Prefilled WFI Syringe Provides High-Quality
Solution for Drug Reconstitution
West, the world’s premier manufacturer of components and systems for injectable drug delivery,
and Vetter, a worldwide leading independent specialist in the contract manufacturing of
prefilled application systems, have introduced a ready-to-use, WFI prefilled syringe for reconstituting
lyophilized drug products.
“The Vetter/West WFI syringe combines the best of pharmaceutical components in a drug
administration system that we believe customers will embrace,” said Mike Schaefers, Vice President,
Marketing, Europe, West. “This system can be applied to our customers’ high-value pharmaceutical
and biopharmaceutical drug products.”
“This system unites two of the world’s leaders in drug administration systems and
pharmaceutical processing,” said Oskar Gold, Vice President, Key Account Management, Vetter. “We
are pleased that we can offer customers a world-class prefilled syringe system.”
The syringe features a plunger with West’s FluroTec barrier film and Vetter’s V-OVS tamper-evident closure, which includes a West tip cap. The film, developed by West’s partner, Daikyo Seiko,
Ltd., provides an effective barrier against organic and inorganic extractables, which helps maintain
the purity of the diluent.
The V-OVS closure system is designed to give a prefilled syringe system effective protection
features. It consists of a tip cap, a Vetter Luer Lock, and a tamper-evident seal. The components are
pre-assembled as a single part, which is mounted on the syringe barrel with a Luer-cone and Luer-groove. The integrity of the syringe system is maintained if the seal has not been broken.
The syringes are available with fill volumes between 0.5 mL and 3.0mL. The glass syringe
barrels are treated with baked silicone for lubricity and are 100% visually inspected to provide
highest quality levels.
Customers will have packaging options, including individual blister packaging.
Vetter fills and terminally sterilizes the syringe at its facility in Langenargen, Germany. The
syringes are supplied with regulatory documentation to meet requirements of markets in Europe,
Japan, North America, and numerous other countries.
Encap Drug Delivery & Probac Collaborate to
Develop an Oral Probiotic for AAD
Encap Drug Delivery and Probac AB recently announced they have entered into an exclusive
collaboration agreement to develop an oral probiotic for the treatment of antibiotic associated
diarrhoea (AAD). Both companies intend to build on their respective experience in this area to
address the problem of hospital infections that can cause AADs, including Clostridium difficile (C
difficile). A neutraceutical/pharmaceutical product will be developed using Probac’s capabilities in
probiotic development and Encap’s expertise in drug delivery. The project will be part funded by both
a Scottish Enterprise R&D grant and Sweden’s Innovationsbron AB.
The use of probiotics in the treatment of C. diff and other AADs has been the subject of great
interest lately. Recent studies have shown that by drinking probiotic yogurt drinks, the incidence of
diarrhea symptoms can be reduced. However, concerns remain about the effectiveness of these
products and the number of live bacteria that can survive passage through the stomach to recolonize
the intestine. Encap and Probac intend to create a novel capsule product that will deliver specially
selected probiotic strains to the small and large intestine. Approximately 20% of all hospital patients
receiving antibiotic treatment will develop AAD, and it is hoped that this probiotic product will help
reduce the incidence and severity of diarrhea, the length of stay in hospital, and ultimately the
mortality rate from severe cases.
Under the terms of the agreement, Encap will perform all development and manufacturing of the
product using their patented DuoCap technology. Probac will be responsible for the supply of selected
microbial strains and for conducting a volunteer study to confirm the benefits of probiotic delivery to
the lower intestinal tract using this technology.
Once the initial volunteer study has been completed, a partner will be sought to provide funding
for a proof-of-principle clinical study in a hospital environment to demonstrate an acceptable level of
efficacy and patient benefits. The partner will also help with subsequent commercialization of the
product.
