PDLLA Poly-DL-Lactide Microspheres | Soft Long-Acting Collagen Regeneration Substrate Material
Technical Specifications
Particle Size (D50): 25–50μm
Raw Material Purity: ≥98%
Endotoxin: ＜0.1EU/mg
Natural Degradation Period: 18–28 Months
Product Overview
PDLLA (Poly-DL-Lactide) is a medical-grade amorphous degradable polyester regenerative material with no crystalline rigid structure. It is a landmarksoft and flexible regenerative substrate material in the industry. Verified by long-term clinical application and biosafety tests, it is widely applied in high-end biomedical fields such as ultra-long-acting soft tissue regeneration, tissue engineering scaffolds, and drug sustained-release carriers.
Compared with crystalline polyester materials such as PCL and PLLA, PDLLA eliminates rigid crystalline nodes completely, featuring a flexible and smooth texture. It degrades gently and uniformly in vivo without sudden accumulation of local acidic substances, resulting in a significantly lower risk of inflammatory irritation and better compatibility and adhesion with human soft tissues. Supported by an 18–28 month ultra-long degradation cycle, flexible 3D stereoscopic support framework, and stable continuous collagen induction capability, this material focuses on soft natural shaping, long-term contour maintenance, and repair of severely aged soft tissues. It serves as a core raw material for high-end soft-texture long-acting regenerative medical devices, medical composite blending substrates, and cutting-edge biomaterial research and development. It can be efficiently compounded with recombinant type Ⅰ/Ⅲ collagen, silk fibroin, hyaluronic acid and other bioactive substrates to form an integrated composite material solution of "soft regenerative microspheres + active protein", perfectly adapting to the R&D and industrial mass production of Class Ⅱ and Ⅲ medical devices with ultra-long-acting regeneration effects.
Working Principle
After implantation into soft tissues, high-purity PDLLA soft microspheres undergo long-term degradation via stable and uniform hydrolysis. The metabolic products are released mildly without peak irritation, fundamentally reducing adverse reactions such as postoperative redness, edema, subcutaneous induration and inflammatory nodules, ensuring higher safety for fragile soft tissue scenarios.
The flexible 3D scaffold constructed by microspheres can continuously activate the physiological activity of fibroblasts, induce the hierarchical and ordered regeneration of autologous collagen fibers and elastic fibers, and specifically improve various aging defects including deep soft tissue depression, large-volume tissue loss, persistent static wrinkles, full-face contour relaxation and sagging, and soft tissue layer dislocation.
The product forms a complete three-stage regeneration cycle: short-term flexible support to quickly fill depressions; medium and long-term continuous collagen activation to reconstruct soft tissue texture; long-term slow degradation to stabilize the original contour. The regeneration effect is gradual and natural without stiffness, achieving simultaneous improvement in contour fullness and skin texture, with the shaping texture highly consistent with the original human soft tissue.
Core Product Advantages
Soft & Flexible Shaping with Ultra-Low Inflammatory Irritation
Featuring an amorphous non-crystalline structure, PDLLA microspheres are soft and smooth, completely avoiding stiff texture and local irritation caused by hard particles. The degradation process maintains a mild acid-base balance without acid accumulation, leading to an extremely low inflammation rate. It is suitable for repairing superficial fragile soft tissues such as periocular and perioral areas, as well as long-term filling of deep contours, with superior full-scenario safety compared with traditional crystalline polyester microspheres.
Ultra-Long-Acting Regeneration for Stable Soft Contour Maintenance
Compared with conventional PCL materials, PDLLA has a longer in-vivo retention and degradation cycle. Its collagen induction and regeneration effect runs through the entire metabolic process, realizing three core effects: gentle shaping, long-term contour fixation and continuous skin texture improvement. It accurately matches the high-end positioning of natural-style long-acting anti-aging and stable regeneration medical devices.
Full-Dimensional Customizable Physical & Chemical Parameters
Custom modification is available for particle size, polymer molecular weight, degradation cycle and microsphere morphology. We can develop multiple specifications including medium-term skin rejuvenation, ultra-long soft contour fixation and special models for drug sustained release. A single substrate supports customers’ differentiated multi-product line layout to meet diverse market demands.
Excellent Compatibility to Reduce R&D Trial and Error Costs
It boasts excellent biocompatibility with hyaluronic acid, recombinant active collagen, plant polysaccharides and various hydrogel substrates. Microspheres are uniformly dispersed in the compound system without agglomeration, stratification or precipitation, ensuring high stability. It effectively shortens the cycle of formula debugging, sample proofing and product iteration, and greatly reduces time and material costs for new product R&D.
Implanted Medical-Grade Quality Control for Device Registration Compliance
Produced with closed polymerization technology using high-purity medical-grade lactide monomers, the material implements strict control over monomer residues, heavy metals, catalyst additives and other impurities, ensuring highly consistent batch performance and strong stability. Manufactured in full compliance with implanted medical raw material quality control standards, all indicators meet the access and registration declaration requirements for Class Ⅱ and Ⅲ implanted medical devices in China, balancing excellent product stability and commercial compliance.
Target Customers & Application Directions
Overseas medical device manufacturers, leading domestic medical aesthetic raw material supply chain enterprises, biomedical research institutes, biomaterial laboratories and university R&D teams
Commercial Application Scenarios
Mass Production Supporting for Medical Device Factories
As a core raw material, it is applied to the industrial mass production of PDLLA+HA long-acting soft composite regenerative substrates, gentle contour shaping materials and implant devices for severe soft tissue defect repair, empowering the manufacturing of high-end long-acting regenerative medical devices.
Bulk Raw Material Cooperation for Supply Chain Enterprises
We supply bulk industrial-grade PDLLA microspheres. Partners can independently compound bioactive proteins and hydrogel substrates secondarily to develop differentiated composite regenerative materials, covering domestic terminal channels and overseas cross-border raw material trade markets.
Sample Cooperation for Scientific Research Institutions
We provide standard samples and customized modified samples for biomaterial research, pre-development of long-acting regenerative medical devices, in-vivo efficacy verification, and pre-registration pharmacological and toxicological tests of medical devices.
Compliance Statement
Our company focuses on the R&D and bulk sales of medical biological raw materials. We do not supply directly to medical aesthetic institutions, beauty salons or individual end consumers, nor do we produce, subpackage or sell terminal medical aesthetic devices and skin care products. Customers shall independently complete all commercial processes including formula development, preparation processing, domestic and overseas medical device registration certification and qualification declaration. Terminal products can only be launched and circulated in the market after obtaining complete compliance approval. The content on this page objectively displays the physical and chemical properties and application directions of raw materials only, and does not constitute clinical efficacy commitments, usage guidance or commercial efficacy endorsement for terminal products.