N/A The intrinsic dissolution rate of the active pharmaceutical ingredients is measured to depict the dissolution rate of a drug and determine its batch to batch chemical equivalence. The intrinsic dissolution rate is the rate of dissolution of pure pharmaceutical ingredients when conditions such as surface area, agitation or stirring speed, pH and ionic strength of the dissolution medium are held constant. The determination of this parameter allows labs to screen experimental drug formulations and to understand their behavior under different biophysical conditions. The kit is available with an optional high sensitivity, low pressure hydraulic press with either a 2 ton or 1 ton capacity. At 600 pounds of force on the press ram, sufficient pressure is applied to the 8mm anvil of the die set to apply the requisite 2000 psi of force on the sample. A standard 12 ton KBr pellet press does not have the sensitivity at low load to allow the user to accurately gauge the lower force levels required for intrinsic ingredients dissolution testing. How it works: The active pharmaceutical ingredients are placed in the 8mm bore of the die and compressed between an 8mm anvil and a base plate using a hydraulic press. The base plate is positioned using 3 pins. Pressure is held for 4-5 minutes at 2000psi. The die has a Viton cap which allows it to be dropped into a glass dissolution vessel without fear of breakage. When the die is disassembled, 0.5 cm2 of the active ingredient sample is exposed in the aperture of the die in which it was compressed. The entire top section of the die containing the sample is dropped, Viton cap down and sample up, onto the flat bottom of the dissolution vessel containing 900ml of dissolution medium at 37°C. The USP Apparatus II paddle is positioned one (1) inch above the die and rotated 50 rpm. Aliquots of media can be removed at timed intervals using an auto sampler and the bath can be interfaced for on-line analysis with a UV-VIS spectrophotometer.
Intrinsic Ingredients Dissolution Apparatus Kit, comprising (2) 316 Stainless Steel dies, 6 anvils (punches), 1 surface pressing plate with 3 nuts and 3 washers, 2 polypropylene "caps", 2 Viton gaskets, (2) 900ml dissolution vessels with flat bottoms. ICL's new dissolution kit enables testing of the intrinsic dissolution rate of active pharmaceutical ingredients.
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