Chinese
Platform and Technology
Long-acting Release DDS (LAR DDS) R&D Center

LAR DDS R&D Center specializes in the development LAR microsphere technology and non-microsphere LAR   technology (Nano/Micro-scale hydrophobic drug crystal LAR technology). The center has a full set of microsphere preparation system and other customized state-of-the-art equipment which comply with current Good Manufacturing Practice (cGMP) regulations to meet the requirements of the LAR products process development.

LAR microsphere technology

 Microsphere technology is one of the most advanced and promising drug delivery systems in the field of pharmacy. In this technology, active drugs are dissolved or dispersed in the polymer matrix to form 10-200μm-sized composite spheres. After subcutaneous or intramuscular injection, the drugs are released gradually with the degradation of polymer materials for several weeks or even months, so that the patients’ blood concentration remains constant, which can improve the therapeutic effect and reduce the side effect. LAR products have significant advantages on the treatment of diabetes, mental illness and other chronic diseases which need long-term, continuous, and regular medication.

Non-microsphere LAR technology

Non-microsphere LAR technology is now mainly represented by nanocrystal technology, also known as nanocrystal suspensions, which is a stable colloidal dispersion system formed by dispersing nano/micron drug particles in water using polymers or surfactants as stabilizers. For insoluble drugs, the release period can reach several weeks or months after intramuscular or subcutaneous injecting because the release depends on particle size of API which can be controlled by suitable pharmaceutical process. Therefore, the patient’s compliance is greatly improved.

Targeted DDS R&D Center

Targeted DDS R&D Center specializes in the development of liposome technology, lipid microsphere technology development. The center has microfluidics homogenizer, high pressure extruder, lyophilizer and other customized state-of-the-art equipment which comply with current Good Manufacturing Practice (cGMP) to meet the requirements of the targeted products process development.

Liposome technology

Liposome is drug-loaded microvesicles with lipid bilayer, a new drug delivery technology of targeted DDS. As a special drug carrier, liposomes have high biocompatibility and certain controlled release ability. The most important is that liposomes can be selectively accumulated in liver, spleen and other tissues. So that the drug concentration in tumor tissues of these organs is higher than that of normal tissue, leading to less damage to normal cells, hence improving the therapeutic effect and reducing the side effects in the meanwhile. The research results have showed that the toxicity of liposome anticancer drugs can be reduced by 50%-70% comparing to the free drugs. Meanwhile, the anticancer activity of liposome drug was much higher than that of free drugs.

Lipid microspheres technology

Lipid microspheres is a new DDS, which is a kind of microparticle dispersion system using fat oil as soft matrix coated with monolayer phospholipid. It belongs to sub-micron emulsions with the particle size of about 200nm suitable for intravenous injection of water-insoluble drugs.
As a drug carrier, lipid microspheres tend to accumulate in the lesion site to realize targeted therapy. In addition to targeting property, there are the following characteristics:
1) improving chemical stability of the product because of that the drug molecular is blocked in the core oil phase of lipid microspheres, avoiding excessive contact with water that would lead to hydrolysis;
2) avoiding the vascular irritation of API because of that the API in the lipid microspheres is distributed in the core oil phase, and there are also aqueous phase and phospholipid covering on the outside, the API doesn’t directly contact the blood vessel wall after intravenous injection;
3) sustaining release because of that it takes a certain time for the drug gradually release from the lipid microspheres to take effect.

Analysis Center

Analysis center specializes in the comprehensive quality analysis and the establishment of quality evaluation system during R&D and industrialization of complex injection projects, mainly including analytical method development, method validation, technical transfer of analysis method, stability study, specification establishment, quality control of raw materials and excipients, compatibility evaluation of packaging materials, etc.

The center has a strong team with reasonable echelon. The project leaders have rich experience in project research, project management and registration. Further more, the project development and laboratory management are guided by a standardized system. When the analysis center was established, Empower 3 online edition was introduced and NuGenesis ELN/SDMS was introduced again in 2018. These measures ensured the safety, integrity and compliance of the research data, and effectively guaranteed the quality and success of the project.
The center is equipped with advanced equipment, including Sotax CE7, Malvern MS3000, Malvern nano-ZS90, TA Discovery DSC, Waters UPLC, Waters HPLC, Agilent GC, Binder Constant climate chambers, etc.