Dissolution testing of a poorly soluble compound using the flow-through cell dissolution apparatus.
Dissolution of Pfizer Compound PD198306, a poorly soluble compound, was studied in 25 mM pH 9 sodium phosphate solution with 0.5% SLS using the flow-through cell dissolution apparatus. Unmicronized and micronized drug powders were tested. Several methods of loading the drug powder into the flow-through dissolution cells and their impact on dissolution were investigated. The influence of flow rate of the dissolution medium on the rate and extent of dissolution were studied. PD198306 has poor wettability even in the presence of 0.5% SLS. It was found that loading the drug powder into the dissolution cell in the form of a suspension provided the best dissolution profile in terms of the rate and extent of dissolution. The flow rate of 4 ml/min resulted in good particle size discrimination.
Bhattachar
Shobha N
SN
Pfizer Global R&D, 2800 Plymouth Road, Ann Arbor, MI 48105, USA. shobha.bhattachar@pfizer.com
Wesley
James A
JA
Fioritto
Ann
A
Martin
Peter J
PJ
Babu
Suresh R
SR
D005434:Flow Cytometry / Q000295:instrumentation* / Q000379:methods; D004364:Pharmaceutical Preparations / Q000737:chemistry; D011208:Powders; D012995:Solubility
D004364:Pharmaceutical Preparations; D011208:Powders