Five minutes at CPhI worldwide with …

Maurizio Silvestri, Managing Director – Bormioli Pharma

Chemistry Today/Pharma Horizon: How is Bormioli Pharma going?

Maurizio Silvestri: When I joined Bormioli Pharma four years ago my task was to combine the glass and plastic business units into a single business unit for pharmaceutical clients. We then worked to create an internal language and vision aligned with the pharmaceutical industry. Now we are not just a packaging producer: we are part of the pharma value chain. It is exciting to see how you can modify and reshuffle the huge amount of good value and competencies of a company such as Bormioli Pharma and elevate them to the next level. The whole process takes five to ten years, since you have to create a different mentality and different competencies.

Elena Piazza Business Development and Marketing Manager – Bormioli Pharma

CT/PH: So you now think and present yourself as a pharmaceutical delivery company. Did this change anything at R&D level?

MS: Yes; we now use a quality by design – QbD – approach into the development of new products, and that is the most difficult challenge. It requires a lot of time and demands a lot of remodeling of our systems to develop molds, for example. It is a bit like when GMP was introduced in pharma: it brought a lot of rethinking and raised constantly the bar. Yet the ability of people to improve continually, year after year, is impressive.

CT/PH: What new packaging innovations are you presenting?

Elena Piazza: We have a new patented, dual-chamber concept called AccuRec, for oral applications. Dual-chamber packaging is a common concept in many applications, such as parenteral, but it is less common in oral applications. However, more and more formulations, for stability reasons, need to be reconstituted as solutions just before intake. When a patient does this, mistakes can be frequent. So we have developed dual-chamber packaging where the reconstitution takes place directly in the packaging, which we deem mistake-proof. The drug is stored in the package cap, with the pre-stored diluent in the bottle. When you screw down the cap, the powder goes down into the bottle, which the patient needs only to shake and remove the cap to ingest the properly reconstituted drug. This solution is very versatile and our customers use it for OTC and prescription drugs, diagnostic applications or even for food supplements. Next year we will introduce AccuRec in Europe and USA, as well as pharmerging markets, where there is a particular need to avoid the use of contaminated water for oral drug reconstitution. AccuRec guarantees an effective way to provide patients with safe water for drug reconstitution; thanks to its dual chamber system, the system provides the water  directly from the pharma companies and stored inside the bottle.

CT/PH: Is this product meeting an increasing demand?

EP: We expect a fast-growing demand for this product since it gives an effective solution to two of the most urgent needs in the pharma market: enhancing drug stability and making drug products even more accessible to the Global South.  . To be sure these needs are addressed, we always start our packaging projects in tight collaboration with the pharmaceutical companies..

CT/PH: This investment in plastic is interesting for a company that has been classically associated with glass.

MS: Plastic forms part of our core know-how from decades past. As of today, Bormioli Pharma is strongly investing in R&D because we believe it’s the triggering factor to move into a higher gear as a pharma solutions partner. We can engineer plastic delivery systems as well as produce high quality plastic packaging that perfectly fits with our glass solutions. Furthermore, plastic is the best way to keep pace with the growing diffusion of the patient-centric approach. Thanks to its design flexibility, assembly opportunities, and rapid development times, plastic enables us to develop a user-friendly packaging from scratch. That’s the key to innovation.

EP: As an example of our plastic innovation, we have put on the market a dry powder inhaler. This medical device has a very lean design with few components, no more than nine pieces, and the activation mechanism is purely mechanical, making it safer and reducing cost. We are targeting this product to emerging markets because it is designed to be cost effective.

CT/PH: But then, do you still innovate in glass as well?

EP: Of course; we have on the market a new glass innovation,  our Delta glass vials. The innovation is a technology allowing us to obtain a better glass distribution for each vial. It means that now we are able to enter the market of packaging for lyophilized products. As you know, lyophilized products are growing at a very high rate, due to biotech development, and this is a very stressful procedure for the vial. We thus developed a vial which is very highly resistant to temperature changes and stress, to avoid breakages during the lyophilisation process. Delta glass vials are also used for liquid parenteral applications. We are also enlarging our range of Type I amber glass vials, used for biotech drugs that need the best protection from environmental and chemical damage.

CT/PH: What about product safety?

EP: Safety, along with drug stability, is one of the two main focuses of Bormioli Pharma. We invented, for example, Safe & Easy, a product that has been chosen, among others, by a world leading multinational company to repack its best-selling syrup.   Safe & Easy is designed to solve a critical issue in pediatric syrup administration: the risk of plug ingestion by the children caused by unsecure packaging.  In our solution, the plug is locked in the neck of the bottle, making it impossible for patients to accidentally ingest.

CT/PH: Are you expanding your capacities?

MS: We are continually growing our plastic operations. We are expanding our French facility in Saint Sulpice, as well as our two North Italian plants. This expansion will greatly involve all our core product segments, with an extra boost on dual-chamber systems.  But we keep expanding also in glass, as shown by our 2013 acquisition of a plant in San Vito al Tagliamento, Italy, where we introduced tubular glass and which serves as our backup facility for borosilicate type I glass. We are also expanding the perimeter of our market by approaching the US and the pharmerging markets with different strategies: glass vials and high-value plastic packaging in the US, and the usual range or market-specific packaging in the Far East. And we can now start to be seen as an innovation company as well, covering advanced needs of the industry.