New Devices Target Home Injection Market

Single-use disposable injectors aim for simplicity and safety.

 

 

 

The BD Physioject, top, prevents needle injury and unintended actuation. Ypsomed�s Silberhorn single-use autoinjection device, second from top, features a three-step activation process for easier use by patients with motor disabilities. Patients deliver a single, reconstituted dose with the Lynx and Trio dual-chamber cartridge-based Ypsomed pens.

The need for ease of use and safe handling in the home care setting has driven innovation in self-injection devices. As more therapies migrate to home administration, new injection system technologies are featuring automated functions and helpful, intuitive designs.

Cartridge-based pens have been available since the 1980s. Patients have used these multidose systems for treatments such as insulin therapy, which requires daily injection. More recently, pharma firms have adopted single-use disposable autoinject devices for drugs requiring less-frequent injection.

Amgen’s SureClick delivers Aranesp (darbepoetin alfa) for anemia treatment in a fully disposable autoinjector pen. The Humira Pen from Abbott provides rheumatoid and psoriatic arthritis patients with an easier-to-use device compared with manual injection using a prefilled syringe.

“Disposable autoinjectors have come a long way over the last few years. These devices require a certain level of internal complexity to ensure they are convenient to use,” says Ian Thompson, head of business development, Ypsomed AG (Burgdorf, Switzerland).

Autoinjectors, for example, feature two-stage injection systems to ensure the skin is fully penetrated before the injection starts. Devices feature audible and tactile injection feedback and needle-hiding and safety functions.

In single-use disposable autoinjection systems, Ypsomed is introducing the Silberhorn. The prefilled syringe-based system features a three-step activation process that promotes safe and easy usage, says Thompson.

The patient pulls off the cap, activates the device, and then pushes it onto the skin for autoinsertion and autoinjection. “Devices from various manufacturers have distinct safety mechanisms, which allow the injection to be activated in different ways. We have found in handling studies that having separate activation and injection steps is easier for patients with motor disabilities,” Thompson says.

BD Medical–Pharmaceutical Systems (Franklin Lakes, NJ) has developed a single-use, fixed-dose disposable autoinjector that uses the BD Hypak 1-ml glass prefillable syringe with a staked needle as the primary container. The BD Physioject autoinjector provides patient convenience for therapies that are being transferred to the home healthcare setting, says Michael Ratigan, worldwide business platform leader for self-injection, BD Medical–Pharmaceutical Systems.

“We developed the BD Physioject disposable autoinjector to make it easier to use for patients and clinicians and easier to manufacture and assemble by our pharmaceutical partners. The BD Physioject provides an easy-to-use, intuitive device, with continuous patient safety and with fewer steps than are required in traditional reusable pens,” Ratigan says.

Aiming for commercialization of the autojector in 2010, BD is in late-stage discussions with several pharmaceutical partners, Ratigan says.

Continuous Safety

Pen-style cartridge-based autoinjectors in a reusable format require multiple steps by the patient. The patient has to load in the cartridge, attach a pen needle, dial back the dose, perform the injection, remove the needle, and dispose of it in a sharps container.

“The BD Physioject looks like a pen-style device, but utilizes a 1ml staked BD Hypak syringe as the primary container. The patient removes the tamper-evident cap, places the device on the skin to unlock a safety mechan­ism, then depresses the dose button for automatic insertion and injection. After ten seconds, the device is removed from the skin, and the entire device is placed in a sharps container,” Ratigan says.

BD Physioject features continuous safety in storage and use. Two safety features are provided: one that prevents unintended actuations, and one that prevents needle stick injury after the injection. A break-off, pull-removal tamper-evident cap that can’t be reattached ensures sterility of the needle prior to injection. When the cap is removed, the first safety feature enables the patient to control the start of the injection once the autoinjector is placed against the skin. As the pen is being pulled off the injection site, the second safety feature, a safety shield, automatically extends to cover the needle. “The needle is never directly exposed to the patient, other than when it is placed on the site and the button is pressed,” Ratigan says.

A mid-body window allows the patient to see the stopper reach the syringe bottom, ensuring full-dose administration. The lower body is frosted so the patient can’t see the needle. “We are able to customize the BD Physioject autoinjector with ergonomic modules that can be clipped on, and are developing temperature indicators and end-of-dose indicators to notify the patient when the dose is completed,” he adds.

BD sought to identify unmet needs of patients, clinicians, an pharmaceutical partners. “We approached it from a simplistic perspective, asking how can we simplify the device at each stage. You need to understand the system from the primary container out through the secondary package. We understand the forces and tolerances that different formulations put on syringe barrel material and syringe functions, so we can ensure the functionality of the entire system,” he says. The BD Physioject will be delivered in two subassemblies for easy assembly by the customer.

Schering-Plough provided the market with the first single-use, disposable, dual-chamber pen system with the Peg-Intron Redipen, for delivery of Peg-Intron. Peg-Intron is an alpha interferon drug for treatment of chronic hepatitis C. The pen system offers patients the first alternative to traditional vial and syringe for once-a-week administration of pegylated interferon therapy.

The patient mixes the medication by pushing down on the pen to combine the powdered drug with sterile water and then attaches a needle. A self-priming action automatically removes air bubbles from the pen. The patient turns a button to dial in a predetermined dose, then pushes a button for delivery.

For many years, Ypsomed has provided reusable pens for dual-chamber cartridges for frequently injected drugs, such as Pfizer’s Genotropin and Roche’s Recormon.

“The demand for new types of dual-chamber cartridge pens is growing with the growing number of new lyophilized drugs, particularly for new monodose formulations that require intuitive disposable devices for self-administering patients. Ypsomed is able to provide its new safety pen needle as part of the system package, so the device does not need to have needle shielding functionality integrated into the devices,”says Thompson.

The company has developed with partners two single-use, dual-chamber injectors: Trio and Lynx. The Trio delivers a fixed dose, while the Lynx delivers a variable or preselectable dose, after which the devices are discarded.

Thompson notes that while these monodose systems bring dual-chamber devices into the realm of one-time use, they are essentially manual, with more steps required of the user than with fully automated prefilled, syringe-based autoinjectors.

“With dual-chamber systems, you have to reconstitute and prime before you can give the injection. The methods used for these steps have to be appropriate to patient groups. Automation of certain steps may help patients with motor disabilities, for example, but it makes the device a lot more complex,” he says. The Trio and Lynx dual-chamber devices are designed so that the handling steps are always performed in the correct order, Thompson says.

Ratigan says that BD is in early-stage product development of a dual-chamber system that would simplify patient use, manufacturing, and device assembly. The next-generation solution would upgrade liquid and dry injectors that the company has on the market.

“The pharma industry is focused on getting liquid-stable products to market, but there are a number of instances where liquid stability is very difficult to achieve. Where you have this inability, lyophilization or powder formulations is the solution,” he says.

“We are looking at the reconstitution market in its entirety and the potential for solutions within primary containers, the device, and pen needles. We are asking how we improve on the multistep reconstitution process, with a more simplified, intuitive, and cost-effective delivery device,” he says.

Component Quality

In addition to core technologies of drug packaging and delivery, West Pharmaceuticals (Lionville, PA) has “safety and administration systems” aimed at simplifying the drug preparation and administration process, says Fran DeGrazio, vice president of marketing and strategic business development, West Pharmaceuticals.

West acquired a range of systems for the reconstitution and administration of injectible drugs with its purchase of Medimop. As an example, its Mixject assists patients with multiple sclerosis in reconstitution and delivery.

The company has focused on testing syringe-system rubber components with the launch of VeriSure. West performs extensive testing on the rubber formulation itself, then quality control tests to ensure that extractable profiles are consistent, says DeGrazio.

“FDA is asking our customers to characterize the closures they are using and perform leachables analysis looking for rubber constituents in the drug product. Customers need to know that the initial extractables and leachables work they do in their stability programs is valid on an ongoing basis. We can demonstrate a consistent extract­ables profile which leads to a consistent leachables profile from lot to lot,” DeGrazio says.

“From the customer’s standpoint, this fits nicely with FDA’s Quality by Design initiative, because they are pushing the controls upstream to minimize variation within their process,” she adds.

Alcan Global Pharmaceutical Packaging, Contract Packaging and Specialty Cartons (Bethlehem, PA) packages parenteral devices and systems, after vials and syringes are sterile-filled by upstream partners.

“Typically, we can label and pack out devices 30 to a carton, or individually carton each vial, and pack them out in, for example, ten count for hospital use,” says Daryl Madeira, director of marketing.
“We have seen growing demand for kits where we might be packaging filled vials with empty syringes, or other components or printed material, in a thermoform tray, with a Tyvek lid,” he adds.

The facility features cold-storage capacity for protein-based drugs and technology to ensure temperature and humidity control throughout the plant.

The contract packager is developing an automated track-and-trace solution for managing temperature-sensitive product. Product will be monitored at the vial level as it is stored and moved through the plant.

“Customers want assurance that the product is being managed efficiently within allowable excursion times. If you don’t manage it, you are liable to lose the entire lot generating significant incremental cost for both the packager and the customer, either at your expense or at the customer’s. This solution will provide transparent, traceable electronic control and documentation, so customers are comfortable that a lot is not spoiled,” he says.

Set for launch this year, the solution will be a more sophisticated approach than manual tracking, but more cost-effective than RFID tagging. “Customers will receive extended value from this solution through subsequent distribution once the technology is installed on their package,” Madeira adds.

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