It is known that the Pharma product packaging needs extreme care and the packaging must ensure maintenance of the efficacy of the product and its safe delivery. Pharma products as a family, probably, use the entire cross section of the packaging materials in varieties, forms and combinations. Security and integrity are the watchwords. The packaging requirements of pharma products can be deliberated from different concepts viz products group, package type and method of use. The broad and general classification can be the ethical and OTC and by their nature both demand packaging in their own ways. The former essentially fall under statutory packaging requirements with longer shelf life and stringent protective needs. OTC products commonly dispensed in smaller quantities should facilitate retail marketing and consumer convenience.
Package decision approach can best be started with the knowledge of the products and their nature and sensitivity. Understanding the effect of various environmental factors and their influence on the spoilage and deterioration becomes the starting stage. The climatic factors that include oxygen/gases, moisture, high and low heat, and light. Whereas quite a few products are formulated with inbuilt resistance characteristics, a judicious selection of package obviously is the ultimate vehicle. A significant aspect is to ensure product package compatibility. Variations in the relative humidity (directly referring to the moisture availability in the atmosphere can result in drying of product, lump formation, chemical changes, and alter the concentration of active ingredients). Oxygen can lead to degradation of the active constituent in the product often catalysed by the light. Light alone can bring in deterioration in some products. Drying of acqeous creams, loss of water of crystallization are typical of effect of high heat conditions. Loss of volatile components and degradation/deactivation are other effects of high heat. Whereas these refer to the environmental factors, the products can also be affected while in storage and movement due to handling, ware housing, actual transportation - normally referred to distribution hazards. The hazards - mechanical/physical, climatic/environmental - and the intensities can vary considerably. The design and development of secondary and tertiary packages assume greater significance in this context.
The selection of a package is thus influenced not by any single or isolated factor but multiple factors. Product package compatibility, degree of protection required, product presentation, mode of dispensing, in-process/production packaging line, dispensing feature and disposal needs of used package besides economical consideration are the basic guidelines in deciding the package. In certain cases amenability to sterilization becomes a necessity. The commonly adopted sterilization techniques are wet & dry-heat sterilization, gas sterilization, irradiation sterilization and chemical sterilization. Notwithstanding the requirements or otherwise, the Pharma packaging line should follow GMP (Good Manufacturing Practices) and there is always scope for updating and improving the system.
To arrive at the right package, it is thus necessary to evolve appropriate packaging materials and packages specifications that will conform to all needs - that may include various operations from within the factory, production line and various operations in the subsequent supply chain that ends at a satisfied customer. Appropriately drawn specifications will help in the proper procurement of right material, quality assessment of receipted materials, in-process and final packaging with the resultant of requisite performance of the package-ready to move out. It helps to avoid any language barrier between the supplier and buyer besides cost optimization. A judicious identification of the properties should help to avoid any ambiguity in as much as larger the number of properties and longer the list of specification heads higher is the chances of debate, even one property defers. Quantitative performance based figures will facilitate the whole process-easy to process, understand and draw parameters to help acceptance or otherwise.
While a number of packages and types & varities are in vogue considerable developments are witnessed in respect of closure and dispensing systems, including child resistant and tamper evident/security closures. Often redesigning of the cap and neck design become necessary where repeated use of the containers (multidose) for OTC products is considered. Closure system also needs to address to problems like products containing volatile constituents. Similarly additives used in the caps, rubber bunks (vial rubber bunks), gumming up (closures for syrup bottles) need proper material selection and design. In respect of metered-dose inhalers the specific facet relate to orientation of the containers. Even storage studies of containers in horizontal placement are recommended. In respect of an ointment (topical product) which is conventionally applied the container with a pump that would meter out the prerequisite quantity is recommended. Use of desiccant (tablet or powder in a sachet) is not uncommon for products that are moisture sensitive. Contamination by the desiccant cannot be overruled. A two compartment system is often the answer wherein the compartments are interconnected with tiny intercommunicating channels. Compatibility problems and product spoilage can also be through various adjuncts like printing inks and adhesives. Migration of any of the constituents can be harmful and hence the formulations should be done with care. Container-adhesive-label stock-printing ink put together can also lead to storage problems like peeling of label, smudging of the print etc. What is required to ensure mutual compatibility, particularly the chemical and often the physical as well. Whereas in respect of blisters, strips, pouches the effect of moisture ingress is prevented by proper laminate substrates and good sealability in respect of bottles, cans where a closure system is a separate entity the design of the neck and closure become significant. The dimensions of the containers may also need to be addressed to avoid excess void/ullage (head space)
A significant area where considerable attention is paid relate to child resistant package/closures and elder friendly closures. The child resistance package is in simple terms defined as that "Package which is difficult for a child to open and yet not difficult for an adult to open and use". A number of developments are seen and some typical ones includes "Turn and Press", "Turn and Lift", "Squeeze and Lift", "Squeeze and Turn", "Lift ring and turn cap", "Hold ring in position and turn cap", "Insert finger and lift over cap". The first three probably are most common. The European protocol (pr EN 862) has clearly spelt out the test procedures to certify the CR caps.
Tamper identification or tamper evident packaging is a term often heard. The genesis is the "Typical packages" appearing in Chicago in 1982 and the furors it has created. Earlier the term Temper resistant packaging was in vogue. Tamper evident packaging essentially is to help consumers to identify evidence of tampering. Increased and wider user of tamper evident packages has helped to tighten the control over tendency to tamper. The other term the industry generally deals with is pilfer proofing. This is not merely tampering wherein the package is opened, contents removed partially or fully. Pilfering is a malicious act.
Tamper resistance or evident packages often is related to security of a package as a whole. Security packaging however does not guarantee prevention of tampering. The system helps to make it difficult to tamper with the product or package. Security packaging provides visible evidence on an attempt that the product / package is tampered with. The advent of self service stores, malls or supermarkets has influenced the increased use of tamper evident system. Whereas in earlier days such tamper evident or tamper resistance means are predominantly used in retail sales but over a period such systems also have penetrated in industrial product as well as military and distribution packages, primarily aimed to resist theft.
Counterfeited and spurious products/drugs affect health, life, product-brand-company image beside the confidence. Counterfeit measures could be through package and package component designs, holograms and smart and intelligent labels
(The author is chair professor & advisor - SIES, Mumbai)