Creating consistent testing protocols for nanocrystalline drugs has been a challenge, primarily because these drugs can take various forms and may need to mimic administration methods beyond traditional oral solid doses.
One of the preferred methods involves using "closed dialysis membrane bags" to contain the nanocrystals while the release media is agitated around the membrane. Technical challenges remain with this approach, including membrane blinding and leakage from the bag. So far, there hasn't been a specific, commercially available device that can seamlessly integrate this method into a standard dissolution apparatus and workflow.
To address this issue, Logan Instruments Corporation has developed a purpose-designed device that enables the use of the dialysis membrane method within a reciprocating flow-through cell apparatus. This innovative device consists of a frame that supports a dialysis membrane, and users can select the most suitable membrane depending on the specific drug formulation. The membrane is securely attached to the frame using O-rings, ensuring a reliable and efficient solution for assessing the release of nanocrystalline drugs.
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