Active Ingredients Intrinsic Dissolution Rate Kit
WHAT THE KIT DOES
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.
with any dissolution test system
air bubble accumulation
Shaft and Die Wobble associated with Wood Apparatus
potential for vessel breakage
"heat sink" effect
IN THE KIT:
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
THE KIT WORKS:
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
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.
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.
Active Ingredients Intrinsic Dissolution Rate Kit,
comprising 6 316 Stainless Steel Dies, 6 anvils (punches),
1 surface pressing plate with 3 nuts and 3 washers,
6 polypropylene "caps", 6 Viton® gaskets,
6 900ml. dissolution vessels with flat bottoms.
||Intrinsic dissolution die sets with 2 dies and 2 flat bottom beakers.
1 ton high sensitivity hydraulic press, CE marked, 57
pound shipping weight.
2 ton high sensitivity hydraulic press, CE marked, 57
pound shipping weight.