You are hereReview on: THE PHARMACEUTICAL PACKAGING
Review on: THE PHARMACEUTICAL PACKAGING
1.1.2-For solid dosage forms:
Tamper – evident containers are closed containers fitted with a device that irreversibly indicates if the container has been opened.
Strip packages have at least one sealed pocket of material with each pocket containing a single dose of the product. The package is made of two layers of film or laminate material. The nature and level of protection which is required by the contained product will affect the composition of these layers.
Blister packages are composed of a base layer, with cavities called blisters which contain the pharmaceutical product, and a lid. This lid is sealed to the base layer by heat, pressure or both. They are more rigid than strip packages and are not used for powders or semi-solids. In tropical areas blister packages with an additional aluminium membrane is used which provide greater protection against high humidity.
Child Resistant Containers, commonly referred to as CRC's, are designed to prevent the child accessing the potentially hazardous product.2
1.1.3-Containers for semi solid and pressurized products:
Semi solid dosage forms like ointments, creams etc are packed in metallic collapsible tubes. Plastic containers are also used for the packaging of creams.
Pressurized packages expel the product through a valve. The pressure exerted for the expulsion of the product is an important consideration while selecting the packaging for any products.
2) Factor influencing the choice of package:
It is essential to have a survey about the market, the distribution system, manufacturing facilities and other considerations before selecting the packaging material.
The physical and chemical characteristics of the drug entity, the excipients, the formulation, route of deterioration of the product, type of patient (baby, child, teenager, adult, elderly, infants etc) must be considered while dealing with the pharmaceutical product. Apart from the properties of drug, package style to attract patient and other legal requirements should also be considered during selection.
The channel of sale should be considered, i.e. where, when, how and by whom it is to be used or administered (e.g. doctor, dentist, nurse, patients etc), whether for home trade and/ or export. The quantity per package and follow up sale must all be care fully considered during package design and selection.
The distribution system:
The distribution system should be carefully monitored, e.g. conventional wholesale/ retail outlet or direct or selective outlets. Less sophisticated transport systems like mules, donkeys, camels etc requires additional protection if intermediate storage facilities are non existent.
The stability of the manufacturing facilities should be considered due to new package, increased sale, improvements in Good Manufacturing Practice, revised product, new product etc.
2.1-Function of packaging:
The various functions of packaging are:
· Protective function
· Storage function
· Loading & Transport functions
Protective function: Protective function of packaging essentially involves protecting the contents from the environment and vice versa. The inward protective function is intended to ensure full retention of the utility value of the packaged goods. The packaging is thus intended to protect the goods from loss, damage and theft.
In addition packaging must essentially be able to withstand the many different static and dynamic forces to which it is subjected during transport, handling and storage operations. The goods frequently also require protection from climatic conditions, such as temperature, humidity etc. The precipitation and solar radiation may require additional packaging measures in the interior portion of the container.
The exterior protection provided by the packaging must prevent any environmental degradation by the goods. This requirement is of particular significance in the transport of hazardous materials, with protection of humans being of primary importance. The packaging must furthermore as far as possible prevent any contamination, damage or other negative impact upon the environment and other goods. The interior and exterior protective function primarily places demands upon the strength, resistance and leak proof properties of transport packaging.
Storage function: The materials used for packaging should be stored properly so as to preserve the quality of the material both before packaging and once the package contents have been used.
Loading and transport functions:
Packaging has a crucial impact on the efficiency of transport, handling and storage of goods. Packaging should therefore be deigned to be easily handled and to permit space-saving storage and stowage. The shape and strength of packages should be such that they may not only be stowed side by side leaving virtually no voids but may also stowed safely one above the other.
The most efficient method of handling general cargo is to make up cargo units. Packaging should thus always facilitate the formation of cargo units; package dimensions and the masses to be accommodated should be possibly tailored to the dimensions and load- carrying capacity of standard pallets and containers.
Identification: The packaging should give clear identification of the product at all stages. The life of the patient may depend upon rapid and correct identification in emergencies. Packaging also serves as a mean to identify the manufacturer of the product. The manufacturer must consider the packaging requirement for the usage of product in different localities.3
3) Properties of packaging materials:
To afford the necessary protection, the materials from which the container is to be made must show certain basic properties which can be divided into four groups.
3.1- Mechanical Properties:
The materials used should possess sufficient mechanical strength to withstand while handling, filling, closing and processing. Typical care is needed during transport, storage and also at the time of usage by the consumer especially in case of glass containers. A glass container will have greater strength if all corners are rounded.
3.2- Physical properties:
- The material should be impervious to any possible contaminants, for example, solids, liquids, gases, vapors or microorganisms.
- The container must be able to withstand heat if the processing includes sterilization.
- The surface must be capable of clear labeling, often difficult, for example, with plastics.
The packaging must have a suitable size, thus, rubber may presents problems if it perishes.
- The material must protect from light if necessary, that is, it must be ultraviolet absorbent.
- The container must not absorb substances from the products; e.g. absorption of water from creams in to cardboard box.
- The container and the closure should not react together, either alone or in the presence of the product. This can occur with certain combination of dissimilar materials.
- The product should not react with the container or closure , as might happen if alkaline substances are placed in aluminium containers.
- Substances must not be extracted from the product, such as the loss of bactericides from injection solution to rubber.
- The container or closure must not yield substances to the product; for example, alkali from glass, plasticizers from plastics etc.
3.4- Biological properties:
The material of the container must be able to withstand attack by insects if this hazard is likely to be encountered. The packing should not support mould growth. T he risk is greatest with cellulosic substance and if the use of such materials is unavoidable, the attack may be minimized by impregnation4.
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