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We currently design, develop and manufacture a wide range of standard and custom biodegradable polymers based on lactide, glycolide and caprolactone under the LACTEL® brand for pharmaceutical and medical device clients for use as raw materials in their products. These materials are manufactured and sold by us directly from our facility in Pelham, Alabama and are used by us and our third-party customers for a variety of controlled-release and medical-device applications, including several FDA-approved commercial products. Until December 31, 2004, this business was conducted by our wholly owned subsidiary, Absorbable Polymers International Corporation (API), formerly known as Birmingham Polymers Inc., an Alabama corporation. API was merged with and into DURECT on December 31, 2004.
Our experience base has allowed us to work with clients to:
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increase polymer solubility |
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increase molecular weight for enhanced mechanical properties |
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tightly control low-molecular-weight polymers to degrade rapidly |
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change molar ratios to give desired drug release profiles |
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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 near Birmingham, Alabama, USA. 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.
To learn more about LACTEL® Absorbable Poymers, please visit our web site at www.absorbables.com.
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