Pharmaceutical Active Ingredients Intrinsic Dissolution Rate Kit
(Patent Pending)

WHAT THE KIT DOES

ICL’s new dissolution kit enables testing of the intrinsic dissolution rate of active pharmaceutical ingredients. 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 bio-physical conditions.

FEATURES:

• Easy to Use
• Use with any dissolution test system
  
• Prevents air bubble accumulation
  
• Eliminates Shaft and Die Wobble associated with Wood Apparatus
  
• Reduces potential for vessel breakage
• Eliminates "heat sink" effect

WHAT’S IN THE KIT:

The kit is available with a 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 ( see technical data to compute actual pressure on a 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. The kit can be used with all dissolution apparatus, such as Distek equipment. The kit comprises six (6) complete 316 Stainless Steel dies and six (6) 900 ml. flat bottom dissolution vessels and, if specified, the optional 1 or 2 ton hydraulic press. The hydraulic press weighs a mere 51 pounds and has a small footprint, making it ideal for lab use.

HOW THE KIT 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, 0.5cm² 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 900 ml of dissolution medium at 37°C. The USP Apparatus II paddle is positioned one (1) inch above the die and rotated at 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.