A key innovation for parenteral packaging and administration.

Pre-filled syringes have emerged as one of the fastest-growing choices for unit dose medication as the pharmaceutical industry seeks new and more convenient drug delivery methods. Pharmaceutical companies are able to minimize drug waste and increase product life span, while patients are able to self-administer injectable drugs at their home instead of the hospital.

The market has expanded and is exploring all options outside of the traditional process. In the past, glass syringes dominated the market, but there has been a movement toward plastic and disposable syringes. Pre-filled syringes have also been utilized across a wide range of therapeutic sectors, such as vaccines, blood stimulants, and therapeutic proteins.

Eliminating dosing errors and ease of use are two of the greatest advantages of pre-filled syringes. However, there are a number of challenges that manufacturers face, such as the interaction between the pre-filled syringes and the drug, stability concerns, and quality control.

Anil Kumar Busimi, Head of Global Product Management Syringe Business at SCHOTT, participated in a Q&A about pre-filled syringes.

Q: What are some of the advantages of pre-filled syringes?

Busimi: Pre-filled syringes make injections easier and safer for both doctors and patients. With a pre-filled syringe, a patient always receives the right dosage. In addition, pharmaceutical companies can benefit from less overfill in pre-filled syringes (compared to vials)—which is an important advantage, particularly with costly biopharmaceuticals. Last but not least, pre-filled syringes work well with increasingly popular safety devices and auto-injection systems—making the injections easy, safe, and convenient.

Q: What are some of the disadvantages of pre-filled syringes?

Busimi: Pharmaceutical companies must be able to ensure patient safety by demonstrating that no component or material has any extractables and leachables (E&L) and that the primary packaging doesn’t have an adverse interaction with the drugs. Some of the E&L can interfere with the drug molecules and could compromise the effectiveness of a drug. In ampoules, the drug is in contact with only glass. In vials, the drug is in contact with glass and rubber. Pre-filled syringes, on the other hand, are in contact with not only the drug, but more materials and components—creating additional opportunities for interactions and E&L.

Q: What are some of the challenges behind manufacturing pre-filled syringes?

Busimi: The design, manufacturing, quality, and choice of a pre-filled syringe—suitable for a specific therapeutic area—is critical. There are many components in contact with the drug. For example, silicone oil (used to lubricate the inner surface of glass pre-filled syringe) is seen as an “essential evil,” which cannot be avoided. On one hand silicone is needed to ensure functionality, i.e. make sure the plunger can be pressed down more easily and smoothly. Silicone oil ensures that the syringe continues to work even after it has been stored for a longer period of time. But, silicone can be a source of E&L or particles, which could alter sensitive proteins under certain conditions—causing them to aggregate or change their form. Quite a few studies have been published on this topic.

Q: What materials are most advantageous when manufacturing pre-filled syringes?

Busimi: Glass dominates the pre-filled syringe market, but the use of polymer is expected to grow in the next few years. The barrier properties and regulatory ease make glass the first choice for drug manufacturers, but polymer’s stability and inert properties, as well as its wide design options, make it an attractive choice as well. So drug manufacturers must ask themselves an important question: is glass or polymer the better material for pre-filled syringes?

Each material has its strengths and weaknesses—there’s no outright winner in this debate. Before analyzing the benefits and drawbacks of each material, pharmaceutical developers must take a holistic view of the drug and a patient’s needs to find what works best for a particular application.

Q: Have you seen any developing trends in the pre-filled syringes industry?

Busimi: Yes, there have been a number of developing trends:

• Drug stability is the primary concern especially for sensitive biotech drugs
• Device compatibility with safety device and autoinjectors
• Regulatory documentation—e.g. human factor studies
• Glass vs. polymer
• Patient safety and convenience—move from hospital to home administration

Q: As a company, what are some of your goals for your pharmaceutical primary packaging branch in 2016?

Busimi: At SCHOTT, we strive to establish a partnership with our customers (pharmaceutical companies) from day one and ensure the primary packaging is ideal for various drugs that treat and protect patients worldwide. 

This article can also be found in the March 2016 edition. 

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