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cGMP EVA for Controlled Release Drug Delivery

Polysciences offers pEVA/Poly(ethylene-co-vinyl acetate), an important biocompatible (USP Class VI) material, used as both a structural component and drug delivery vehicle in biomed application. We manufacture specialized grades of pEVA following cGMP guidelines, meeting specific release profiles.

Biomedical pEVA by Polysciences

Biomedical applications require specialized grades, approved additives, documented processes and characterization to meet specific release profiles and regulatory requirements. They are often not well served by large scale industrial manufacturer.

Polysciences manufactures pEVA with those specific requirements in mind, offering multiple grades that meet the demands of biomedical device manufacturers and pharmaceutical companies. These grades are prepared with the appropriate cGMP documentation and traceability, the option of including no additives or customized additive packages, and full characterization employing state-of-the-art analytical technique.

cGMP Manufacturing

To provide specialized grades of pEVA made following cGMP guidelines, Polysciences has adopted a solution polymerization technique that allows using lower pressures, lower reaction temperatures, and equipment more suitable to lower volume production. The conditions of the polymerization allows for additive-free processing and EP/USP approved additives can be incorporated into the pEVA post-reaction if desired for particular application.

Polysciences pEVA Manufacturing Capabilities

Polysciences’ batch processing capabilities yield pEVA lot sizes ranging from 1kg – 100kg. Our processes allow the preparation of pEVA with tailored properties to meet the needs of your specific applications.

Biomedical Applications

Under physiological conditions, drugs will migrate through the pEVA over time and be released into the body to provide a steady supply of the required therapeutic. Because pEVA can be dissolved in solvents or blended with drug and melt extruded, a wide range of  physical forms can be created including microparticles and essentially any shape that can be extruded or molded. Common biomedical applications for pEVA include microparticles, vaginal rings, and implanted devices that release drug over time as well as the structural and cushioning components of orthotics.

We are pleased to offer our scientific and technical expertise, strong ISO 13485:2016 Quality Management System and cGMP capabilities to our partners in the pharmaceutical and medical device industries. Please reach out to us to find out how we can put our decades of knowledge and real-world experience to work for you. 

 

 

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