Steve Smith and the product development team at B. Braun's pharmaceutical division (Irvine, CA) have a cure for what's ailing the pharmaceutical industry. They designed a multi-chambered bag that helps hospitals reduce the 3 to 10% of intravenous (IV) pharmaceutical medications wasted by hospital pharmacies each year. The bag also improves drug efficacy and reduces the chances for medication errors. But designing a bag that meets all of the medical packaging requirements was enough to give anyone an ulcer.
As Director of Product Development at B. Braun, Smith's concerns started with the medications themselves. "Our challenges began with the moisture and oxygen sensitivity of the active drug ingredients," says Smith. Some are powders. Others are liquids, which need to be packaged alongside the powders. "The powders are especially moisture sensitive and we had to keep them separated from the liquids during manufacture, sterilization processes, and long periods they would sit on shelves in hospital pharmacies," he says.
Once packaged, the medications have a two-year shelf life. "We also needed a way for people to inspect shelved product before it is administered to patients," says Smith. The solution to his challenges is the creation of multiple seals within the bag. Polymeric film laminate and deposition-based barrier technologies form multiple chambers in the bag before application of the outer foil layer. B. Braun named it the Duplex drug delivery system.
The integrity of drug powders and fluids is protected with patented sealing technology that forms the separate compartments. Properly squeezing the container breaks the seals separating the drugs and dilutants, allowing them to mix and compound.
With the multi-chamber approach, the pharmaceutical company measures the drugs and dilutants, not the hospital pharmacy or technician at the patient's bedside. "The multi-chamber bag eliminates the possibility of medication error by hospital personnel," says Smith. In addition to eliminating waste by making it impossible for nurses and technicians to mix the wrong ingredients together, it also eliminates the possibility for hospital personnel to mix the wrong proportions of drugs and diluting fluids together.
"Sometimes prescriptions are cancelled after the hospital pharmacy dispenses the medicines," says Smith. In one system he encountered, the current practice includes thawing the drug's frozen diluting fluids.
"If the prescriptions are cancelled, these medicines frequently cannot be returned to the pharmacy, so they become waste," he explains. The Duplex bag requires no freezing and can be re-shelved if prescriptions are cancelled after dispensing and before infusion into the patient.
When the properly combined mixture is ready for infusion, the nurse or technician breaks a final seal leading to the administration port. Bedside mixing maximizes the drug's efficacy by preventing degradation of the drug's potency once mixed with the diluting fluid. After mixing, the technician spikes the bag's port and administers the medication to the patient.
The B. Braun team's prescription for the pharmaceutical industry has an added benefit. It eliminates the need for needles sometimes used for putting drugs into vials of dilutants. Current bag applications are centered on Cephalosporin antibiotics. However, B. Braun tests indicate the de-sign is also suitable for other medical applications.