Resealable foil laminate pouch protects moisture-sensitive drug

Food & Drug Packaging, Nov, 1998 by William Makely

An innovative delivery system for Atridox[TM]--a new unique site-specific treatment from Atrix Laboratories used to dramatically reduce the bacteria associated with periodontal disease--is expected to be an important new weapon in the treatment of this leading cause of tooth loss in adults.

Atridox combines the company's proprietary drug delivery medium Atrigel[R] with the antibiotic doxycycline. When the mixture is applied to the affected area beneath the gum line, it conforms to the shape of the periodontal pocket and solidifies, releasing the antibiotic over a period of about seven days.

The new product is delivered to dental offices in separate syringes and is mixed at chairside. The syringes are connected to each other (one has a male and the other a female tip, which snap together) and the two constituents are mixed by pushing the syringe plungers to move the contents back and forth. When thoroughly mixed, the contents are pushed into the male-ended tube, the tubes separated and a canula (a curved tube) is snapped onto the male tip. The Atridox mixture is then dispensed, where it hardens to conform to the shape of the periodontal pocket. Medication not used immediately can be retained in the syringe and remains flexible for three days if sealed in a moisture-resistant container.

Atrigel, the polymer medium that delivers the antibiotic to the site, is moisture-activated. To keep the carrier stable until it is used--and to keep it usable for several days after mixing--Atrix needed a water-protecting pouch that could be opened and resealed. Atrix worked with LPS Industries to design packaging that protects the carrier from moisture while keeping the two syringes and canula together until used.

The material used is a proprietary laminate developed by LPS and designated Tamper-Evident VF52. The polyester/polyethylene/foil/polyethylene laminate is formed into a 4 x 10.5-inch pouch that carries both syringes, the canula and the requisite informational insert. The syringe carrying the Atrigel vehicle is also enclosed in a second pouch made of the same laminate material for additional moisture protection.

The outer pouch has a resealable closure strip. At the dental office, the staff tears open a perforated tamper-evident strip and opens the resealable strip. After use, the syringe and its already-mixed contents are returned to the pouch and resealed.

"Our product development group did considerable research on the pouch material," says Linda Tholen of Atrix Laboratories' Manufacturing Group. "What attracted them to the LPS design was the zipper closure resealable feature. Atrigel can be kept in the mixed syringe for several days if protected against moisture."

For more information from LPS, call (800) 275-4577 or Circle 589.

In a nutshell

Goal: Protect moisture-sensitive drug before and after application

How: Develop a resealable pouch

Result: Security and convenience for a unique new product