title: Temperature-mediated absorption of phenylmercuric nitrate on polyethylene and polypropylene containers in chloramphenicol eye drops.
abstract: The aim of this work was to find the effect of temperature and manufacturing source of phenylmercuric nitrate (PMN) on PMN absorption on low-density polyethylene (LDPE) and polypropylene containers in chloramphenicol eye drops. Two factorial experiments were designed to study the effect of temperature on PMN assay in chloramphenicol eye drops stored in LDPE and prepared from two different PMN sources. PMN source had no effect on PMN assay at 2-8 °C, however at stress conditions (30 °C/75%RH) for 3 weeks, the effect of PMN source on PMN assay was found significant (p < 0.05) in formulations stored in LDPE bottles. Temperature was the major contributor to decreased PMN assay. In formulations stored in polypropylene containers, PMN source had significant effect on PMN assay at 2-8 °C and 30 °C/75%RH. Overall, new PMN and polypropylene bottles performed better. The eye drops complied with preservative efficacy test both initially and at the end of shelf life. The concentration exponent of PMN is very low and in spite of its high absorption by container/closure, PMN was still able to protect the eye drops at the end of shelf life. It can be inferred that preservative efficacy test is the better indicator of preservative activity.
authors.affiliation: Innovation and Development, Xepa Soul Pattinson , Melaka , Malaysia.
authors.forename: Naseem
authors.initials: N
authors.lastname: Charoo
authors.forename: Magdalene
authors.initials: M
authors.lastname: Chiew
authors.forename: Amelia
authors.initials: A
authors.lastname: Tay
authors.forename: Lai
authors.initials: L
authors.lastname: Lian
mesh_terms: D065966:Absorption, Physicochemical; D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents / Q000737:chemistry*; D000891:Anti-Infective Agents, Local / Q000737:chemistry*; D002701:Chloramphenicol; D004349:Drug Packaging; D004355:Drug Stability; D009883:Ophthalmic Solutions; D010663:Phenylmercury Compounds / Q000737:chemistry*; D020959:Polyethylene / Q000737:chemistry*; D011126:Polypropylenes / Q000737:chemistry*; D011310:Preservatives, Pharmaceutical / Q000737:chemistry*; D013696:Temperature
chemical_list: D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D000891:Anti-Infective Agents, Local; D009883:Ophthalmic Solutions; D010663:Phenylmercury Compounds; D011126:Polypropylenes; D011310:Preservatives, Pharmaceutical; D002701:Chloramphenicol; D020959:Polyethylene; C008860:phenylmercuric nitrate, basic
keywords: Concentration coefficient; phenylmercuric nitrate; preservative absorption; preservative efficacy test