LOGAN PERMETRO 800 Eight-Station Dissolution-Permeation System

Overview

The LOGAN PERMETRO 800 is an integrated, eight-station online dissolution-permeation system engineered for rigorous pharmaceutical quality assessment in support of bioequivalence (BE) studies and regulatory submissions. Unlike conventional dissolution testers, the PERMETRO 800 combines standardized USP Apparatus 2 (paddle) or Apparatus 1 (basket) dissolution testing with a physiologically relevant permeation module—enabling simultaneous quantification of drug release kinetics and membrane transport behavior under controlled hydrodynamic and thermal conditions. The system operates on the principle of coupled mass transfer: dissolution profiles are generated in USP-compliant vessels while permeation across a biomimetic membrane (e.g., PAMPA, Caco-2 monolayers, or excised intestinal tissue) is monitored in real time or via discrete fraction collection. This dual-parameter output—dissolution rate and apparent permeability coefficient (P_app)—provides mechanistic insight into formulation-dependent absorption barriers, supporting root-cause analysis during generic development and QbD-based process optimization.

Key Features

• Eight independent dissolution stations with synchronized temperature control (20–60 °C, ±0.1 °C accuracy) and precise rotational actuation (25–250 rpm, ±1 rpm tolerance), compliant with USP & Ph. Eur. requirements for apparatus calibration.
• Dual-pump architecture: segregated peristaltic pumps for dissolution sampling and permeation sampling—minimizing cross-contamination and enabling staggered or concurrent collection schedules across both modules.
• Biomimetic permeation chamber compatible with standard artificial membranes (e.g., PAMPA lipid formulations) and biological monolayers; designed for low-volume donor/acceptor compartments and laminar flow conditions to ensure reproducible diffusion gradients.
• Dry-heating thermal management eliminates water bath maintenance overhead and simplifies cleaning of vessel holders, paddle shafts, and permeation cell assemblies—critical for GLP-compliant lab environments.
• Modular mechanical design supports seamless integration with HPLC/UHPLC autosamplers via standardized tubing interfaces and programmable fraction triggers, enabling automated offline or online analytical workflows.
• Robust mechanical alignment: paddle wobble ≤0.5 mm and basket wobble ≤1.0 mm meet USP mechanical verification criteria, ensuring hydrodynamic consistency across all eight positions.

Sample Compatibility & Compliance

The PERMETRO 800 accommodates solid oral dosage forms—including immediate-release tablets, modified-release capsules, and multiparticulates—across all eight vessels. Its permeation module accepts standard 24-well or 96-well plate formats for membrane inserts, facilitating high-throughput screening of formulation variants. The system complies with key regulatory expectations for dissolution method validation (ICH Q5A, Q5C) and supports audit-ready documentation for FDA 21 CFR Part 11, EU Annex 11, and WHO TRS 1019 compliance when paired with validated software. All thermal and rotational performance data are traceable to NIST-calibrated references, and mechanical verification reports align with USP , , and .

Software & Data Management

Control and data acquisition are managed via LOGAN’s proprietary PC-based software, which provides time-synchronized logging of dissolution concentration, permeation flux, temperature, rotation speed, and sampling events. The software generates raw absorbance or peak-area datasets exportable in CSV and ASCII formats for statistical analysis (e.g., f2 similarity factor, P_app regression, Weibull modeling). Audit trails record user actions, parameter changes, and system alerts with timestamped metadata. Optional electronic signature modules support 21 CFR Part 11 compliance, including role-based access control, password policies, and immutable log archiving.

Applications

• Comparative dissolution-permeation profiling of generic versus reference listed drugs (RLDs) to identify formulation-related absorption limitations prior to BE studies.
• Early-stage screening of excipient effects on membrane permeability and supersaturation stability.
• Supporting biowaiver justification under ICH M9 for BCS Class II and III compounds where dissolution-permeation correlation is demonstrated.
• QbD-driven formulation development: linking critical material attributes (CMAs) and critical process parameters (CPPs) to dissolution rate and P_app outputs.
• Regulatory submission packages for ANDAs, DMFs, and pediatric formulation dossiers requiring mechanistic absorption evidence.

FAQ

Is the PERMETRO 800 compliant with USP dissolution apparatus standards?
Yes—the system meets mechanical verification requirements for USP Apparatus 1 (basket) and Apparatus 2 (paddle), including dimensional tolerances, wobble limits, and rotational accuracy.
Can the permeation module be used with live cell monolayers such as Caco-2?
Yes—the chamber design accommodates Transwell®-compatible inserts and maintains physiological temperature and CO₂-buffered media compatibility when external incubation support is provided.
Does the system support automated fraction injection into HPLC systems?
Yes—via TTL-triggered fraction collection and optional HPLC interface kits, enabling direct injection without manual handling.
What calibration documentation is provided with the instrument?
Each unit ships with a factory calibration certificate covering temperature sensors, rotational encoders, and pump flow rates, traceable to NIST standards.
Is remote monitoring or networked operation supported?
The control software operates on Windows-based PCs with Ethernet connectivity; remote desktop access is permitted within secure institutional networks, though no native cloud interface is included.