Drug Delivery Finds Its Way Home
The growth of the home healthcare market is fueling the development of simple, intuitive drug-delivery systems that ease self-administration.
by Kassandra Kania, Managing Editor
Pharmaceutical Research & Manufacturers of America (PhRMA) recently reported that new medicines and technologies are driving the shift from inpatient hospital care to outpatient services and home care.
As a result of this shift, it is safe to assume that recovery and chronic conditions are being managed at home, and many probably require the delivery of complex drug regimens. According to Gerhard Mayer, PhD, director of marketing and business development for Becton Dickinson Pharmaceutical Systems (BD; Franklin Lakes, NJ), self-injection is becoming a common form of drug delivery in the home, with diabetes patients constituting the majority of that group.
An auto-injector from Meridian is used to self-administer medication in an emergency situation, while prefilled syringes from Becton Dickinson can help manage chronic diseases.
Another growing segment consists of rheumatoid arthritis patients, who are turning to self-administration of injectable drugs. To help these patients, pharmaceutical companies are coming up with innovative drug-delivery systems that make it safer and easier for them—particularly those whose physical abilities may be impaired by their disease or condition—to administer drugs themselves on a routine basis.
Often, says Mayer, when patients need to administer their own drugs, they use a prefilled, single-dose syringe. Benefits include ease of use and convenience, and less risk of misidentification and contamination. In many cases, drugs require reconstitution prior to administration, and there are a number of drug-delivery systems available to assist patients. BD supplies a dry reconstitution system that contains a syringe prefilled with diluent, which the patient attaches to a vial containing the dry drug. After reconstitution, the patient draws back the syringe and injects himself or herself.
Duoject (Bromont, Quebec, Canada) offers a novel double-chamber reconstitution device called Inter-Vial Plus in which the traditional wet/dry positions have been reversed. With its new Set-to-Process (STP) technology, the company's Vari-Vial cartridges can be prefilled on standard powder fillers, or its prefilled liquid contents can be lyophilized in conventional freeze dryers. "By reversing the positions of the drug and diluent, less expensive commercially available WFI [water for injection] vials can now be connected to the vial receptable section of our system," explains Dan MacDonald, director of engineering services. "Our clients therefore now have the option of either liquid filling, powder filling, or lyophilizing their drug in a cartridge for use with our reconstitution device."
The Inter-Vial and Inter-Vial Plus systems are also designed to prevent accidental needle sticks. "Needle sticks are avoided because the transfer needle through which admixture transfer takes place is automatically detached and discarded with the vial section after reconstitution," says MacDonald. "End-users can then connect the syringe to needle-free sites, syringe pump infusion tubing, or attach their own sterility-assured needles."
Amgen's SimpleJect system, which won a 2002 Medical Design Excellence Award and a Compliance Package of the Year Award from the Healthcare Compliance Packaging Council, addresses both the physical and psychological hurdles patients face when self-injecting. The system was designed to administer Kineret, a daily self-injectable drug to treat rheumatoid arthritis. "This disease can be very crippling and painful," says Craig Lester, marketing manager for Amgen (Thousand Oaks, CA). "It may be difficult to extend your thumb or fingers, and light pressure on the joints can be painful. We had to design a device that would allow for simple administration of a drug where patients' lack of dexterity is a concern."
The patient opens the lid of the SimpleJect case and drops a prefilled syringe of Kineret into the syringe housing. He or she then removes the blue handle from the case and pushes it onto the blue rod in the middle of the case until a click is heard. Next, the handle is attached to the syringe housing, which is then pulled from the case and applied to the injection site. The patient pushes down on the handle until it clicks, which starts the injection process. After 10 seconds, the injection is complete. The patient unscrews the handle from the syringe housing and discards the syringe.
Through research, Amgen found that patients often have psychological issues with self-injection, particularly related to watching a needle penetrate their skin. So the company designed SimpleJect to automatically remove the needle cover and hide the syringe from the patient's view during the injection process. In fact, the whole injection process takes less than a minute. "The patient doesn't see the needle until after they've injected the drug," says Lester.
Single-dose prefilled syringes are also being used to self-administer drugs in emergency situations. Meridian Medical Technologies (Columbia, MD) sells auto-injectors to the U.S. military for nerve-agent antidotes and drugs taken for treatment of nerve-agent casualties. The company's number one commercial seller, based on the military design, is the EpiPen, which is used to treat anaphylaxis, a severe allergic response to triggers such as food, medications, insect bites, or latex. "People who have an allergic reaction don't have the luxury of waiting for the ambulance to arrive," says Tom Handel, vice president–sales. "They have seconds or minutes to get treatment or that's it; there's no other opportunity for rescue."
The patient removes the safety pin and safety cap from the EpiPen and pushes the point down on the injection site, which activates the device, driving the syringe forward and depositing the drug in the tissue. "What we've found with these products is you need to make them exceptionally simple to use," says Handel. "You can't have a number of different steps because a patient's functional and mental capacity is really compromised in these situations. A lot of people give these to their children for food allergies, so they have to be simple, intuitive, and rugged. People carry these outside the case. Some may take an injection hours after getting the product; others may never use it. So it's important that the labeling is clear and conducive to someone just picking it up and using it."
While single-use disposable systems make sense for emergency drugs, Handel admits that they can be expensive for drugs used on a routine basis, and it becomes difficult to justify the cost. In these instances, reusable pen systems may be more appropriate. BD manufactures reusable pen systems, which are commonly used for diabetes patients. However, as Mayer notes, pen systems have their limitations as well. "If you use a pen system, it needs to have a preservative, and a lot of biotech products don't have preservatives." Another limitation is the amount of product the pen system can hold. "Typically, pen systems are limited to 3 ml. So if you have a dosage that is 1 ml or greater, you're not going to get more than three doses out of that pen."
Manufacturers are also paying attention to the design features of secondary packaging and other supplies that will help patients self-inject medication. Multivac (Kansas City, MO) has sold packaging equipment to PCI Services (Philadelphia) for the packaging of home healthcare kits for arthritis and multiple sclerosis. The arthritis kit has Tyvek lidding designed to overhang the tray by two inches so that someone with arthritis can easily grip and open the packaging. The multiple sclerosis kit also has a Tyvek overhang with two holes punched in it so that the patient can put two fingers in the holes and pull the package open. "In the case of the extended lidding with the holes in the Tyvek, we had to design a special hole-punching unit that could easily and smoothly cut through the Tyvek without leaving any particulate on it," explains Marty Moscowitz, Multivac's regional manager.
The package also incorporated a feature whereby the vial can stand up. "If you have multiple sclerosis, it may be difficult to hold the vial steady enough to fill the syringe," he says. "There's a feature in the package where you can stand the vial up in a circle that's formed in the package. It stands upright and is fairly secure, so you can take the syringe and put it in the vial to fill it."
West Pharmaceutical Services (Lionville, PA) has developed systems to provide added safety and quality assurance for at-home patient care. One of West's drug delivery devices, the Clip'n'Ject, reduces the complexity of administering the growing number of lyophilized drugs. Another product, West's D-I-D System (Decoration-Identification-Differentiation), uses the company's unique technology to print vital information regarding the contents of a vial—dosage, strength, storage, and disposal—on the aluminum seal, the plastic button, or both. Another helpful advantage is that these seals can be color coded to differentiate them from other pharmaceuticals. This is helpful for patients who cannot read the type on the seal.
"Many drugs given in the home healthcare environment have to be mixed with diluent and then injected," says Bill O'Dell, vice president, global marketing of West Pharmaceutical Services, "It's often a complex process, and there are issues with compliance and safety. Products like Clip'n'Ject and the D-I-D System were specifically designed to simplify these processes and to improve parenteral drug delivery."
Beyond the Syringe
Syringes aren't the only novel means of administering product. Advancements are also happening with nasal, transdermal, and oral delivery systems (see sidebar, "Taking the Sting Out of Oral-Dose Syringes"). West Pharmaceutical Services is working on a drug-delivery system that delivers a microdose of pharmaceutical active compound to the eye. "With a traditional dropper bottle, you overdose the eye," says Scott Young, ATOMist program manager. "ATOMist accurately administers a small dose that can barely be felt by the patient. The patient is more likely to stay in compliance with his dosing regimen, and the drug manufacturer will not have to overfill the container to compensate for lost product. It's a win-win situation."
"Home healthcare of any type is something that's increasing considerably," says Moscowitz. Pharmaceutical companies are responding to this increase with packaging that helps patients self-administer drugs safely and easily.