Compatibility of a commercially available low-density polyethylene eye-drop container with antimicrobial preservatives and potassium ascorbate.
The compatibility of the 7 ml size of Steri-Dropper, a commercially available low-density polyethylene sterile eye-drop container, was studied for use with solutions containing the antimicrobial preservatives benzalkonium chloride and phenylmercuric acetate. For benzalkonium chloride, there was no difference between the Steri-Dropper and the glass eye-drop bottles throughout the study period of 84 days. However, there was less phenylmercuric acetate present in the Steri-Dropper compared to the glass containers by the end of the study. The suitability of the Steri-Dropper bottle was also studied for use with potassium ascorbate eye drops; these degraded more in Steri-Dropper compared to glass containers and a yellow discoloration of the product was also seen in these containers. The Steri-Dropper bottle is therefore potentially compatible with dispensed formulations containing benzalkonium chloride and, for short periods only, with phenylmercuric acetate. The container would only be suitable for use with oxygen-sensitive drugs for short periods. Further validation of the suitability of the Steri-Dropper bottle would be required for use with any specific formulation.
Barnes
A R
AR
Pharmaceutical Sciences Institute, Aston University, Birmingham, U.K.
D001205:Ascorbic Acid / Q000737:chemistry; D001548:Benzalkonium Compounds / Q000737:chemistry; D004349:Drug Packaging; D004355:Drug Stability; D009883:Ophthalmic Solutions; D010662:Phenylmercuric Acetate / Q000737:chemistry; D011095:Polyethylenes / Q000737:chemistry; D011310:Preservatives, Pharmaceutical / Q000737:chemistry*
D001548:Benzalkonium Compounds; D009883:Ophthalmic Solutions; D011095:Polyethylenes; D011310:Preservatives, Pharmaceutical; D010662:Phenylmercuric Acetate; D001205:Ascorbic Acid