Automatic dissolution testing for sustained release dosage forms
Effortlessly simulate pH changes for accurate dissolution testing of extended and sustained release dosage forms, ensuring precise in vivo conditions for reliable drug release profiling.
Simulates Gastrointestinal pH Conditions for Tablet Dissolution
The BioDis RRT 10 from ERWEKA is a precision dissolution tester designed for the pharmaceutical and biotech industries, specializing in the analysis of extended and sustained release dosage forms. This equipment is distinguished by its capability to precisely simulate the varying pH conditions of the human gastrointestinal tract, facilitating accurate testing and profiling of tablets, coated tablets, and nutraceuticals. Featuring an external flow-through heater, it ensures minimal vibration and a constant temperature, enhancing test consistency. The modular system operates with adjustable speeds and includes an automated sample transport mechanism for seamless testing across various media pH zones. Its compliance with USP, EP, and JP standards makes it ideal for R&D and quality control environments focused on meeting strict regulatory requirements. With the option for configurations involving USP methods 3 and 7, and customizable vessel sizes ranging from 50 ml to 1000 ml, the BioDis RRT 10 offers the flexibility to meet diverse testing needs. A user-friendly touch display and automated vessel cover system reduce media evaporation and simplify operation and maintenance, making it a versatile solution for modern laboratories.
Benefits
- Enhances test accuracy by simulating real gastrointestinal pH conditions.
- Simplifies operation with intuitive touch control, reducing training time.
- Ensures regulatory compliance with full USP, EP, and JP standard adherence.
- Increases testing flexibility with multiple configurable vessel sizes and methods.
- Minimizes media evaporation and maintenance needs with automated covers.
- Applications
- Coated tablets,Pharmaceutical tablets,Extended release dosage forms,Nutraceuticals,Sustained release dosage forms,Pharmaceutical powders
- End products
- Metformin extended release,Ibuprofen sustained release,Vitamin c powder,Enteric-coated acetaminophen tablets,Omega-3 supplements,Aspirin tablets
- Steps before
- Media Preparation,Dissolution Software Configuration,Sample Loading
- Steps after
- Dissolution Profiling Analysis,Data Evaluation,Document Generation
- Input ingredients
- extended release dosage forms,sustained release dosage forms,different media,tablets,coated tablets,oblongs
- Output ingredients
- dissolution profiles,IV/IVC testing results,release profiles in various pH zones
- Market info
- ERWEKA is renowned for manufacturing high-quality pharmaceutical testing equipment, including dissolution testers, tablet hardness testers, and other analytical instruments, known for their precision and reliability in laboratory testing environments.
- Speed
- 5–40 strokes/min,accuracy better than ±5%
- Capacity
- 30 liters water bath
- Temperature Accuracy
- ±0.2° C
- Vessel Sizes
- 50 ml,100 ml,300 ml,1000 ml
- Stroke Height USP 3
- 100 mm
- Stroke Height USP 7
- 20 mm
- Heating Rate
- 1500 W,30-50° C
- Control
- Color touch screen,password-protected
- Automation
- Automated vessel cover,automated sample transport
- Material
- Stainless steel screens,PTFE holders
- Automation level
- Manual / PLC
- Batch vs. continuous operation
- Batch
- CIP/SIP
- CIP 121°C
- Cleaning method
- CIP
- Cleanability
- Automated vessel cover to reduce media evaporation
- Corrosive resistance (e.g. acids)
- Stainless steel
- Density/particle size
- 50 ml,100 ml,300 ml,1000 ml vessels
- USP Compliance
- Yes
- EP Compliance
- Yes
- JP Compliance
- Yes
- Vessel Size
- 50 ml,100 ml,300 ml,1000 ml
- Vessel Type
- Cylindrical Flat Bottomed Glass
- Valve Type
- Outlet valve for cleaning
- Number of Rows
- 8 rows
- Number of Stations
- 6 stations (standard configuration),7 test stations
- Water Bath Capacity
- 30 liters
- Material
- Acrylic glass,stainless steel
- Heater
- External flow-through heater
- Touch Screen
- Portable touch display