Description

Poly(L-lactide) – Pharmaceutical-Grade Biodegradable Polymer

Poly(L-lactide) (PLLA) is a biodegradable polymer derived from L-lactic acid It is widely used in biomedical and pharmaceutical applications owing to its biocompatibility and readily hydrolyzable ester bonds. It serves as a high-purity excipient for controlled-release drug delivery systems, including long-acting injectables and implantable devices, where it safely biodegrades into naturally occurring metabolites.

Key Features

• High Purity & Quality: A pharmaceutical-grade polymer with low residual monomer content for consistent performance and stability. Produced via controlled ring-opening polymerization, ensuring batch-to-batch uniformity and traceability.
• Biocompatible & Bioresorbable: Safe, bioresorbable material that hydrolyzes in vivo to non-toxic L-lactic acid, eliminating the need for surgical removal Its degradation products are naturally metabolized, reflecting a proven safety profile in parenteral applications.
• Sustained Release Performance: Enables extended drug release profiles (over days to months) in depot formulations, significantly reducing dosing frequency. The polymer’s hydrophobic, semi-crystalline nature slows water uptake and erosion, supporting ultra-long release durations compared to faster-degrading co-polymers.
• Tailorable Properties: Available in defined molecular weight and intrinsic viscosity grades (e.g., ~10 kDa) to fine-tune degradation rate and drug release kinetics. Higher molecular weight or crystalline grades of Poly(L-lactide) provide slower polymer resorption, allowing customization of release from weeks to several months.
• Regulatory Compliance: Manufactured under strict cGMP conditions in GMP-quality facilities, with robust quality control. Supported by regulatory documentation to facilitate incorporation into pharmaceutical development. Comprehensive Certificates of Analysis (CoA) and Safety Data Sheets are provided with each batch for full transparency.

Applications

• Long-Acting Injectables (LAI): Used as a matrix polymer in microspheres and nanoparticles for injectable depot formulations. Poly(L-lactide) microsphere systems encapsulate peptides, proteins, or small-molecule drugs, releasing them gradually as the polymer slowly biodegrades. This approach improves patient compliance by maintaining therapeutic levels over prolonged periods (weeks to months).
• Implantable Drug Delivery: Employed in biodegradable implants (rods, pellets, or wafers) that provide sustained release of medications inside the body. For example, implantable PLLA-based devices can continuously elute contraceptives, oncology drugs, or hormones over an extended duration, then harmlessly absorb without removal.
• In Situ Forming Depots: Suitable for injectable sol–gel systems where a Poly(L-lactide) solution (in biocompatible solvent) is injected and then solidifies in vivo. The resulting depot slowly releases the drug as the PLLA matrix solidifies and degrades, offering a patient-friendly alternative to pre-formed implants.
• Extended-Release Coatings: Acts as a sustained-release coating on medical devices or combination products. Poly(L-lactide) can be applied as a thin film on drug-eluting stents, orthopedic pins, or microsphere surfaces to modulate drug diffusion rates. Its slow hydrolysis rate provides controlled elution while the coating gradually dissolves. (Note: For medical device uses, PLLA’s mechanical strength and biocompatibility also make it suitable for absorbable sutures and tissue scaffolds, though these may not involve drug release.)

Detailed Description

Poly(L-lactide), also known as poly(L-lactic acid) or PLLA (CAS 26811-96-1), is a high-quality bioresorbable polyester offered by CarboMer for advanced pharmaceutical formulation development. Synthesized from renewable L-lactide monomer via ring-opening polymerization, this polymer exhibits excellent purity and lot-to-lot consistency, making it ideal for research and manufacturing of controlled-release therapeutics. CarboMer provides pharmaceutical (and cosmetic) grade Poly(L-lactide) for sale in a range of quantities, serving as a reliable supplier of biodegradable polymers for long-acting injectables, implants, and other drug delivery systems. Formulators seeking to buy Poly(L-lactide) will find a dependable source in CarboMer, backed by our expertise in polymer science and drug delivery technology.

In controlled-release applications, Poly(L-lactide) enables the creation of biocompatible drug carriers that gradually release active compounds in the body. Its hydrophobic and semi-crystalline molecular structure causes it to degrade more slowly than faster-resorbing co-polymers, such as PLGA, allowing developers to achieve ultra-long release profiles for certain therapies. For instance, injectable microspheres made from PLLA can encapsulate proteins or peptides and maintain therapeutic drug levels over extended periods (e.g. monthly dosing) as the polymer matrix erodes. Likewise, in solid implants, high-molecular-weight Poly(L-lactide) provides a stable, long-lasting depot that releases drug payloads in a controlled manner. Over time, the polymer chains hydrolyze into lactic acid monomers, which are naturally metabolized by the body’s Krebs cycle, ensuring biocompatibility and eliminating residual material. This predictable degradation behavior (amorphous regions of the polymer breaking down first, followed by crystalline regions) allows for reliable and steady drug release kinetics. Because of these attributes, polylactide-based materials are widely utilized in FDA-approved long-acting injectable formulations, with a long track record of safety and efficacy in clinical use.

CarboMer’s Poly(L-lactide) is engineered for quality and compliance to meet the demands of pharmaceutical development. The polymer is manufactured in state-of-the-art, cGMP-compliant facilities and conforms to rigorous internal specifications for purity, molecular weight distribution, and residual solvents. High purity is a hallmark of this product – residual lactide monomer levels are tightly controlled, yielding an ultrapure polymer that offers improved stability for sensitive drug molecules and more consistent release profiles in finished dosage forms. Each production batch undergoes extensive analytical characterization (e.g. chromatographic assay of monomer content, intrinsic viscosity measurements correlating to molecular weight, endotoxin testing for parenteral suitability) to ensure it meets predefined quality criteria. A Certificate of Analysis documenting these parameters is provided with every lot, and material traceability is maintained for regulatory auditing purposes.

To support our clients’ regulatory submissions, CarboMer can provide comprehensive documentation including Safety Data Sheet (SDS) to facilitate compliance with FDA and EMA requirements. Our polymer also aligns with relevant pharmacopeial and GMP guidelines for medical-grade materials (for example, polymer class testing and biocompatibility standards), giving formulators confidence in its suitability for parenteral and implantable use.

Packaging of Poly(L-lactide) is designed to preserve its integrity and extend shelf life. The polymer is typically supplied as a white to off-white granule or powder, packaged in moisture-barrier containers (such as aluminum foil laminate pouches or airtight HDPE drums). This prevents premature hydrolysis during storage, as even slight moisture uptake can initiate degradation of PLA polymers. CarboMer ships the product in sealed, vacuum-tight bags with desiccants as needed, inside robust secondary containers to protect against physical damage and environmental humidity. Standard pack sizes (e.g. 10 g, 100 g, 1 kg) are available for R&D and scale-up, and bulk quantities can be provided to meet commercial manufacturing needs. All shipments include a CoA and any requested documentation (analytical methods, regulatory certificates), ensuring you have the information needed for quality assurance and inventory control upon receipt.

In summary, CarboMer’s Poly(L-lactide) delivers a combination of performance, quality, and support that makes it an ideal choice for developers of long-acting pharmaceutical products. Its proven biodegradability and controlled-release capabilities enable drug delivery innovations in injectable depots and implants, while our manufacturing rigor and regulatory documentation help de-risk the path to clinical and commercial use. By choosing CarboMer as your polymer supplier, you gain not only a high-grade material but also a collaborative partner dedicated to your success.

CarboMer – Your trusted development partner in bringing next-generation drug delivery systems to life, with reliable materials and expert support from concept to market.