Primary Packaging used in Pharmaceuticals

Primary Packaging:

  • Primary Packaging is the material that holds or contains the Pharmaceutical Products. It comes in direct contact with the products and might have a direct effect on the product’s shelf life.
  • Examples: Plastic bottles (HDPE Bottles), Blister packs, Wrappers & Aerosol spray cans, Glass Containers.

A. Glass Containers as Primary Packaging

  • Glass is a uniform substance that is typically created when a viscous molten substance cools rapidly below its glass transition temperature without giving a regular crystal lattice enough time to form.
  • It is a material that has no biological activity, but its qualities can be changed by heating it up or by adding other substances.
  • Glass is frequently used as a container in pharmaceutical packaging systems because it is affordable, has excellent protective characteristics, and is widely accessible in a variety of sizes and shapes.
  • The glasses are typically robust, stiff, impermeable, and chemically inert.
  • Additionally, they are approved by the FDA (Food and Drug Administration). Glass is an effective barrier material with a suitable closure since it is resistant to ageing (it does not degrade with time).

Composition of Glass:

  1. Sand (pure silica),
  2. Soda ash (sodium carbonate),
  3. Limestone (calcium carbonate) and
  4. Cullet (broken glass acts as a fusion agent, mixed with the batch).
  5. Different ionic substances are added with the glass mixture to render stability.
  6. Some of the common cationic substances: silicon, boron, aluminum, sodium, potassium, magnesium, calcium, zinc and barium.
  7. Only anion present in a glass is oxygen.
  8. Glass develops chemically resistant by the decrease in the proportion of sodium ions, but this increase time and make it expensive. Also it make difficult for glass to melt without sodium or any other alkalis.
  9. Boron oxide assistances in reducing the melting temperature.
  10. Lead used for clarity and brilliance (Added in small quantities).
  11. Aluminum oxide: It is used to increase the durability & hardness, also for resistance to chemical

Types of Glasses used in Pharmaceuticals:

1. Type I: Borosilicate Glass:

  • This form of extremely resistant glass has boron and/or aluminum and zinc in place of a large portion of the earth cations and alkali.
  • In terms of chemistry, type I glass is more resistant to strong acids, alkalis, and solvents, particularly water.
  • The interaction of water with glass causes sodium ions that are in loose contact with silicon contained in glass to begin to leach.
  • With type I borosilicate glass, which allows just 0.5 percent ppm leaching every year, boron at a concentration of 6 percent is added to lessen leaching.

2. Type II: Treated Sodium Lime Glass:

  • These glass containers are made from commercial soda lime glass that has had the surface alkali removed.
  • The de-alkalizing procedure is referred to as a sulphur treatment, and it protects empty bottles against weathering, also known as blooming (the dissolution of salt from glass by condensed moisture when glasses are stored for some months in damp -moist weather).
  • Aqueous vehicle-based parenteral products are kept in it for storage.

3. Type III: Soda Lime Glass:

  • These types of glass containers are commercially available and manufactured of soda-lime glass, which has ordinary or higher than average chemical resistance.
  • Both dry powder parenteral medicines and greasy injections are kept in them.

4. Type IV—General Purpose Soda Lime Glass:

  • These glass containers are prepared from soda lime glass. They are mainly used for non-parenteral products like, oral and topical formulations.

Related: Testing of Glass Container as per USP

B. Plastic Containers

Advantages of Plastic Packaging container in Pharma:

  • They provide design freedom, are of great quality, and are simple to form.
  • Additionally, they are resistant to breaking, providing consumers with safety and convenience.
  • Typically, one or more polymers and a few additives make up the containers.

Types of Plastic Containers

  • Polyethylene: The most regularly used material in the pharmaceuticals is high density polyethylene. It is resistant to moisture but cannot resist oxygen and other gases. It is also unaffected by strong acids and alkalis.
  • Polypropylene: They are made to stress cracking and to all types of chemicals including strong acids, alkalis and organic materials. Polypropylene has a high melting point, which helpful for them to suitable for sterilizable products and boilable packages. It is also resistant to permeation of gas and vapor. The major disadvantage is brittle at low temperatures.
  • Polystyrene: It is not beneficial for liquid products as it holds high oxygen permeability and water vapor transmission.
  • Polyvinyl Chloride (PVC): PVC has some advantages over polyethylene, including improved clarity, a better oxygen barrier, and increased rigidity. To boost its physical stability, various stabilisers, antioxidants, lubricants, and colorants might be added. For volatile fixed alcohols, oils, and petroleum solvents, it serves as a superb barrier. It can withstand gases, moisture, and oxygen as well.
  • Nylon (Polyamides)

C. Metal Containers as a Primary Packaging

  • Pharmaceutical formulations including creams, pastes, and gels can be stored in metal containers made of ductile metals like tin, aluminum, and lead.
  • A collapsible metal tube makes a good container since it makes it simple to dispense a certain amount.
Primary Packaging used in Pharmaceuticals

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