Generic Drugs- are they as good as brand-names?
Abstract
Purpose
The aim of the present study was to investigate different characteristics of six Latanoprost generics.
Methods
Prize, drop size and volume in each generic were determined. The hardness of each bottle was further evaluated using a fish weight and a hook. Finally, pH was measured and the buffer capacity evaluated by addition of NaOH.
Results
Price, drop size and volume varied significantly between the brand version (xalatan) and the generic latanoprost products. Hence, drops sized were in the range 40–47 µl and the number of drops in each generic bottle varied between 95 and 111 drops. The embalages of each latanoprost product were different in both size and hardness. The control value of pH in the brand version (Xalatan) was 5.99 ± 0.01 (mean ± SD), whereas the generic latanoprost products had significantly higher values within the range 6.70–6.82. Hence, titration of 2.5 µl Xalatan to neutrality required 70.4 ± 0.4 nmol NaOH compared to the generic latanoprost products which required within the range 28.1–33.7 nmol NaOH.
Conclusions
The present study identifies differences among latanoprost generics such as different pH values and different buffer capacities. Moreover, the emballages varies significantly, thereby leading to critical variations in the handling of the generics. Finally, the number and size of drops in each generic were different, not to mention the prize variations between the brand version and the generics. Over all, generic eye drops should not be considered identical. Therefore, re-evaluation of the requirements for introducing generic drugs seems reasonable.
