Liposomes · Nanoparticles · Lipid Emulsion/Drug-Loaded Emulsion · Microemulsion · Nanoemulsion — covering the full technology spectrum of mainstream nano drug delivery systems, supporting generic drug development, Class 2.2 modified new drugs, and high-end complex injectables with one-stop CRO R&D services
Nanoparticle Drug Delivery Systems (NDDS) represent a core technology direction in advanced pharmaceutics. Their development barriers are exceptionally high — every step from formulation design to process scale-up tests the comprehensive technical capability of a CRO.
Phospholipid bilayer vesicle structures, particle size 50–500 nm. Suitable for targeted delivery of anticancer and antifungal drugs. Core challenges: encapsulation efficiency, particle size distribution, long-term stability, and sterility assurance.
PLGA/PLA and other polymeric carriers, albumin nanoparticles. Particle size 100–300 nm. Suitable for solubilization and sustained-release delivery of poorly soluble drugs. Core challenges: drug loading, release kinetics, and residual organic solvent control.
O/W submicron emulsion systems, particle size 150–400 nm. Suitable for intravenous administration of lipophilic drugs. Core challenges: physical stability (Ostwald ripening), sterilization stability, and large-scale manufacturing.
Thermodynamically stable transparent dispersion systems, particle size 10–100 nm. Suitable for oral, transdermal, and mucosal drug delivery. Core challenges: surfactant safety evaluation, phase behavior studies, and drug loading optimization.
Taikomed possesses deep project experience in the lipid emulsion/drug-loaded emulsion field, having established a complete technology platform from formulation development to regulatory submission. We are one of the few CROs in China covering both parenteral nutrition and drug-loaded lipid emulsion types.
The global liposome and lipid nanoparticle formulation market reached approximately USD 15.8 billion in 2024, with YoY growth of 17.3%. China's lipid emulsion injection market exceeds RMB 10 billion, with drug-loaded lipid emulsions (propofol, etomidate, flurbiprofen, etc.) being high-barrier, high-margin core products.
Covering long-chain triglyceride (LCT), medium/long-chain triglyceride (MCT/LCT), structured lipid emulsion, multi-oil lipid emulsion (SMOF), fish oil lipid emulsion, and all other categories. Completed and ongoing products cover multi-chamber bags (lipid emulsion/amino acids/glucose) and other complex packaging forms, meeting diverse parenteral nutrition clinical requirements.
Using lipid emulsion as a carrier for poorly soluble drugs — Propofol Injectable Emulsion, Etomidate Lipid Emulsion Injection, Flurbiprofen Axetil Injection, Clevidipine Emulsion Injection, etc. Core challenges include the physicochemical stability of the emulsion after drug loading, particle size changes before and after sterilization, and control of free drug content.
Developing modified new drugs using lipid emulsion as a carrier — Zedoary Turmeric Oil Lipid Emulsion Injection, Silymarin Lipid Emulsion Oral Liquid, Artesunate Lipid Emulsion Injection, Ginkgo Biloba Liposome Injection, etc. Class 2.2 modified new drugs are currently encouraged by policy, with better market exclusivity periods and pricing advantages.
Formulation process development for specialty liposome formulations such as Ciclosporin Eye Drops (II) Liposome and Ginkgo Biloba Liposome Injection. Liposome development challenges include phospholipid type selection, encapsulation efficiency optimization, lyophilization protectant screening, and scalable manufacturing processes.
From preformulation studies to regulatory submission, every stage of nano-delivery formulation development requires meticulous technical control.
API physicochemical property characterization, oil phase/surfactant screening, pseudo-ternary phase diagram studies
Primary emulsion preparation, high-pressure homogenization/microfluidization, formulation composition DoE optimization, particle size/PDI control
Particle size/Zeta potential, encapsulation efficiency/drug loading, pH/free fatty acids, stress testing & accelerated/long-term stability
High-pressure homogenizer scale-up, sterilization process validation, filter compatibility, process validation batch manufacturing
Related substances methods, particle size method validation, sterility/endotoxin, container-closure compatibility, elemental impurities
CTD dossier preparation, BE study design, regulatory strategy consultation, deficiency response & on-site inspection support
Nano-formulation research is highly dependent on instrumentation and process know-how. Taikomed has established a systematic technical capability framework in this domain.
Mastery of both high-pressure homogenization and microfluidization core technologies, supporting seamless scale-up from laboratory 50 mL to pilot-scale 50 L. Established mature design space and process control strategies for critical parameters including homogenization pressure, cycle count, and temperature control.
Utilizing dynamic light scattering (DLS), laser diffraction (LD), NTA, and other particle size analysis methods, combined with Zeta potential measurement, to comprehensively characterize nano-formulation particle size distribution, dispersion stability, and long-term aggregation tendency.
Established a systematic oil phase/surfactant/co-surfactant screening system, covering phospholipids (egg lecithin, soy lecithin), non-ionic surfactants (poloxamer, polysorbate), natural emulsifiers, and other excipient types.
Systematic validation of terminal sterilization (rotary autoclave sterilization) processes for lipid emulsions/nanoemulsions, ensuring stability and comparability of critical quality attributes (particle size, PDI, pH, related substances) before and after sterilization.
Established ultrafiltration centrifugation/solid-phase extraction methods to separate free drug from encapsulated drug, combined with HPLC/UPLC/MS analytical methods for precise quantification of free drug content. This is one of the core quality control indicators for drug-loaded emulsions.
For the specific characteristics of nano-formulations (where conventional dissolution methods are unsuitable), developed dialysis, reverse dialysis, Franz diffusion cell, and other suitable in vitro release evaluation methods, establishing in vitro–in vivo correlation (IVIVC).
Core development considerations and Taikomed technical solutions for different nano-formulation types.
| Formulation Type | Representative Products | Key Quality Attributes | Development Challenges | Taikomed Solution Strategy |
|---|---|---|---|---|
| Drug-Loaded Lipid Emulsion Injection | Propofol Injectable Emulsion, Flurbiprofen Axetil Injection, Etomidate Lipid Emulsion | Mean particle size <300 nm, PFAT5 <0.05%, ζ potential <-30 mV | Physical stability decline after drug loading, high-pressure homogenization scale-up, particle size change before/after sterilization | DoE optimization of homogenization parameters + staged homogenization strategy + phospholipid/oleic acid combination stabilization approach |
| Multi-Chamber Bag Parenteral Nutrition | Lipid emulsion/amino acids/glucose 3-chamber bag, olive oil lipid emulsion 3-chamber bag | Three-chamber independent container-closure compatibility, post-mixing emulsion stability, in-use stability | Inter-chamber substance migration after long-term storage, impact of pre-use mixing operation on emulsion | Container material screening + migration studies + 24h post-mixing stability verification |
| Liposome Injection/Eye Drops | Ciclosporin Liposome Eye Drops, Ginkgo Biloba Liposome Injection | Encapsulation efficiency >90%, particle size 100–300 nm, phospholipid degradation product control | Scalability of high encapsulation efficiency formulations, integrity after liposome lyophilization and reconstitution | Ethanol injection/thin-film dispersion method screening + lyoprotectant gradient optimization |
| Class 2.2 Modified New Drug Lipid Emulsion | Zedoary Turmeric Oil Lipid Emulsion, Silymarin Lipid Emulsion Oral Liquid, Calcitriol Lipid Emulsion | Maximized drug loading, safety evaluation (hemolytic, vascular irritation) | Safety assessment of novel excipients, clinical advantage demonstration for modified new drugs | Comprehensive formulation safety evaluation + modified new drug clinical protocol design |
One of the few CROs in China with concurrent development capabilities across liposomes, nanoparticles, lipid emulsion/drug-loaded emulsion, and microemulsion technology platforms. From parenteral nutrition to drug-loaded emulsions to modified new drugs — providing full-lifecycle R&D services.
Established a 20+ product project matrix for lipid emulsion/drug-loaded emulsion, covering Class 4 generics, Class 3 generics, and Class 2.2 modified new drugs across multiple registration categories, with deep understanding of regulatory review requirements.
164 cumulative invention patent applications and 12 PCT international patents, building a solid intellectual property moat in the nano-delivery formulation field. Able to provide patent strategy support for partnered products.
From reference listed drug selection and registration classification decisions to CTD dossier preparation and deficiency response — full-process regulatory strategy consulting. 10+ years of pharmaceutical regulatory research ensures compliance and efficiency of the submission pathway.
Each stage in the nano-delivery formulation development chain tests a CRO's technical depth. Click below to explore individual service area capabilities.
API physicochemical property characterization, oil phase/surfactant/co-surfactant screening, pseudo-ternary phase diagram studies. Established a systematic excipient screening system to lay the foundation for nano-formulation process development.
Explore Preformulation Capabilities →High-pressure homogenization/microfluidization parameter optimization, formulation composition DoE screening, precise particle size/PDI control. Seamless scale-up from laboratory 50 mL to pilot-scale 50 L.
Explore Formulation Capabilities →Dynamic light scattering (DLS), laser diffraction (LD), NTA multi-method particle size analysis. Combined with Zeta potential, encapsulation efficiency, free drug content, and other key technical indicators for comprehensive quality characterization.
Explore Analytical Capabilities →Systematic validation of rotary autoclave sterilization processes for lipid emulsions/drug-loaded emulsions, ensuring stability and batch-to-batch consistency of critical quality attributes — particle size, PDI, pH, related substances — before and after sterilization.
Explore Process Validation Capabilities →Full CTD-format dossier preparation, complex injectable regulatory strategy development, deficiency response. Covering Class 4 generics, Class 3 generics, and Class 2.2 modified new drug registration pathways.
Explore Regulatory Affairs →Clinical advantage demonstration protocol design for Class 2.2 modified new drugs, BE/confirmatory clinical protocol development, clinical CRO coordination management. Maximizing the policy advantages and market exclusivity of modified new drugs.
Explore Clinical Research Capabilities →Lipid emulsion injections are recognized as one of the highest-barrier complex injectables. Development challenges focus on: ① Emulsification process — precise control of high-pressure homogenization pressure, cycle count, and temperature is required, as process parameters significantly impact particle size/PDI; ② Physical stability — Ostwald ripening and coalescence are major challenges to long-term stability; ③ Sterilization stability — terminal sterilization may cause particle size growth and pH drift; ④ Scale-up — seamless scale-up from laboratory to GMP manufacturing scale is a critical bottleneck. Currently, very few lipid emulsion products have passed consistency evaluation in China, with technical barriers being the primary constraint.
Parenteral nutrition lipid emulsions focus on physical stability, requiring control of particle size distribution, ζ potential, free fatty acids, and peroxide value. Drug-loaded lipid emulsions add drug loading requirements on top of this — drug introduction may destabilize the emulsion, requiring additional studies on drug-droplet interactions, free drug content, and drug degradation behavior under sterilization conditions.
Class 2.2 modified new drugs offer core advantages: ① Market exclusivity — legally entitled to a 3–5 year monitoring period, immune to volume-based procurement (VBP); ② Greater pricing flexibility — modified new drugs can seek better pricing through clinical advantage demonstration; ③ IP protection — formulation patents can be filed to create a combined barrier; ④ Development timeline — significantly shorter R&D cycle and lower cost compared to Class 1 innovative drugs. For modified new drug products developed with lipid emulsion as a carrier, Taikomed provides full-process support from formulation development to clinical protocol design.
Multi-chamber bags (3-chamber bags) are a high-end parenteral nutrition dosage form. Beyond routine lipid emulsion quality requirements, development requires special attention to: ① Container-closure compatibility of three-layer film materials — long-term contact may lead to migration of film additives; ② Inter-chamber oxygen and water vapor transmission rates — affecting long-term stability of contents in each chamber; ③ Convenience of pre-use mixing operation and post-mixing emulsion stability verification (typically 24 hours); ④ Sterility assurance and particulate control during manufacturing. Taikomed has completed development of multiple multi-chamber bag products.
Liposomes and lipid emulsions have fundamental differences in physical form — liposomes are phospholipid bilayer vesicle structures (solid or semi-solid core), while lipid emulsions are O/W submicron emulsion systems (liquid oil core). These determine differences in registration classification, reference listed drug selection, and quality standards. From a generic drug development perspective, both are high-barrier complex formulations, with development strategies similarly emphasizing particle size control, encapsulation efficiency/drug loading, and sterilization process validation.
Key challenges in BE studies for nano-injectables: ① Complex in vivo drug release and distribution behavior of drug-loaded lipid emulsions/liposomes — plasma concentration alone may not fully reflect bioequivalence; ② Certain products (e.g., propofol, etomidate) are anesthetic/sedative drugs, with specific ethical and operational requirements for BE study design and conduct. Key strategies to reduce BE risk: establishing reliable in vitro–in vivo correlation (IVIVC) models during the formulation development phase, combining in vitro data from multiple release conditions to predict in vivo behavior. Taikomed provides end-to-end support from pre-BE protocol design to formal BE clinical CRO coordination management.
Nano-formulation quality research requires additional focus on: ① Particle size and size distribution (PDI) — the most critical quality attribute of nano-formulations, directly impacting in vivo distribution and release behavior; ② Zeta potential — reflecting the physical stability of the dispersion system; ③ Encapsulation efficiency/drug loading — key evaluation indicators for liposomes and drug-loaded emulsions; ④ Free drug content — requiring establishment of separation methods such as ultrafiltration centrifugation/solid-phase extraction; ⑤ Pre- and post-sterilization quality attribute comparison — terminal sterilization may cause particle size growth and pH drift. Taikomed has established a systematic quality research methodology covering all the above indicators.
In CTD dossiers for complex injectables (including nano-formulations), Module 3 (Quality) requires emphasis on: ① Detailed justification of formulation composition (function and quantity basis of each excipient); ② Identification and control strategy of critical process steps and parameters (e.g., high-pressure homogenization pressure, cycle count, temperature); ③ Complete method validation of particle size methods and related substance methods; ④ Container-closure compatibility and administration device compatibility study data; ⑤ Method validation for sterility/endotoxin. Module 2 (QOS) must compellingly demonstrate comparability with the reference listed drug at the nano-structural level. Taikomed's regulatory team has deep understanding of complex injectable review focus areas.
Whether for generic drug consistency evaluation, Class 2.2 modified new drug development, or high-end complex injectables, our nano-delivery technology team is ready to provide professional technical assessment and R&D solutions.
📞 Call: +86-29-81107958 ✉️ Email Inquiry