkali and alkaline earth metals are replaced by aluminum and/or boron and
zinc.

·        
It is chemically more inert
glass than the soda lime glass.

·        
It is use for strong acids
and alkalies

·        
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.

·        
Leaching action of type 1
glass can be reduce by use approximately 6% of boron.

 

 

Type II: Treated Soda-Lime Glass

·        
The container of type 2  glass is made by de-alkalized or treated to
remove surface alkali.

·        
The process of de-alkalizing
also is known as “sulfur treatment” and thus prevent “weathering” of empty
bottles.

·        
 Sulfur treatment neutralizes the alkaline
oxides on inner surface of container this made can rendering the glass
chemically more resistant.

 

 Type III – Regular
Soda-Lime Glass

·        
This glass is untreated
glass and it is made up of commercial soda-lime glass that provides better or
average chemical resistance.

Type NP – General Purpose Soda-Lime Glass

·        
Type 4 glass is containers
are made up of soda lime glass which is use for non parenteral products
intended for oral or topical administration.

 

PLASTIC CONTAINERS:

Advantages:

·        
It be can be easily
manufacturing

·        
A large variety of plastics
are available.

·        
It is highly resistant to
breakage.

·        
Various designs of plastics
are available.

Limitations of Plastic Materials:

·        
Permeation

·        
Leaching

·        
Sorption

·        
Chemical interaction

·        
Alteration of content of the
container 1.

TYPES OF CONTAINERS

Injectables can be placed either in the single or multiple dose
containers.

 Single-dose container:

·        
It is a hermetic container
that can holds the content of the sterile product that is intended for
parenteral administration, once it is opened, it cannot be resealed with the
assurance that the sterility of the product has been remain intact.

 Multiple-dose container:

·        
It
is a hermetic container for which the withdrawal of successive portion of the
contents of the container is possible with the assurance the strength, quality,
or purity of the remaining portion is maintained 3.

Ampoules

·        
It is usually use for small
volume parenteral products.

·        
Usually glass or plastic
ampoules are use for it.

·        
It is intended for single
use, lacking any preservative material.   

·        
It size usually range from
1ml to 10ml in volume although larger sizes are available.

·        
Usually type 1 glass or
borosilicate glass is used for it.

·        
It is narrow necked
containers that are sealed by fusion.

·        
 Its neck is painted with ceramic ring on it.

·        
Baking process is used for
fusing the ceramic to the glass, which can be served as weak point at which the
ampoule can be easily break up.

 

 

Advantages

·        
Glass ampoules are less
expensive

·        
It has very little
interaction with content of the parenteral product.

Disadvantages

·        
Glass ampoules are usually fragile

·        
Usually glass particles can be
disposed off into the container while breaking the neck of the ampoule.

·        
Finger of a person can be
injured by glass while breaking it.

Vials

·        
Containers for vials are
composed of borosilicate glass (Type 1 glass).

·        
Due to presence of rubber closure
it can allow multiple withdrawals of the sample.

·        
It size range from 5ml to
100ml.

·        
Synthetic rubber polymers
called as bromobutyl or chorobutyl can be use to seal the vials

·        
Aluminium seal crimped
around the neck of glass vial can be used to held the rubber closure in place.

·        
Plastic flip-off cap can
be used to protect the rubber closure or septum.

·        
Rubber closure has the
ability of self sealing so multiple withdrawal can be possible.

·        
Vials allow multiple
withdrawal so a preservative agent should be added to a vial.

Advantage:

·        
Glass material is usually
inert it does not interact with any drug.

Disadvantage:

·        
Due to multiple puncturing
of the rubber closure large particles of rubber can be introduced into the
content of the drug product.

 
Infusion bags and bottles

·        
Large volume parenterals
are usually packaged in large collapsible plastic bags, glass bottles, and semi
rigid plastic bottles.

·        
Infusion bags and bottles
size range from 100 to 1000 ml.

·        
Most commonly collapsible plastic
begs are use for it.

·        
Plastic material is
usually PVC or polyolefin plastic.

·        
Additive port in
collapsible bags usually allow other injectable drugs products to be added to
the infusion fluid.

·        
Polyolefin have certainly
replace PVC to be used for infusion begs.

·        
Large volume parenteral
products are usually used for single use only.

Advantages:

·        
Plastic bags are
collapsible so contents of drug product can be easily move out under normal
atmospheric pressure, therefore air inlet system to equilibrate air pressure is
not require.

Disadvantages:

·        
Drug substance e.g insulin
can be adsorbed on the plastic bags or react with the plactic.

·        
Plastic component may
leach out of the plastic such as monomers and phthalate platicizers, which may
be prove toxic on long term exposure.

 

·        
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

·        
Parenteral drug products
may be packaged in a syringe act as a prefilled syringe.

·        
Prefilled syringe act as
ready to use mePackaging
of Parenterals

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:

·        
Those components and
subcomponents that come into direct contact with the product, and these
components having direct effect on the shelf life of the product.

Secondary or tertiary
package system:

·        
Such packaging includes
cartons, corrugated shippers and pallets.

Packaging must meet the following Requirements: ideal
requirements

·        
It protect the component of preparation
from environmental conditions.

·        
It should be non-reactive with
content of container.

·        
It should maintain identity
of the product intact.

·        
It does not impart any
tastes or odors to the content of the product.

·        
It should be non toxic.

·        
It should be FDA approved.

·        
It should provide mechanical
support to damage or breakage.

·        
It must meet FDA
requirements for tamper-resistance requirements, whenever it is applicable 1.

Packaging materials & closures: 

Injectable formulations are usually packaged into glass or plastic
containers. Container systems for parenteral include:

·        
Ampoules,

·        
Vials,

·        
Syringes,

·        
Cartridges,

·        
Bottles, and

·        
Bags 2.

FOUR TYPES OF GLASS  

·        
Type I  is called as  Borosilicate Glass

·        
Type II is called as Treated
Soda-Lime Glass

·        
Type III is called as
Regular Soda-Lime Glass

·        
Type NP  is also called as General Purpose Soda-Lime
Glass

Type I: Borosilicate Glass 

·        
Type 1 glass is Highly
resistant glass.

·        
In this type of glass usually
the alkali and alkaline earth metals are replaced by aluminum and/or boron and
zinc.

·        
It is chemically more inert
glass than the soda lime glass.

·        
It is use for strong acids
and alkalies

·        
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.

·        
Leaching action of type 1
glass can be reduce by use approximately 6% of boron.

 

 

Type II: Treated Soda-Lime Glass

·        
The container of type 2  glass is made by de-alkalized or treated to
remove surface alkali.

·        
The process of de-alkalizing
also is known as “sulfur treatment” and thus prevent “weathering” of empty
bottles.

·        
 Sulfur treatment neutralizes the alkaline
oxides on inner surface of container this made can rendering the glass
chemically more resistant.

 

 Type III – Regular
Soda-Lime Glass

·        
This glass is untreated
glass and it is made up of commercial soda-lime glass that provides better or
average chemical resistance.

Type NP – General Purpose Soda-Lime Glass

·        
Type 4 glass is containers
are made up of soda lime glass which is use for non parenteral products
intended for oral or topical administration.

 

PLASTIC CONTAINERS:

Advantages:

·        
It be can be easily
manufacturing

·        
A large variety of plastics
are available.

·        
It is highly resistant to
breakage.

·        
Various designs of plastics
are available.

Limitations of Plastic Materials:

·        
Permeation

·        
Leaching

·        
Sorption

·        
Chemical interaction

·        
Alteration of content of the
container 1.

TYPES OF CONTAINERS

Injectables can be placed either in the single or multiple dose
containers.

 Single-dose container:

·        
It is a hermetic container
that can holds the content of the sterile product that is intended for
parenteral administration, once it is opened, it cannot be resealed with the
assurance that the sterility of the product has been remain intact.

 Multiple-dose container:

·        
It
is a hermetic container for which the withdrawal of successive portion of the
contents of the container is possible with the assurance the strength, quality,
or purity of the remaining portion is maintained 3.

Ampoules

·        
It is usually use for small
volume parenteral products.

·        
Usually glass or plastic
ampoules are use for it.

·        
It is intended for single
use, lacking any preservative material.   

·        
It size usually range from
1ml to 10ml in volume although larger sizes are available.

·        
Usually type 1 glass or
borosilicate glass is used for it.

·        
It is narrow necked
containers that are sealed by fusion.

·        
 Its neck is painted with ceramic ring on it.

·        
Baking process is used for
fusing the ceramic to the glass, which can be served as weak point at which the
ampoule can be easily break up.

 

 

Advantages

·        
Glass ampoules are less
expensive

·        
It has very little
interaction with content of the parenteral product.

Disadvantages

·        
Glass ampoules are usually fragile

·        
Usually glass particles can be
disposed off into the container while breaking the neck of the ampoule.

·        
Finger of a person can be
injured by glass while breaking it.

Vials

·        
Containers for vials are
composed of borosilicate glass (Type 1 glass).

·        
Due to presence of rubber closure
it can allow multiple withdrawals of the sample.

·        
It size range from 5ml to
100ml.

·        
Synthetic rubber polymers
called as bromobutyl or chorobutyl can be use to seal the vials

·        
Aluminium seal crimped
around the neck of glass vial can be used to held the rubber closure in place.

·        
Plastic flip-off cap can
be used to protect the rubber closure or septum.

·        
Rubber closure has the
ability of self sealing so multiple withdrawal can be possible.

·        
Vials allow multiple
withdrawal so a preservative agent should be added to a vial.

Advantage:

·        
Glass material is usually
inert it does not interact with any drug.

Disadvantage:

·        
Due to multiple puncturing
of the rubber closure large particles of rubber can be introduced into the
content of the drug product.

 
Infusion bags and bottles

·        
Large volume parenterals
are usually packaged in large collapsible plastic bags, glass bottles, and semi
rigid plastic bottles.

·        
Infusion bags and bottles
size range from 100 to 1000 ml.

·        
Most commonly collapsible plastic
begs are use for it.

·        
Plastic material is
usually PVC or polyolefin plastic.

·        
Additive port in
collapsible bags usually allow other injectable drugs products to be added to
the infusion fluid.

·        
Polyolefin have certainly
replace PVC to be used for infusion begs.

·        
Large volume parenteral
products are usually used for single use only.

Advantages:

·        
Plastic bags are
collapsible so contents of drug product can be easily move out under normal
atmospheric pressure, therefore air inlet system to equilibrate air pressure is
not require.

Disadvantages:

·        
Drug substance e.g insulin
can be adsorbed on the plastic bags or react with the plactic.

·        
Plastic component may
leach out of the plastic such as monomers and phthalate platicizers, which may
be prove toxic on long term exposure.

 

·        
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

·        
Parenteral drug products
may be packaged in a syringe act as a prefilled syringe.

·        
Prefilled syringe act as
ready to use medication in emergencies.

·        
Usually aseptic filling is
requires specialist equipments to be used.

·        
Drug from prefilled
syringe could be administered through the use of infusion device 4.dication in emergencies.

·        
Usually aseptic filling is
requires specialist equipments to be used.

·        
Drug from prefilled
syringe could be administered through the use of infusion device 4.