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Poly(DL-lactide) and Poly(L-lactide)

poly(DL-lactide) and poly(L-lactide) polymers from LACTEL

 

We produce poly(DL-lactide) and poly(L-lactide), also referred to as PDLA or PLLA respectively, by ring-opening polymerization from lactide monomers. These linear aliphatic polyesters are often used in medical devices such as sutures, and scaffolds for tissue engineering. The LACTEL brand has been a reliable and proven source of these materials for 30 years.

Our range of PLAs encompasses monomer compositions from 100% PLA to 50:50 poly(lactide-co-glycolide). These products are offered in a range of molecular weights, as well as acid, hydroxy and ester end groups. Please refer to the table below.

For other PLAs, please contact us to discuss your requirements. We do a significant amount of custom synthesis for customers.  For example, we can provide block and copolymers from mPEG and PEGs.  We can perform additional purification to achieve residual monomer levels below 0.5 weight %, and manipulate other polymer characteristics to ensure the material performs to your requirements.

 

Our commitment to quality includes a thorough analysis of each lot of polymer, and every shipment of medical grade polymer includes a Certificate of Analysis (COA). Analyses include:

  • Identification by 1H-NMR and FTIR
  • Inherent viscosity (IV)
  • Monomer ratio
  • Residual monomer levels by 1H-NMR
  • Residual tin (from catalyst)
  • Residual solvents
  • Bioburden (total aerobes, spores, and anaerobes)
  • Pyrogens (LAL)

Other analyses can be provided if desired, including heavy metals, solubility and cloud point in various solvents, DSC, and other compendial tests. We also have considerable expertise in measuring molecular weights using GPC and NMR techniques.

DURECT maintains both Drug and Device Master Files with the FDA. All pharmaceutical grade polymer production is conducted in accordance with the International Pharmaceutical Excipients Council (IPEC) Good Manufacturing Practices Guide 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, USA.

 

Product No. Chemical Name End Group Abbrev. Inherent Viscosity (IV)
 dL/g
Ester Terminated Polymers
B6005-1 Poly(DL-lactide) E DL-PL 0.26 - 0.54
B6005-2 Poly(DL-lactide) E DL-PL 0.55 - 0.75
B6002-1* Poly(L-lactide) E L-PL 0.15 - 0.35
B6002-2 Poly(L-lactide) E L-PL 0.90 - 1.20
Acid Terminated Polymers
B6014-1* Poly(DL-lactide) A DL-PL 0.16 - 0.25
 
End Group: E - Ester Terminated, A - Acid Terminated
*Not routinely stocked. Please call for quote and availability.

Order Polymers

We offer a variety of polymers and sample kits in stock for prompt delivery.

Technical Data

Data describing characteristics of lactide, glycolide and ε-caprolactone polymers to assist you in selecting the optimal polymer for your program.

Safety Data Sheets

 

The following Safety Data Sheets are saved in a format that can be viewed and printed from Acrobat Reader.
CONTACT US:

LACTEL Absorbable Polymers

2200 Riverchase Center, Suite 501
Birmingham, AL 35244 USA


Customer Service:


Phone: (877) 705-8072 Fax: (408) 865-1406

E-mail: absorbablescs@durect.com

LACTEL Technical Support:

Phone: (205) 578-5102

E-mail: absorbables@durect.com