Comar, an original member of the safe dosing initiative PROTECT, is launching a new version of its DoseGuard for easier integration into drug packaging. The company will be showcasing the new design at Booth #2871 during EastPack June 14-16, and Comar’s Russ Granato will be speaking in a panel discussion on PROTECT June 16.
DoseGuard is a bottle adapter featuring a valve (shown above) that remains closed until the tip of an oral syringe is inserted. When the syringe is removed, the valve closes to resecure the liquid medicine.
The new low-profile design allows drug manufacturers to use a standard bottle and closure with no special modifications. “They can use what they already have,” reports LouAnn Evans, Director of Strategic Marketing at Comar. “The original design required a modified bottle neck and a modified syringe, and it only worked with select resins. The new product is compatible with a wider range of materials.”
Features of the new DoseGuard include:
- Compatibility with industry-standard (20-mm) plastic bottles of HDPE, LDPE, PP, PET resins, or glass.
- Secure connection to the container finish.
- A valve opening customizable to specific product viscosities.
- Easily adaptable to an open hole flow restrictor for use with products requiring dosage cups.
- Single-material, one-piece construction to reduce contamination risks.
Evans reports that manufacturers can now access such product features with “less hassle, less expense.”
Rendering of the redesigned DoseGuard
In addition, the design could help drug manufacturers comply with FDA’s April 2016 Guidance for Industry, “Safety Considerations for Product Design to Minimize Medication Errors,” she says.
“The latest FDA Guidance for Industry mentions ‘Safety-by-Design,’ which is a concept we strongly believe in,” says Evans. “DoseGuard helps manufacturers fit the FDA recommendations, both figuratively and literally. By increasing its compatibility with industry standard containers and materials, it’s an easier fit in packaging lines. The DoseGuard adapter with its proven effectiveness in passive child safe performance and the accurate dosing of our oral syringe can help significantly to minimize medication errors,” she added.
Caregivers and patients won’t notice any difference in use, says Evans. “They will continue to get the dose accuracy and passive protection they got before,” she says.
Russ Granato, regulatory & quality lab manager, Comar, will be speaking in the panel discussion “Drug Dosing Safety, Part 2 Panel Discussion: New Child Safety Packaging Features for OTC Packages with Potential Applications for Other Products” held June 16 during EastPack. Joining Granato on the panel will be Daniel Budnitz, director of the CDC’s Medication Safety Program in the division of Healthcare Quality Promotion; Mike Reiter, associate director of packaging engineering, Perrigo Co.; and Elizabeth Quaal Hines, MD, clinical fellow, Medical Toxicology, Department of Emergency Medicine, New York University & Bellevue Hospital, New York City Poison Control Center. The panel discussion follows a presentation by Budnitz titled “Drug Dosing Safety, Part 1: The Case for Safety Innovations and Standardized Dosing in mL: Implications for Packaging & Labeling.” In the session, which is part of the "Ensuring Patient Safety & Product Efficacy Through Successful Packaging" track, he’ll share national safety data, advances in medication safety packaging, the move to standardize dosing to milliliters, and the implications of both for packaging and labeling. Use promo code NY16PMPN to get 20% off conference registration.