A New Automatic Solution for the “Half-Change” Test of Delayed Release Dosage Forms
A New Automatic Solution for the “Half-Change” Test of Delayed Release Dosage Forms
The PTWS 820-MA is the first dissolution testing instrument with a media addition system from Pharma Test which is used for the testing of delayed release dosage forms. It can automatically dose 250 ml of preheated concentrated buffer solutions quickly and simultaneously into all vessels. The operation is fully compliant to USP, EP and CP dissolution procedures for delayed release dosage forms. The new system combined with the highly advanced, user-friendly and fully 21 CFR part 11 compliant WinDiss ARGUS dissolution software ensures a comfortable automatic and unattended addition of media. Additional requirements for data integrity are fulfilled.
Current Challenges Without a Media Addition System
The buffer change is usually done manually using cylinders with pre-heated buffer solution since USP, CP and EP recommend to perform the media change quickly. The main problems for the manual operation are:
- Adding of buffer solutions simultaneously to all vessels is not possible
- It is almost impossible to keep the temperature in the cylinders at a constant 37°C
- The media addition is done in a non-reproducible way and could differ from one vessel to the next
- An employee needs to wait 2h for the media change, needs to pre-heat the media and add the buffer to the vessels one by one
The PTWS 820-MA with Media Addition System is the New Automatic Solution
The PTWS 820-MA with Media Addition System combined with the highly advanced, user-friendly and fully 21 CFR part 11 compliant WinDiss ARGUS dissolution software solves all these challenges of the buffer change and can ensure a comfortable automated and unattended addition of media. The operation is fully compliant to USP, CP and EP dissolution procedures for delayed release dosage forms. It can automatically dose 250 ml of preheated concentrated buffer solutions quickly and simultaneously into all vessels.
Availability and Compatibility
The PTWS 820-MA consists of the PTWS 820 8-position USP/EP dissolution testing instrument with a media addition system for a simultaneous filling of all 8 vessels. The new system is available for test trials and sale through the Pharma Test distribution network. An upgrade for existing PTWS 820 is also possible. For more information please feel free to contact us.
PTWS 820-MA
8-Position USP/EP Tablet Dissolution Testing Instrument with Media Addition Station
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