Comparative study of the stability of bimatoprost 0.03% and latanoprost 0.005%: a patient-use study.
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).


CONCLUSIONS
This study showed that bimatoprost maintained > or =100% concentration throughout the study period while latanoprost did not.
Paolera
Mauricio D
MD
Private practice, São Paulo, Brazil. paolera@terra.com.br
Kasahara
Niro
N
Umbelino
Cristiano C
CC
Walt
John G
JG
D000328:Adult; D000577:Amides / Q000008:administration & dosage / Q000737:chemistry* / Q000592:standards; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000737:chemistry* / Q000592:standards; D000069580:Bimatoprost; D003008:Cloprostenol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry / Q000592:standards; D004349:Drug Packaging; D004355:Drug Stability; D005500:Follow-Up Studies; D005901:Glaucoma / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D000077338:Latanoprost; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage / Q000737:chemistry* / Q000592:standards; D012189:Retrospective Studies; D012621:Seasons; D013696:Temperature; D013997:Time Factors
D000577:Amides; D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D003008:Cloprostenol; D000077338:Latanoprost; D000069580:Bimatoprost