RYJ-12B Transdermal Diffusion Tester – In-Vitro Skin Absorption Testing Instrument

Pharmaceutical Transdermal Diffusion Instruments

RYJ-12B Pharmaceutical Transdermal Diffusion Tester

The RYJ-12B Transdermal Diffusion Tester is a specialized pharmaceutical testing instrument designed to perform in-vitro transdermal drug delivery testing.

Utilizing a precision-controlled system and Franz diffusion cells, this device simulates skin absorption of topical or transdermal drug formulations under laboratory conditions.

The RYJ-12B is widely used in pharmaceutical R&D, formulation screening, and bioequivalence studies, ensuring reproducibility and compliance with international research standards.

As a core part of our pharmaceutical testing instruments lineup, the RYJ-12B helps pharmaceutical scientists evaluate drug release profiles and optimize transdermal delivery systems.

Description

The RYJ-12B Pharmaceutical Transdermal Diffusion Tester is a collaborative product developed with the National Pharmaceutical Engineering Research Center (NPERC). It adopts an improved vertical Franz diffusion cell structure, where the film is clamped between the donor chamber lid (donor) and the receptor chamber (receptor). The inner surface of the film is immersed in a solution in the receptor chamber under conditions of constant temperature water bath circulation. With precise agitation, it ensures uniform distribution of the medium, simulating the drug’s transdermal penetration and release processes through biological membranes or artificial membranes.

 

Product Features

   •  Innovative Franz Cell Design: Features 12 independently improved vertical Franz diffusion cells.

   •  Magnetic Stirring Mechanism: Stable and uniform agitation ensures consistent dissolution concentration distribution.

   •  Precise Flow System: Proprietary design guarantees uniformity in the diffusion medium circulation.

   •  Temperature Insulation: Ensures stable minimum temperature deviation during tests.

   •  Comprehensive Data Export: Equipped with USB ports for exporting test records.

   •  User-Friendly Interface: Features a touch-screen interface supporting both English and Chinese operations for enhanced usability.

 

Technical Specifications

 

l   Model    RYJ-12B

l   Product Code      10110100

l   Number of Diffusion Cells  12 groups

l   Volume of Diffusion Cells  8mL

l   Diffusion Area      Approx. 2.2cm²

l   Stirring Speed Range 100–800RPM

l   Speed Stability Deviation  ≤±1%

l   Temperature Range   Room temperature to 45°C

l   Temperature Resolution    0.1°C

l   Temperature Accuracy     ≤±0.3°C

l   Sample Collection Count ≤15 times

l   Sample Collection Timing ≤9999 minutes

l   Power Supply       AC220V±10%, 50Hz

🛡️ Safety Standard: Engineered to meet Class I Div 1 / ATEX explosion-proof standards, ensuring safe handling of volatile transdermal solvents.

---

Frequently Asked Questions

Q: What is the regulatory pathway for transdermal patch approval?

A: In the US, transdermal patches are regulated as drug products under FDA 21 CFR Parts 210/211. New patches typically require an ANDA (for generic) or NDA (for novel formulations). Key dossier requirements include in vitro permeation testing (IVPT) data using Franz diffusion cells (USP <724>), comparative adhesion studies, and stability data at ICH conditions. The RYJ-12B Franz Cell Tester generates the IVPT data required for regulatory submissions, using 12-cup vertical diffusion geometry conforming to FDA guidance. Contact us for pricing.

Q: What is in vitro permeation testing (IVPT) and why is it required?

A: IVPT measures the rate and cumulative amount of API that permeates through a membrane (synthetic or excised skin) over time, using a Franz diffusion cell setup. For transdermal patches, IVPT data: (1) establishes in vitro release specifications for batch release; (2) supports bioequivalence claims for generic patches; (3) monitors manufacturing consistency batch-to-batch. FDA's 2022 draft guidance on topical drug bioavailability recommends IVPT as the primary method for many dermatological products. The RYJ-12B supports 12 parallel diffusion cells with temperature-controlled receptor compartments (37°C ± 0.5°C).

Q: How does solvent-based ODF production differ from hot-melt extrusion (HME)?

A: Solvent-based casting (used by Huanghai MJ150/MJF180 systems) dissolves API in a polymer solution, spreads it onto a release liner, and dries off the solvent. This enables higher drug loading, better uniformity for viscous APIs, and broader polymer compatibility. HME processes API and polymers at elevated temperatures—suitable only for thermostable APIs. Solvent-based systems require solvent management infrastructure (Class I/II classified areas, explosion-proof equipment, solvent recovery), while HME avoids this. For most pharmaceutical and nutraceutical ODF applications, solvent-based casting remains the preferred method due to formulation flexibility.

Q: What room classification is required for ODF/transdermal patch manufacturing?

A: For pharmaceutical ODF manufacturing using organic solvents (ethanol, acetone, IPA), the production area requires Class I Division 1 or 2 (NEC) electrical classification (equivalent to ATEX Zone 1 in Europe). Air handling must provide minimum 10 ACH with 100% exhaust (no recirculation), continuous LEL monitoring, and explosion-proof lighting/electrical. Huanghai MJ150/MJF180 machines are designed for installation in classified solvent areas and comply with relevant explosion protection standards. Contact us for site preparation requirements documentation.