Pharma packaging going places

Indian pharmaceutical research is going places with new drugs and novel delivery systems in the pipeline. How well is the packaging industry going along to deal with the increasing demands of the drug industry? Katya Naidu finds out

Sudip Dutta Chairman and MD Dutta Group of Companies

Packaging has become a very important part of pharma companies as the innovation in drugs and the novel drug delivery system reach new heights. According to Sudip Dutta, Chairman and MD, Dutta Group of Companies, “Research on pharma packaging has just started in its real sense. It is not reasonable to compare pharma packaging and traditional packaging.

Pharma Packaging has to be research based, while traditional packaging is more customer oriented.” The stage, however, has been set for research based pharmaceutical packaging as there are some companies treading this way. “There is considerable progress being made by companies focused in providing total value proposition to the global pharmaceutical sector in making packaging evolve from a functional tool to an integrated part of the pharma product,” says Praful R Naik, President of Bilcare Limited.

Packaging for pharma

Due to the unique requirement of pharma products, pharmaceutical packaging also has to ensure the quality of the drug at the time of delivery in terms of impact harmful reactions to natural conditions, and to increase shelf life.

Packaging is crucial to the stability of the drugs. Most of the drugs are prone to external and internal reactions, owing to their volatile nature. Hence, pharma packaging is guided by certain regulatory and food grade guidelines, derived by the national and international bodies. Stringent stability requirements and development of new diagnostics and drugs increase the demand on pharmaceutical packaging systems.

Packaging Coatings

Innovative packaging solutions have become all the more significant in the packaging of drugs that contain potent bio-molecules, like proteins. They have the property of interacting with the innermost or the primary packaging of the drug. A solution for this kind of specialised packaging comes in the form of innovative coating technology. “Coatings on pharmaceutical packaging can help to avoid protein interaction with packaging surfaces and protein adsorption. It can speed up the formulation process to keep time to market, short,” says Vikas Acharya, Manager— Competence Center, Pharmaceutical Packaging India, Schott Glass India.

A plasma coating technology, in which, a silicon dioxide layer is coated to the surface of the internal container, can avoid the chemical interaction between the container and the product. This is called the Plasma Impulse Chemical Vapour Deposition technology (PICVD). The PICVD coating technology offers the possibility to improve the barrier properties of plastic materials. These coatings work for different container types, like cartridges, syringes and vials.

Research in pharma packaging can also help drug companies package a product in different states. By means of a multiplexed screening method, various formulations can be incubated with different packaging surfaces in a quick test with little material. “The results indicate a feasibility to develop the final drug in a liquid versus a more expensive lyophilised form. Finally, a decision on the ideal combination of packaging surface and drug can be taken and the risk of failures in stability trials can be minimised”, says Acharya.

Low gauge

With all the challenges ahead, in terms of re-inventing its strategies to get more competent, the packaging industry is not lagging behind. According to Dutta, there is a need for rationalisation in pharma packaging. “Most of the products are either under-packaged or over-packaged. We are working on rationalisation, to provide a solution for the primary packaging, which will just be the ideal or optimum packaging.”.

To cite some examples, many products are currently packed in 40 microns soft foil but can be packed in 30-micron foil. The ones packed in 30 microns foil can be packed in blister packs. Products that are not stable with only PVC, but are over packaged with polyvinylidene chloride (PVdC) could be put in a laminate of polyvinyly chloride (PVC) with polyethylene (PE) research should be stepped up in this area of down gauging. There is the necessity for focused research in the area of down gauging.

There is scope for down gauging of both the forming film and the lid foil. An important measure is introduction of metalised[?] PVC of 200 microns with a better WVTR, as against plain PVC of 250 microns. “We are also working on a combination of laminated films which will provide the same kind of barrier at a lower cost. Further down gauging of blister foils is on the cards, which should benefit the pharma packaging sectors in a substantial way,” says Dutta.

Time and cost

Like in any other field, the pharma packaging industry is also looking at making their products cost-effective. Research is on to ensure the complete integration of the packaging system to the drug product it encases and also the viability of total effective costing model. “Some new technologies have been researched and developed but have not really been successfully adopted by the pharma industry. The reason is that, the industry is looking at conventional ways of cost-cutting and not at total effective costing. The industry becomes more satisfied on the cost per kg concept without realising that they are loosing more on a comprehensive and overall basis,” laments Naik.

However, technology can come to the rescue of tackling the cost issues. The development of technology, which can identify the optimum packaging system on an enhanced speed to avoid multiple studies during stability programs, is on the cards. Bilcare, for instance, was successful in developing a novel technology, which has the capability of identifying the sensitivity of any formulation in a short span of 30 day evaluation program and establish scientifically, the most suitable packaging system for that product, based on several key packaging dependent parameters.

Other than cost cutting, yet another dream of pharma marketing strategists is the enhancement of shelf life of a product. Research is on for technologies than can re-define the shelf life of pharma products in general.

With the incremental speed in globalisation and the export market pie that Indian pharma companies are eyeing, the shelf-life parameter has become of utmost importance to ensure the coverage of the additional transit time now required for the product to travel long distances.

Shelf-life increase can be done by either making the formulation more robust or by scientific re-designing of the packaging system. The former way is proving to be very cost oriented and results in a high cost formulation. “The option of increased shelf life through the use of better and newer packaging systems is now gathering momentum. Packing has the capability of safeguarding the efficacy and potency of the drug product for a significantly longer time,” says Naik.

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