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PACKAGING MATERIALS IN PHARMACEUTICAL INDUSTRY

By Preethi Swetha. S

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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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TYPES OF PACKAGING 

  • Primary packaging- is the material that first envelops the product and holds it. This is usually the smallest unit of distribution or use. Ex. Aerosol spray can, blister packs, bottles

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  • Secondary packaging - the package external to primary package is known as secondary package, this package provides additional protection during warehousing and also provides information about drug product ex. Boxes, cartons, leaflets

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  • Tertiary packaging - It is outer package of secondary packaging & prevents damage to the products. It is used for bulk handling & shipping.

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CHARACTERISTICS OF PACKAGING MATERIAL

  • The material selected must have the following characteristics
  • Must meet tamper-resistance requirements
  • Must be FDA approved
  • Must be non-toxic
  • Must not impart odor/taste to the product
  • Must not reactive with the product
  • They must protect the preparation from environmental conditions

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TYPES OF PACKAGING MATERIALS USED FOR PHARMACEUTICAL PACKAGING

GLASS

PLASTIC

METALS

PAPER BOARDS

RUBBERS

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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

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Types of glass

Type 2

Type 3

Np-soda glass

Type 1

  • Type I—Highly resistant borosilicate glass
  • Type II—Treated soda lime glass
  • Type III—soda lime glass
  • NP—soda glass (non parenteral usage)

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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

  • 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

  • Absorption permeable to moisture
  • Poor printing, thermostatic charge

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Types of plastic

    • 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)

Thermosetting

    • On heating they are soften to viscous fluid which harden again on cooling.

2. e.g. Polyethylene{HDPE – LDPE}, Polyvinylchloride(PVC),Polystyrene Polypropylene, Nylon(PA), Polyethylene terepthalate(PET) ,Polyvinylidene chloride(PVdC), Polycarbonate Acrylonitrile butadiene styrene(ABS)

Thermoplastics

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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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TYPES OF METALS

Aluminium

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
  • Aluminium tubes offer significant savings in product shipping costs because of their light weight
  • They are attractive in nature
  • 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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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

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BUTYL RUBBER

Advantages:

Permeability to water vapour .Water absorption is very low. They are relatively cheaper compared to other synthetic rubbers

Disadvantages:

Slow decomposition takes place above 130 ▫ C. Oil and solvent resistance is not very good

NITRILE RUBBER

Advantages:

Oil resistant due to polar nitrile group. Heat resistant.

Disadvantages:

Absorption of bactericide and leaching of extractives are considerable.

CHLOROPRENE RUBBERS

Advantages:

Oil resistant. heat stability is good.

SILICON RUBBERS

Advantages:

Heat resistance.Extremely low absorption and permeability of water. Excellent aging characteristic

Types of Rubber

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PAPER 

  • Paper and paper boards as packaging material are used to prepre containers as envelops for dispensing powders,few tablets few capsules etc. of as cartoons boxes drums for storing large quantity of drugs in an industries .

• They are mostly used for secondary packging and tertiary packaging

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