To acquire knowledge of topic.

1. PACKAGING of
pharmaceuticals
BY
Miss. Harshada Bafna
M.Pharmacy (QA)

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.
 Pharmaceutical packaging can be defined as the economical means of
providing presentation, protection, identification , information,
convenience ,compliance , integrity and stability of the product .
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3. Characteristics of Packaging Materials
 They must protect the preparation from environmental conditions.
 They must not be reactive with the product.
 They must not impart to the product tastes or odors.
 They must be nontoxic.
 They must be FDA approved.
 They must meet applicable tamper-resistance requirements.
 They must be adaptable to commonly employed high speed packaging
equipment.
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4.  single dose containers.
 Multidose container.
 Light resistant container.
 Well closed container.
 Air tight container.
 Tightly closed container.
 Temper evident container.
 Aerosol container.
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Types of containers-
Packaging of pharmaceuticals (HRB)

5. TYPES OF PACKAGING MATERIAL
I) Glass
II) Metals
III) Rubbers
IV) Plastics
V) Fibrous material paper and board.
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Packaging of pharmaceuticals (HRB)

6. GLASS:
 Glass has been widely used as a drug packaging material.
 Glass is composed of sand, soda ash, limestone,& cullet.
 Si, Al, Na, K, Ca, Mg, Zn & Ba are generally used into preparation
of glass
Advantages
• They are hygienic and suitable for sterilization
• They are relatively non reactive ( depending on the grade chosen)
• It can accept a variety of closures
• They can be used on high speed packaging lines
• They are transparent.
• They have good protection power.
• They can be easily labeled.
Disadvantages
• It is relatively heavy
• Glass is fragile so easily broken.
• Release alkali to aqueous preparation 6
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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
Packaging of pharmaceuticals (HRB)

8. TYPESOF GLASS:
1) Type I ( Neutral or Borosilicate Glass)
2) Type II ( Treated Soda lime glass)
3) Type III ( Soda lime glass)
4) Type IV ( General purpose soda lime glass)
TYPE I GLASS
 Least reactive.
 Higher ingredients and processing cost
therefore used for more sensitive
pharmaceutical products such as parenteral or
blood products.
 Mostly ampoules and vials are made up of
Type I glass.
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Packaging of pharmaceuticals (HRB)

9. TYPE II GLASS
 Higher chemical resistance but not as
much as type I.
 Cheaper than Type I.
 Acceptable for most products accept
blood products and aqueous
pharmaceutical with a pH less than 7.
TYPE III AND TYPE IV GLASS
 Have similar composition and are distinguished from
each other on the basis of their hydraulic resistance
 Type III is suitable for non- aqueous parenterals and
non parenteral products.
Type III glass containers are normally dry
sterilized before being filled.
 Type IV has lowest hydraulic resistance and is suitable
for solid products, some liquids and semi solids and
not for parenteral.
Type II and Type III glass
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Packaging of pharmaceuticals (HRB)

10. PLASTIC
Plastics may be defined as any group of substances, of natural or synthetic
origins, consisting chiefly of 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
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11. 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)
Thermoplastics 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)
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12. COMPOSITION OF PLASTICS
POLYETHYLENE
 This is used as high and low density polyethylene
 Low density polyethylene (LDPE) is preferred plastic for squeeze bottles.
Properties: Ease of processing , barrier to moisture, strength /toughness,
flexibility, ease
of sealing.
 High density poly ethylene (HDPE) is less permeable to gases and more
resistant to oils, chemicals and solvents.
Properties: Stiffness, strength / toughness, resistance to chemicals.
It is widely used in bottles for solid dosage forms.
 Drawback: prone to stress cracking in the presence of surfactants or vegetable
or mineral oils.
POLYPROPYLENE
 It is very light and having 1700c M.P.
 Good resistance to heat sterilization.
 It is colorless, odorless thermoplastic material with excellent tensile properties
even at high temperature.
 Excellent resistance to strong acids and alkalis.
 Low permeability to water vapour
 Permeability to gases is intermediate between polyethylene HD and un-
plasticized PVC
 Suitable for use in closures , tablet containers and intravenous bottles.
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Packaging of pharmaceuticals (HRB)

13. POLYSTYRENE
 It is hard, rigid, light material.
 It can be moluded into any shape so it is used for preparing bottles,
tubes,jars,boxes and syringes.
POLYVINYL CHLORIDE
 It is less flexible, heavier,more permiable to water vapour as compared with
normal polythene.
 It has high clarity and is not effected by sunlight.
 It is used for preparing eye ointement tubes.
POLY METHYL METHOACRYLATE:
 It is a hard , strong but light, transparent plastic.
It is soften about 1000c
It is used for preparing bottles and tubes.
POLYTETRA FLUROETYLENE-
 It is translucent,opaque,possesses high resistances to solvent and
chemicals.
It is unchanged even at a temperature of 2500c.
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Packaging of pharmaceuticals (HRB)

14. Polyamides ( nylon)-
 great flexibility and heat resistances.
Melting point is 2000c
Used in preparation of syringes, tubings,packaging films for surgical dressings
and instruments.
POLYCARBONATE-
 It is transparent, high impact strength and very good heat resistances.
It is used for preparing of surgical equipments..
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Packaging of pharmaceuticals (HRB)

15. Plastic bottles made from PP, HDPE and
PS
Plastic pouches of HDPE Bottle- PET and spray- PP
EXAMPLES OF PLASTICS
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Packaging of pharmaceuticals (HRB)

16. METALS
Metals are used for construction of containers. The metals commonly used
for this purpose are aluminium ,tin plated steel, stainless steel, tin and lead
Advantages:
 They are impermeable to light, moisture and gases.
 They are made into rigid unbreakable containers by impact extrusion.
 They are light in weight compared to glass containers.
 Labels can printed directly on to their surface.
Disadvantages:
 They are expensive.
 They react with certain chemicals
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17. COLLAPSIBLE TUBES METAL
 The collapsible metal tube is an attractive container that permits controlled
amounts to be dispensed easily, with good reclosure, and adequate
protection of the product.
 It is light in weight and unbreakable and lends itself to high speed
automatic filling operations.
 Most commonly used are tin, aluminium and lead.
Tin:
 Tin containers are preferred for food, pharmaceuticals and any product for
which purity is considered.
 Tin is the most chemically inert of all collapsible metal tubes .
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18. Aluminium:
 Aluminium tubes offer significant savings in product shipping costs
because of their light weight .
 They are attractive in nature
Lead:
 Lead has the lowest cost of all tube metals and is widely used for non food
products such as adhesives, inks. paints and lubricants.
 Lead should never be used alone for anything taken internally because of
the risk lead poison .
 With internal linings, lead tubes are used for products such as chloride
tooth paste.
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FIBROUS MATERIALS:
 Paper & board are used in various form for packaging of pharmaceutical
products.
They are used for preparing outer container such as cartons, boxes,
envelopes.
Packaging of pharmaceuticals (HRB)

20. CLOSURES
 Closures are the devices by means of which containers can be
opened and closed. Proper closing of the container is necessary
because
◦ It prevents loss of material by spilling or volatilization.
◦ It avoids contamination of the product from dirt, microorganisms
or insects.
◦ It prevents deterioration of the product from the effect of the
environment such as moisture , oxygen or carbon dioxide.
 Material used for closures are
The closures for containers meant for storage of pharmaceutical
products are generally made from the following basic materials.
◦ Cork
◦ Glass
◦ Plastic
◦ Metal
◦ Rubber
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Packaging of pharmaceuticals (HRB)

21. Types of Closures:-
a. PLUG TYPE-
b.CROWN TYPE
c.PUSH FIT TYPE
d. SCREW TYPE-
It consist of 1. cap 2. wad 3. liner.
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22.  Cork-
 The bark of oak tree.
 Chemically inert.
 Does not impart odour or flavour.
 They can not be used in liquide preparation bcoz of danger mould growth.
 Glass-
 Ideal but they slip during transport and handling.
 Used in reagent bottles in lab rotaries.
 Plastics-
 Mostely used
 Available in various shapes and size.
 Light in weight and unbreakable.
 Metals-
 Made up off tin plate and aluminum however aluminum closures are
proffered bcoz their ductility and also ease of conversion into desired
shapes.
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Packaging of pharmaceuticals (HRB)

23. RUBBERS (Elastomers)
• Mainly used for the construction of closure meant for vials, transfusion fluid
bottles,etc.
• Natural rubber-
• In this the latex of heavea braziliensis is used.
• Following additives are added to change its physical chemical propertises-
• Activators- eg. Zinc oxide , zinc stearate.
• Filters – eg. Asbestos, calcium carbonate.
• Vulcanising agent- eg. Sulphur.
• Accelerators- eg. Thiazoles.
• Pigments- eg. Antimony, cadmium, iron.
• Softeners – eg. Mineral oil, pine oil.
• Pharmaceutical propertise of natural and synthetic rubber -
• It should be soft.
• It should be quite elastic.
• It should not absorb medicament.
• It should withstand the temperature and pressure of an autoclave.
• It should be compatible with ingredients.
• It should fulfill all the standards of pharmacopeia.
• It should be impermeable to moisture and air.
• It sholud be release only neglible amount of undesired substances.
before using rubber closures the test such as extractive test, permeablity test,
compatiblity test, fragementation test, penetrability must be performed.
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24. BLISTER PACKAGING-
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 These consist of a lid and blister.
 The blister package is formed by heat softening of a sheet of
thermoplastic resin and vacuum drawings the softening of sheet of
plastic into a contoured mould after cooling the sheet is released
from the mould.
 The lid material commonly used as the aluminum foil & metallised
polyester.
 Lid material has to satisfy criteria-
 It should protect the pack material.
 It act as a barrier to moisture and atmospheric gases.
 It must seal to the blister.
 It should tear easily.
 It should accept printing to label.
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 The material used for thermoformable blister are pvc, polystyren,
polypropylene etc.
Qualities of blister material –
It should act as barrier to moisture & atmospheric gases.
Provide protection to medicament.
It must be soften without shrinking.
Flexible.
Packaging of pharmaceuticals (HRB)

26. STRIP PACKING
 It is commonly used for the packaging of tablets and capsules. A strip
package is formed by feeding two webs of a heat sealable flexible film
through a heated crimping roller .The product is dropped into the
pocket formed before forming the final set of seals. A continuous strip
of packets is formed which is cut to the desired number of packets in
length.
 The materials used for strip package are cellophane, polyester,
polyethylene, polypropylene, polyvinylchloride.
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Packaging of pharmaceuticals (HRB)

27.  BUBBLE PACKAGE-
 The bubble package usually formed by sandwiching the product
between a thermoformable, heat shrinkable plastic films& a rigid
backing material.
 SACHET PACKAGE-
 This is laminated with aluminum foil serving as a centre core
besides heat sealable plastic material as the product contact
substances.
 sachet made by 3 steps-
1. formation of carrying pouch.
2. dosing with requisite product.
3. hermetically sealing process.
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