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Injectable system delivers for Watson Pharmaceuticals
Reconstitution device simplifies drug delivery for physicians, while reducing pain for patients with advanced prostate cancer.
By Jim Butschli, Editor
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 Pharma, Inc.'s TRELSTAR® (triptorelin pamoate for injectable suspension), is a Lutenizing 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. Sharp receives TRELSTAR vials from DebioPharm, 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, the vial is inverted 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 suppresion. 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."
Blister machine expands capacity for Contract Pharmaceutical Packaging
By installing a new high-speed blister-packaging machine, Compass Pharma Services, LLC expanded its blister-packaging capacity for contract pharmaceutical packaging and contract vitamin packaging.
The Uhlmann thermoformer UPS4 operates at up to 50 cycles/min, says Compass, depending upon product size, configuration and packaging material.
"Blister packaging and unit-dose packaging continues to grow in popularity among our pharmaceutical packaging and nutritional packaging customers," says Tony Fenno, chief operating officer at the Clifton, NJ-based independently owned and operated contract cGMP packager. "Our investment in additional blister packaging capacity was necessary to keep pace with this increased demand.
"Uhlmann systems are among the most widely used blister-packaging machines in the pharmaceutical and nutrition industry," he says. "This new machine supports Compass' business strategy of providing contract pharmaceutical packaging services with the same quality and consistency of in-house production."
With the installation of the new machine, Compass Pharma can produce cold-foil blisters or thermoformed blister packages from PVC, PVDC, and barrier films such as PCTFE (Aclar®). Package and fill consistency are assured with an integrated vision detection system that continuously inspects manufacturing quality and tablet or capsule fill accuracy.
Among Compass Pharma's new cGMP blister packaging capabilities are the following:
- Integrated filling and large-format tooling option to fill multiple tablets/capsules into a common blister, for regimen and compliance packaging
- Inline cartoning and secondary operations for a complete turnkey line
- Inline flexo printing for high-quality, cost-effective package labeling options.
- Balcony construction for cGMP packaging requirements
- Deep-draw (12-mm to 35-mm) thermoforming capabilities for large tablets/capsules.
- Chilled feed area, isolated from heating elements, to allow for packaging of temperature-sensitive products including probiotics.
Compass operates a fully-equipped cGMP contract packaging facility on a two-shift-per-day schedule for packaging solid-dose preparations, liquids, and powders into virtually all packaging forms, including blisters, pouches, bottles, and cans. Customers include pharmaceutical, nutraceutical, and manufacturers of over-the-counter (OTC) products.
–Jim Butschli
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