title: Effects of Pump Pulsation on Hydrodynamic Properties and Dissolution Profiles in Flow-Through Dissolution Systems (USP 4).
abstract: To clarify the effects of pump pulsation and flow-through cell (FTC) dissolution system settings on the hydrodynamic properties and dissolution profiles of model formulations.
  
  
  
  Two FTC systems with different cell temperature control mechanisms were used. Particle image velocimetry (PIV) was used to analyze the hydrodynamic properties of test solutions in the flow-through dissolution test cell. Two pulsation pumps (semi-sine, full-sine) and a non-pulsatile pump were used to study the effects of varied flows on the dissolution profiles of United States Pharmacopeia standard tablets.
  
  
  
  PIV analysis showed periodic changes in the aligned upward fluid flow throughout the dissolution cell that was designed to reduce the temperature gradient during pump pulsation (0.5 s/pulse). The maximum instantaneous flow from the semi-sine pump was higher than that of the full-sine pump under all conditions. The flow from the semi-sine wave pump showed faster dissolution of salicylic acid and prednisone tablets than those from other pumps. The semi-sine wave pump flow showed similar dissolution profiles in the two FTC systems.
  
  
  
  Variations in instantaneous fluid flow caused by pump pulsation that meets the requirements of pharmacopoeias are a factor that affects the dissolution profiles of tablets in FTC systems.
authors: Division of Drugs, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan. h.yoshida@nihs.go.jp.
authors: Hiroyuki
authors: H
authors: Yoshida
authors: Division of Drugs, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan.
authors: Akemi
authors: A
authors: Kuwana
authors: Division of Drugs, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan.
authors: Hiroko
authors: H
authors: Shibata
authors: Division of Drugs, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan.
authors: Ken-Ichi
authors: K
authors: Izutsu
authors: Division of Drugs, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan.
authors: Yukihiro
authors: Y
authors: Goda
mesh_terms: D004867:Equipment Design; D057446:Hydrodynamics; D007700:Kinetics; D011673:Pulsatile Flow; D012212:Rheology; D020156:Salicylic Acid / Q000737:chemistry*; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000295:instrumentation* / Q000379:methods; D013696:Temperature
chemical_list: D013607:Tablets; D020156:Salicylic Acid
keywords: dissolution testing; flow-through cell system; hydrodynamics; pulsatile pump