English Product Name

Overview

The Dolomite Drug Encapsulation System for PLGA Nanoparticles is a benchtop microfluidic platform engineered for the reproducible, continuous-flow synthesis of monodisperse poly(lactic-co-glycolic acid) (PLGA) nanoparticles. It operates on the principle of hydrodynamic flow focusing and controlled interfacial polymer precipitation—enabling precise spatiotemporal control over nanoparticle nucleation, growth, and drug incorporation. Unlike bulk emulsification or solvent evaporation methods, this system generates particles with deterministic size, narrow polydispersity index (PDI < 0.05), and highly uniform drug loading—critical parameters for regulatory compliance, pharmacokinetic predictability, and scalable GMP-aligned process development. The platform is designed for early-stage formulation screening, dose optimization, and translational research in oncology, neurology, and regenerative medicine.

Key Features

• Continuous-flow microfluidic architecture enabling real-time process control and scalability from µg to mg/day output
• Monodisperse particle generation with coefficient of variation (CV) ≤ 5% across batch-to-batch runs
• Adjustable particle diameter range: 80 nm to 500 nm—tunable via flow rate ratio, total flow rate, and PLGA concentration
• Integrated solvent-compatible fluid handling: compatible with dichloromethane (DCM), ethyl acetate, and acetonitrile-based organic phases
• Chip-based design eliminates cross-contamination; single-use chips ensure assay integrity and reduce cleaning validation burden
• Modular pump interface supporting syringe pumps with ±0.5% volumetric accuracy and sub-µL/min resolution

Sample Compatibility & Compliance

The system accommodates a broad spectrum of active pharmaceutical ingredients (APIs), including hydrophobic small molecules (e.g., paclitaxel, camptothecin), hydrophilic biologics (e.g., insulin, lysozyme), and nucleic acid therapeutics (e.g., siRNA, antisense oligonucleotides). PLGA molecular weight (5–100 kDa) and lactide:glycolide ratios (50:50 to 85:15) are fully configurable to modulate degradation kinetics and release profiles. All chip materials comply with USP Class VI and ISO 10993-5 cytotoxicity standards. The platform supports documentation workflows aligned with GLP and early-phase GMP environments—including audit trails for flow parameter logging, chip lot traceability, and environmental condition monitoring (temperature, humidity).

Software & Data Management

The system operates via Dolomite’s proprietary control software, which provides synchronized pump sequencing, real-time flow visualization (via optional integrated high-speed imaging), and automated protocol storage. All experimental metadata—including flow rates, solvent composition, temperature setpoints, and chip identification—are timestamped and exportable in CSV/JSON format. Software architecture supports 21 CFR Part 11-compliant user access controls (role-based permissions, electronic signatures) when deployed in regulated laboratories. Data exports integrate seamlessly with LIMS platforms and statistical process control (SPC) tools for DOE-driven formulation optimization.

Applications

• Rapid screening of PLGA formulation parameters (polymer MW, LA:GA ratio, PVA stabilizer concentration)
• Development of sustained-release injectables meeting USP and FDA guidance on nanosuspensions
• Encapsulation efficiency quantification (up to 95% for model compounds such as fluorescein isothiocyanate–dextran)
• Co-encapsulation of multiple payloads (e.g., chemotherapeutic + immune adjuvant) with spatial segregation control
• Preclinical PK/PD correlation studies requiring low inter-batch variability in particle size and drug release kinetics

FAQ

Is the system compatible with sterile processing?

Yes—chip mounting hardware and fluid paths support aseptic assembly under laminar flow hoods; optional gamma-sterilized chip kits are available.

Can I use my own PLGA or API formulations?

Absolutely—the system imposes no proprietary reagent constraints; users retain full control over polymer source, solvent selection, and surfactant chemistry.

What level of technical support does Dolomite provide?

Dolomite offers application-specific protocol development, on-site installation qualification (IQ), and remote troubleshooting with SLA-backed response times under annual service agreements.

Does the system meet regulatory requirements for IND-enabling studies?

While not a GMP manufacturing system, its design, documentation, and data integrity features align with ICH M3(R2) and FDA’s “Quality by Design” principles for early-phase nanomedicine development.