Comparative study of the stability of bimatoprost 0.03% and latanoprost 0.005%: A patient-use study

Mauricio D Paolera¹ , Niro Kasahara¹ , Cristiano C Umbelino¹ and John G Walt²

¹Private practice, São Paulo, Brazil

²Global Health Outcomes Strategy & Research, Allergan, Inc., Irvine, CA, USA

author email corresponding author email

BMC Ophthalmology 2008, 8:11doi:10.1186/1471-2415-8-11


Published:	11 June 2008

Abstract

Background

The stability of ophthalmic preparations in multidose containers is influenced by the preservative as well as the stability of the active ingredient. Unstable drugs may require refrigeration to preserve their active ingredient level and they are more likely to degrade over time, therefore becoming more susceptible to degradation based on patient mishandling. The purpose of this study was to determine the degree of molecular degradation that occurs in bimatoprost and latanoprost in a patient-use setting.

Methods

This was an open-label, laboratory evaluation of the relative stability of bimatoprost and latanoprost. Patients presently using bimatoprost (n = 31) or latanoprost (n = 34) were identified at 2 clinical sites in Brazil. Patients were instructed to use and store their drops as usual and return all used medication bottles between day 28 and day 34 after opening.

Results

Bimatoprost demonstrated no degradation, but latanoprost degraded at various levels. The mean age of bimatoprost was 43.0 ± 3.4 days and the mean age of latanoprost was 43.9 ± 2.8 days (P = .072). The mean percentage of labeled concentration was 103.7% in the bimatoprost bottles and 88.1% in the latanoprost bottles (P < 001).

Conclusion

This study showed that bimatoprost maintained ≥100% concentration throughout the study period while latanoprost did not.