Innovative Pharmaceutical Packaging and Data-Driven Support Accelerate Time-to-Market of Parenteral Drugs

Anna Malori

Parenteral drugs are a highly demanding and rapidly growing market for pharmaceutical manufacturers. The market requires high-quality and safe packaging to protect and store formulations for injection. For this reason, the pharmaceutical packaging manufacturer is not just a supplier but also a partner for pharmaceutical companies to rely on for joint collaboration initiatives.

According to Global Advanced Parenteral Drug Market 2024, the USD 2.64 billion parenteral market is expected to grow at a compound annual rate of 7.2%, reaching USD 4.6 billion by 2032. This impressive growth trajectory presents an interesting challenge for pharmaceutical packaging manufacturers: meeting the stringent quality and safety requirements of the sector with innovative, sustainable solutions.

As a leading global pharmaceutical packaging company, Bormioli Pharma has always been committed to innovation. Its mission is to make drug administration simpler, easier, and more accessible for everyone, including the elderly and others facing difficulties opening and operating drug delivery devices. This commitment is not only a business strategy but also a social responsibility, acknowledging the crucial role that packaging plays in ensuring the efficacy and safety of medications.

Bormioli Pharma's cutting-edge R&D is translated into concrete outcomes through specific Centers of Excellence focusing on distinct product lines. These centers, dedicated to new applications, product engineering, and innovative technologies, position Bormioli Pharma as a robust and reliable partner in advancing parenteral packaging solutions.

A testament to its continuous innovation, Bormioli Pharma boasts a diverse, full-service array of integrated primary packaging systems. These include containers, caps, closures, and accessories that align seamlessly with its vision of simplifying and enhancing drug administration. All these solutions are matchable to each other, allowing customers to configure the complete packaging solution from a single supplier while building process efficacy.

The ‘forTherapy’ portfolio represents Bormioli Pharma's dedication to complete packaging systems designed for maximum dosing accuracy. These all-in-one packaging solutions include the highest quality containers and vials made from molded and tubing glass, as well as a wide variety of aluminum and rubber closures and accessories. Each component is designed to cater to specific applications within the industry, offering tailored solutions that meet the unique needs of each client.

Additionally, Bormioli Pharma extends data-driven support and consultancy throughout the packaging selection process. This ensures informed decisions and successful outcomes in the value chain, reinforcing the company's role as a trusted partner. Indeed, choosing the best packaging solution for parenteral medicines’ containment means taking into account a large array of options.

For example, the forTherapy portfolio features glass vials and bottles that meet particular material specifications – Type I, II, and III – according to different manufacturing technologies. These specifications address the specific characteristics and challenges of each drug product, ensuring the medications’ effective containment and preservation.

• Type I is a borosilicate glass, featuring enhanced mechanical resistance and a high degree of hydrolytic stability. This makes it ideal to contain all types of injectable products with an acid, neutral or slightly alkaline pH.
• Type II is a soda-lime glass that achieves the performance required for parenteral applications through appropriate surface treatment. It is particularly suitable for packaging injectable and non-injectable preparations with acid and pH-neutral solutions.
• Type III is a low-alkaline sodium-calcium glass with moderate hydrolytic resistance and limited thermal strength compared to Type I. These features make it ideal for non-aqueous or powdered injectable preparations, excluding drugs that must undergo a freeze-drying process.

Type I glass might come from two different manufacturing technologies: premium molded glass or tubing glass. The former is obtained from an improved molding process known as press-and-blow, where glass is melted into a furnace at over 1600°C, extruded, and then blown into a high-precision mold using mechanical tools (a piston) and a jet of hot air. In just one continuous process, the melted glass is transformed into a parenteral vial ready to be filled.

Tubing glass containers require a multi-step process: they are made by transforming a glass pipe into a vial by means of localized flames and then several steps to give the desired shape. This meticulous process ensures the creation of high-quality, durable vials that can safely store parenteral drugs.

In recent years, high-value polymeric alternatives have been developed, such as COC and COP vials, ensuring excellent performance in parenteral containment. These polymeric alternatives feature additional advantages, such as an enhanced shelf-life stability for large molecule-based drugs and products with extreme pH values, superior chemical and mechanical resistance, efficient fill-and-finish process, as well as secured drug consistency and protection at very low temperature or in critical applications.

The integrated packaging system is completed by a rubber stopper, and aluminum classic or tear-off rings. The most common rubber compounds used for pharmaceutical application to minimize interaction with drug product are bromobutyl rubber and chlorobutyl rubber. Both provide low gas permeability, good elasticity over the time, and robust performance during the vulcanization process. Bormioli Pharma features one of the widest product ranges of rubber stoppers, with a specialized plant in Italy dedicated to its production.

The aluminum seal that firmly adheres to the glass bottle neck is responsible for the hermetic sealing of the product itself. This defends the integrity and efficacy of the formulation. Seals can be classified in two types: classic aluminum seal, similar to the one used in soft drink cans, and tear-off seals, a predrilled aluminum closure together with a plastic cap that provides usability advantages for professional users.

Looking forward, Bormioli Pharma is constantly working to maximize glass performance. During Pharmapack 2024 in Paris, the company presented a brand-new recycled PP cap for tear-off closure, a packaging element which does not come into contact with the pharmaceutical formulation. It also has an institutional collaboration in place with Consiglio Nazionale delle Ricerche, the most important public body in Italy related to R&D.

Moreover, Bormioli Pharma further increases its value proposition through a spectrum of additional services to amplify operational efficiency for its clients. The ready-to-sterilize option underscores the company's dedication to streamlining the production process. Equally notable, the ready-to-use service addresses a crucial aspect of pharmaceutical manufacturing: this service not only reduces operational burdens but also guarantees consistent and reliable sterilization, ensuring the integrity of products and adherence to the industry's rigorous regulatory standards.

Bormioli Pharma has also recently announced a traceability solution consisting of a new laser-marking technology. This uniquely marks glass bottles with a complex code, extending product traceability to the primary packaging level and preventing product duplication.

As a unique, full-service partner for parenteral packaging, Bormioli Pharma delivers substantial benefits throughout the value chain, including:

• Streamlining customers’ supplier base, centralizing the purchasing of all the components through a single packaging partner;
• Accelerating time-to-market for medicines thanks to turn-key packaging solutions;
• Simplifying the drug development process by outsourcing the packaging sterilization phase.

About Bormioli Pharma

Bormioli Pharma is a world-renowned packaging player serving the pharmaceutical and biopharmaceutical markets with complete packaging solutions, including glass and plastic bottles and plastic, rubber, and aluminum closures and accessories for parenteral, oral, ophthalmic, and topical applications. The company operates nine plants across Europe, supplying its solutions to over 100 countries. In 2023 its annual turnover exceeded 370 million euros, selling over 8 billion units. Bormioli Pharma innovative pharma packaging solutions pioneer sustainability to make health a positive practice.