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PACKAGING OF
PHARMACEUTICALS
INTRODUCTION
 Packaging is the science, art and technology of
enclosing or protecting products for distribution,
storage, sale, and use.
 Packaging also refers to the process of design,
evaluation, and production of packages.
 Pharmaceutical packaging can be defined a
technology and science which deals with the
study of materials and methods used to pack the
product and also the knowledge of the
machinery used for packing the product.
WHAT IS PACKAGE ?
 A Package consist of :
 The container in which the product is placed.
 The closure which is used to seal the container
and to protect oxygen ,moisture,bacteria and
prevent the loss of product through evaporation.
 The carton or outer cover which is made variety
of material such as cardboard ,plastic and
polymer and its give the protection against
mechanical and environmental hazrds.
 The box in which products are packed.the box
usually contains suitable shock absorbers ,in
order to protect the products from mechanical
shock.
 Materials selected for packaging must have
following characteristics:
 They must product from enviromental condition
such as temperature ,humidity,oxygen and light.
 They must not reactive with product or
ingredients .
 They must not impart any odour or taste .
 They must be non toxic .
 They must be approved by food and drugs
administration.
 They must be tempor-resistant.
 They should be suitable for commonly used
packaging equipments and machines .
PHARMACEUTICAL PACKAGE
1.container : is the devic that hold the drug .
It have direct contact with the drug
2. Closure : is the part of package which can open
and closed to facilitate access to the content and
removal of products .
3.Liner : is a material which inserted in a cap to
effect perfect seal between a the closure and
container .
TYPES OF CONTAINERS
1.Light resistant container
2.Well closed container
3.Tight container
4.Hermatic container
5.Single dose container
6.Multiple dose container
1.Light resistant container :
 it protects the contents from the effects of light.
2.Well – closed container
 it is one which protects the contents from
extraneous solids and from the loss of a drug under
normal or ordinary conditions of handling ,storage and
distribution .
3.Tight container( tightly closed container):
a tight container protects the contents from
contamination by extraneous solids or vapours ;from loss
of drug due to effervescence and evaporation under
ordinary conditions of handling ,storage and distribution
.
4.Hermatic container ( Hermatically sealed
container )
It is impervious to air and other gases
under normal condition of handling ,storage and
distribution .
5.Single dose container
these types of containers contain only a single
dose for one use .it is closed in such a manner
that the contents can be removed without
destruction of the closures ,as the contents are
intendes for single use only.
6.Multiple dose container
is a container ,which permits the
withdrawl of successive portions of the contents
,without changing the strenght ,quality or purity
of the contents .
MATERIALS FOR CONTAINER
1.Glass
2.Plastic
3.Rubber
4.paper/card board
5.Metals
GLASS
 Glass has been widely used as a drug packaging
material.
 Advantages
1. They are transparent.
2. They have good protection power.
3. They can be easily labelled.
4. Economical
5. Variety of sizes and shapes
6. Chemically inert ...it does not react with not chemicals .
7.Glass can be sterlised by any sterlisation method .
7.It is approved by food and drug administration.
 Disadvantages
1. Glass is fragile so easily broken.
2.Release alkali to aqueous preparation.
3.Glass is heavier than other packaging material
4.Transportation is not easy .
COMPOSITION OF GLASS
 Sand (silicon dioxide) Soda ash (sodium carbonate)
Limestone (calcium carbonate) Cullet (broken glass) -
aluminium, boron, potassium, magnesium, zinc,
barium,
 Amber: light yellowish to deep reddish brown, carbon
and sulphur or iron and manganese dioxide
 Yellow: Compounds of cadmium and sulphur
 Blue: Various shades of blue, cobalt oxide or
occasionally copper (cupric) oxide
 Green: iron oxide, manganese dioxide and chromium
dioxide
MANUFACTURE OF GLASS:
 The four basic processes used in the production of
glass are:
1.Blowing uses compressed air form the molten glass in
the cavity of metal mold.
2.In drawing , molten glass is pulled through dies or
rollers that shape the soft glass.
3. In pressing mechanical force is used to press the
molten glass against the side of a mold.
4. Casting uses gravity or centrifugal force to cause
molten glass to form in the cavity of mold.
TYPES OF GLASS
 Type I—Highly resistant borosilicate glass
 Type II—Treated soda lime glass
 Type III—soda lime glass
 NP—soda glass (non parenteral usage)
 Type I-borosilicate glass
 Alkalinity is removed by using boric oxide to neutralized the
oxide of potassium and sodium
 It is highly resistant glass.
 It has high melting point so can with stand high temperatures.
 It is more chemically inert than the soda lime glass
 It can resist strong acids,alkalies and all types of solvents.
 Reduced leaching action.
 USES:
 Laboratory glass apparatus.
 For injection and water for injection.
 Type II-treated soda lime glass
 Type II containers are made of commercial soda lime
glass that
 has been dealkalized or treated to remove surface alkali
 The de-alkalizing process is know as sulphur treatment.
 Sulfur treatment neutralizes the alkaline oxides on the
surface, rendering the glass more chemically resistant.
 Uses: Used for alkali sensitive products. Infusion fluids,
blood and plasma.
 Large volume container.
 Type III or regular soda lime glass is commericla soda
lime glass of average chemical resistence .
 Type IV or NP glass as the name indicates is not for
parentral products and is made of soda lime glass .this
type of glass is used for oral or topical used.
PLASTICS
 Plastics may be defined as any group of
substances, of natural or synthetic origins,
consisting polymers of high molecular weight
that can be moulded into a shape or form by heat
and pressure.
 Advantages
1. Less weight than glass,
2. flexible
3.Variety of sizes and shapes
4.Essentially chemically inert, strong, rigid Safety use,
high quality, various designs.
5.Extremely resistant to breakage.
 Disadvantages
1.Absorption permeable to moisture.
2.Poor printing, thermostatic charge .
3.Discoluration of the product may occur .
TYPES OF PLASTICS
 Thermosetting type –
 When heated they may become flexible but they do
not become liquid
 e.g. Urea formaldehyde (UF),Phenol formaldehyde
,Melamine
 formaldehyde (MF), Epoxy resins (epoxides),
Polyurethanes (PURs)
 Thermoplastic type
 On heating they are soften to viscous fluid which harden
again on cooling. e.g. Polyethylene{HDPE – LDPE},
Polyvinylchloride(PVC),Polystyrene Polypropylene,
Nylon(PA), Polyethylene terepthalate(PET)
,Polyvinylidene chloride(PVdC), Polycarbonate
Acrylonitrile butadiene styrene(ABS)
RUBBER
 Rubber is used mainly for the construction of
closure meant for vials, transfusion fluid bottles,
dropping bottles and as washers in many other
types of product
 Butyl rubber
Merits
 permeability to water vapour .
 Water absorption is very low.
 They are relatively cheaper compared to other synthetic
rubbers.
Demerits:
 Slow decomposition takes place above 130 ▫ C.
 Oil and solvent resistance is not very good.
 Nitrile rubber
Merits
 Resistant due to polar nitrile group.
 Heat resistant.
Demerits :
 Absorption of bactericide and leaching of
extractives are considerable
 chloroprene rubbers
 Merits -oil resistant. heat stability is good
 Silicon rubber
Merits
 Heat resistance.
 Extremely low absorption and permeability of water.
 Excellent aging characteristic.
Demerits :
 They are very expensive.
AEROSAL PACKAGING
 "Aerosol is a pressurized dosage forms
containing one or more therapeutic active
ingredients which upon actuation emit a fine
dispersion of liquid and/or solid materials in a
gaseous medium".
 Aerosol principle
 the simple principle upon which the
mechanicm is based is that a compressed or
liquefied gas exrerts a force upon the internal
surface of the container in which the gas is
enclosed .
 The pressure of an aerosol system refers to the
pressure exerted by the vapour within the
container.
COMPONENTS OF AEROSOL PACKAGING
1.propellants
2.containers
3.valve and actuator
4.product concentrate
1.Propellants
it is responsible for developing the pressure within the
container and expels the product when the valve is opened .
Classes of propellants ;
 liquefied gases :
a.fluorinated hydrocarbons
b.hydrocarbons –butane , isobutane ,propane
 Compressed gases
a. insoluble in water… e.g nitrogen ,argon ,
b.Soluble in water e.g carbondioxide ,nitrous oxide
2.Container :
various materials have been used for the
manufacture of aerosol containers , which
withstand pressure as high as 140 to 180 psig at
130 degree F.
types of containers
1.metal
2.glass
3.Synthetic resind and plastic
4.valves
 Advantages of aerosols
1. Convenience ,sped and ease of application
2. Efficient dispersion of medicament
3. A dose can be removed without contamination of the
remaining material .
4. Direct local application
5. Absence of manual contact of medicament
 Disadvantages
1.It damages the ozone layer of the earth ,causing increase
of UV radiation leading to skin cancer .
thank you ………..

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Packaging of pharmaceuticals

  • 2. INTRODUCTION  Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use.  Packaging also refers to the process of design, evaluation, and production of packages.
  • 3.  Pharmaceutical packaging can be defined a technology and science which deals with the study of materials and methods used to pack the product and also the knowledge of the machinery used for packing the product.
  • 4. WHAT IS PACKAGE ?  A Package consist of :  The container in which the product is placed.  The closure which is used to seal the container and to protect oxygen ,moisture,bacteria and prevent the loss of product through evaporation.  The carton or outer cover which is made variety of material such as cardboard ,plastic and polymer and its give the protection against mechanical and environmental hazrds.
  • 5.  The box in which products are packed.the box usually contains suitable shock absorbers ,in order to protect the products from mechanical shock.
  • 6.  Materials selected for packaging must have following characteristics:  They must product from enviromental condition such as temperature ,humidity,oxygen and light.  They must not reactive with product or ingredients .  They must not impart any odour or taste .
  • 7.  They must be non toxic .  They must be approved by food and drugs administration.  They must be tempor-resistant.  They should be suitable for commonly used packaging equipments and machines .
  • 8. PHARMACEUTICAL PACKAGE 1.container : is the devic that hold the drug . It have direct contact with the drug 2. Closure : is the part of package which can open and closed to facilitate access to the content and removal of products . 3.Liner : is a material which inserted in a cap to effect perfect seal between a the closure and container .
  • 9. TYPES OF CONTAINERS 1.Light resistant container 2.Well closed container 3.Tight container 4.Hermatic container 5.Single dose container 6.Multiple dose container
  • 10. 1.Light resistant container :  it protects the contents from the effects of light. 2.Well – closed container  it is one which protects the contents from extraneous solids and from the loss of a drug under normal or ordinary conditions of handling ,storage and distribution .
  • 11. 3.Tight container( tightly closed container): a tight container protects the contents from contamination by extraneous solids or vapours ;from loss of drug due to effervescence and evaporation under ordinary conditions of handling ,storage and distribution .
  • 12. 4.Hermatic container ( Hermatically sealed container ) It is impervious to air and other gases under normal condition of handling ,storage and distribution . 5.Single dose container these types of containers contain only a single dose for one use .it is closed in such a manner that the contents can be removed without destruction of the closures ,as the contents are intendes for single use only.
  • 13. 6.Multiple dose container is a container ,which permits the withdrawl of successive portions of the contents ,without changing the strenght ,quality or purity of the contents .
  • 15. GLASS  Glass has been widely used as a drug packaging material.  Advantages 1. They are transparent. 2. They have good protection power. 3. They can be easily labelled. 4. Economical 5. Variety of sizes and shapes
  • 16. 6. Chemically inert ...it does not react with not chemicals . 7.Glass can be sterlised by any sterlisation method . 7.It is approved by food and drug administration.
  • 17.  Disadvantages 1. Glass is fragile so easily broken. 2.Release alkali to aqueous preparation. 3.Glass is heavier than other packaging material 4.Transportation is not easy .
  • 18. COMPOSITION OF GLASS  Sand (silicon dioxide) Soda ash (sodium carbonate) Limestone (calcium carbonate) Cullet (broken glass) - aluminium, boron, potassium, magnesium, zinc, barium,  Amber: light yellowish to deep reddish brown, carbon and sulphur or iron and manganese dioxide  Yellow: Compounds of cadmium and sulphur  Blue: Various shades of blue, cobalt oxide or occasionally copper (cupric) oxide  Green: iron oxide, manganese dioxide and chromium dioxide
  • 19. MANUFACTURE OF GLASS:  The four basic processes used in the production of glass are: 1.Blowing uses compressed air form the molten glass in the cavity of metal mold. 2.In drawing , molten glass is pulled through dies or rollers that shape the soft glass. 3. In pressing mechanical force is used to press the molten glass against the side of a mold. 4. Casting uses gravity or centrifugal force to cause molten glass to form in the cavity of mold.
  • 20. TYPES OF GLASS  Type I—Highly resistant borosilicate glass  Type II—Treated soda lime glass  Type III—soda lime glass  NP—soda glass (non parenteral usage)
  • 21.  Type I-borosilicate glass  Alkalinity is removed by using boric oxide to neutralized the oxide of potassium and sodium  It is highly resistant glass.  It has high melting point so can with stand high temperatures.  It is more chemically inert than the soda lime glass  It can resist strong acids,alkalies and all types of solvents.  Reduced leaching action.  USES:  Laboratory glass apparatus.  For injection and water for injection.
  • 22.  Type II-treated soda lime glass  Type II containers are made of commercial soda lime glass that  has been dealkalized or treated to remove surface alkali  The de-alkalizing process is know as sulphur treatment.  Sulfur treatment neutralizes the alkaline oxides on the surface, rendering the glass more chemically resistant.  Uses: Used for alkali sensitive products. Infusion fluids, blood and plasma.  Large volume container.
  • 23.  Type III or regular soda lime glass is commericla soda lime glass of average chemical resistence .  Type IV or NP glass as the name indicates is not for parentral products and is made of soda lime glass .this type of glass is used for oral or topical used.
  • 24. PLASTICS  Plastics may be defined as any group of substances, of natural or synthetic origins, consisting polymers of high molecular weight that can be moulded into a shape or form by heat and pressure.
  • 25.  Advantages 1. Less weight than glass, 2. flexible 3.Variety of sizes and shapes 4.Essentially chemically inert, strong, rigid Safety use, high quality, various designs. 5.Extremely resistant to breakage.
  • 26.  Disadvantages 1.Absorption permeable to moisture. 2.Poor printing, thermostatic charge . 3.Discoluration of the product may occur .
  • 27. TYPES OF PLASTICS  Thermosetting type –  When heated they may become flexible but they do not become liquid  e.g. Urea formaldehyde (UF),Phenol formaldehyde ,Melamine  formaldehyde (MF), Epoxy resins (epoxides), Polyurethanes (PURs)
  • 28.  Thermoplastic type  On heating they are soften to viscous fluid which harden again on cooling. e.g. Polyethylene{HDPE – LDPE}, Polyvinylchloride(PVC),Polystyrene Polypropylene, Nylon(PA), Polyethylene terepthalate(PET) ,Polyvinylidene chloride(PVdC), Polycarbonate Acrylonitrile butadiene styrene(ABS)
  • 29. RUBBER  Rubber is used mainly for the construction of closure meant for vials, transfusion fluid bottles, dropping bottles and as washers in many other types of product
  • 30.  Butyl rubber Merits  permeability to water vapour .  Water absorption is very low.  They are relatively cheaper compared to other synthetic rubbers. Demerits:  Slow decomposition takes place above 130 ▫ C.  Oil and solvent resistance is not very good.
  • 31.  Nitrile rubber Merits  Resistant due to polar nitrile group.  Heat resistant. Demerits :  Absorption of bactericide and leaching of extractives are considerable  chloroprene rubbers  Merits -oil resistant. heat stability is good
  • 32.  Silicon rubber Merits  Heat resistance.  Extremely low absorption and permeability of water.  Excellent aging characteristic. Demerits :  They are very expensive.
  • 33. AEROSAL PACKAGING  "Aerosol is a pressurized dosage forms containing one or more therapeutic active ingredients which upon actuation emit a fine dispersion of liquid and/or solid materials in a gaseous medium".
  • 34.  Aerosol principle  the simple principle upon which the mechanicm is based is that a compressed or liquefied gas exrerts a force upon the internal surface of the container in which the gas is enclosed .  The pressure of an aerosol system refers to the pressure exerted by the vapour within the container.
  • 35. COMPONENTS OF AEROSOL PACKAGING 1.propellants 2.containers 3.valve and actuator 4.product concentrate
  • 36. 1.Propellants it is responsible for developing the pressure within the container and expels the product when the valve is opened . Classes of propellants ;  liquefied gases : a.fluorinated hydrocarbons b.hydrocarbons –butane , isobutane ,propane  Compressed gases a. insoluble in water… e.g nitrogen ,argon , b.Soluble in water e.g carbondioxide ,nitrous oxide
  • 37. 2.Container : various materials have been used for the manufacture of aerosol containers , which withstand pressure as high as 140 to 180 psig at 130 degree F. types of containers 1.metal 2.glass 3.Synthetic resind and plastic 4.valves
  • 38.  Advantages of aerosols 1. Convenience ,sped and ease of application 2. Efficient dispersion of medicament 3. A dose can be removed without contamination of the remaining material . 4. Direct local application 5. Absence of manual contact of medicament
  • 39.  Disadvantages 1.It damages the ozone layer of the earth ,causing increase of UV radiation leading to skin cancer .