Topical Metered-dosing Dispenser Performance Evaluation.
Topical metered-dosing dispensers are designed for dosing accuracy and ease-of-use by the patients while protecting the packaged products from environmental exposure and contamination. The objective of this study was to evaluate the accuracy, precision, and residual of available topical metered-dosing dispensers with different types of topical cream for practical application. Triplicate samples of five different dispensers were tested. This test was completed using three types of commercial topical cream-bases of dissimilar Total Active Pharmaceutical Ingredient Load Percentages, Transdermal Penetration Percentages, and Specific Gravities. The dispensers were evaluated according to specified dose-uniformity criteria for a total dispensing capacity of 30 mL at 0.5 mL per dose for 60 doses. The study shows Topi-CLICK performed with the best precision and accuracy of dosing in comparison to the airless-pump type dispensers. While the dispensing was highly variable with airless pumps and may require calibration for each packaged product, remarkably the performance of Topi-CLICK was not affected by different types of cream-bases and does not require additional metering calibration.
Analytical Research Laboratories Inc., Oklahoma City, Oklahoma.
Qiang
Q
Liu
Analytical Research Laboratories Inc., Oklahoma City, Oklahoma.
Thomas C
TC
Kupiec
Analytical Research Laboratories Inc., Oklahoma City, Oklahoma. nvu@arlok.com.
Nicole T
NT
Vu
D000287:Administration, Topical; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*
D004364:Pharmaceutical Preparations