Packaging material in pharmacy , (Pharmaceutics)

Packaging material

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CHAPTER – II PHARMACEUTICS
CHAPTER – 2
Syllabus: Packaging materials: Types, selection criteria, advantages and
disadvantages of glass, plastic, metal, rubber as packaging materials
Packaging
Introduction:
 Pharmaceutical packaging can be defined as the economical means of
providing presentation, protection, identification, information, convenience,
compliance, integrity and stability of the product.
 Packaging is the science, art and technology of enclosing or protecting
products for distribution, storage, sale, and use.
 Packaging refers to the process of design, evaluation, and production of
packages.
 Packaging is important in material handling, storage and transportation.

Function of packaging:
 Product identification
 Product protection
 Product promotion
 Facilitating the use of product

Types of Packaging:

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CHAPTER – II PHARMACEUTICS

(i) Primary packaging-
• It is the material that first envelops the product and hold it.
• This usually is the smallest unit of distribution or use.
Ex. Aerosol spray can, blister packs, bottle
(ii) Secondary packaging –
• It is outside the primary packaging perhaps used to group primary
package together.
Ex. Boxes, cartons
(iii) Tertiary packaging-
• It is used to bulk handling and shipping.
• Contain many units of secondary packaging.
Ex. Barrel, container, edge protector
Package Testing:
 Drop test
 Vibration test
 Shock test
 Inclined impact test
 Revolving drum test

Selection criteria of the Packaging material
The selection of packaging material depends on the requirement such as
protection from environmental factors and degree of protection required:
Criteria for selection:
 Physical properties of the product
 Economy
 Stability of formulation
 Formulation components
 Facilities available for packaging
 Government regulation

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CHAPTER – II PHARMACEUTICS
 Environmental criteria: Light, Temperature
 Convenience: e.g. size, weight of dosage form,

Types of packaging materials used for
pharmaceutical Packaging
 Glass
 Plastics
 Rubbers
 Paper / card boards
 Metals
Glass
Introduction:
 Glass is generally used in Pharmaceutical packaging because it possesses
greater protection quality.
 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:
 Economical
 Easily available in various shapes and sizes
 They are chemically inert
 They are hygienic and suitable for sterilization
 They are relatively non- reactive
 It can accept variety of closure
 They can be used in high speed packaging lines
 They are transparent.
 They have good protection power.
Disadvantages:
 Break easily
 Release alkali to aqueous preparation
 They may crack when subjected to sudden changes of temperature

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CHAPTER – II PHARMACEUTICS
Types of Glass container:
1. Type I / Borosilicate glass
2. Type II/ Treated soda lime glass
3. Type III/ Soda lime glass
4. Type IV/ NP-general purpose soda lime glass
Some other types of glass are:
 Silicon treated glass
 Sulphured glass
 Neutral glass
 Ambered colored glass
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, alkalis 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 known as sulphur treatment. Sulfur treatment
neutralizes the alkaline oxides on the surface, rendering the glass more chemically
resistant.
• Uses:
Used for alkali sensitive products.

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CHAPTER – II PHARMACEUTICS
Infusion fluids, blood and plasma.
Large volume container.

Type III and Type IV glass
• Both have similar composition and are distinguished from each other on the basis
of their hydraulic resistance
• Type III has average or slight better than average resistance and is suitable for non-
aqueous parenteral 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.
Types of glass Description Type of test Size(ml)
I Highly resistant
borosilicate glass
Powdered glass All
II Treated soda lime
glass
Water attack 100 ml or less
III Soda-lime glass Powdered glass All
IV(NP) General purpose
soda-lime glass
Powdered glass All

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CHAPTER – II PHARMACEUTICS

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.
 Plastic is made from one or more polymers together with certain additives.
 The additives included in plastic formulation are antioxidants, antistatic
agents, colors, lubricants, plasticizers.
 The polymers commonly used to make plastic container are as follows:
 Polyethylene
 PVC
 Polymethyl metho acrylate (PMMA)
 Polystyrene
Advantages:
• Least expensive than glass
• Ease of transportation
• No risk of breakage
• Less weight than glass,
• Flexible
• Variety of sizes and shapes
• Essentially chemically inert, strong, rigid Safety use, high quality, various designs
• Extremely resistant to breakage
Disadvantages:
• They are not as chemically inert as Type-I glass
• Leaching from container to product
• Sorption (absorption or adsorption) of drug molecule or ion on the plastic materials
• They may possess an electrostatic charge which will attract particle

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CHAPTER – II PHARMACEUTICS

Classes of plastics:
There are two classes of plastics, reflecting the behavior with respect to individual
or repeated exposure to heating and cooling.
i) Thermoplastics:
• Capable of being shaped after initial heating and solidifying by cooling.
• On heating they are soften to viscous fluid which harden again on cooling
• Resistant to breakage and cheap to produce and providing the right plastics are
Chosen will provide the necessary protection of the product in an attractive
Containers.
• E.g.: Polystyrene, polyethylene and polyvinyl chloride, Polyethylene {HDPE –
LDPE}, Polyvinylchloride (PVC), Polystyrene Polypropylene, Nylon (PA),
Polyethylene terephthalate(PET) ,Polyvinylidene chloride(PVdC), Polycarbonate
Acrylonitrile butadiene styrene(ABS)
ii) Thermosetting type:
• They need heat for processing into a permanent shape.
• When heated they may become flexible but they do not become liquid
• During heating such materials form permanent crosslinks between the linear
chains, resulting in solidification and loss of plastic flow.
• E.g.: Urea formaldehyde (UF), Phenol formaldehyde, Melamine formaldehyde
(MF), Epoxy resins (epoxides), Polyurethanes (PURs).
METAL CONTAINER
 Metals are used for construction of containers.
 The metals commonly used for this purpose are aluminum, tin plated, steel, and
stainless steel, tin and lead.
 The collapsible metal tube is an attractive container that allows controlled
amounts to be dispensed easily, with high-quality re-closure and enough
environmental defence to be product.

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CHAPTER – II PHARMACEUTICS
Advantage:
 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 print directly on their surface.
Disadvantages:-
 They are expensive.
 They react with certain chemicals.

Rubber Packaging
• Elastomers are a group of polymers usually referred to as 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.
• Common rubbers used in pharmaceutical packaging are as follows:
 Butyl rubber
 Chlorobutyl rubber
 Natural rubber
 Silicone rubber
Types of rubber:
1. Natural: It consist of latex from heave a brazileinsis and is an isoprim
polymer. Natural rubber can be converted into smoked sheet of pale crepe.
2. Synthetic: Synthetic rubber are silicon, neoprene, nitrite or butyl rubber.
They are expensive.
Advantages:
 Rubber does not deteriorate with age.
 Good quality rubber is resistant to sterilization conditions.
 They are unbreakable, tough and easily transported.
Disadvantages:
 Manufacturing process is complicated.
 They are very expensive