ブリモニジン酒石酸塩点眼液の先発医薬品・後発医薬品の物性および使用性に関する製剤評価

抄録

Brimonidine tartrate, an ophthalmic solution used for glaucoma treatment, is marketed under the brand name Aiphagan^® and is available in generic form. In this study, we evaluated the physical properties and usability of Aiphagan^® and five other generic products to assist pharmacists in selecting the optimal solution for their patients. The pH and viscosity of the solution were measured. Additionally, the total number of drops per product, average drop weight, and squeeze force required to expel a drop were measured using a digital force gauge. Additionally, a colorimeter was used to measure the differences in bottle-nozzle color and a questionnaire on usability was administered to 45 healthy subjects. Although the solutions had comparable pH and osmotic pressure, viscosity differed among the products. Variations were also observed in the total number of drops per product, individual drop weight, and squeeze force required to expel a drop. All six products received high ratings for usability, with the most highly rated characteristics being ease of opening the cap, ease of squeezing out a drop, ease of seeing the nozzle, and ease of holding the container. Overall, this study revealed the factors that users associate with an ideal ophthalmic drug container, information which is currently not listed in package inserts or interview forms. By disclosing this information, pharmacists could provide users with better guidance when prescribing brimonidine tartrate ophthalmic solutions. In conclusion, our study contributes to pharmacists’ knowledge in selecting an appropriate solution for their patients.