Is the use of a 200 ml vessel suitable for dissolution of low dose drug products?
This work evaluated the use of a commercially available 200 ml vessel for dissolution of five drug products with various solubilities. Each of the five drug products (four with USP monographs and one proprietary tablet formulation) was run at four different conditions (USP 25 monograph, six dosage units in single 1l vessel, 200 ml at the USP Monograph speed, and 200 ml at calculated paddle speed which matches the hydrodynamics of the USP vessel). Six dosage units in a single vessel were used as a comparison to increase the drug concentration for dissolution testing. Due to the different dissolution hydrodynamics, drug dissolution from the dosage forms was slower using the 200 ml conversion kit than when the USP method with a 1l vessel was used. However, use of the 200 ml vessel at higher paddle speeds calculated by the power/volume equation, yielded similar results as the monograph method. Thus, it appears that using the power/volume ratio calculation to obtain comparable hydrodynamics lends utility to the 200 ml vessel as a means for characterizing the dissolution profile of low dose solid oral drug products. The results of the multiple dosage units per vessel also gave similar results to that of the USP monograph method.
Crail
Debbie J
DJ
Procter & Gamble Pharmaceuticals, 8700 Mason Montgomery Road, Mason, OH 45040, USA. crail.dj@pg.com
Tunis
Adam
A
Dansereau
Richard
R
D002214:Capsules; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation; D002851:Chromatography, High Pressure Liquid; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D019999:Pharmaceutical Solutions / Q000737:chemistry; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000295:instrumentation*; D013997:Time Factors
D002214:Capsules; D004364:Pharmaceutical Preparations; D019999:Pharmaceutical Solutions; D013607:Tablets