Evonik’s RESOMER® and LACTEL® standard polymers represent the industry’s broadest and most versatile portfolio for controlled release applications. Both brands have strong records for safety and timely delivery of complex parenteral drug products. An extensive range of bioresorbable polymers are stocked and available for rapid shipment around the world to meet your lab, clinical and commercial requirements. Regardless of your polymer choice, Evonik can leverage decades of experience to ensure the polymer design, particle morphology and specification attributes match your specific release profile and other product specification requirements.

The standard RESOMER® catalog of biodegradable polymers for controlled release includes high and low molecular weight homo-polymers, co-polymers and block co-polymers. Standard compositions include Poly (D,L-lactide) and Poly (D,L-lactide-co-glycolide) polymers with acid and ester end group chemistries. The RESOMER® portfolio also includes specialized co-polymers manufactured via polycondensation and di-block co-polymers made of PLA and mPEG. A variety of molecular weights are available to help modulate degradation times from weeks to years. 

All polymers are purified as part of the standard manufacturing process to achieve low residual monomer content and avoid possible interaction of any remaining monomer with an API. RESOMER® polymers are typically produced in conformance with the Joint IPEC- PQG Good Manufacturing Practice Guide for Bulk Pharmaceutical Excipients 2017 and USP-NF General Chapter GMPs for Bulk Pharmaceutical Excipients via validated manufacturing processes in large batch sizes from production sites in Germany or the U.S.

RESOMER® R is a platform of PLA / poly (D,L-lactide)-based biodegradable polymers for controlled release. Designed, in particular, for microparticles and drug-loaded implants, these amorphous polymers are available with either acid or ester end groups. Degradation times can vary from as little as a few weeks or less to nine months or more. Inherent Viscosities (IV) can range from 0.15 to 0.75 dL / g, with molecular weights between 10,000 and 28,000 Daltons. Polymer properties including crystallinity can be easily tuned to match specific formulation and release profile requirements. 

*Approximate degradation times are intended to guide polymer selection. Actual resorption times are dependent upon the process and application and must be empirically determined.

RESOMER® RG is a platform of PLGA / poly (D,L-lactide-co-glycolide)-based bioresorbable excipients for controlled release. Designed for use with a range of complex parenteral drug products, these amorphous polymers are also available with either acid or ester end groups. Standard mole ratios include 50:50, 65:35, 75:25 and 85:15. Degradation times can extend for up to 18 months or more. Inherent Viscosities (IV) can range from 0.09 to 1.7 dL / g, with molecular weights between 7,000 and 240,000 Daltons. Polymer properties including crystallinity can be easily tuned to match specific formulation and release profile requirements. 

*Approximate degradation times are intended to guide polymer selection. Actual resorption times are dependent upon the process and application and must be empirically determined.

The synthesis of RESOMER® grades of Poly (D,L-lactide-co-clycolide) or PLGA via direct polycondensation eliminates any requirement for the use of tin as a catalyst. Two RESOMER® Condensate PLGA polymers with a 50:50 mole ratio are available as standard products without any tin content. Both are low molecular weight polymers with an Mn of 800 and 2,300 Daltons. Additional molecular weight ranges are possible via the RESOMER® Select platform for customization.

The RESOMER® RP d catalog includes di-block copolymers of poly(DL-lactide) and poly(ethylene glycol) incorporating various weight fractions of mPEG-5000. These amphiphilic polymers are available to help achieve shorter degradation times than standard lactide/glycolide-containing polymers and are especially suited for nanoparticle formation.

The standard LACTEL® portfolio boasts of more than 20 polymers available as a cost effective supply due to streamlined manufacturing processes. Common application areas for LACTEL standard polymers include veterinary medicine, where bioresorbable polymers are used in long-acting injectable formulations, and generic drug formulations, which require price-sensitive planning and quick shipment to support demanding, fast-paced markets. These non-solvent purified polymers are appropriate for many formulation applications, from existing generic products to novel therapeutics. For development projects, LACTEL® is available in small volumes that can then be scaled and optimized as a project progresses from small-scale research to full-scale commercial batches.

*value measured in HFIP

**value measured in chloroform

***Approximate degradation times are intended to guide polymer selection. Actual resorption times are dependent upon the process and application and must be empirically determined.

The Glucose Star Polymer is a branched 55:45 DL-PLG that is highly purified to achieve nearly undetectable levels of residuals including tin and monomer. Developed specifically for the formulation of microspheres with octreotide, its branched nature provides unique drug delivery characteristics and may be beneficial for use in applications involving highly sensitive or reactive APIs.

**value measured in chloroform

All pharmaceutical grade polymer production is conducted in accordance with the International Pharmaceutical Excipients Council (IPEC) Good Manufacturing Practices guidance for Bulk Pharmaceutical Excipients, which are recognized and published in the United States Pharmacopeia. Polymers are produced in ISO 8 clean rooms with controlled temperature and humidity in our modern, well-equipped production and laboratory facilities in Birmingham, Alabama, U.S. Both Drug and Device Master Files are maintained with the FDA.

Our web portal onCare is the central platform for customers and prospects of Evonik's Health Care business line. It provides you with useful tools and resources around our products and services – available anytime and anywhere. To learn more about onCare please see the below article or directly visit oncare.evonik.com to create your free acount and explore the various tools and functionalities.