Comparison of the flow properties of aqueous suspension corticosteroid nasal sprays under differing sampling conditions.
Many aqueous suspension corticosteroid nasal sprays become less viscous when shaken and sprayed, then return to a more viscous state after application. This time-dependent, reversible loss of viscosity under shear (e.g., shaking or spraying) can be quantified in the rheological property of thixotropy. The flow properties of 5 corticosteroid nasal sprays were measured over a range of shear rates. The formulations tested included Nasonex, Vancenase AQ, Nasacort AQ, Rhinocort Aqua, and Flonase. The yield stress values, as well as an estimate of thixotropy, were compared by using three different sampling techniques, including one that simulated patient use (shaking for 30 sec, spraying, and immediately transferring the sample to the rheometer). The rheological properties of all products indicated that when initially shaken and dispensed, they flowed more freely, followed by recovery of viscosity that would likely inhibit the suspensions from flowing out of the nasal cavity. Under all three tested conditions, Nasonex exhibited the highest yield stress, the largest apparent initial and final viscosities, and the highest apparent thixotropy. The study protocol that simulated patient-use conditions produced the following rank order of measured thixotropy: Nasonex > Flonase > Vancenase AQ > Rhinocort Aqua > Nasacort AQ. The thixotropy of Nasonex was 3.4 to 21.4 times greater and the final viscosity was 3.2 to 17.4 times greater than the values of the other tested products.
Sharpe
S A
SA
Schering-Plough Research Institute, Kenilworth, New Jersey 07033-0530, USA. stefan.sharpe@spcorp.com
Sandweiss
V
V
Tuazon
J
J
Giordano
M
M
Witchey-Lakshmanan
L
L
Hart
J
J
Sequeira
J
J
D000281:Administration, Intranasal; D000305:Adrenal Cortex Hormones / Q000032:analysis / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D033081:Shear Strength; D013535:Suspensions; D014783:Viscosity; D014867:Water / Q000737:chemistry*
D000305:Adrenal Cortex Hormones; D013535:Suspensions; D014867:Water