Logan PERMETRO Permeation System (Dissolution and Penetration Simulation System)
Logan Permetro In Vitro Dissolution and Biomimetic Permeation Combined System: Designed specifically for predicting and evaluating the bioequivalence (BE) of oral solid dosage forms, poorly soluble drugs, sustained-release formulations, and generic drugs. Traditional dissolution tests (USP 1/2 method) only reflect the dissolution rate of drugs in a fixed medium and cannot truly simulate the dynamic peristalsis and physiological barrier absorption mechanisms of the gastrointestinal tract. The Permetro system is the first to seamlessly connect the dissolution tank and the biomimetic membrane permeation cell, simultaneously monitoring the dynamic kinetic curves of "drug dissolution" and "membrane permeation absorption," comprehensively assisting in prescription screening and helping to reduce the risk of BE failure.
I. Patented Biomimetic Membrane: Utilizing the patented PB-m biomimetic membrane, it can withstand continuous pH transitions from 1.0 to 8.0, realistically simulating the dynamic emptying of the gastrointestinal tract and the fasting/postprandial absorption environment.
II. Patented Permetro Cell: Patented 6-core flow path and bubble-free clamp design, combined with independent dual pumps for precise speed control, maintains solvent volume stability and dynamic mass transfer balance.
III. Compatible USP 1–7 dissolution equipment: Seamlessly connect USP 1/2 (supports 6+6 comparison of original and generic drugs), USP 3/7 (multi-pH sustained-release monitoring) and USP 4 (microsphere/nano-specific formulations).
IV. Online Automated Hyperbolic Analysis: Real-time synchronous generation of dissolution and breakthrough dual kinetic curves, supporting online UV/Vis scanning, online HPLC/UPLC automatic dilution injection, or offline automatic collection.
V. Logan-ADSC Integrated Platform: A pioneering 5-in-1 platform integrating dissolution, API solubility meter, sampler, and penetration system; compliant with FDA 21 CFR Part 11 and ALCOA+ data integrity and audit tracking requirements.
Equipment Introduction
Dual-dynamic synchronous analysis: Combining the traditional pharmacopoeia dissolution method (USP Apparatus 1/2/3/4/7) with a biomimetic membrane permeation module, it breaks through the blind spots of the traditional single dissolution test and monitors the dual dynamic curves of the drug in "dissolution release" and "transmembrane absorption" in real time.
Bioequivalence (BE) and IVIVC prediction: Designed specifically for poorly soluble BCS II/IV drugs, oral solid dosage forms (OSD), sustained-release prescriptions, and novel microparticle delivery systems, providing highly correlated in vitro/in vivo absorption kinetics (IVIVC) predictions.
Patented 6-Port Permetro Cell & Biomimetic PB-m Membrane
Patented modular osmosis cell: featuring a 6-port precision flow path design (Inlet, Donor Chamber, Membrane Holder, Receptor Chamber, Sampling Port, and Outlet) to ensure hydrodynamic stability and prevent shear damage.
PB-m Bionic Artificial Membrane: Equipped with a patented bionic membrane with high chemical tolerance, it can maintain high stability for 4 to 24 hours in a wide pH range of 1.0 to 8.0 and in surfactant environments, accurately simulating the physiological environment of various segments of the gastric acid to the intestines and the eating/fasting state.
DSC-800 Intelligent Offline Autosampler Workstation
Dual-loop synchronous automatic collection: Equipped with a high-precision multi-channel syringe pump, it can automatically and accurately sample from the "donor chamber" and "receptor chamber" of the osmosis pool according to a set schedule.
Multi-sample dispensing and dilution: The sample solution can be automatically dispensed into standard test tubes or directly dispensed into HPLC/UPLC sample vials; online automatic precise dilution and secondary buffer addition are supported, saving subsequent manual sample pretreatment time.
Isothermal Media Replacement: After sampling, an equal volume of receiver solvent is automatically replaced to maintain a constant liquid level and sink condition in the osmosis system.
High-Throughput Parallel Testing & System Modularity
Multi-channel parallel comparison: Supports 8-well, 12-well or 14/15-well multi-channel dissolution analyzers used in conjunction with multiple Permetro osmosis cells, enabling high-throughput parallel screening of 6 vs 6 (original manufacturer versus generic drugs).
Full pharmacopoeia specification support: flexible tandem USP 1/2 basket/paddle method, USP 3/7 reciprocating cylinder/reciprocating rack method (enteric coating and colon-targeted release), and USP 4 flow cell method (microspheres, microliposomes, nano suspensions).
Data Integrity and 21 CFR Part 11 Compliance
Fully enclosed audit trail: The system has a built-in high-capacity, tamper-proof electronic audit trail that fully records all sampling time points, operator permissions, method parameters, and alarm history.
Fully compliant with regulations: Fully complies with FDA 21 CFR Part 11, cGMP and ALCOA+ data integrity guidelines, and provides multi-level access control (administrator/supervisor/analyst) and electronic signature authentication mechanisms.
Product Features
Patented biomimetic permeation cell and resistant membrane (PB-m)
6 vs 6 parallel alignment
Compatible USP 1-7
Fully automated dual-loop sampling
Online dilution
Overall Specifications
System composition and architecture configuration:
An integrated offline automated biomimetic osmosis analysis platform, standard configuration includes:
Front-end dissolution drive unit (compatible with USP Apparatus 1 / 2 / 3 / 4 / 7)
Patented Permetro 6-port Flowing Osmosis Cell Module (Donor Chamber + Recipient Chamber)
DSC-800 Intelligent Microcomputer Sampling Control Workstation
High-precision multi-channel bidirectional push-pull injection sampling pump system
Fully automated sample collection and dilution tray for test tubes/HPLC/UPLC
Channel and permeation groove configuration:
Standard configuration supports simultaneous parallel operation of 6, 8, 12, or 14 Permetro penetration modules.
Supports 6 vs 6 dual-region independent parallel comparison trials (simultaneous release/osmotic dynamics evaluation of 6 groups of original drug RLD vs 6 groups of test generic drug prescriptions)
Patented Permetro Osmosis Cell Specifications:
Modular 6-port flow path architecture: featuring a donor inlet, a donor outlet, a donor port, a receiver inlet, a receiver outlet, and a receiver port.
Micro-donor/receptor volume: The receptor chamber features an extremely small dead volume and low adsorption design to maintain high-sensitivity transmembrane accumulation concentration.
Fluid dynamics optimization: Low internal flow resistance and vortex-free flow channels ensure uniform shear force on the membrane surface and eliminate deposition dead zones and bubble residue.
Biomimetic artificial membrane (PB-m) specifications:
Membrane material characteristics: Patented polymer composite biomimetic membrane (PB-m), mimicking the lipid bilayer and hydrophilic/hydrophobic permeability barrier of human intestinal epithelial cells.
Chemical and pH tolerance: Excellent chemical stability, tolerant of a wide pH range of 1.0–8.0; highly tolerant of surfactants such as SLS, Tween-80, and CTAB, as well as high-viscosity biochemical gastrointestinal media (such as FaSSIF/FeSSIF).
Membrane stability and lifespan: The membrane structure can remain stable for more than 4–24 hours without denaturation or perforation during continuous immersion testing, meeting the requirements for long-acting sustained-release and colon-targeted formulation tests.
Sampling and flow path drive specifications:
Drive mechanism: Employs an industrial-grade, high-precision, multi-channel syringe pump.
Dual-loop synchronous sampling: Supports simultaneous bidirectional sampling from the donor and recipient chambers, with independent piping design to avoid cross-contamination.
Sampling accuracy: Sampling volume range 0.1 mL to 10.0 mL, volume accuracy up to 1% per millimeter.
Isothermal Media Replacement: After sampling, an equal volume and temperature of receiver solvent is automatically and synchronously replenished to maintain a constant liquid level and sink condition.
Online automatic dilution and preprocessing functions:
Built-in high-precision online dilution function, supporting programmable and variable dilution ratios from 1:1 to 1:100.
It supports automatic quantitative addition of secondary buffer and bubble mixing and shaking, allowing samples to be directly dispensed into HPLC/UPLC sample vials for direct injection.
Compatibility of dissolution host and method:
USP 1/2 (Basket Method/Oar Method): Compatible with various dissolution tank models (8/12 baths) for standard solid preparations 4-to-4 or 6-to-6 dissolution and permeation monitoring.
USP 3/7 (Reciprocating cylinder method/Reciprocating rack method): Used with various USP3/7 systems for pH gradient transfer and colonic targeted release osmosis.
USP 4 (Flow-through Cell Method): Used in conjunction with various USP4 systems for continuous flow osmosis analysis of microspheres, liposomes, implants, and nano suspensions.
Temperature control accuracy:
The entire system features an independent constant-temperature water bath jacket and flow path insulation design.
Temperature control range: room temperature to 45.0 °C (expandable to 60.0 °C), measured temperature difference between each tank in the infiltration pool is 0.2 °C, supports real-time temperature sensing and over-temperature alarm.
Sampling point quantity and method storage:
Sampling schedule: A single test method can customize up to 20-30 independent sampling time points (supports irregular long-term segment settings).
Method storage: The system can store more than 100 linear/multi-stage penetration test methods.
Sample rack and collection tray specifications:
Standard configuration includes a high-throughput sample collection rack, supporting standard glass tube racks (10×16 mm) and 2 mL / 1.5 mL HPLC/UPLC standard sample vial racks.
Supports optional dual-layer sample trays (for independent sample collection of donor/receptor areas) and low-temperature cooled sample trays (to prevent degradation of photosensitive/thermal APIs).
Data integrity and regulatory compliance:
Regulatory Compliance: Fully compliant with FDA 21 CFR Part 11, cGMP, GLP, and ALCOA+ data integrity guidelines.
Security and Auditing: Built-in tamper-proof electronic audit trail with a capacity of 3 million records (5-7 years without overwriting).
Access Control: 4-level user access control (system administrator, supervisor, operations analyst, visitor), supporting over 100 independent accounts and password expiration security policies.