LACTEL® Absorbable Polymers
DURECT designs, develops, and manufactures a wide range of standard and custom biodegradable polymers based on lactide, glycolide, and caprolactone for use as raw materials in pharmaceutical and medical device products under the LACTEL brand. These polymers are manufactured and sold by DURECT at our facility in Birmingham, AL. They are used by DURECT and its third-party customers for a variety of controlled-release and medical-device applications, and they are incorporated into several FDA-approved commercial products.
Our deep experience in this field has allowed us to work with clients to:
- Increase polymer solubility
- Increase molecular weight for enhanced mechanical properties
- Tightly control low-molecular-weight polymers to degrade rapidly
- Change molar ratios to give desired drug release profiles
- Tailor polymers with hydroxy, ester, carboxylic acid, or polyethylene glycol end groups to influence hydrophilicity, degradation, and drug release rates
LACTEL polymers are produced in modern, well-equipped production and laboratory facilities in Birmingham, AL. All polymer production is in accordance with the International Pharmaceutical Excipients Council (IPEC) Good Manufacturing Practices guidance for Bulk Pharmaceutical Excipients. Production is conducted in ISO 8 clean rooms with controlled temperature and humidity. Both Drug and Device Master Files (DMFs) are maintained with the FDA to support regulatory filings for our customers.