Characterization and quantitation of PVP content in a silicone hydrogel contact lens produced by dual-phase polymerization processing.

Polyvinylpyrrolidone (PVP) has been incorporated over the years into numerous hydrogel contact lenses as both a primary matrix component and an internal wetting agent to increase lens wettability. In this study, complementary analytical techniques were used to characterize the PVP wetting agent component of senofilcon A and samfilcon A contact lenses, both in terms of chemical composition and amount present. Photo-differential scanning calorimetry (photo-DSC), gas chromatography with a flame ionization detector (GC-FID), and high-resolution/accurate mass (HR/AM) liquid chromatography-mass spectrometry (LC-MS) techniques confirmed dual phase reaction and curing of the samfilcon A silicone hydrogel material. Gel permeation chromatography (GPC) demonstrated that high molecular weight (HMW) polymer was present in isopropanol (IPA) extracts of both lenses. High-performance liquid chromatography (HPLC) effectively separated hydrophilic PVP from the hydrophobic silicone polymers present in the extracts. Collectively, atmospheric solids analysis probe mass spectrometry (ASAP MS), Fourier transform infrared (FTIR) spectroscopy, 1 H nuclear magnetic resonance (NMR) spectroscopy, GC-FID, and LC-MS analyses of the lens extracts indicated that the majority of NVP is consumed during the second reaction phase of samfilcon A lens polymerization and exists as HMW PVP, similar to the PVP present in senofilcon A. GC-FID analysis of pyrolyzed samfilcon A and senofilcon A indicates fourfold greater PVP in samfilcon A compared with senofilcon A. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 1064-1072, 2018.

Comparative studies of hyaluronan in marketed ophthalmic products.

PURPOSE: Research has indicated that there is a correlation between the molecular weight of hyaluronan or hyaluronic acid (HA) and its biocompatibility/biological functions with high molecular weight HA showing many biological benefits. The purpose of this research was to characterize and compare the molecular weights, molecular weight distributions, and concentrations of HA present in a series of commercially available HA-containing ophthalmic products. METHODS: On-line size-exclusion chromatography with triple detection (SEC-TD) was used to determine the molecular weights and concentration of HA in commercially available products, including marketed contact lens multipurpose solutions and contact lens packaging solutions. Eleven commercially available HA-containing ophthalmic products were characterized by SEC-TD. RESULTS: The weight-average molecular weights of the products tested ranged from 155,000 Daltons (Da) to 1,400,000 Da, the number-average molecular weight of the products ranged from 99,000 to 927,000 Da, and the concentration of HA ranged from 0.003 to 0.15%. CONCLUSIONS: A wide range of HA molecular weights and concentrations were found in the 11 ophthalmic products characterized in the present study. This study is the first reported to characterize HA molecular weights and concentrations in various marketed HA-containing ophthalmic products. Future investigation of the effect of low molecular weight HA on eye is required.

Detailed characterization of hyaluronan using aqueous size exclusion chromatography with triple detection and multiangle light scattering detection.

Hyaluronan (HA) has attracted great interest and attention from ophthalmic surgical and eye care companies owing to its unique properties. A more complete understanding of HA biopolymers has, therefore, become increasingly critical as thorough characterization of raw materials helps promote product quality and process control. Often, such detailed information requires the use of a combination of analytical techniques. In this study, we compared size exclusion chromatography (SEC) with online multiangle light scattering (SEC-MALS) and SEC with triple detection (SEC-TD) experiments for HA analysis. Three lots of commercially available eye drop grade HA were characterized by SEC-MALS and SEC-TD. The absolute molecular weight averages, molecular weight distribution, radius of gyration, and solution conformation of the three HA lots were determined and compared by the two techniques. In addition, the intrinsic viscosity and intrinsic viscosity distribution were measured by SEC-TD.