Prefilled syringes are used with increasing frequency in parenteral drug administration. Their advantages include reducing medical errors, ease of use, accurate dosage, elimination of preservatives, and enabling of patient-controlled self-therapy. However, most commercial protein-based drugs are not compatible with prefilled syringes. This is because of complications that arise from the almost ubiquitous presence of silicone oil that is used as lubricant to aid in syringe plunger depression and to ensure reliable and safe operation. Silicone microdroplets that shed from the lubricated surfaces of the syringe react with the drug medium and cause aggregation of protein therapeutics compromising their safety and efficacy. Attempts to replace standard silicone oil lubricant in prefilled syringes have thus far fallen short in achieving sufficiently high lubricity and chemical inertness. To address this problem GVD Corporation proposes to develop a highly inert, low- particulate, silicone-free lubricant system to enable reliable storage and delivery of protein therapeutics in prefilled syringes. GVD Corporation's all-dry, initiated vapor deposition (iCVD) technology will be leveraged to coat syringe components with an ultra-thin, low-friction polytetrafluoroethylene (PTFE) fluoropolymer coating. This coating offers an unparalleled combination of lubricity and chemical and biological inertness. GVD's coating technology is well-suited for conformally coating chemically-pure, well-adhered PTFE on syringe components and overcomes challenges of common liquid phase coating methods such as lack of conformality over 3D features, solvent contamination. Excellent control over chemical composition, substrate adhesion, and coating thickness uniformity are achieved by appropriate selection of iCVD process parameters. GVD's coating process also operates at low temperature and will not degrade rubber stopper materials. In Phase I we will carry-out a feasibility study to demonstrated basic functional and safety performance of GVD's PTFE coatings and show superior performance versus silicone oil lubricant. By systematic optimization of coating synthesis conditions we will fine tune the molecular structure to achieve coatings favoring (a) low-friction, (b) low- particulate, (c) unifor thickness coverage over stopper features, and (d) stability during sterilization. These coatings will also be designed to serve as a barrier to inhibit migration of leachables from the rubber stopper. Finally, upon successful demonstration of GVD's PTFE coatings, we will initiate the design of a pilot-scale production coating tool to be built and demonstrated during Phase II. Successful commercialization of GVD's coatings will debottleneck the use of protein therapeutics for prefilled syringes, thereby increasing both availability and affordability of protin drugs in a form factor that also greatly improves patient care.

Public Health Relevance

Patient controlled-self therapy is an attractive factor for packaging of protein therapeutics in single-dose prefilled syringe formats for treatment of a variety of diseases including autoimmune diseases, arthritis, hepatitis, diabetes, and more. Silicone oil which serves as a lubricant for reliable, safe operation of prefilled syringes, can contaminate protein drugs compromising their safety and efficacy. The proposed chemically-inert, low-friction fluoropolymer coating will overcome the problem of lubricant contamination of protein therapeutics and enable their compatibility in a prefilled syringe format.

National Institute of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1)
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Cole, Alison E
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Gvd Corporation
United States
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