Making Injectables Safer and Easier to Use

Image of the BD Systeo courtesy BD Medical— Pharmaceutical Systems

Ypsomed (Switzerland), whose Alexander Seibold, MD and PhD, head of diabetes business and medical services, will be speaking at Pharmapack, reports that self-injection is growing, particularly in biotech markets. The focus is on needle safety and disposable systems.

Home healthcare is on the rise, reports another Pharmapack speaker, Mike Schaefers, vice president, marketing, Europe, West Pharmaceutical Services (Germany). As a result, “patients want easy self-administration, especially for daily doses,” he says.

Traditionally, patients have had to use a separate syringe for drugs packaged in vials to reconstitute and/or withdraw contents into the syringe for injection. Change is in order, says Schaefers. “It is easy for patients to make mistakes in reconstitution, or for needles to break.”

Prefilled syringes, pens, and autoinjecting devices are all systems that make self-injection easier. New dosage forms may therefore be in order for some drugs currently packaged in vials, Schaefers says.

Injectable treatments for diabetes, autoimmune diseases such as rheumatoid arthritis (RA) and psoriasis, multiple sclerosis (MS), Parkinson’s, allergies, AIDS, cancer, and other diseases or disorders could all benefit from new delivery systems, speakers says.

BD Medical—Pharmaceutical Systems has announced a new passive safety-engineered system for prefilled syringes, the BD Systeo. “It is equivalent to a naked BD Hypak syringe from a drug-delivery standpoint,” says Pharmapack speaker Karim Benazzouz, who handles European marketing and business development. “One of the most important innovations is its two-part plunger rod. The usual plunger rods used in the syringes including safety features have two functions: pushing the stopper to inject the drug and triggering the safety mechanism. Our innovation separates the injection function from the safety function, but retains it in a single two-part plunger rod. As a result, the push-back force usually generated from activation of the safety mechanism, which often results in a potentially incomplete dose delivery, can be controlled and significantly reduced from that of other devices.” Systeo suits both users who like to control safety activation as well as those who prefer passive activation.

Benazzouz will detail BD’s systems-approach working methodology behind Systeo and other innovations during his presentation. He will explain also how Systeo can be assembled at high speeds.

Ypsomed’s and West’s speakers will each discuss a range of delivery options, including sophisticated systems such as pens, for delivering insulin and other injectable products.

Ian Thompson, Yposmed’s head of business development, says that the scale of convenience covering the key handling features of prefilled syringes, safety syringes, and autoinjectors is becoming established. Pharma companies are now focusing on refining devices to even better meet patient needs in different therapeutic areas.

Explains West’s Schaefers: “The next step for a drug out of a vial is into a prefilled syringe. If the target patient is handicapped, though, such as one with RA or MS, even a prefilled syringe will give the patient problems. A pen-like system would be easier.”

Even patients with hand dexterity may prefer cartridge-based pens, Schaefers says. “The application of insulin to treat diabetes is a very good example for this trend,” he says. “Pen systems to administer insulin to diabetes patients have become the gold standard, especially in Europe.” Schaefers’s presentation will describe dosage-form evolution from manual application using a vial and disposable syringe to today’s cartridge-based pen systems. Benefits to patients and to therapy efficacy will be highlighted.

Seibold of Ypsomed will provide a history of insulin delivery (pen systems, pumps, inhalation) and describe the needs and expectations of diabetes patients, based on results of a patient questionnaire in Germany. Between 1993 and 2000, Seibold practiced as a medical doctor at the University Ulm (Germany) in the department of internal medicine and endocrinology with a major focus on diabetology. In 2000 he joined Disetronic where he advised on development of insulin pumps and injection pens. Ypsomed evolved out of Disetronic in 2003, and Seibold moved from Germany to Ypsomed’s headquarters in Switzerland in 2007. His doctoral thesis was titled “Computer-Aided Dose Adjustment in the Intensified Treatment of Insulin-Dependent Diabetes Mellitus.”

Transitioning drug or biotech products out of vials and into prefilled syringes or cartridges will take investments in time and capital, speakers say. Compatibility tests as well as accelerated aging and shelf-life stability tests are required before launch. In addition, if a medical device–like pen system is sought, consideration of Design for Manufacture (DFM) requirements must be made to prepare for scaling up to commercial manufacturing.

However, by offering new injectable drug delivery options to patients, “there are competitive advantages to be gained in market share,” Schaefer adds. “It may also save brand manufacturers time against generic competition, and it significantly raises the bar for generics.”

“Ultimately, the final choice of device is dependent on fully understanding patient preferences for each therapeutic area,” concludes Ypsomed’s Thompson.

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