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Unit Objectives::

Unit Objectives: After the end of this lecture, students would be able to : Define Packaging Classify Packaging Significance of pack design Different types of protection offered by packs & packaging Selection criteria for deciding the type of pack


definition Packaging has been defined as the means of economically providing: Presentation Identification and information Protection Convenience and compliance Containment during storage To a product during all phases of its lifespan.


Classification: Packs may be classified as: primary packs , which are in direct contact with the product and have a primary role in maintaining product quality. secondary packs , which contain the product and primary pack and have more of a presentational and protective function .

Pack design:

Pack design Good design principles are applied to all the elements of a pack to ensure safety, compliance and convenience for the patient (Wang 2005).

Pack design:

Pack design Prescription products tend to have a relatively straight forward design in keeping with their primary market of healthcare professionals. OTC products are more distinctive to attract customers at point of sale and there are also common design features amongst products from the same brand line to enhance the brand identity .

Use Of Product :

Use Of Product The pack should encourage: convenience of product use and patient compliance with usage instructions maintaining quality does not normally affect the functioning of the product .

Protective function of packs: :



ENVIRONMENTAL PROTECTION TEMPERATURE : If a medicine is sold worldwide it can potentially be exposed to an extremely wide range of temperatures. High temperatures increase the rate of reaction and can therefore shorten a product’s shelf life , and repeated cycling between high and low temperatures can also cause stability problems (e.g. ‘cracking’ of creams). The packaging materials need to be chosen carefully as extremes of temperature may alter the materials properties.


ENVIRONMENTAL PROTECTION Moisture And Humidity: Chemical reactions are usually sustained much more easily in aqueous solution . Water itself can cause chemical instability via hydrolysis. aqueous environment can support the growth of microorganism. Physical problems at high atmospheric humidity include the caking of powders. Dulling or tarnishing of metals and, depending on the difference in moisture levels inside and outside the container, either loss of water from the product or dilution of the product .


ENVIRONMENTAL PROTECTION Light Photo degradation is another major cause of chemical instability, with ultraviolet light being the most damaging. This is easily protected against by using colored or opaque containers, as well as secondary packs.


ENVIRONMENTAL PROTECTION Gases And Volatile Materials: Oxygen is another cause of instability, via oxidation. carbon dioxide may also cause problems with un buffered aqueous products as it can dissolve in the water to lower pH by forming carbonic acid. Volatile compounds may also cause problems with permeable packaging materials.


MECHANICAL PROTECTION The product will need to be protected against a variety of mechanical stresses during its life cycle, especially during transportation and storage , and secondary packaging is of particular importance here. Compression: Protection against compression is afforded by secondary packs made from cardboard of a suitable thickness.


MECHANICAL PROTECTION Impact : More sudden and intense forces can happen during movement of the pack or by accident (e.g. dropping). Damage from impact can be minimized by cushioning the primary pack or holding it snugly in the secondary pack. Vibration: This frequently occurs during transportation and can lead to physical instability in the product (such as separation of powders) or gradual opening of closures such as screw caps.

Biological Hazards :

Biological Hazards Microbiological : The pack should, as far as possible, minimize contamination by microorganisms, which can cause spoilage of the product as well as pose an inherent health risk. Sometimes microorganisms can attack the packaging itself: paper and other fibrous materials are susceptible to attack by fungi (e.g. Aspergillus or Penicilluim species) in damp conditions.

Type Of Pack :

Type Of Pack There are many factors which need to be considered when selecting a suitable type of pack for a product: The product or pack contents. The application of the product Content stability, and the need for protection from any environmental factors Content reactivity (with relation to the packaging material) Acceptability of the pack to the consumer or user The packaging process Regulatory, legal and quality issues.

  Solid Products:

Solid Products Solid dosage forms such as tablets and capsules are by far the most commonly used today. Traditionally they have been packed in bottles, originally made from glass but latterly from various plastics. The mouth of the bottle should be wide enough to allow rapid filling on a high speed production line and during dispensing. The sachets will be formed from laminated materials which confer good water-barrier properties (the powders or granules are often effervescent) and allow attractive and informative designs to be printed on them.

Solid Products:

Solid Products Metal containers will need to be lined to prevent corrosion problems, although it is usual for bulk powders to be contained within a polyethylene bag as the primary pack. Polyethylene bags are sometimes used for temporary storage of materials in process if the quantity is in the order of tens of kilograms; these packs must be closed and labeled properly-self-adhesive paper labels should be used rather than writing directly on the pack with a marker pen, as components of the ink can migrate into the product.

Semi Solid Products :

Semi Solid Products The product should be adequately preserved as there will be a relatively large surface area open to contamination. Flexible tubes are frequently used to contain semi-solids; these can be made from aluminum , although this is not as common as it once was a plastic such as polyethylene or a plastic-aluminum composite .

Semi Solid Products:

Semi Solid Products plastic alone tends to spring back into its original position once the deforming forces has been removed. This can lead to the phenomenon of ‘suck back’ , where product which has been exposed to the external environment can be pulled back into the tube and cause contamination problems.

Liquid Products :

Liquid Products Aqueous products are the most common type of liquid pharmaceutical formulation and usually materials such as high-density polyethylene are suitable for short to medium term storage without losing water through the walls of the container. Oils may present a problem with plastics , however, as they may be absorbed by the plastic with results that range from altering the strength of the product to a catastrophic weakening of the plastic. Volatile oils may present particular problems if they have an affinity for plastic packaging, as they often give fragrance or flavor to a product and even a minimal sorption of the oil to the plastic may substantially alter the product’s taste or smell.

Liquid Products::

Liquid Products: Glass is an excellent choice for sterile products as it is not normally affected by sterilization procedures, it can be formed into a wide variety of pack formats (bottles, vials, ampoules, etc.) and it can be hermetically sealed. There is a limited choice of plastics , as there is a much greater potential for the sterilization process to cause interactions between the product and the pack or for the packaging material’s properties to alter.

Unit Packs :

Unit Packs Unit packs, in which individual doses are separated from each other, are popular for many types of dosage form. A convenient course of medication can be packed into a carton by the manufacturer with a patient information leaflet, and the carton itself provides a more convenient area for giving statutory information than a label on a bottle. A variety of plastics, metals and laminates can be used in forming unit packs and careful selection of these materials will confer any combination of desirable properties on the pack.

Tamper-Resistant Packaging :

Tamper-Resistant Packaging Tamper resistant can be conferred on a pack by using a Roll-on closure which has a perforated collar which grips onto a lip on the bottle neck, and these perforations must be broken before the cap can be unscrewed. Alternatively a clear plastic film collar can be put around the cap, or a film wrap over the whole container. Blister packs, sachets and similar packs are inherently tamper resistant as the pack must be broken open to gain access to the product.

Child –Resistant Packaging :

Child –Resistant Packaging Child-resistant containers work on one of two principles: in the first a certain degree of strength will be needed to open the product, and for the second a high degree of manual coordination is required. These translate into three basic types of cap: one which needs to be pushed down before turning ; one which needs squeezing before turning ; and one where arrows on the cap and container need to be lined up . Blister packs and sachets also have a degree of child resistance.

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