An Advanced Low Tin Biodegradable Polymer for Sensitive APIs
The same RESOMER® quality for biodegradable polymers with low tin
RESOMER® Zero is a premium offering of low tin biodegradable polymers for parenteral depot formulations. As an extension of the RESOMER® Select product line, this advanced PLGA controlled release polymer leverages a proprietary purification process to enable residual tin content of less than 1 ppm. In addition to providing optimal purity, this low tin biodegradable polymer delivers formulation flexibility with a full range of molecular weights and a broad choice of polymer parameters. These low tin biodegradable polymer properties can help to minimize degradation during melt processing, resulting in improved process control.
Our new low tin biodegradable polymer addresses a key pharma challenge
The reduction of elemental impurities in drug formulations is an increasing challenge for the pharmaceutical industry. These impurities can interact with some sensitive active pharmaceutical ingredients. Evonik has developed RESOMER® Zero for use with delicate formulations and applications by keeping the polymer as pure as possible. When compared to conventional PLGA polymers, RESOMER® Zero represents a new class of low tin biodegradable polymer that can help to meet new regulatory requirements and increase stability during melt processing.
A low tin biodegradable polymer ready for clinical or commercial use
The low tin biodegradable polymers are designed to meet specific customer requirements while preserving the proven and trusted attributes of RESOMER® products. The polymer technology is applicable to both low and high molecular weight D,L-lactide homopolymers and D,L-lactide / glycolide copolymers of different ranges including 50:50 and 75:25. The validated and proprietary GMP manufacturing process utilized for RESOMER® Zero can be applied to a wide range of RESOMER® catalog and RESOMER® Select products for parenteral controlled release. With a tin content below 1 ppm, RESOMER® Zero polymers also provide an attractive alternative to polycondensate polymers with the addition of delivering a wide range of custom options. The low tin biodegradable polymer is highly customizable, enabling molecular weight, end group functionality, and copolymer composition to be tailored to specific requirements.
A high-quality, reliable low tin biodegradable polymer solution
RESOMER® Zero polymers are available as technical grade for evaluation and screening and GMP (Good Manufacturing Practice) grade for clinical and commercial manufacturing. Batches are available from laboratory quantities to the multi-kilogram scale. A full range of standard testing methods and established master specifications are utilized. Supply can occur from sites in the U.S. and Europe with a strong market reputation for quality and reliability. In addition to the supply of RESOMER® Zero, our formulation and application specialists can further assist you in the development, production and filling of your parenteral drug product.