Reconstitution device simplifies drug delivery for physicians, while reducing pain for patients with advanced prostate cancer.
With more biologics products entering the market in lyophilized (freeze-dried) form, reconstitution at the point of use is becoming more prevalent. One such product, Watson Pharmaceuticals’ TRELSTAR® (triptorelin pamoate for injectable suspension), is a Luteinizing Hormone-Releasing Hormone (LHRH); agonist used as a palliative treatment for advanced prostate cancer. It is sold in the MixJect® delivery system, developed and manufactured by West’s subsidiary, Medimop Medical Projects Ltd.
The patented reconstitution device ensures the safe and easy delivery of lyophilized drugs. West provides the reconstitution system in a kit, which also contains a diluent-filled syringe for reconstitution at a physician’s office, where the drug is administered to the patient. After receiving U.S. Food and Drug Administration approval, Watson launched TRELSTAR in the MixJect system in June 2008.
TRELSTAR was first introduced by Watson in 2004 as a hormonal treatment for patients with advanced prostate cancer. It works by decreasing testosterone secretion and reducing the patient’s PSA (Prostate-Specific Antigen) level.
Joe Elliott, director of marketing for urology for Watson Pharma, a subsidiary of Corona, CA-based global pharmaceutical company Watson Pharmaceuticals, explains that MixJect replaces a device whose performance was deemed unsatisfactory.
“With the previous device, you actually had to insert the needle with the prefilled syringe into the vial, shoot the diluents into the vial, and then withdraw it back into the syringe before giving the injection,” says Elliott. “But some people felt that inserting the needle into the rubber stopper in the vial dulled the needle before the actual injection. Physicians didn’t like it because they believed it made the needle duller and more painful for patients. So in this case, you don’t have to insert the needle into anything except the patient. The MixJect device allows you to inject the diluents right into the vial through the use of this valve, and withdraw it back into the syringe before the injection, without the needle even being exposed. So it’s much easier.”
Assembly process
The MixJect, which measures 3 in. long (including a Becton-Dickinson needle) x 1 in. wide x 1 in. high, is manufactured at Medimop in Israel. MixJect has three injection-molded components made of polycarbonate and high-density polyethylene (for the valve).
The convenience kit for TRELSTAR is assembled at West’s facility in Lititz, PA. The aasembled MixJect convenience kit is sent to Watson’s third-party packaging company, Sharp Corp. (www.sharpcorporation.com). Sharp receives TRELSTAR vials from DebioPharm (www.debiopharm.com), the Switzerland-based manufacturer of the drug. Sharp inserts the vial in the MixJect tray, and includes labels and final packages in cartons. The product is then sent to a Watson facility in Gurnee, IL, for distribution.
Elliott explains that the TRELSTAR vial is connected to the MixJect delivery system, which uses a prefilled diluent syringe that’s attached to a MixJect body housing a valve that diverts the diluents from the syringe into the vial. Once TRELSTAR is reconstituted, the user swirls the vial, inverts the vial and withdraws the liquid back into the syringe. Detaching the empty vial turns the valve to deliver the mixture from the syringe directly through the needle for injection. The medication is administered at a physician’s office from the syringe through the attached needle.
“We actually have two different formulations of TRELSTAR,” Elliott explains. “We have a one-month injection and a three-month injection. In other words, it lasts that long in terms of testosterone suppression. And we have a six-month version being reviewed by the FDA.
“All three will use the MixJect device because it works equally well with each of the formulations. One of the things that we like about the MixJect is that the needle size was smaller—21-gauge compared with the former 19-gauge version, which was bigger, and therefore, more painful.” Compared to competitive products, Elliott says “this represents an improvement on the technology that benefits physicians and patients.” [
