A New Automatic Solution for the “Half-Change” Test of Delayed Release Dosage Forms from Pharma Test
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.
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 as follows:
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 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.
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