Evolution of parenteral drug packaging
Requirements of product purity, activity and shelf life order high standards for parenteral drug packaging. As said, parenteral drug packaging is among the toughest jobs that packaging service providers will have to do. However, industry experts do feel that the packaging sector proved itself competent while providing packaging solutions for parenteral drugs.
Manav Soni CGM & Plant Head, Venus Remedies |
Manav Soni, CGM & Plant Head, Venus Remedies, opines, “Earlier, the requirements of pharma packaging focused exclusively on preserving the quality of enclosed medication. Now, they are extended to cover such criteria as prevention of product tampering and counterfeiting, assurance of product dispensing accuracy and promotion of patient compliance with product dosage schedules. Therefore, we have a variety of packaging available which includes glass, PET bottles, strip and blister packs, injectables, ampoules, bulk packs etc.”
Murli Sundrani Business Director – BD Medical-Pharmaceutical Systems, India |
Murli Sundrani, Business Director – BD Medical-Pharmaceutical Systems, India, echoes Soni’s views. BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. He says, “Surely, we have better, safer and user friendly packaging and devices for delivery of parenteral drugs. Pre fillable syringes, self-administered pen injections, auto injectors are efforts in this direction.”
Side effects
Packaging in pharma industry is a serious business as it protects the products during shelf life, meets the legal compliances, provides convenience to customers and explains the route of administration. Soni lists the possible side effects of faulty packaging of parenteral drugs. He says, “A poorly designed packaging can expose the patients to a risk of serious adverse effects. Any fault in primary packaging can lead to decrease in tonicity and potency of the drug, presence of impurities, microbial contamination, exposure to gases or light or water vapour and so on, thereby causing adverse side effects. For example, sterile powders for injections must be protected from exposure to water vapours, else it will end up disturbing the chemical nature of the drug thereby reducing its potency. While secondary packaging faults can create problems in transportation of the drugs, delay in regulatory compliances, misguide the end user and so on.”
He adds, “In other words, the unique requirements of pharma products ask for special considerations on the quality of drug at the time of delivery and ways to increase the shelf life while designing the packaging for products.”
Recent trends
Sundrani feels that putting drugs in packaging which is safe, convenient and easy to use while ensuring that the drug retains its effectiveness is the recent trend in the packaging of parenteral drugs. As discussed the parenteral drug segment is enjoying a boom around the globe and so is its packaging. The clinical efficacies, high value and price tags demand high level of awareness in primary as well as secondary packaging. According to Soni, with the advancement in technologies, new material has come to surface due to their better technical and material properties.
“Nanotechnology, the science of very small materials, is poised to have a big impact in pharma packaging and will enable it to bring innovative and new generation packaging solutions to the market. Increasing demand for drug delivery devices and blister packaging will also boost the growth of pharma packaging industry,” opines Soni.
| Guidelines recommended in The International Pharmacopoeia for drug packaging that cover quality of packaging, material used and set standards of labels.
The quality of the packaging of pharma products plays a very important role in the quality of such products. It must:
The kind of packaging and the materials used must be chosen in such a way that:
Apart from this, the most important part of packaging is ‘its label’. All finished drug products should be identified by labelling, as required by the national legislation, bearing at least the following information:
Source: Manav Soni, CGM & Plant Head, Venus Remedies |
Packaging market in India
With the boom in the parenteral drug market, the packaging market is also enjoying a remarkable growth. The approach of pharma companies have changed over time. “Now, they have the same approach towards the science and risk-based packaging material as they do with molecule development entering the clinical stage. Drugs firms have trained, professional packaging staff of their own to ensure the smooth and successful transition of drugs from the lab to market,” says Soni.
With the rising demand for better and effective drugs, the pharma industry is poised to grow tremendously well in the near future and so is the pharma packaging industry. Soni provides the statistics, “It is estimated that the world pharma packaging demand is to increase 6.3 per cent annually to $62.3 billion in 2013. In India, the parenteral drug packaging market is around Rs 1,500 crore which is growing steadily at around 15 per cent per annum and is expected to follow an upward trend in global medication consumption.”
Future perfect
Pharma industry has hardly lost its momentum over the years. As parenteral drugs is the buzz word in the global pharma industry, it is a given that more opportunities will be lining up for packaging service providers in this particular category of medicines.
According to Sundrani, the future would be for packaging which is lighter, safer and easy to use and discard and convenient / intuitive to use. However, there is no data available on which player dominates the market as this involves both primary and secondary packaging.
Even Soni puts a positive picture for the packaging sector. He says, “Global medication consumption is speculated to expand at a strong pace because of the ageing demographic patterns that are leading to increasing number of diseases and disorders. Besides this, the antibiotic segment of the industry is facing a downfall because of the growing dry drug pipelines and increasing resistance for antibiotics against the deadly infections.”
The pharma industry across the world is poised for growth and packaging being an intrinsic part of the industry will definitely grow at the same pace too. As India is already on the radar of many big pharma players across the globe, it is widely speculated that India will be the key partner in the growth of not just the pharma industry but also allied sectors like packaging in the future.