The global pharmaceutical industry has evolved over the last decade and is now increasingly focused on efficacy of the medicine and patient safety. Pharmaceutical packaging too has come of age and is now beginning to get its due importance. Formulation development teams and regulators are both keeping a keen eye on product packaging and its impact on formulation integrity through its shelf life. One of the main reason for this is that new age APIs in addition to being highly potent are also very sensitive to moisture, oxygen and light.
The exposure of solid dosage products like tablets or capsules to hostile conditions can result in:
- Physical damage - Softening & disaggregation (breaking of the tablet or capsule shell)
- Chemical interaction – Hydrolysis of active ingredient leading to loss of potency
- Oxidative degeneration – Oxidation of the active ingredient rendering it ineffective or toxic
In an extreme case, there can be fatality due to absence of the medicament as it has degenerated into something ineffective or harmful. To avoid such a situation, the medicament has to be packed in a suitable protected blister that protects the formulation from moisture, oxygen and light.
Materials for barrier needs
Barrier protection to the product can be provided by using different material:
a) Metal – Aluminium is the most commonly used metal in pharma packaging
b) Silicates – Glass packaging is inert and provides good barrier from water and oxygen
c) Polymers – Plastics used to pack tablets and capsules in blister packs
It is for this reason that many companies manufacturing packaging material provide a range of coated film that provide varying degrees of barrier from the harmful elements. But till recently, truly effective high barrier meant that the product be packed in cold form blister or in barrier packaging films coated with imported high barrier material PCTFE (also known as Aclar®) – both eating into product profitability due to their high cost.
Perlen Packaging introduces a high barrier range that is not just effective but also highly cost effective. It is for this reason that they are amongst the key suppliers to Abbott, Actavis, Astra Zeneca, Catalent, GSK, Novartis, Pfizer, Sanofi and Teva to name a few.
Pharmaceutical blister film specialists
Perlen Packaging is amongst the world’s top pharmaceutical barrier packaging films supplier from Europe and one of the main suppliers to some of the world’s leading pharmaceutical formulation and generic multinationals. Our focus is 100 per cent the pharmaceutical industry and all our energies are directed to providing our customers with innovative and newer barrier substrates for blister packing, at optimal costs.
Perlen is the pioneer for PVdC coating on PVC and was the first to develop this application in 1970, thus producing a packaging film that provides a barrier from both, moisture and oxygen. This film application is now being used as a proven blister packaging material across the world. High barrier was limited to a WVTR of 0.12 and an OTR of 0.30. Then came the era of Ultra High Barrier films which helped formulation development scientists to launch a range of new products which could now be suitably packaged to maintain product functionality and integrity. The main challenge with the present day Ultra High Barrier packaging films is the cost and its negative impact on productivity – especially with cold form blisters.
The most commonly used packaging film in the Ultra High Barrier range is PCTFE 51 µm (commonly known as Aclar®). Perlen Packaging has introduced the PERLALUX®- Tristar ultra range of films – Tristar ultra 120 which matches the barrier properties of PCTFE 51 µm.
The advantage of PERLALUX® - Tristar ultra and Ultra protect range offers advantages on the blister packaging line as well – with very good thermoforming at standard setting, significantly lower sealing temperatures compared to PCTFE, no curling, less wastage, no plug assist needed and significantly higher output speed. It is for this reason that companies around the world have switched to PERLALUX® high barrier blister packaging films from Perlen Packaging.
Moreover, PERLALUX®- Tristar ultra can be operated with the same set of blister format parts, the same thermoforming conditions and with same machine parameters.
Pharma certifications and regulatory requirements
Barrier films from Perlen Packaging meet global regulatory requirements. They have the US FDA DMF and have also been approved by the CFDA of China.
One specific quality certification that speaks volumes about the Perlen quality is the approval received from the Japanese authorities – Japanese Ministry of Health, Labor and Welfare. This is a major advantage for pharmaceutical companies who are exporting their formulations to Japan.
In addition to this, the facilities meet the GMP Zone Concept and are ISO 15378, ISO 9001 and ISO 14001 compliant, thus making Perlen the supplier of choice for high barrier films across Europe.
Continuous development support
The barrier optimization process that is followed at Perlen Packaging is absolutely customer centric. It begins with a discussion with the packaging development teams at the customer end. This discussion gives both teams to be on a common platform regarding the product’s barrier requirement. Based on this data, the Perlen team conducts an in house exercise of product selection – mono film and the barrier coating structure to meet the product requirement.
This is followed by preparation of a customized blister film sample to suit the requirement of that particular product. The film is then evaluated for machinability on the in-house automatic blister packing machine. Perlen has its very own Uhlmann blister packing line for conducting all its product tests. Unlike many other suppliers who conduct the barrier test on the packaging film, the Perlen system involves conducting the necessary WVTR and OTR tests on the formed blister. As a conclusion to this study, there is a recommendation made for optimization of the packaging material in terms of the film and the coating. This ensures that the product gets the best protection, without an overkill – thus optimizing packaging cost and output.
The author is Director, Sales and Marketing, Perlen Packaging